UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM

10-Q

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended ~~June 30, 2021~~March 31, 2022

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from

Commission File Number:

001-38205

ZAI LAB LIMITED

(Exact Name of Registrant as Specified in its Charter)


Cayman Islands		98-1144595
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)



4560 Jinke Road Bldg. 1, Fourth Floor Pudong Shanghai, China		201210
(Address of principal executive offices)		(Zip Code)

+86 21 6163 2588

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

*	Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not registered or listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such ~~rep~~

~~rts)~~reports), and (2) has been subject to such filing requirements for the past 90 days. Yes

☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation

S-T

(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes

☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a

non-accelerated

filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule

12b-2

of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule

12b-2

of the Exchange Act).

Yes ☐ No

☒

As of ~~July 31, 2021, 95,408,743~~May 5, 2022, 979,087,430 ordinary shares of the registrant, par value ~~$0.00006~~$0.000006 per share, were outstanding, of which ~~65,826,281~~729,604,650 ordinary shares were held in the form of American Depositary Shares.

Table of Contents

Zai Lab Limited

Quarterly Report on Form

10-Q


			Page
PART I.	FINANCIAL INFORMATION		1
Item 1.	Financial Statements (Unaudited)			12
	Condensed Consolidated Balance Sheets as of ~~June 30, 2021~~March 31, 2022 and December 31, ~~2020~~	��	1
	~~Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30,~~ 2021 ~~and 2020~~		2
	Condensed Consolidated Statements of ~~Comprehensive Loss~~Operations for the Three ~~and Six~~ Months Ended ~~June 30,~~March 31, 2022 and 2021 ~~and 2020~~		3
	Condensed Consolidated Statements of ~~Shareholders�� Equity~~Comprehensive Loss for the Three ~~and Six~~ Months Ended ~~June 30,~~March 31, 2022 and 2021 ~~and 2020~~		4
	Condensed Consolidated Statements of ~~Cash Flows~~Shareholders’ Equity for the ~~Six~~Three Months Ended ~~June 30,~~March 31, 2022 and 2021 ~~and 2020~~		5
	Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2022 and 2021		6
	Notes to ~~the~~ Unaudited Condensed Consolidated Financial Statements		67
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		1817
Item 3.	Quantitative and Qualitative Disclosures ~~About~~about Market Risk		3028
Item 4.	Controls and Procedures		3129
PART II.	OTHER INFORMATION		3130
Item 1.	Legal Proceedings		3130
Item 1A.	Risk Factors		3130
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds		3635
Item 3.	Defaults ~~Upon~~upon Senior Securities		3635
Item 4.	Mine Safety Disclosures		3635
Item 5.	Other Information		3635
Item 6.	Exhibits		3736
Signatures			3937

Table of Contents

~~PART I—FINANCIAL INFORMATION~~SPECIAL NOTES REGARDING THE COMPANY

Forward-Looking Statements

This Quarterly Report on Form

10-Q

and the audited consolidated financial information and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission, or SEC, on March 1, 2021.

~~This discussion~~ contains certain forward-looking statements that involve risks and uncertainties. These forward-looking statements include, without limitation, statements containing words such as “aim,”�� “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potentially,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward-looking” information, that are not statements of historical facts, nor are they guarantees or assurances of future performance. These forward-looking statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. These

forward-looking

statements are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements because they relate to events and depend on circumstances that may or may not occur in the future. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to ~~the risk factors~~those discussed in ~~the “Risk Factors” section of~~ our Annual Report on Form

10-K

for the year ended December 31, 2021, filed with the U.S. Securities and ~~those “Risk Factors” discussed below~~Exchange Commission (SEC) on March 1, 2022 (the “2021 Annual Report”) and in ~~Part II, Item 1A.~~this Quarterly Report on Form 10-Q. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. These statements, like all statements in this Quarterly Report on Form

10-Q,

speak only as of their date. We anticipate that subsequent events and developments will cause our expectations and assumptions to change and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10-Q. We caution investors that our business and financial performance are subject to substantial risks and uncertainties.

Usage of Terms

Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Greater China” refer to mainland China, Hong Kong Special Administrative Region (“HKSAR” or “Hong Kong”), Macau Special Administrative Region (“Macau SAR” or “Macau”) and Taiwan, collectively; and references in this Quarterly Report on Form 10-Q to “Zai Lab,” the “Company,” “we,” “us,” and “our” refer to Zai Lab Limited, a holding company and its subsidiaries, on a consolidated basis; and references to “Zai Lab Limited” refer to Zai Lab Limited, a holding company. Zai Lab Limited is the entity in which investors are purchasing their interest.

Our operating subsidiaries consist of Zai Lab (Hong Kong) Limited, domiciled in Hong Kong; Zai Auto Immune (Hong Kong) Limited, domiciled in Hong Kong; Zai Anti Infectives (Hong Kong) Limited, domiciled in Hong Kong; Zai Lab (Shanghai) Co., Ltd., domiciled in mainland China; Zai Lab International Trading (Shanghai) Co., Ltd., domiciled in mainland China; Zai Lab (Suzhou) Co., Ltd., domiciled in mainland China; Zai Biopharmaceutical (Suzhou) Co., Ltd., domiciled in mainland China; Zai Lab Trading (Suzhou) Co., Ltd., domiciled in mainland China; Zai Lab (Taiwan) Limited, domiciled in Taiwan; Zai Lab (AUST) Pty. Ltd., domiciled in Australia; Zai Lab (US) LLC, domiciled in the United States. Additionally, as of the date of this Quarterly Report on Form 10-Q, Zai Anti Infectives (Hong Kong) Limited has non-substantial business operations.

Disclosures Relating to Our Chinese Operations

Zai Lab Limited is not a Chinese operating company, but a holding company incorporated in the Cayman Islands.

Zai Lab Limited is not a Chinese operating company, but a holding company incorporated in the Cayman Islands. As a holding company, we conduct a substantial portion of our operations through wholly owned subsidiaries based in mainland China. Investors will not hold direct investments in our Chinese operating companies. In July 2021, the Chinese government provided new guidance on Chinese companies raising capital outside of mainland China, including through arrangements called variable interest entities, or VIEs. Currently, our corporate structure contains no VIEs and the life sciences industry in which we operate is not subject to foreign ownership limitations in mainland China. However, there are uncertainties with respect to the Chinese legal system and there may be changes in laws, regulations and policies, including how those laws, regulations and policies will be interpreted or implemented. If, in the future, the Chinese government determines that our corporate structure does not comply with Chinese regulations, or if Chinese regulations change or are interpreted differently, the value of our American Depositary Shares (“ADSs”) or ordinary shares may decline or become worthless.

Table of Contents

There are significant legal and operational risks associated with conducting a substantial portion of our operations in mainland China, including that changes in the legal, political and economic policies of the Chinese government, the relations between mainland China and the United States, or Chinese or U.S. regulations may materially and adversely affect our business, financial condition, results of operations and the market price of our ADSs or ordinary shares. Any such changes could significantly limit or completely hinder our ability to offer or continue to offer our ADSs or ordinary shares to investors and could cause the value of our ADSs or ordinary shares to significantly decline or become worthless. Recent statements made and regulatory actions undertaken by the Chinese government, including the recent enactment of China’s Data Security Law, as well as our obligations to comply with China’s new Cybersecurity Review Measures (which became effective on February 15, 2022), regulations and guidelines relating to the multi-level protection scheme, Personal Information Protection Law, or PIPL and any other future laws and regulations may require us to incur significant expenses and could materially affect our ability to conduct our business, accept foreign investments or continue to be listed on a U.S. or foreign stock exchange.

For more information on these risks and other risks relating to our ADSs and ordinary shares, see “Item 1A. Risk Factors” in our 2021 Annual Report and in this Quarterly Report on Form 10-Q.

We are required to obtain certain permissions from Chinese authorities to operate, issue securities to foreign investors and transfer certain scientific data.

We are required to obtain certain permissions from Chinese authorities to operate, issue securities to foreign investors and transfer certain scientific data. The Chinese government has exercised, and may continue to exercise, substantial influence or control over virtually every sector of the Chinese economy through regulation and state ownership. Our ability to operate in mainland China may be undermined if our Chinese subsidiaries are not able to obtain or maintain approvals to operate in mainland China. The central or local governments could impose new, stricter regulations or interpretations of existing regulations that could require additional expenditures and efforts on our part to comply with such regulations or interpretations.

As of the date of this Quarterly Report on Form 10-Q, we are not currently required to obtain approval or prior permission from the China Securities Regulatory Commission, or CSRC, or any other Chinese regulatory authority under the Chinese laws and regulations currently in effect to issue securities to foreign investors. However, the CSRC recently released for public comment draft rules titled Provisions of the State Council on the Administration of Overseas Securities Offering and Listing by Domestic Companies (Draft for Comments) and Administrative Measures for the Filing of Overseas Securities Offering and Listing by Domestic Companies (Draft for Comments), or the Draft Rules. If the Draft Rules are adopted in their current form, we would likely be required to submit filings to the CSRC in connection with the future issuance of our equity securities to foreign investors. As there are uncertainties with respect to the Chinese legal system and changes in laws, regulations and policies, including how those laws, regulations and policies will be interpreted or implemented, we could be subject to additional requirements, approvals, or permissions in the future. We are required to obtain certain approvals from Chinese authorities in order to operate our Chinese subsidiaries. We are also required to obtain certain approvals from Chinese authorities before transferring certain scientific data abroad or to foreign parties or entities established or actually controlled by them.

If our Chinese subsidiaries do not receive or maintain approvals or inadvertently conclude that approvals needed for their business are not required, or if there are changes in applicable laws (including regulations) or interpretations of laws, and our Chinese subsidiaries are required but unable to obtain approvals in the future, then such changes or need for approvals (if not obtained) could adversely affect the operations of our Chinese subsidiaries, including limiting or prohibiting the ability of our Chinese subsidiaries to operate, and the value of our ADSs or ordinary shares could significantly decline or become worthless.

For more information on these required permissions, see “Item 1A. Risk Factors” in our 2021 Annual Report and in this Quarterly Report on Form 10-Q.

To operate our general business activities currently conducted in mainland China, each of our Chinese subsidiaries is required to obtain a business license from the local counterpart of the SAMR. Each of our Chinese subsidiaries has obtained a valid business license from the local counterpart of the SAMR and no application for any such license has been denied. Our Chinese subsidiaries are also required to obtain certain licenses and permits, including but not limited to the following material licenses and permits: Pharmaceutical Manufacturing Permits, Pharmaceutical Distribution Permits and Medical Device Distribution Permits to manufacture and/or distribute drugs and/or applicable medical devices. No application for any such material license or permit has been denied.

Table of Contents

Because the majority of our operations are in mainland China and our auditor has been located in mainland China, a jurisdiction where the U.S. Public Company Accounting Oversight Board (“PCAOB”) is currently unable to conduct inspections without the approval of Chinese authorities, there have been concerns regarding oversight of the audits of our financial statements filed with the SEC. In March 2022, SEC staff conclusively identified us under the Holding Foreign Companies Accountable Act (“HFCAA”) as an issuer that uses an auditor that the PCAOB is unable to inspect or investigate completely. Although in April 2022 our Audit Committee approved the engagement of KPMG LLP (“KPMG”), a U.S. auditor that is subject to inspection by the PCAOB, as our independent public accounting firm for the fiscal year ending December 31, 2022, KPMG is in the process of concluding its standard client evaluation procedures, including obtaining approval from the Hong Kong Stock Exchange to audit the Company’s consolidated financial statements submitted to the Hong Kong Stock Exchange. If for any reason we continue to fail to meet the audit requirements of the HFCAA for three consecutive years, the HFCAA requires the SEC to prohibit the trading of our securities on a national securities exchange, including Nasdaq, or on over-the-counter markets in the United States. In addition, the U.S. Senate and U.S. House of Representatives have each passed bills, which, if enacted, would decrease the number of non-inspection years from three consecutive years to two, thus reducing the time period before our securities may be prohibited from trading on a U.S. securities exchange or delisted from Nasdaq. The foregoing could adversely affect the market price of our ordinary shares and/or ADSs and our ability to raise capital effectively.

Auditors of companies that are registered with the SEC and traded publicly in the United States, including our independent registered public accounting firm, are required to be registered with the PCAOB and to undergo regular inspections by the PCAOB to assess their compliance with the laws of the United States and applicable professional standards. Because our current auditor is located in mainland China, a jurisdiction where the PCAOB is currently unable to conduct inspections without the approval of Chinese authorities, our auditor is not currently inspected by the PCAOB.

PCAOB inspections of auditors located outside of mainland China and Hong Kong have at times identified deficiencies in those auditors’ audit procedures and quality control procedures, which may be addressed as part of the PCAOB’s inspection process to improve future audit quality. The lack of PCAOB inspections of audit work undertaken in mainland China and Hong Kong prevents the PCAOB from regularly evaluating our auditor’s audits and its quality control procedures. As a result, investors are deprived of the benefits of PCAOB inspections, which could result in limitations or restrictions on our access to the U.S. capital markets.

Furthermore, in recent years, the U.S. Congress and regulatory authorities have continued to express concerns about challenges in their oversight of financial statement audits of U.S.-listed companies with significant operations in China. As part of this continued focus on access to audit and other information currently protected by national law, in particular under Chinese law, the United States enacted the HFCAA in December 2020. The HFCAA requires the SEC to identify issuers that have filed an annual report with an audit report issued by a registered public accounting firm that is located in a foreign jurisdiction and that the PCAOB has determined it is unable to inspect or investigate completely because of a restriction imposed by a non-U.S. authority in the auditor’s local jurisdiction (a “Commission-Identified Issuer”). Under the HFCAA, if the SEC conclusively identifies an issuer as a Commission-Identified Issuer for three consecutive years, the SEC is required to prohibit the trading of the issuer’s securities on a national securities exchange or through any other method that is within the jurisdiction of the SEC to regulate, including over-the-counter markets in the United States. Our securities may be prohibited from trading on the Nasdaq or other U.S. stock exchanges if our auditor is not inspected by the PCAOB for three consecutive years, and this ultimately could result in our ADSs being delisted.

Furthermore, in June 2021, the U.S. Senate passed the Accelerating Holding Foreign Companies Accountable Act (“AHFCAA”), which, if enacted, would amend the HFCAA and require the SEC to prohibit an issuer’s securities from trading on any U.S. stock exchanges if its auditor is not subject to PCAOB inspections for two consecutive years (as opposed to the three years under the HFCAA). In February 2022, the U.S. House of Representatives passed the America Creating Opportunities for Manufacturing Pre-Eminence in Technology and Economic Strength (COMPETES) Act of 2022 (the “America COMPETES Act”), which similarly would amend the HFCAA to shorten the number of non-inspection years from three years to two years. The America COMPETES Act, however, includes a broader range of legislation than the AHFCA Act in response to the U.S. Innovation and Competition Act passed by the U.S. Senate in 2021. The U.S. House of Representatives and the U.S. Senate will need to agree on amendments to these respective bills to allow the legislature to pass their amended bills before the President can sign the bill into law. It is unclear if or when either of these bills will be signed into law.

In September 2021, the PCAOB adopted PCAOB Rule 6100, Board Determinations Under the Holding Foreign Companies Accountable Act, which provides a framework for the PCAOB to use when determining whether the PCAOB is unable to inspect or investigate completely a registered public accounting firm located in a foreign jurisdiction because of a position taken by one or more authorities in that jurisdiction for the purposes of the HFCAA. PCAOB Rule 6100 establishes the manner of the PCAOB’s determinations; the factors the PCAOB will evaluate and the documents and information it will consider when assessing whether a determination is warranted; the form, public availability, effective date, and duration of such determinations; and the process by which the PCAOB will reaffirm, modify or vacate any such determinations. In November 2021, the SEC announced that it had approved Rule 6100.

Table of Contents

In December 2021, the SEC adopted amendments to finalize rules implementing the submission and disclosure requirements in the HFCAA for Commission-Identified Issuers, which became effective on January 10, 2022. In addition, the PCAOB issued a Determination Report, pursuant to PCAOB Rule 6100, which found that the PCAOB is unable to inspect or investigate completely registered public accounting firms headquartered in mainland China and Hong Kong because of positions taken by Chinese authorities in those jurisdictions. The SEC began to identify Commission-Identified Issuers for fiscal years beginning after December 18, 2020. A Commission-Identified Issuer will be required to comply with the submission and disclosure requirements in the annual report for each year in which it was so identified. If an issuer is identified as a Commission-Identified Issuer based on its annual report for the fiscal year ended December 31, 2021, the issuer will be required to comply with the submission or disclosure requirements in its annual report for the fiscal year ended December 31, 2022.

In March 2022, SEC staff conclusively identified the Company as a Commission-Identified Issuer. In April 2022 the Audit Committee of our Board of Directors approved the engagement of KPMG, an auditor located in the United States that is inspected by the PCAOB, as our independent registered public accounting firm for the fiscal year ending December 31, 2022 for the annual consolidated financial statements of the Company filed with the SEC and the Company’s internal controls over financial reporting in accordance with the Exchange Act. KPMG will also be engaged to audit the consolidated financial statements of the Company for the year ending December 31, 2022 submitted to the Hong Kong Stock Exchange in accordance with the Rules Governing the Listing of Securities of the Hong Kong Stock Exchange, subject to the Company’s receipt of the approval from the Hong Kong Stock Exchange and the FRC. Even though such approval is expected to be administrative in nature, if such approval is rejected by the Hong Kong Stock Exchange or the FRC, or, for some reason, we are not able to enter into an engagement agreement with KPMG, the Company would need to engage another auditor that is inspected by the PCAOB in order to comply with the audit requirements of the HFCAA. Additionally, even if KPMG is approved as our auditor by the Hong Kong Stock Exchange and the FRC, there remains a risk that the CSRC or another Chinese governmental agency could limit or prohibit our ability to use KPMG as our auditor. The foregoing could adversely affect the market price of our ordinary shares and/or ADSs and our ability to raise capital effectively.

While we understand that there appears to be ongoing, constructive dialogue among the CSRC, the SEC and the PCAOB regarding permitting the inspection of PCAOB-registered accounting firms in China, there can be no assurance that the U.S. and Chinese governments ultimately reach an agreement on these matters, or that we will be able to comply with requirements imposed by U.S. regulators, Nasdaq, the CSRC, or other Chinese regulators. If for any reason we continue to be identified as a Commission-Identified Issuer that uses an auditor not subject to PCAOB inspection for three consecutive years or, if the AHFCAA or the America COMPETES Act is passed, two consecutive years, our ADSs may be delisted from Nasdaq as a result. Delisting of our ADSs would force holders of our ADSs to sell their ADSs or convert them into our ordinary shares. Further, we may be prohibited from listing our ADSs on another U.S. securities exchange. The market price of our ordinary shares and/or ADSs could be adversely affected as a result of anticipated negative impacts of such legislative or executive actions upon, as well as negative investor sentiment toward, companies with significant operations in mainland China and Hong Kong that are listed in the United States, regardless of whether such actions are implemented and regardless of our actual operating performance.

Table of Contents

PART I – FINANCIAL INFORMATION

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and the accompanying notes included in this Quarterly Report on Form 10-Q and the audited consolidated financial information and the accompanying notes included in our 2021 Annual Report.

Table of Contents

Item 1. Financial ~~Statements~~

Statements.

Zai Lab Limited

Unaudited condensed consolidated balance sheets

(In thousands of U.S. dollars (“$”) except for number of shares and per share data)


			As of
	Notes		March 31, 2022			December 31, 2021
			$			$
Assets
Current assets:
Cash and cash equivalents		3		846,957			964,100
Short-term investments				465,274			445,000
Accounts receivable (net of allowance for credit loss of $10 and $11 as of March 31, 2022 and December 31, 2021, respectively)				33,394			47,474
Notes receivable				10,848			7,335
Inventories		4		20,288			18,951
Prepayments and other current assets				16,490			18,021

Total current assets				1,393,251			1,500,881
Restricted cash, non-current				803			803
Long term investments (including the fair value measured investment of $8,444 and $15,383 as of March 31, 2022 and December 31, 2021, respectively)				8,444			15,605
Prepayments for equipment				4,978			989
Property and equipment, net		5		45,227			43,102
Operating lease right-of-use assets				16,986			14,189
Land use rights, net				7,774			7,811
Intangible assets, net				1,745			1,848
Long-term deposits				941			870
Value added tax recoverable				20,766			23,858

Total assets				1,500,915			1,609,956

Liabilities and shareholders’ equity
Current liabilities:
Accounts payable				98,161			126,163
Current operating lease liabilities				6,795			5,927
Other current liabilities		8		49,956			60,811

Total current liabilities				154,912			192,901

Deferred income				26,896			27,486
Non-current operating lease liabilities				11,099			9,613

Total liabilities				192,907			230,000

Commitments and contingencies (Note 1 4 )				0			0
Shareholders’ equity
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 957,035,440 and 955,363,980 shares issued as of March 31, 2022 and December 31, 2021, respectively; 956,637,360 and 954,981,050 shares outstanding as of March 31, 2022 and December 31, 2021, respectively)				6			6
Additional paid-in capital				2,838,655			2,825,948
Accumulated deficit				(1,500,468	)		(1,418,074	)
Accumulated other comprehensive loss				(25,838	)		(23,645	)
Treasury Stock (at cost, 398,080 and 382,930 shares as of March 31, 2022 and December 31, 2021, respectively)				(4,347	)		(4,279	)

Total shareholders’ equity				1,308,008			1,379,956

Total liabilities and shareholders’ equity				1,500,915			1,609,956

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

Table of Contents

Zai Lab Limited

Unaudited condensed consolidated statements of operations

(In thousands of U.S. dollars (“$”) except for number of shares and per share data)


			Three Months Ended March 31,
	Notes		2022			2021
			$			$
Revenues:
Product revenue , net		6		46,095			20,103
Collaboration revenue		6		629			—

Total revenues				46,724			20,103
Expenses:
Cost of sales				(15,643	)		(7,505	)
Research and development				(53,854	)		(203,852	)
Selling, general and administrative				(56,991	)		(35,838	)

Loss from operations				(79,764	)		(227,092	)
Interest income				188			214
Other expenses, net				(2,597	)		(6,227	)

Loss before income tax and share of income (loss) from equity method investment				(82,173	)		(233,105	)
Income tax expense		7		0—			0
Share of income (loss) from equity method investment				(221	)		195

Net loss				(82,394	)		(232,910	)

Net loss attributable to ordinary shareholders				(82,394	)		(232,910	)

Loss per share - basic and diluted		9		(0.09	)		(0.26	)
Weighted-average shares used in calculating net loss per ordinary share - basic and diluted				955,499,030			883,749,280
Loss per American Depositary Shares (“ADS“)- basic and diluted				(0.86	)		(2.64	)
Weighted-average ADS s used in calculating net loss per ADS - basic and diluted				95,549,903			88,374,928

Note: All the numbers of ordinary shares and per share data in these unaudited condensed consolidated financial statements have been retrospectively adjusted as a result of the Share Subdivision and the ADS Ratio Change that became effective on March 30, 2022. The Share Subdivision and ADS Ratio Change did not result in any change to the number of outstanding ADSs of the Company. Refer to Note 2(a) for a detailed discussion.

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

Table of Contents

Zai Lab Limited

Unaudited condensed consolidated statements of comprehensive loss

(In thousands of U.S. dollars (“$”) except for number of shares and per share data)


	Three Months Ended March 31,
	2022			2021
	$			$
Net loss		(82,394	)		(232,910	)
Other comprehensive (loss) income, net of tax of NaN:
Foreign currency translation adjustments		(2,193	)		2,900

Comprehensive loss		(84,587	)		(230,010	)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

Table of Contents

Zai Lab Limited

Unaudited condensed consolidated ~~balance sheets~~statements of shareholders’ equity

(In thousands of U.S. dollars (“$”) except for number of shares and per share data)

As of


June 30,
2021

December 31,
2020


Notes

$

$

Assets

Current assets:






Cash and cash equivalents
   3    1,766,573 442,116
Short-term investments
   5    —   744,676
Accounts receivable (net of allowance of $5 and $1 as of June 30, 2021 and
December
31
,
2020, respectively)
      18,029 5,165
Inventories
   6    11,114 13,144
Prepayments and other current assets
      12,887 10,935


Total current assets
      1,808,603 1,216,036
Restricted cash,
non-current
   4    743 743
Investments in equity investees
   7    1,070 1,279
Prepayments for equipment
      1,846 274
Property and equipment, net
   8    31,642 29,162
Operating lease right-of-use assets
      17,015 17,701
Land use rights, net
      7,849 7,908
Intangible assets, net
      1,733 1,532
Long term deposits
      891 862
Value added tax recoverable
      23,823 22,141


Total assets


1,895,215

1,297,638



Liabilities and shareholders’ equity

Current liabilities:

Accounts payable
      125,621 62,641
Current operating lease liabilities
      6,371 5,206
Other current liabilities
   11    61,925 30,196


Total current liabilities
      193,917 98,043
Deferred income
      17,632 16,858
Non-current
operating lease liabilities
      11,968 13,392


Total liabilities


223,517

128,293



Commitments and contingencies (Note
17
)
      0 0
Shareholders’ equity

Ordinary shares (par value of $0.00006 per share; 500,000,000 shares authorized, 94,758,189 and 87,811,026 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively)
      6 5
Additional
paid-in
capital
      2,799,318 1,897,467
Accumulated deficit
      (1,109,837 ) (713,603 )
Accumulated other comprehensive loss
      (16,865 ) (14,524 )
Treasury Stock (at cost, 6,086 and 0nil shares as of June 30, 2021 and December 31, 2020, respectively)
      (924 ) —


Total shareholders’ equity


1,671,698

1,169,345



Total liabilities and shareholders’ equity


1,895,215

1,297,638


	Ordinary Shares				Additional paid in capital		Accumulated deficit			Accumulated other comprehensive (loss) income			Treasury Stock						Total
	Number of Shares		Amount		Additional paid in capital		Accumulated deficit			Accumulated other comprehensive (loss) income			Shares			Amount			Total
			$		$		$			$						$			$
Balance at December 31, 2020		878,110,260		5		1,897,467		(713,603	)		(14,524	)		—			—			1,169,345
Issuance of ordinary shares upon vesting of restricted shares		816,000		0		0		—			—			—			—			0
Exercise of shares option s		583,640		0		702		—			—			—			—			702
Issuance of ordinary shares in connection with collaboration and license arrangement (Note 1 2 )		5,681,820		0		62,250		—			—			—			—			62,250
Issuance cost adjustment for secondary listing		—		—		65		—			—			—			—			65
Share-based compensation		—		—		7,318		—			—			—			—			7,318
Net loss		—		—		—		(232,910	)		—			—			—			(232,910	)
Foreign currency translation		—		—		—		—			2,900			—			—			2,900

Balance at March 31, 2021		885,191,720		5		1,967,802		(946,513	)		(11,624	)		—			—			1,009,670


Balance at December 31, 2021		955,363,980		6		2,825,948		(1,418,074	)		(23,645	)		(382,930	)		(4,279	)		1,379,956
Issuance of ordinary shares upon vesting of restricted shares		514,800		0		0		—			—			—			—			—
Exercise of shares options		1,156,660		0		297		—			—			—			—			297
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation		—		—		—		—			—			(15,150	)		(68	)		(68	)
Share-based compensation		—		—		12,410		—			—			—			—			12,410
Net loss		—		—		—		(82,394	)		—			—			—			(82,394	)
Foreign currency translation		—		—		—		—			(2,193	)		—			—			(2,193	)

Balance at March 31, 2022		957,035,440		6		2,838,655		(1,500,468	)		(25,838	)		(398,080	)		(4,347	)		1,308,008

~~The accompanying notes are an integral part of these unaudited condensed consolidated financial statements~~

~~Table of Contents~~

~~Zai Lab Limited~~

~~Unaudited condensed consolidated statements of operations~~

~~(In thousands of U.S. dollars (“$”) except for number of shares and per share data)~~

Three Months Ended June 30,

Six Months Ended June 30,


Notes

2021

2020

2021

2020


$

$

$

$

Revenue
   9    36,935 10,995 57,038 19,213
Expenses:

Cost of sales
      (10,868 ) (2,896 ) (18,373 ) (4,980 )
Research and development
      (142,224 ) (68,307 ) (346,076 ) (102,049 )
Selling, general and administrative
      (54,414 ) (23,758 ) (90,252 ) (42,472 )


Loss from operations
      (170,571 ) (83,966 ) (397,663 ) (130,288 )
Interest income
      244 1,227 458 2,882
Interest expenses
      —   (55 ) —   (114 )
Other income (expense), net
      7,406 2,434 1,179 (691 )


Loss before income tax and share of loss from equity method investment
      (162,921 ) (80,360 ) (396,026 ) (128,211 )
Income tax expense
   10    0—   —   0—   —
Share of loss from equity method investment
      (403 ) (269 ) (208 ) (406 )


Net loss
      (163,324 ) (80,629 ) (396,234 ) (128,617 )


Net loss attributable to ordinary shareholders
      (163,324 ) (80,629 ) (396,234 ) (128,617 )


Loss per share - basic and diluted
   12    (1.76 ) (1.08 ) (4.37 ) (1.74 )
Weighted-average shares used in calculating net loss per ordinary share - basic and diluted
      93,045,531 74,738,563 90,723,132 73,847,551

~~The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.~~

~~Table of Contents~~

~~Zai Lab Limited~~

~~Unaudited condensed consolidated statements of comprehensive loss~~

~~(In thousands of U.S. dollars (“$”) except for number of shares and per share data)~~

Three Months Ended June 30,

Six Months Ended June 30,


2021

2020

2021

2020


$

$

$

$

Net loss
   (163,324 ) (80,629 ) (396,234 ) (128,617 )
Other comprehensive (loss) income, net of tax of NaN:

Foreign currency translation adjustments
   (5,241 ) (1,173 ) (2,341 ) 2,366


Comprehensive loss
   (168,565 ) (81,802 ) (398,575 ) (126,251 )

~~The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.~~

~~Table of Contents~~

~~Zai Lab Limited~~

~~Unaudited condensed consolidated statements of shareholders’ equity~~

~~(In thousands of U.S. dollars (“$”) except for number of shares and per share data)~~

Ordinary Shares

Additional

paid

in capital

Accumulated

deficit

Accumulated
other

comprehensive

(loss) income

Treasury Stock

Total


Number of

Shares

Amount

Shares

Amount


$

$

$

$

$

$

Balance at December 31, 2020
   87,811,026    5    1,897,467 (713,603 ) (14,524 ) —   —   1,169,345
Issuance of ordinary shares upon vesting of restricted shares
   81,600    0    0 —   —   —   —   0
Exercise of shares option
   58,364    0    702 —   —   —   —   702
Issuance of ordinary shares in connection with collaboration and license arrangement (Note 15)
   568,182    0    62,250 —   —   —   —   62,250
Issuance cost adjustment for secondary listing
   —      —      65 —   —   —   —   65
Share-based compensation
   —      —      7,318 —   —   —   —   7,318
Net loss
   —      —      —   (232,910 ) —   —   —   (232,910 )
Foreign currency translation
   —      —      —   —   2,900 —   —   2,900






Balance at March 31, 2021
   88,519,172    5    1,967,802 (946,513 ) (11,624 ) —   —   1,009,670






Issuance of ordinary shares upon vesting of restricted shares
   32,100    0    0 —   —   —   —   0
Exercise of shares option
   490,517    0    3,289 —   —   —   —   3,289
Issuance of ordinary shares upon
follow-on
public offering, net of

issuance cost of $879
   5,716,400    1    817,995 —   —   —   —   817,996
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation
   —      —      —   —   —   (6,086 ) (924 ) (924 )
Share-based compensation
   —      —      10,232 —   —   —   —   10,232
Net loss
   —      —      —   (163,324 ) —   —   —   (163,324 )
Foreign currency translation
   —      —      —   —   (5,241 ) —   —   (5,241 )






Balance at June 30, 2021
   94,758,189    6    2,799,318 (1,109,837 ) (16,865 ) (6,086 ) (924 ) 1,671,698






Balance at December 31, 2019
   68,237,247    4    734,734 (444,698 ) 4,620 —   —   294,660
Issuance of ordinary shares upon vesting of restricted shares
   80,200    0    0 —   —   —   —   0
Exercise of shares option
   49,278    0    346 —   —   —   —   346
Issuance of ordinary shares upon
follow-on
public offering, net of

issuance cost of $740
   6,300,000    0    280,568 —   —   —   —   280,568
Share-based compensation
   —      —      6,463 —   —   —   —   6,463
Net loss
   —      —      —   (47,988 ) —   —   —   (47,988 )
Foreign currency translation
   —      —      —   —   3,539 —   —   3,539






Balance at March 31, 2020
   74,666,725    4    1,022,111 (492,686 ) 8,159 —   —   537,588






Issuance of ordinary shares upon vesting of restricted shares
   36,000    0    0 —   —   —   —   0
Exercise of shares option
   179,613    0    2,729 —   —   —   —   2,729
Issuance cost for
follow-on
public offering
   —      —      (13 ) —   —   —   —   (13 )
Share-based compensation
   —      —      6,964 —   —   —   —   6,964
Net loss
   —      —      —   (80,629 ) —   —   —   (80,629 )
Foreign currency translation
   —      —      —   —   (1,173 ) —   —   (1,173 )






Balance at June 30, 2020
   74,882,338    4    1,031,791 (573,315 ) 6,986 —   —   465,466

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. “0” in above table means less than 1,000 dollars.

Zai Lab Limited

Unaudited condensed consolidated statements of cash flows

(In thousands of U.S. dollars (“$”) except for number of shares and per share data)

Six Months Ended June 30,


2021

2020


$

$

Operating activities






Net loss
   (396,234 ) (128,617 )
Adjustments to reconcile net loss to net cash used in operating activities:

Allowance for doubtful accounts
   4 2
Inventory write-down
   290 7
Depreciation and amortization expenses
   2,975 2,107
Amortization of deferred income
   (156 ) (156 )
Share-based compensation
   17,550 13,427
Noncash research and development expenses (Note 1
5
)
   62,250 —
Share of loss from equity method investment
   208 406
Loss on disposal of property and equipment
   4 1
Noncash lease expenses
   2,779 2,114
Changes in operating assets and liabilities:

Accounts receivable
   (12,868 ) (3,235 )
Inventories
   1,740 (571 )
Prepayments and other current assets
   (1,952 ) (948 )
Long term deposits
   (29 ) (335 )
Value added tax recoverable
   (1,682 ) (2,422 )
Accounts payable
   62,980 9,732
Other current liabilities
   28,077 4,697
Operating lease liabilities
   (2,214 ) (1,539 )
Deferred income
   930 13,011


Net cash used in operating activities
   (235,348 ) (92,319 )


Cash flows from investing activities:

Purchases of short-term investments
   —   (205,000 )
Proceeds from maturity of short-term investments
   743,902 200,000
Purchase of property and equipment
   (5,647 ) (1,303 )
Purchase of intangible assets
   (427 ) (218 )


Net cash provided by (used in) investing activities
   737,828 (6,521 )


Cash flows from financing activities:

Repayment of short-term borrowings
   —   (2,130 )
Proceeds from exercises of stock options
   3,992 3,075
Proceeds from issuance of ordinary shares upon public offerings
   818,874 281,295
Payment of public offering costs
   (1,323 ) (740 )
Employee taxes paid related to net share settlement of equity awards
   (594 ) —


Net cash provided by financing activities
   820,949 281,500


Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash
   1,028 12


Net increase in cash, cash equivalents and restricted cash
   1,324,457 182,672
Cash, cash equivalents and restricted cash - beginning of period
   442,859 76,442


Cash, cash equivalents and restricted cash - end of period
   1,767,316 259,114


Supplemental disclosure on
non-cash
investing and financing activities:

Payables for purchase of property and equipment
   1,720 984
Payables for intangible assets
   58 —
Payables for public offering costs
   555 —
Supplemental disclosure of cash flow information:

Cash and cash equivalents
   1,766,573 258,604
Restricted cash,
non-current
   743 510


Total cash and cash equivalents and restricted cash
   1,767,316 259,114


Interest paid
   —   122


	Three Months Ended March 31,
	2022			2021
	$			$
Operating activities
Net loss		(82,394	)		(232,910	)
Adjustments to reconcile net loss to net cash used in operating activities:
Allowance for credit loss		(1	)		1
Inventory write-down		138			14
Depreciation and amortization expenses		2,013			1,448
Amortization of deferred income		(708	)		(78	)
Share-based compensation		12,410			7,318
Noncash research and development expenses		0			62,250
Share of (income) loss from equity method investment		221			(195	)
Loss from fair value changes of equity investment with readily determinable fair value		6,939			0
(Gain) loss on disposal of property and equipment		(11	)		4
Noncash lease expenses		2,017			1,322
Changes in operating assets and liabilities:
Accounts receivable		14,080			(3,651	)
Notes receivable		(3,513	)		0
Inventories		(1,475	)		502
Prepayments and other current assets		1,531			(3,386	)
Long - term deposits		(71	)		(47	)
Value added tax recoverable		3,092			(1,558	)
Accounts payable		(28,002	)		(21,226	)
Other current liabilities		(11,122	)		21,707
Operating lease liabilities		(2,389	)		(893	)
Deferred income		118			(122	)

Net cash used in operating activities		(87,127	)		(169,500	)

Cash flows from investing activities:
Purchases of short-term investments		(120,274	)		0
Proceeds from maturity of short-term investment		100,000			743,902
Disposal of property and equipment		25			—
Purchase of property and equipment		(9,743	)		(1,683	)
Purchase of intangible assets		(152	)		(214	)

Net cash (used in) provided by investing activities		(30,144	)		742,005

Cash flows from financing activities:
Proceeds from exercises of stock options		297			702
Payment of public offering costs		0			(973	)
Employee taxes paid related to net share settlement of equity awards		(39	)		—

Net cash provided by (used in) financing activities		258			(271	)

Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash		(130	)		(930	)

Net (decrease) increase in cash, cash equivalents and restricted cash		(117,143	)		571,304
Cash, cash equivalents and restricted cash - beginning of period		964,903			442,859

Cash, cash equivalents and restricted cash - end of period		847,760			1,014,163

Supplemental disclosure on non-cash investing and financing activities:
Payables for purchase of property and equipment		668			439
Payables for intangible assets		73			26
Payables for public offering costs		0			26
Payables for treasury stock		55			—
Supplemental disclosure of cash flow information:
Cash and cash equivalents		846,957			1,013,420
Restricted cash, non-current		803			743

Total cash and cash equivalents and restricted cash		847,760			1,014,163

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

Table of Contents

Zai Lab Limited

Notes to the unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)

1. Organization and principal activities

Zai Lab Limited ~~(the “Company”)~~ was incorporated on March 28, 2013 in the Cayman Islands as an exempted company with limited liability under the Companies Law of the Cayman ~~Islands. The Company~~Islands (as amended). Zai Lab Limited and its subsidiaries (collectively referred to as the ~~“Group”~~“Company”) are focused on developing and commercializing therapies that address medical conditions with unmet medical needs including, in particular, oncology, autoimmune disorders, infectious diseases, and ~~infectious diseases.~~neuroscience.

The ~~Group’s~~Company’s principal operations and geographic markets are in mainland China, ~~(hereinafter referred to as “China”),~~ Hong Kong, Macau and Taiwan (hereinafter collectively referred to as “Greater China”). The ~~Group~~Company has a substantial presence in Greater China and the United ~~States~~

.States.

2. Basis of presentation and consolidation and significant accounting policies

(a) Basis of presentation

The unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the instructions to Form

10-Q

and Article 10 of Regulation

S-X.

Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations, shareholders’ equity and cash flows in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). In the opinion of management, these financial statements reflect all normal recurring adjustments and accruals necessary for a fair statement of the Company’s unaudited condensed consolidated financial statements for such periods. The results of operations for any interim period are not necessarily indicative of the results for the full year. The December 31, ~~2020~~2021 condensed consolidated balance ~~sheets~~sheet data were derived from audited financial statements, but do not include all disclosures required by U.S. GAAP. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form

10-K

for the year ended December 31, ~~2020.~~2021.

Interim results are not necessarily indicative of full year results and the unaudited condensed consolidated financial statements may not be indicative of the Company’s future performance.

Effective as of March 30, 2022, the Company subdivided each of its issued and unissued ordinary shares into ten ordinary shares (the “Share Subdivision”). Following the Share Subdivision, the Company’s authorized share capital became $30 divided into 5,000,000,000 shares with a par value of US$0.000006 each. The numbers of issued and unissued ordinary shares and per share data as disclosed elsewhere in these unaudited condensed consolidated financial statements and notes thereto are presented on a basis after taking into account the effects of the Share Subdivision and have been retrospectively adjusted, where

applicable. In connection with the Share Subdivision, the conversion ratio of our ADSs to ordinary shares changed from one ADS to one ordinary share to a new ratio of one ADS representing ten ordinary shares (the “ADS Ratio Change”). The Share Subdivision and ADS Ratio Change did not result in any change to the number of outstanding ADSs of the Company.

(b) Principles of consolidation

The unaudited condensed consolidated financial statements include the financial statements of the Company and its subsidiaries. All intercompany transactions and balances among the

Company

and its subsidiaries are eliminated upon consolidation.

The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the period. Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating the current expected credit losses for financial assets, assessing the impairment of long-lived assets, discount rate of operating lease liabilities, ~~revenue recognition,~~accrual of rebate, allocation of the research and development service expenses to the appropriate financial reporting period based on the progress of the research and development projects, share-based compensation expenses, recoverability of deferred tax assets and a lack of marketability discount of the ordinary shares issued in connection with collaboration and license ~~arrangement~~arrangements (Note 1

152

). Management bases the estimates on historical experience and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from these estimates.

~~(d) Fair value measurements~~

~~The Group applies ASC topic 820 (“ASC 820”),~~

~~Fair Value Measurements and Disclosures~~

~~, in measuring fair value. ASC 820 defines fair value, establishes a framework for measuring fair value and requires disclosures to be provided on fair value measurement.~~

~~ASC 820 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:~~

~~Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.~~

~~Level 2 - Include other inputs that are directly or indirectly observable in the marketplace.~~

~~Level 3 - Unobservable inputs which are supported by little or no market activity.~~

Table of Contents

Zai Lab Limited

Notes to the unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share

data)

~~ASC 820 describes three main approaches to measur~~

(d) Fair value measurements

As of March 31, 2022 and December 31, 2021, information about inputs into the fair value measurement of the Company’s assets ~~and liabilities: (1) market approach; (2) income approach and (3) cost approach.~~ that are measured at a fair value on a recurring basis in periods subsequent to their initial recognition is as follows:


Description	Fair Value as of March 31, 2022 US$		Fair Value Measurement at Reporting Date Using Quoted Prices in Active Markets for Identical Assets (Level 1) US$
Equity Investments with Readily Determinable Fair Value		8,444		8,444

Description	Fair Value as of December 31, 202 1 US$		Fair Value Measurement at Reporting Date Using Quoted Prices in Active Markets for Identical Assets (Level 1) US$
Equity Investments with Readily Determinable Fair Value		15,383		15,383

The ~~market approach uses prices and other relevant information generated from market transactions involving identical or comparable~~Company does not have assets or ~~liabilities. The income approach uses valuation techniques to convert future amounts to~~liabilities measured at fair value on a ~~single present value amount. The measurement is based on~~nonrecurring basis during the ~~value indicated by current market expectations about those future amounts. The cost approach is based on the amount that would currently be required to replace an asset.~~periods presented.

Financial instruments of the ~~Group~~Company primarily include cash, cash equivalents and restricted cash, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable and other ~~payables.~~current liabilities. As of ~~June 30, 2021~~March 31, 2022 and December 31, ~~2020,~~2021, the carrying values of cash and cash equivalents, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable and other ~~payable~~current liabilities approximated their fair values due to the short-term maturity of these instruments, and the carrying value of restricted cash approximates its fair value based on the nature of the assessment of the ability to recover these amounts.

(e) Recent accounting pronouncements

Adopted Accounting Standards

In ~~December 2019,~~November 2021, the FASB issued ~~ASU~~

~~2019-12,~~

~~Income Taxes~~ASU2021-10, Government Assistance (Topic ~~740):~~

~~Simplifying~~832) — Disclosures by Business Entities about Government Assistance. The amendments in this ASU require disclosures about transactions with a government that have been accounted for by analogizing to a grant or contribution accounting model to increase transparency about (1) the ~~Accounting for Income Taxes~~

~~. This update simplifies~~types of transactions, (2) the accounting for ~~income taxes as part~~the transactions, and (3) the effect of the ~~FASB’s overall initiative to reduce complexity in accounting standards.~~transactions on an entity’s financial statements. The amendments ~~include removal of certain exceptions to the general principles of ASC 740,~~

~~Income taxes~~

~~, and simplification~~ in ~~several other areas such as accounting~~this ASU are effective for ~~a franchise tax (or similar tax) that is partially based on income. The update is effective in fiscal years~~all entities within their scope for financial statements issued for annual periods beginning after December 15, 2020, and interim periods therein, and early adoption is permitted. Certain amendments in this update should be applied retrospectively or modified retrospectively, all other amendments should be applied prospectively.2021. The ~~Group~~Company adopted this standard onas of January 1, ~~2021.~~2022. There was no material impact to the ~~Group’s~~Company’s financial position or results of operations upon the adoption.

(f) Significant accounting policies

For a more complete discussion of the Company’s significant accounting policies and other information, the unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form

~~Form~~ 10-K

for the year ended December 31, ~~2020.~~2021.

Table of Contents

Zai Lab Limited

Notes to the unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)

3. Cash and cash equivalents


	As of				As of
	June 30, 2021		December 31, 2020		March 31, 2022		December 31, 2021
	$		$		$		$
Cash at bank and in hand		1,465,757		441,283		547,259		663,472
Cash equivalents (note (i))		300,816		833
Cash equivalents (i)						299,698		300,628

		1,766,573		442,116		846,957		964,100

Denominated in:
US$		907,662		297,813		782,295		932,888
RMB (note (ii))		36,222		23,898
RMB (ii)						58,569		23,791
Hong Kong dollar (“HK$”)		822,182		119,695		5,551		6,674
Australian dollar (“A$”)		471		710		495		475
Taiwan dollar (“TW$”)		36		—		47		272

		1,766,573		442,116		846,957		964,100

~~Note:~~

Notes:

(i)	Cash equivalents represent short-term and highly liquid investments in a money market fund.

(ii)

Certain cash and bank balances denominated in RMB were deposited with banks in

mainland

China. The conversion of these RMB denominated balances into foreign currencies is subject to the rules and regulations of foreign exchange control promulgated by the ~~government of the People’s Republic of China (“PRC”).~~

Chinese

government.

74. Inventories

The Company’s inventory balance of $20,288 and $18,951 as of March 31, 2022 and December 31, 2021, respectively, mainly consisted of finished goods purchased from Tesaro Inc., now

GlaxoSmithKline (“GSK”), for distribution in Hong Kong, and from NovoCure Limited (“NovoCure”) for distribution in Hong Kong and mainland China

, and from Deciphera Pharmaceuticals, LLC (“Deciphera”) for distribution in Hong Kong, mainland China and Taiwan, as well as finished goods and certain raw materials for ZEJULA

and NUZYRA

commercialization in

mainland

China.


	As of
	March 31, 2022		December 31, 2021
	$		$
Finished goods		4,733		5,632
Raw materials		15,555		13,231
Work in Progress		0		88

Inventories		20,288		18,951

The Company writes down inventory for any excess or obsolete inventories or when the Company believes that the net realizable value of inventories is less than the carrying value. During the three months ended March 31, 2022 and 2021, the Company recorded write-downs of $138 and $43, in cost of revenues, respectively.

Table of Contents

Zai Lab Limited

Notes to the unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)

~~4. Restricted cash, non-current~~5

The Group’s restricted cash balance of $743 and $743 as of June 30, 2021 and December 31, 2020, respectively, was long-term bank deposits held as collateral for issuance of letters of credit. These deposits will be released when the related letters of credit are settled by the Group.

~~5. Short-term investments~~

~~Short-term investments are primarily comprised of time deposits with original maturities between~~

~~three months~~

~~and~~

~~one year.~~

~~As of June 30, 2021, the Group held 0~~

~~short-term~~

investments. As of December 31, 2020, the Group’s short-term investments consisted entirely of short-term held to maturity debt instruments with high credit ratings, which were determined to have remote risk of expected credit loss. Accordingly, 0allowance for credit loss was recorded as of December 31, 2020.

~~6. Inventories~~

~~The Group’s inventory balance of $11,114 and $13,144 as of June 30, 2021 and December 31, 2020,~~

respectively, mainly consisted of finished goods purchased from Tesaro, Inc., now GlaxoSmithKline (GSK), for distribution in Hong Kong, and from NovoCure Limited (“Novocure”) and Deciphera Pharmaceuticals, LLC (“Deciphera”) for distribution in Hong Kong and China, as well as finished goods, work in process and certain raw materials for ZEJULA commercialization in China.

As of


June 30, 2021

December 31, 2020


            $

            $

Finished goods
   4,477    3,041
Raw materials
   6,269    10,103
Work in process
   368    0




Inventories
   11,114    13,144

The Group writes down inventory for any excess or obsolete inventories or when the Group believes that the net realizable value of inventories is less than the carrying value. During the three and six months ended June 30, 2021, the Group recorded

~~write-downs~~

~~of $277 and $290, respectively, in cost of revenues. During the three months and six months ended June 30, 2020, the Group recorded~~

~~write-downs~~

~~of $7 and $7, respectively, in cost of revenues.~~

~~7. Investments in equity investees~~

~~In June 2017, the Group entered into an agreement with 3~~

~~third~~

~~parties~~

to launch JING Medicine Technology (Shanghai) Ltd. (“JING”), an entity which provides services for product discovery and development, consultation and transfer of pharmaceutical technology. The capital contribution by the Group was RMB26,250 in cash, which was paid by the Group in 2017 and 2018, representing 20% and 18% of the equity interest of JING as of December 31, 2020 and

~~June 30, 2021, respectively~~

. The Group accounts for this investment using the equity method of accounting due to the fact that the Group can exercise significant influence on the investee. The Group recorded its gain on deemed disposal in this investee of

~~NaN~~

~~and $~~

~~463~~

~~for the three months and six months ended June 30, 2021, and recorded loss of~~

~~403~~

~~and $~~

~~671~~

~~for its portion of JING’s net loss for the three months and six months ended June 30, 2021, respectively. The Group recorded share of loss in this~~

~~investee of $269 and~~

~~406~~

~~for the three and six months ended June 30, 2020, respectively.~~

~~Table of Contents~~

~~Zai Lab Limited~~

~~Notes to the unaudited condensed consolidated financial statements~~

~~(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)~~

8. Property and equipment, net

Property and equipment

, net

consist of the following:


	As of						As of
	June 30, 2021			December 31, 2020			March 31, 2022			December 31, 2021
	$			$			$			$
Office equipment		444			430			838			836
Electronic equipment		3,269			2,646			5,932			5,036
Vehicle		218			143			222			220
Laboratory equipment		13,384			11,933			18,130			17,069
Manufacturing equipment		12,838			12,198			14,721			14,600
Leasehold improvements		9,889			9,641			10,506			10,432
Construction in progress		4,699			2,423			13,126			11,334

		44,741			39,414			63,475			59,527
Less: accumulated depreciation		(13,099	)		(10,252	)		(18,248	)		(16,425	)

Property and equipment, net		31,642			29,162			45,227			43,102

Depreciation expenses for the three

months

ended March 31, 2022 and ~~six months ended June 30,~~ 2021 were ~~$1,407~~$1,869 and ~~$2,747,~~$1,340, respectively. ~~Depreciation expenses for the three and six months ended June 30, 2020 were $968 and $1,974, respectively.~~

6. Revenue

~~he Group’s~~

Product revenue, net

The Company’s

product

revenue is primarily derived from the sale of ZEJULA, Optune, QINLOCK and ~~QINLOCK~~NUZYRA in mainland China and Hong Kong. The table below presents the ~~Group’s~~Company’s net product sales for the three ~~and six~~ months ended ~~June 30, 2021~~March 31, 2022 and ~~2020.~~2021.

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended March 31,

Product revenue - gross

Less: Rebate and sales return

Product revenue - net

Sales rebates are offered to distributors in

mainland

China and the amounts are recorded as a reduction of revenue. Estimated rebates are determined based on contracted rates, sales volumes and level of distributor inventories.

Due to the inclusion of ZEJULA in the National Reimbursement Drug List (“NRDL”) in December 2020 and December 2021 for certain therapies, the Company accrued sales rebates

$2,587 and $22,009 compensation to distributors for those products previously sold at the price prior to the NRDL implementation, for the three months ended March 31, 2022 and 2021,

respectively.

The following table disaggregates net revenue by product for the three

months

ended March 31, 2022 and ~~six~~2021:

Three Months Ended March 31,

Zai Lab Limited

Notes to the unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)

Collaboration revenue

The Company’s collaboration revenue for the three months ended ~~June 30, 2021 and 2020:~~March 31, 2022 amounted to $629 was from the

collaborative arrangement with Huizheng (Shanghai) Pharmaceutical Technology Co., Lt

Three Months Ended June 30,

Six Months Ended June 30,


2021

2020

2021

2020


            $

            $

            $

            $

ZEJULA
   23,366    7,446    35,972    13,791
Optune
   9,535    3,549    16,665    5,422
QINLOCK
   4,034    —      4,401    —








Product revenue - net
   36,935    10,995    57,038    19,213

~~10.~~

7. Income Tax

No provision for income taxes has been required to be accrued because the Company and all of its subsidiaries are in cumulative loss positions for all the periods presented.

The Company recorded a full valuation allowance against deferred tax assets of all its consolidated entities because all entities were in a cumulative loss position as of ~~June 30, 2021~~March 31,

2022 and December 31, ~~2020.~~2021. NaN unrecognized tax benefits and related interest and penalties were recorded in any of the periods presented.

8. Other current liabilities

Other current liabilities consist of the following:


	As of
	March 31, 2022		December 31, 2021
	$		$
Payroll		16,318		25,685
Accrued professional service fee		5,170		4,319
Payables for purchase of property and equipment		668		2,568
Accrued rebate to distributors		14,625		15,001
Tax payables		9,931		8,817
Others (note (i))		3,244		4,421

Total		49,956		60,811

Note:

(i)	Others are mainly payables to employees for exercising the share-based compensations, payables related to travel and business entertainment expenses.

. Loss per share

Basic and diluted net loss per share for each of the period presented are calculated as follows:


	Three Months Ended March 31,
	2022			2021
	$			$
Numerator:
Net loss attributable to ordinary shareholders		(82,394	)		(232,910	)
Denominator:
Weighted average number of ordinary shares- basic and diluted		955,499,030			883,749,280

Net loss per share - basic and diluted		(0.09	)		(0.26	)

Table of Contents

Zai Lab Limited

Notes to the unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)

~~11. Other current liabilities~~As

~~Other current liabilities consist of the following:~~

As of


June 30,

2021

December 31,

2020


            $

            $

Payroll
   12,474    13,694
Professional service fee
   9,610    3,128
Payables for purchase of property and equipment
   1,720    788
Accrued rebate to distributors
   22,416    7,067
Others (note (i))
   15,705    5,519




Total
   61,925    30,196

~~Note:~~

~~(i)~~

~~Others are mainly payables to employees for exercising the share-based compensations, tax payables and payables related to travel and business entertainment expenses.~~

~~12. Loss per share~~

~~Basic and diluted net loss per share for each of the period presented are calculated as follows:~~

Three Months Ended June 30,

Six Months Ended June 30,


2021

2020

2021

2020


            $

            $

            $

            $

Numerator:

Net loss attributable to ordinary shareholders
   (163,324 )    (80,629 )    (396,234 )    (128,617 )
Denominator:

Weighted average number of ordinary shares- basic and diluted
   93,045,531    74,738,563    90,723,132    73,847,551








Product revenue - net
   (1.76 )    (1.08 )    (4.37 )    (1.74 )

As a result of the ~~Group’s~~Company’s net loss for the ~~six~~three months ended ~~June 30,~~ March

2022

and

2021 ~~and 2020,~~

, share options and

non-vested

restricted shares outstanding in the respective periods were excluded from the calculation of diluted loss per share as their inclusion would have been anti-dilutive.


	As of
	March 31, 2022		March 31, 2021
Share options		80,514,330		86,932,740
Non-vested restricted shares		9,846,360		4,800,100

As of


June 30,

2021

June 30,

2020

Share options
   8,629,440    9,808,561
Non-vested
restricted shares
   632,535    710,068

~~13.~~

10. Related party ~~transactions~~transactions

The table below sets forth the major related party and the relationship with the ~~Group~~Company as of ~~June 30,~~March 31, 2021:


Company Name		Relationship with the ~~Group~~ Company
MEDx (Suzhou) Translational Medicine Co., Ltd.		Significant influence held by Samantha Du’s (Director, Chairwoman and Chief Executive Officer of the Company) immediate family

~~Table of Contents~~

~~Zai Lab Limited~~

~~Notes to the unaudited condensed consolidated financial statements~~

~~(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)~~

For the three ~~and six~~ months ended ~~June 30,~~March 31, 2022 and 2021, the ~~Group~~Company incurred ~~$104~~$74 and ~~$207~~$103 research and ddevelopment

~~evelopment~~

~~expense with MEDx (Suzhou) Translational Medicine Co., Ltd.~~expenses for product research and development services provided by

MEDx (Suzhou) Translational Medicine Co., Ltd

respectively. The Group incurred $129 and $184 research and development expense for the three and six months ended June 30, 2020, respectively. All of the transactions are carried out with normal business terms and are on arms’ length basis.

~~14.~~1

. Share-based compensation

Share options

On March 5, 2015, the Board of Directors of the Company approved an Equity Incentive Plan (the “2015 Plan”) which is administered by the Board of Directors. Under the 2015 Plan, the Board of Directors may grant options to purchase ordinary shares to management including officers, directors, employees and individual advisors who render services to the ~~Group~~Company to purchase an aggregate of no more than ~~4,140,945~~41,409,450 ordinary shares of the ~~Group~~Company (“Option Pool”). Subsequently, the Board of Directors approved the increase in the Option Pool to ~~7,369,767~~73,697,670 ordinary shares.

In connection with the completion of the initial public offering (the “IPO”), the Board of Directors approved the 2017 Equity Incentive Plan (the “2017 Plan”) and all equity-based awards subsequent to the IPO would be granted under the 2017 Plan.

~~For~~The 2017 Plan provides for an automatic annual increase to the ~~six months ended June 30, 2020, the Group granted 960,878 share options to certain management, employees and individual advisors~~number of ~~the Group at the exercise price ranging from $44.94 to $82.13 per share~~ordinary shares reserved under the 2017 ~~Plan. These options granted have a contractual term~~Plan on each January 1st between January 1, 2018 and January 1, 2027 equal to the lesser of ~~ten years and generally vest over a~~ ~~five-~~ or

~~three-year~~

~~period, with 20% or 33.3%~~4% of the ~~awards vesting beginning~~number of ordinary shares outstanding as of the close of business on the ~~anniversary~~immediately prior December 31st or such number as approved by the Board on or prior to such date ~~one year after~~each year. Accordingly, on January 1, 2022, the ~~grant date.~~number of shares reserved under the 2017 Plan

~~For~~increased by 38,563,500. The aggregate number of shares reserved and available for issuance under our 2017 Plan as of April 1, 2022 was

75,562,170.

On April 20, 2022, the ~~six~~Board of Directors of the Company approved the Zai Lab Limited 2022 Equity Incentive Plan (the “2022 Plan”), which is conditioned on and subject to the dual-primary listing of the Company on the Main Board of The Stock Exchange of Hong Kong Limited becoming effective and shareholder approval at the annual general meeting scheduled on June 22, 2022, and subject to the granting of the waiver on Note 1 to Rule 17.03(9) of the HK Listing Rules by The Stock Exchange of Hong Kong Limited. If approved and adopted, the aggregate number of shares that may be delivered in satisfaction of awards under the 2022 Plan is 97,908,743 ordinary shares. Once the 2022 Plan becomes effective, no new grants will be made under the 2015 Plan or the 2017

Plan.

Table of Contents

Zai Lab Limited

Notes to the unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)

For

the three months ended ~~June 30,~~March 31, 2021, the ~~Group~~Company granted ~~512,088~~151,000 share options to certain management and employees of the ~~Group~~Company at the exercise price ~~ranging from $130.96 to $180.00~~$16.20 per share under the 2017 Plan. These options granted have a contractual term of ten years and generally vest over a five-year period, with 20% of the awards vesting beginning on the anniversary date one year after the grant date.

For the three months ended March 31, 2022, the Company granted 984,310 share options to certain management and employees of the Company at the exercise price ranging from $5.26 to $6.29 per share under the 2017 Plan. These options granted have a contractual term of ten years and generally vest over a five-year period, with 20% of the awards vesting beginning on the anniversary date one year after the grant date.

The weighted-average grant-date fair value of the options granted in the ~~six~~three months ended ~~June 30,~~March 31, 2022 and 2021 were $3.24

and ~~2020 were $81.37 and $33.51~~$9.88 per share, respectively. The ~~Group~~Company recorded compensation expense related to the options of ~~$12,776~~$7,207 and ~~$10,355~~$5,549 for the ~~six~~three months ended ~~June 30,~~March 31, 2022 and 2021, ~~and 2020,~~ respectively, which were classified in the accompanying unaudited condensed consolidated statements of operations as follows:

Three Months Ended June 30,

Six Months Ended June 30,


2021

2020

2021

2020


            $

            $

            $

            $

Selling, general and administrative
   4,123    2,804    7,382    5,548
Research and development
   3,104    2,630    5,394    4,807








Total
   7,227    5,434    12,776    10,355


	Three Months Ended March 31,
	2022		2021
	$		$
Selling, general and administrative		4,069		3,259
Research and development		3,138		2,290

Total		7,207		5,549

~~Table of Contents~~

~~Zai Lab Limited~~

~~Notes to the unaudited condensed consolidated financial statements~~

~~(In thousands~~ of ~~U.S. dollars (“$”) and Renminbi (“RMB��) except for number of shares and per share data)~~March

2022

~~As of June 30, 2021,~~, there was ~~$97,837~~ $

89,126

of total unrecognized compensation expense related to unvested share ~~opt~~

~~ons~~options granted. That cost is expected to be recognized over a

weighted-average

period of ~~1.48~~

2.79

years which is determined based on the number of

unvested

shares and unrecognized years.

Non-vested restricted shares

For the ~~six~~three months ended ~~June 30, 2020, 50,000~~March 31, 2021, 192,600 ordinary shares were authorized for grant to the independent directors. The restricted shares will vest and be released from the restrictions in full on the first anniversary from the date of the agreement. Upon termination of the independent directors’ service with the ~~Group~~Company for any reason, any shares that are outstanding and not yet vested will be immediately forfeited.

For the ~~six~~three months ended ~~June 30, 2020, 45,000~~March 31, 2021, 31,000 ordinary shares were authorized for grant to certain management. ~~One fifth~~One-fifth of the restricted shares will vest and be released from the restrictions on each yearly anniversary from the date of the agreement. Upon termination of the certain management’s service with the ~~Group~~Company for any reason, any shares that are outstanding and not yet vested will be immediately forfeited.

For the ~~six~~three months ended ~~June 30, 2021, 19,260~~March 31, 202

, 388,150 ordinary shares were authorized for grant to the independent directors. The restricted shares will vest and be released from the restrictions in full on the first anniversary from the date of the agreement. Upon termination of the independent directors’ service with the ~~Group~~Company for any reason, any shares that are outstanding and not yet vested will be immediately

forfeited.

~~For~~

Table of Contents

Zai Lab Limited

Notes to the ~~six~~unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)

For

the three months ended ~~June 30, 2021, 203,575~~March 31, 2022, 477,150 ordinary shares were authorized for grant to certain management. ~~One fifth~~One-fifth of the restricted shares will vest and be released from the restrictions on each yearly anniversary from the date of the agreement. Upon termination of the certain management’s service with the ~~Group~~Company for any reason, any shares that are outstanding and not yet vested will be immediately forfeited.

The ~~Group~~Company measured the fair value of the

non-vested

restricted shares as of respective grant dates and recognized the amount as compensation expense over the deemed service period using a graded vesting attribution model on a straight-line basis.

As of ~~June 30, 2021,~~March 31, 2022, there was ~~$40,562~~$68,292 of total unrecognized compensation expense related to

non-vested

restricted shares. The ~~Group~~Company recorded compensation expense related to the restricted shares of ~~$4,774~~

5,203 and ~~$3,072~~$1,769 for the ~~six~~three months ended ~~June 30,~~March 31, 2022 and 2021, ~~and 2020,~~ respectively, which were classified in the accompanying unaudited condensed consolidated statements of operations as follows:


	Three Months Ended March 31,
	2022		2021
	$		$
Selling, general and administrative		2,923		1,211
Research and development		2,280		558

Total		5,203		1,769

Three Months Ended June 30,

Six Months Ended June 30,


2021

2020

2021

2020


$

$

$

$

Selling, general and administrative
   1,839    1,046    3,050    2,114
Research and development
   1,166    484    1,724    958








Total
   3,005    1,530    4,774    3,072

~~Table of Contents~~

~~Zai Lab Limited~~

~~Notes to the unaudited condensed consolidated financial statements~~

~~(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)~~

.12. Licenses and collaborative ~~arrangement~~arrangements pursuant to which milestone payments were made

The following is a description of the ~~Group’s~~Company’s significant ongoing collaboration agreements ~~for the three and six months ended June 30, 2021.~~

~~License and collaboration agreement with GSK~~

~~In September 2016, the Group entered into a collaboration, development and license agreement with Tesaro, Inc., a company later acquired by GSK, pursuant to which it obtained an exclusive sublicense~~ under ~~certain patents and~~

~~know-how~~

~~of GSK (including such patents and~~

~~know-how~~

licensed from Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., and AstraZeneca UK Limited) to develop, manufacture and commercialize GSK’s proprietary PARP inhibitor, niraparib, in China, Hong Kong and Macau for the diagnosis and prevention of any human diseases or conditions (other than prostate cancer). The Group also obtained the right of first negotiation to obtain a license to develop and commercialize certain

~~follow-on~~

compounds of niraparib being developed by GSK in the licensed territory. Under the agreement, the Group agreed not to research, develop or commercialize certain competing products, and the Group also granted GSK the right of first refusal to license certain immuno-oncology assets developed by the Group. In February 2018, the Group entered into an amendment with GSK that eliminated GSK’s option to

~~co-market~~

~~niraparib in the licensed territory.~~

Under the terms of the agreement, the Group made an upfront payment of $15,000 and 1 milestone payment of $1,000, and accrued 1 development milestone payment of $3,500 to GSK. On top of those, if the Group achieves other specified regulatory, development and commercialization milestones, the Group may be additionally required to pay further milestone payments up to $36,000 to GSK. In addition, if the Group successfully develops and commercializes the licensed products, the Group will pay GSK tiered royalties on the net sales of the licensed products, until the later of the expiration of the

~~last-to-expire~~

licensed patent covering the licensed product, the expiration of regulatory exclusivity for the licensed product, or the tenth anniversary of the first commercial sale of the licensed product, in each case on a

~~product-by-product~~

~~and~~

~~region-by-region~~

~~basis.~~

~~The Group has the right to terminate this agreement at any time by providing written notice of termination to GSK.~~

~~License and collaboration agreements with MacroGenics Inc. (“MacroGenics”)~~

~~In November 2018, the Group entered into a collaboration agreement with MacroGenics, pursuant to which it obtained an exclusive license under certain patents and~~

~~know-how~~

~~of MacroGenics to develop and commercialize margetuximab, tebotelimab~~

~~(MGD-013)~~

~~and an undisclosed multi-specific TRIDENT molecule in~~

~~pre-clinical~~

~~development, each as an active ingredient in all human fields of use, except to the extent limited by any applicable third party agreement of MacroGenics in Greater China.~~

Under the terms of the agreement, the Group paid an upfront license fee of $25,000 and 2 milestone payments in total of $4,000 to MacroGenics. The Group also agreed to pay certain development and regulatory-based milestone payments up to an aggregate of $136,000, and tiered royalties at percentage rates for net sales of Margetuximab, tebotelimab and TRIDENT molecule in the territory.

~~The Group has the right to terminate this agreement at any time by providing written notice of termination to MacroGenics.~~

~~In June 2021, the Group entered into a collaboration and license agreement with MacroGenics, pursuant to~~ which the ~~Group and MacroGenics~~Company has made four collaboration programs involving up to four immuno-oncology molecules. The first collaboration program covers a lead research molecule that incorporates MacroGenics’ DART platform and binds CD3 and an undisclosed target that is expressed in multiple solid tumors. The second collaboration program will cover a target to be designated by MacroGenics. For both molecules, the Group received commercial rights in Greater China, Japan, and Korea and MacroGenics received commercial rights in all other territories. For the lead molecule, the Group receives an option upon reaching a predefined clinical milestone to convert the regional arrangement into a global 50/50 profit share. The Group also obtained exclusive, global licenses from MacroGenics to develop, manufacture and commercialize

~~additional molecules. For these four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.~~

~~Under the terms of the agreement, the Group accrued an upfront payment of $25,000~~

~~to MacroGenics. In addition, MacroGenics is also eligible to receive up to~~

~~$1,386,000 in potential development, regulatory and commercial~~ milestone payments for the 4

~~programs. If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in the Group’s territories.~~

~~Pursuant to the collaboration and license agreement, the Group also agreed to make an equity investment of $30,000 in MacroGenics’ common stock at $31.30 per share (see Note 18).~~three months ended March 31, 2022.

~~The Group has the right to terminate this agreement at any time by providing written notice of termination to MacroGenics.~~

~~Table of Contents~~

~~Zai Lab Limited~~

~~Notes to the unaudited condensed consolidated financial statements~~

~~(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)~~

~~License and collaboration agreement with Deciphera~~

~~In June 2019, the Group entered into a license agreement with Deciphera, pursuant to which it obtained an exc~~

~~usive license under certain patents and~~

~~know-how~~

of Deciphera to develop and commercialize products containing ripretinib in the field of the prevention, prophylaxis, treatment, cure or amelioration of any disease or medical condition in humans in Greater China.

Under the terms of the agreement, the Group paid Deciphera an upfront license fee of $20,000 and 3milestone payments of $12,000. The Group also agreed to pay certain additional development, regulatory and commercial milestone payments up to an aggregate of $173,000, and certain tiered royalties (from

~~low-to-high~~

~~teens on a percentage basis and subject to certain reductions) based on the net sales of the licensed products in the territory.~~

~~The Group has the right to terminate this agreement at any time by providing written notice of termination to Deciphera.~~

~~License agreements with Turning Point Therapeutics Inc (“Turning Point”)~~

In July 2020, the Group entered into an exclusive license agreement with Turning Point pursuant to which Turning Point exclusively licensed to the Group the rights to develop and commercialize products containing repotrectinib as an active ingredient in all human therapeutic indications, in Greater China.

Under the terms of the agreements, the Group paid an upfront payment of $25,000 and 1 milestone payment of $2,000, and accrued 2 milestone payments totaling $3,000 to Turning Point. Turning Point is also eligible to receive up to $146,000 in development, regulatory and sales milestones. Turning Point will also be eligible to receive certain tiered royalties (from

~~mid-to-high~~

~~teens on a percentage basis and subject to certain reductions) based on annual net sales of repotrectinib in Greater China.~~

~~The Group has the right to terminate this agreement at any time by providing written notice of termination to Turning Point.~~

In January 2021, the Group entered into a license agreement with Turning Point, which expanded their collaboration. Under the terms of the new agreement, the Group obtained exclusive rights to develop and commercialize

~~TPX-0022,~~

~~Turning Point’s MET, SRC and CSF1R inhibitor, in Greater China.~~

The Group paid an upfront license fee in the amount of $25,000 to Turning Point. The Group also agreed to pay certain development, regulatory and commercial milestone payments up to an aggregate of $336,000. Turning Point will also be eligible to receive certain tiered royalties (from

~~mid-teens~~

~~low-twenties~~

~~on a percentage basis and subject to certain reductions) based on annual net sales of~~

~~TPX-0022~~

~~in Greater China. In addition, Turning Point will have the right of first negotiation to develop and commercialize an oncology product candidate discovered by the Group.~~

~~Table of Contents~~

~~Zai Lab Limited~~

~~Notes to the unaudited condensed consolidated financial statements~~

~~(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)~~

~~License and collaboration agreement with Five Prime Therapeutics, Inc. (“Five Prime”)~~

In December 2017, the Group entered into a license and collaboration agreement with Five Prime (a company later acquired by Amgen Inc.), pursuant to which it obtained an exclusive license under certain patents and

~~know-how~~

of Five Prime to develop and commercialize products containing Five Prime’s proprietary afucosylated FGFR2b antibody known as bemarituzumab (FPA144) as an active ingredient in the treatment or prevention of any disease or condition in humans in Greater China.

~~Under the terms of the agreement, the Group made an upfront payment of $5,000 and~~ ~~a milestone~~ payment of $2,000 to Five Prime. Additionally, the Group also agreed to pay further development and regulatory milestone payments of up to an aggregate of $37,000 to Five Prime and certain tiered royalties (from high-teens to

~~low-twenties~~

~~on a percentage basis and subject to certain reductions) based on the number of patients the Group enrolls in the bemarituzumab study.~~

~~The Group has the right to terminate this agreement at any time by providing written notice of termination to Five Prime.~~

~~License agreement with Cullinan Pearl Corp. (“Cullinan”)~~

In December 2020, the Group entered into a license agreement with Cullinan, a subsidiary of Cullinan Management, Inc., formerly Cullinan Oncology, LLC, pursuant to which it obtained an exclusive license under certain patents and

~~know-how~~

~~of Cullinan to dev~~

~~lop, manufacture and commercialize products containing~~

~~CLN-081~~

~~as an active ingredient in all uses in humans and animals in Greater China.~~

Under the terms of the agreement, the Group paid an upfront payment of $20,000 to Cullinan. Cullinan is also eligible to receive up to $211,000 in development, regulatory and sales-based milestone payments. Cullinan is also eligible to receive certain tiered royalties (from high-single-digit to

~~low-teen~~

~~tiered royalties on a percentage basis and subject to certain reductions) based on annual net sales of~~

~~CLN-081~~

~~in Greater China.~~

~~The Group has the right to terminate this agreement at any time by providing written notice of termination to Cullinan.~~

~~License agreement with Takeda Pharmaceutical Company Limited (“Takeda”)~~

~~In December 2020,~~

the Group entered into an exclusive license agreement with Takeda. Under the terms of the license agreement, Takeda exclusively licensed to the Group the right to exploit products in the licensed field during the term.

Collaboration

~~Table of Contents~~

~~Zai Lab Limited~~

~~Notes to the unaudited condensed consolidated financial statements~~

~~(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)~~

Under the terms of the agreement, the Group paid an upfront payment of $6,000 to Takeda. Takeda is also eligible to receive up to $481,500 in development, regulatory and sales-based milestone payments. Takeda is also eligible to receive certain tiered royalties (from high-single-digit to

~~low-teen~~

~~tiered royalties on a percentage basis and subject to certain reductions) based on net sales of each product sold by selling party during each year of the applicable royalty term.~~

~~The Group has the right to terminate this agreement at any time by providing written notice of termination to Takeda.~~

~~Collaboration~~ and license agreement with argenx BV (“argenx”)

In January 2021, the ~~Group~~Company entered into a collaboration and license agreement with argenx. The ~~Group~~Company received an exclusive license to develop and commercialize products containing argenx’s proprietary antibody fragment, known as efgartigimod, in Greater China. The ~~Group~~Company is responsible for the development of the licensed compound and licensed product and will have the right to commercialize such licensed product in the territory.

Pursuant to the collaboration and license agreement, a share issuance agreement was entered into between the ~~Group~~Company and argenx. As the upfront payment to argenx, the ~~Group~~Company issued ~~568,182~~5,681,820 ordinary shares of the Company to argenx with par value ~~$0.00006~~$0.000006 per share on the closing date of January 13, 2021. In determining the fair value of the ordinary shares at closing, the Company considered the closing price of the ordinary shares on the closing date and included a lack of marketability discount because the shares are subject to certain restrictions. The fair value of the shares on the closing date was determined to be $62,250 in the aggregate. ~~The Group recorded this upfront payment in research and development expenses.~~

In addition, the ~~Group~~Company made a

non-creditable,

non-refundable

development cost-sharing payment of $75,000 to argenx during the first quarter in 2021 to argenx. ~~Argenx is also eligible to receive~~During the three months ended March 31, 2022, the Company made a ~~cash~~milestone payment of $25,000 ~~upon~~to argenx due to the first regulatory approval ~~of a licensed product~~ by the U.S. Food and Drug Administration (“FDA”) in December 2021 for ~~myasthenia gravis~~VYVGART (efgartigimod alfa-fcab). The Company recorded these expenses in research and development expenses. Argenx is also eligible to receive tiered royalties (from

mid-teen

low-twenties

on a percentage basis and subject to certain reductions) based on annual net sales of all licensed product in the ~~territory.~~

~~Collaboration and license agreement with Mirati Therapeutics, Inc. (“Mirati”)~~territory.

In May 2021, the Group entered into a collaboration and license agreement with Mirati. The Group obtained the right to research, develop, manufacture and exclusively commercialize adagrasib in Greater China. The Group will support accelerated enrollment in key global, registration-enabling clinical trials of adagrasib in patients with cancer who have a KRASG12C mutation. Mirati has an option to

~~co-commercialize~~

~~in Greater China and retains full and exclusive rights to adagrasib in all countries outside of Greater China.~~

Under the terms of the agreement, the Group accrued an upfront payment of $65,000 to Mirati. Mirati is also eligible to receive up to $273,000 in development, regulatory and sales-based milestone payments. Mirati is also eligible to receive ~~high-teen- to~~

~~low-twenties-percent~~

~~tiered royalties based on annual net sales of adagrasib in Greater China.~~

~~The Group has the right to terminate this agreement at any time by providing written notice of termination to Mirati.~~

Table of Contents

Zai Lab Limited

Notes to the unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)

License and collaboration agreement with Paratek Bermuda Ltd. (“Paratek”)

In April 2017, the Company entered into a license and collaboration agreement with Paratek Bermuda Ltd., a subsidiary of Paratek Pharmaceuticals, Inc., pursuant to which it obtained both an exclusive license under certain patents and know-how of Paratek and an exclusive sub-license under certain intellectual property that Paratek licensed from Tufts University to develop, manufacture and commercialize products containing omadacycline (ZL-2401) as an active ingredient in Greater China in the field of all human therapeutic and preventative uses other than biodefense. Under certain circumstances, the exclusive sub-license to certain intellectual property Paratek licensed from Tufts University may be converted to a non-exclusive license if Paratek’s exclusive license from Tufts University is converted to a non-exclusive license under the Tufts Agreement. The Company also obtained the right of first negotiation to be Paratek’s partner to develop certain derivatives or modifications of omadacycline in our licensed territory. Paratek retains the right to manufacture the licensed product in our licensed territory to support development and commercialization of the same outside our licensed territory. The Company also granted to Paratek a non-exclusive license to certain of our intellectual property. Under the agreement, the Company agreed not to commercialize certain competing products in our licensed territory.

Under the terms of the agreement, the Company made an upfront payment of $7,500

to Paratek in 2017, $5,000 upon approval by the FDA of a New Drug Application (“NDA”) submission in 2018, $3,000 upon submission of the first regulatory approval application for a licensed product in the People’s Republic of China in 2020. The Company made another milestone payment of $6,000 during the three months ended March 31, 2022 upon regulatory approval of omadacycline for the treatment of adults with Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”) and Community-Acquired Bacterial Pneumonia (“CABP”) in the People’s Republic of China in December 2021.The Company may be required to pay further commercial milestone payments of up to an aggregate of

$40,500 to Paratek for the achievement of certain development and sales milestone events. In addition, the Company will pay to Paratek tiered royalties on the net sales of licensed products, until the later of the abandonment, expiration or invalidation of the last-to-expire licensed patent covering the licensed product, or the eleventh anniversary of the first commercial sale of the licensed product, in each case on a product-by-product and region-by-region basis.

The

Company has the right to terminate this agreement at any time by providing written notice of termination to Paratek.

Full details of the licenses and collaborative arrangements are included in the notes to financial statements in our Annual Report on Form

10-K

for the year ended December 31, ~~2020~~2021 as filed with the SEC on March 1, ~~2021 and this Quarterly Report on Form 10-Q.~~2022. As noted above, the ~~Group~~Company has entered into various license and collaboration agreements with third party licensors to develop and commercialize product candidates. Based on the terms of these agreements, the ~~Group~~Company is contingently obligated to make additional material payments upon the achievement of certain contractually defined milestones. Based on management’s evaluation of the progress of each project noted above, the licensors will be eligible to receive from the ~~Group~~Company up to an aggregate of approximately

~~4,541,502~~

5,589,801 in future contingent milestone payments dependent upon the achievement of contractually specified development milestones, such as regulatory approval for the product candidates, which may be before the ~~Group~~Company has commercialized the product or received any revenue from sales of such product ~~candidate, which~~candidate. These milestone payments are subject to uncertainties and contingencies and may ~~never~~not occur.

~~. Restricted net assets~~

13. Restricted net assets

The ~~Group’s~~Company’s ability to pay dividends may depend on the ~~Group~~Company receiving distributions of funds from its Chinese ~~subsidiary.~~subsidiaries. Relevant ~~PRC statutory~~Chinese laws and regulations permit payments of dividends by the ~~Group’s~~Company’s Chinese ~~subsidiary~~subsidiaries only out of its retained earnings, if any, as determined in accordance with ~~PRC~~Chinese accounting standards and regulations. The results of operations reflected in the unaudited condensed consolidated financial statements prepared in accordance with U.S. GAAP differ from those reflected in the statutory financial statements of the ~~Group’s PRC subsidiary.~~Company’s Chinese

subsidiaries.

Table of Contents

Zai Lab Limited

Notes to the unaudited condensed consolidated financial statements

(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)

accordance with the Company Law of the ~~PRC,~~People’s Republic of China, a domestic enterprise is required to provide statutory reserves of at least 10% of its annual

after-tax

profit until such reserve has reached 50%

of its respective registered capital based on the enterprise’s ~~PRC~~Chinese statutory accounts. A domestic enterprise ~~is also required to~~may provide discretionary surplus reserve, at the discretion of the Board of Directors, from the profits determined in accordance with the enterprise’s ~~PRC~~Chinese statutory accounts. The aforementioned reserves can only be used for specific purposes and are not distributable as cash dividends. The ~~Group’s~~Company’s Chinese ~~subsidiary was~~subsidiaries were established as domestic ~~invested enterprise~~enterprises and therefore isare subject to the above-mentioned restrictions on distributable profits.

During the three ~~and six~~ months ended ~~June 30,~~March 31, 2022 and 2021, ~~and 2020, 0appropriation~~0 appropriation to

statutory reserves was made because the ~~Group’s~~ Chinese ~~subsidiary~~subsidiaries had substantial losses during such periods.

As a result of these ~~PRC~~Chinese laws and regulations, subject to the ~~restrictions~~limits discussed above that require annual appropriations of 10% of

after-tax

~~income~~profit to be set aside, prior to payment of dividends, as general reserve fund, the ~~Group’s~~Company’s Chinese ~~subsidiary is~~subsidiaries are restricted in their ability to transfer a portion of their net assets to the ~~Group.~~

Company.

Foreign exchange and other regulation

in mainland China may further restrict the ~~Group’s~~Company’s Chinese ~~subsidiary~~subsidiaries from transferring funds to the ~~Group~~Company in the form of dividends, loans and advances. As of ~~June 30, 2021~~March 31, 2022 and December 31, ~~2020,~~2021, amounts restricted are the

paid-in

capital of the ~~Group’s~~Company’s Chinese subsidiaries, which both amounted to ~~$306,010 and $205,858, respectively.~~$406,010.

.14. Commitments and Contingencies

(a) Purchase commitments

As of ~~June 30, 2021,~~March 31, 2022, the ~~Group’s~~Company’s commitments related to purchase of property and equipment contracted but not yet reflected in the unaudited condensed consolidated financial statement were ~~$28,191 and $49~~$22,294 which ~~are~~is expected to be incurred within one ~~year and within one to two years, respectively.~~

~~Table of Contents~~

~~Zai Lab Limited~~

~~Notes to the unaudited condensed consolidated financial statements~~

~~(In thousands of U.S. dollars (“$”) and Renminbi (“RMB”) except for number of shares and per share data)~~

year.

(b) Contingencies

The ~~Group~~Company is a party to or assignee of license and collaboration agreements that may require it to make future payments relating to milestone fees and royalties on future sales of licensed products (Note 1

.15. Subsequent Event

~~In July 2021,~~From April 1, 2022 to May 5, 2022, the ~~Group made an equity investment in MacroGenics in a private placement with total contributions amounting to~~

~~$30,000 and obtained 958,467~~

~~newly issued common~~Company granted 16,614,930 shares of ~~MacroGenics at $31.30 per share.~~

~~In July and August 2021, the Group granted 11,701 share~~stock options to certain management and employees of the ~~Group~~Company at exercise prices ranging from ~~$144.61~~$3.96 to ~~$178.37~~$4.55 per share under the 2017 Plan. These options granted have a contractual term of ten years and generally vest over a ~~five-year~~5-year period, with 20% of the awards vesting beginning on the anniversary date one year after the grant date.

~~In July and August 2021, 32,341~~ During the same period, the Company also granted 5,173,390 restricted ordinary shares ~~were authorized for grant~~ to certain management and employees of the ~~Group.~~Company. One-fifth of the restricted shares will vest ~~and be released from the restrictions~~ on each yearly anniversary from the date of the agreement. Upon termination of the ~~certain management’s~~optionees’ service with the ~~Group~~Company for any reason, any unvested shares ~~that are outstanding and not yet vested~~ will be immediately forfeited.

In August 2021, the Group entered into a global discovery, development and commercialization collaboration with Schrödinger, Inc., or Schrödinger, pursuant to which the parties will jointly conduct a research program focused on a novel DNA damage repair program in the area of oncology. Following the selection of a development candidate, the Group will assume primary responsibility for global development, manufacturing and commercialization of the program.

Table of Contents

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Overview

We are a ~~commercial stage,~~patient-focused, innovative, commercial-stage, global biopharmaceutical company with a substantial presence in both Greater China and the United States. We are discovering, developing and commercializing innovative products that target medical conditions with unmet needs affecting patients in Greater China and worldwide, particularly in the areas of oncology, autoimmune disorders, infectious diseases and ~~infectious diseases.~~neuroscience. As of ~~August 9, 2021,~~May 5, 2022, we have ~~three~~four commercialized products that have received marketing approval in one or more territories in Greater China and twelve programs in late-stage product development.

Since our inception, we have incurred net losses and negative cash flows from our operations. Substantially all of our losses have resulted from funding our research and development programs and general and administrative costs associated with our operations. Developing high quality product candidates requires a significant investment related to our research and development activities over a prolonged period of time, and a core part of our strategy is to continue making sustained investments in this area. Our ability to generate profits and to generate positive cash flow from operations over the next several years depends upon our ability to successfully market our ~~current three~~four commercial products – ZEJULA, Optune, QINLOCK and ~~QINLOCK~~

,NUZYRA – and our other product candidates that we are able to successfully commercialize. We expect to continue to incur substantial expenses related to our research and development activities. In particular, our licensing and collaboration agreements require us to make upfront payments upon our entry into such agreements and milestone payments upon the achievement of certain development, regulatory and commercial milestones as well as tiered royalties based on the net sales of the licensed products. These upfront payments and milestone payments upon the achievement of certain development and regulatory milestones are recorded in research and development expense in our unaudited condensed consolidated financial ~~statements and totaled $269.2 million for~~statements. We did not accrue any such payments during the ~~six~~three months ended ~~June 30, 2021.~~March 31, 2022. In addition, we expect to incur substantial costs related to the commercialization of our product candidates, in particular during the early launch phase.

Furthermore, as we pursue our strategy of growth and development, we anticipate that our financial results will fluctuate from quarter to quarter based upon the balance between the successful marketing of our commercial products and our significant research and development expenses. We cannot predict whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such product(s) and whether or when they may become profitable.

~~Table of Contents~~

Recent Developments

Recent Business Developments

On ~~April 12, 2021,~~January 6, 2022, we ~~achieved first-patient-in~~announced that the NMPA accepted the new drug application (NDA) for margetuximab, an investigational,

Fc-engineered

monoclonal antibody that targets HER2. The margetuximab NDA is for the ~~Phase 3 pivotal LUNAR trial.~~treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease, in combination with chemotherapy.

On ~~April 13, 2021,~~January 12, 2022, we announced ~~in a joint press release with our partner, Novocure, an update regarding Novocure’s Phase 3 pivotal LUNAR trial~~treatment of ~~Tumor Treating Fields in stage~~

~~4 non-small cell~~

~~lung cancer (NSCLC) following platinum failure. Following a routine review of the study by an independent data monitoring committee (DMC), Novocure was informed that~~

~~the pre-specified interim~~

analysis for the LUNAR trial would be accelerated given the length of accrual and the number of events observed to date. The interim analysis included data from 210 patients accrued to the LUNAR trial through February 2021. After review of the interim analysis report, the DMC concluded that the LUNAR trial should continue with no evidence of increased systemic toxicity. On May 18, 2021, Novocure announced the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for its LUNAR trial to 276 patients with 12 months

~~follow-up.~~

~~In addition, in April 2021, we achieved~~

~~first-patient-in~~

~~for the LUNAR trial in Greater China.~~

On April 23, 2021, we announced the closing of a global offering of American depositary shares and ordinary shares, including the full exercise of the greenshoe option, for total gross proceeds to us of $857.5 million. This offering was the first ever dual-tranche offering on both Nasdaq and the Stock Exchange of Hong Kong.

~~On May 24, 2021, we announced~~ the first patient ~~treated~~in Greater China in the ~~METIS~~

PANOVA-3

trial, a Phase 3 pivotal trial of Tumor Treating Fields in ~~brain metastases from NSCLC in Greater China.~~patients with pancreatic cancer.

PANOVA-3

is a global, open-label, randomized Phase III trial evaluating the efficacy of TTFields administered concomitantly with gemcitabine and

nab-paclitaxel

as front-line treatment for patients with unresectable, locally advanced pancreatic cancer. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate,

one-year

survival rate, quality of life, pain-free survival, resectability rate and toxicity.

~~On June 1, 2021, we announced that we entered into a collaboration and license agreement with Mirati~~In February 2022, the Center for ~~adagrasib, a small-molecule KRASG12C inhibitor, in Greater China (mainland China, Hong Kong, Macau and Taiwan). Under the terms~~Drug Evaluation (CDE) of the agreement, we obtained the right to research, develop, manufacture and exclusively commercialize adagrasib in Greater China. We will support accelerated enrollment in key global, registration-enabling clinical trials of adagrasib in patients with cancer who have a KRAS G12C mutation.

~~On June 4, 2021, our partner, Cullinan, announced additional details pertaining to Cullinan’s ongoing Phase 1/2a trial of~~

~~CLN-081~~

~~in NSCLC patients whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations, including that~~

~~CLN-081~~

~~continues to demonstrate acceptable overall safety and tolerability with encouraging GI toxicity profile.~~

On June 15, 2021, we announced that we entered into an exclusive collaboration and license agreement with MacroGenics, pursuant to which we agreed to collaboratively develop and commercialize up to four bispecific antibody-based molecules with MacroGenics based on the MacroGenics’ proprietary DART

~~and TRIDENT~~

multi-specific technology platforms. Under the agreement, each party agrees to contribute specified intellectual property to enable the research, development, manufacture and commercialization of up to four future CD3 or CD47-based bispecific molecules. We wereNMPA granted ~~exclusive rights in Greater China, Japan, and Korea~~Breakthrough Therapy Designation for ~~two programs and exclusive global rights for two other programs.~~

On August 4, 2021, we announced that we entered into a global discovery, development and commercialization collaboration with Schrödinger, pursuant to which we will jointly conduct a research program focused on a novel DNA damage repair program in the area of oncology. Schrödinger is a recognized leader in providing physics-based computational software platforms used in drug discovery. The research program will be conducted jointly by the scientific teams of our two companies. Following the selection of a development candidate, we will assume primary responsibility for global development, manufacturing and commercialization of the program.

~~Recent Regulatory Developments~~

~~PRC Medical Device Regulations~~

The sale and marketing of imported medical device products in China are subject to notifications (for Class I devices) or registrations (for Class II and III devices) with China’s National Medical Products Administration (NMPA). We launched Optune in China in June 2020 after the NMPA approved Optune in May 2020 in combination with temozolomiderepotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have not been treated with a ROS1 TKI. The breakthrough therapy designation was supported by the initial data from both global and Chinese

TKI-naïve

ROS1-positive NSCLC patients enrolled in the Phase I/II

TRIDENT-1

study. We plan to participate in all cohorts of the global

TRIDENT-1

study.

Table of Contents

In March 2022, we presented positive results from the Phase 3 PRIME study of ZEJULA (niraparib) as maintenance therapy at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting. ZEJULA demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with a tolerable safety profile in Chinese patients with newly diagnosed ~~GBM~~advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status. In the PRIME study, median PFS was significantly longer for patients treated with niraparib compared to placebo: 24.8 months versus 8.3 months, hazard ratio (HR), 0.45; p<0.001.

We also continued to strengthen and expand our leadership team. On March 15, 2022, we announced the appointment of Joshua Smiley as our Chief Operating Officer, effective on August 1, 2022. Mr. Smiley brings over 26 years of experience working with the biopharmaceutical industry, including experience leading finance, corporate strategy, business development, venture capital and global business services operations at Eli Lilly and Company. In addition, in April 2022, Jonathan Wang became our Chief Business Officer, taking on increased responsibilities after the departure of Tao Fu, our former Chief Strategy Officer.

In March 2022, our shareholders approved a Share Subdivision whereby the Company subdivided each of its issued and unissued ordinary shares into ten ordinary shares, effective March 30, 2022. The

one-to-ten

Share Subdivision increased the number of our ordinary shares in issue and reduced the nominal value and trading price of each ordinary share. Our Board of Directors believes that the Share Subdivision will increase the trading liquidity of the ordinary shares, lower the investment barrier, and attract more investors to trade in the ordinary shares. In connection with the Share Subdivision, the Company also effected the ADS Ratio Change, whereby the conversion ratio of our ADSs to ordinary shares changed from one ADS to one ordinary share to a new ratio of one ADS representing ten ordinary shares. The Share Subdivision and ADS Ratio Change did not result in any change to the number of outstanding ADSs of the Company.

In March 2022, SEC staff conclusively identified us under the HFCAA as a ~~monotherapy~~“Commission-Identified Issuer” because Deloitte Touche Tohmatsu Certified Public Accountants LLP and Deloitte Touche Tohmatsu (together, “Deloitte”), our auditor for the ~~treatment~~financial statements included in our 2021 Annual Report, is located in a foreign jurisdiction and the PCAOB has determined that it is unable to inspect or investigate the auditor completely because of ~~patients~~a restriction imposed by a

non-U.S.

authority in the auditor’s local jurisdiction. In April 2022, the Audit Committee of our Board of Directors approved the engagement of KPMG, an auditor located in the United States that is subject to PCAOB inspection, as our independent registered public accounting firm for the fiscal year ending December 31, 2022. KPMG will be engaged to audit our annual consolidated financial statements filed with ~~recurrent GBM. Optune~~the SEC and our internal controls over financial reporting in accordance with the Exchange Act. KPMG also will be engaged to audit our consolidated financial statements submitted to The Hong Kong Stock Exchange in accordance with the Rules Governing the Listing of Securities of the Hong Kong Stock Exchange, subject to our receipt of the requisite approvals from the Hong Kong Stock Exchange and the Financial Reporting Council of Hong Kong (“FRC”), which are expected to be administrative in nature. KPMG is ~~regulated~~in the process of concluding its standard client evaluation procedures, including obtaining approval from the Hong Kong Stock Exchange to be appointed as our auditor. Upon completion of these standard procedures, KPMG will be in a ~~Class III imported medical device~~position to execute an engagement letter and formally commence the engagement. For more information on the HFCAA and risks related to audits of companies with significant operations in China, see “Item 1A. Risk Factors” in this Quarterly Report on Form

10-Q.

In April 2022, we presented new data from its internal oncology discovery portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2022. Key early-stage discovery programs were featured in these presentations, including first preview of preclinical data on

ZL-1218

(a novel anti-CCR8 antibody for solid tumors) in oral presentation, as well as poster presentations featured

ZL-1201

(a CD47-targeting antibody for advanced hematologic malignancies and solid tumors),

ZL-1211

Claudin18.2-specific

antibody for gastric and pancreatic cancer) and

ZL-2201

(a highly selective small-molecule

DNA-PK

inhibitor for anti-cancer therapy).

In April 2022, we ~~act as~~announced topline data for repotrectinib within the China region from the previously disclosed Phase 1/2

TRIDENT-1

study dataset. We plan to discuss topline TKI-naïve data with Chinese ~~legal agent~~health authority in the fourth quarter of 2022.

In TKI-naïve patients

(EXP-1),

in 71 total patients, there was a confirmed objective response rate (cORR) of 79% across the global trial. Ten of 11 patients responded within China for ~~our collaboration partner, Novocure, who is~~a cORR of 91% (95% CI: 59,100) and DOR ranged from 3.6+ to 7.5+ months with a median duration of follow-up of 3.7 months.

Table of Contents

In patients previously treated with 1 TKI and platinum-based chemotherapy

(EXP-2),

in 26 total patients, there was a cORR of 42% across the ~~foreign marketing authorization holder (MAH)~~global trial. Two of 3 patients responded within China for ~~Optune~~a cORR of 67% (95% CI:9,99) and DOR ranged from 3.6+ to 3.7+ months with a median duration of follow-up of 3.7 months.

In patients previously treated with two TKIs without prior chemotherapy (EXP-3), in ~~China. We are preparing~~18 total patients, there was a cORR of 28% across the global trial. Two of 4 patients responded within China for a cORR of 50% (95% CI: 7,93) and DOR ranged from 1.9+ to ~~submit~~3.4+ months with a median duration of follow-up of 2.6 months.

In patients previously treated with 1 TKI without prior chemotherapy (EXP-4), in 56 total patients, there was a cORR of 36% across the global trial. Four of 11 patients responded within China for a cORR of 36% (95% CI: 11,69) and DOR ranged from 2.0+ to 3.7+ months with a median duration of follow-up of 3.1 months.

In April 2022, the ~~NMPA~~Board of Directors of the Company authorized the Company’s senior management to proceed with the relevant preparatory work and undertake necessary steps to pursue a ~~Marketing Authorization Application for Optune Lua~~voluntary conversion to dual-primary listing on the Hong Kong Stock Exchange. Following the voluntary conversion, the Company’s ordinary shares and American Depositary Shares will continue to be traded on the Hong Kong Stock Exchange and the Nasdaq Global Market, respectively, and remain mutually fungible. Becoming a dual-primary listed company will enable the Company to be eligible for the ~~treatment of unresectable, locally advanced or metastatic malignant pleural mesothelioma.~~Hong Kong Stock Exchange Stock Connect, a channel by which investors in mainland China can invest in stocks traded on the Hong Kong Stock Exchange.

Recent Legal and Regulatory Developments

Provisions on Strengthening Confidentiality and Archives Administration of Overseas Securities Offering and Listing by Domestic Companies (Draft for Comments)

On April 2, 2022, the CSRC published the revised Provisions on Strengthening Confidentiality and Archives Administration of Overseas Securities Offering and Listing by Domestic Companies (Draft for Comments) (the “Draft Archives Rules”).

The Draft Archives Rules require that, in relation to the overseas securities offering and listing activities of Chinese domestic enterprises, such domestic enterprises, as well as securities companies and securities service institutions providing relevant securities services, are required to strictly comply with the relevant requirements on confidentiality and archives management, establish a sound confidentiality and archives system and take necessary measures to implement their confidentiality and archives management responsibilities.

According to the Draft Archives Rules, if during the course of an overseas offering and listing (whether listed directly or indirectly), if a Chinese domestic company needs to publicly disclose or provide, or publicly disclose or provide through its overseas listed entity, to relevant entities or individuals including securities companies, other securities service providers and overseas regulators, any documents and materials that contain relevant state secrets, government department work secrets or that have a sensitive impact (i.e., that are detrimental to national security or the public interest if divulged), the Chinese domestic company should complete the relevant approval/filing and other regulatory procedures stipulated by applicable national regulations.

In addition, the Draft Archives Rules explicitly include within the scope of its supervision overseas accounting firms that engage in auditing business related to overseas securities offering and listings of Chinese domestic enterprises. Overseas accounting firms that engage in auditing business related to overseas securities offering and listings of Chinese domestic enterprises are required to abide by corresponding procedures in accordance with relevant Chinese national regulations.

Amended China Civil Procedure Law

The Civil Procedure Law of the People’s Republic of China, or the China Civil Procedure Law, which was adopted on April 9, 1991 and amended on October 28, 2007, August 31, 2012, June 27, 2017, and December 24, 2021, prescribes the conditions for instituting a civil action, the jurisdiction of the people’s courts, the procedures for conducting a civil action and the procedures for enforcement of a civil judgment or ruling. The most recent amendments to the China Civil Procedure Law on December 24, 2021, which came into effect on January 1, 2022, include the following improvements to the civil procedure under China’s current judicial system: (i) with the consent of the parties, civil litigation activities may be conducted online through the information network platform and such online litigation activities have the same legal effect as offline litigation activities; (ii) in addition to civil cases followed by summary procedure, civil cases followed by ordinary procedure and civil cases of second instance which meet certain criteria may also be tried by a single judge; (iii) the scope of the litigation documents which are allowed to be served by electronic means expands to include judgments, awards and mediation statements; (iv) the period of service which is effected by public announcement in cases where the location of the recipient of the service is unknown or the service cannot be served by other means specified in the China Civil Procedure Law is shortened from 60 days to 30 days; (v) with respect to small claims procedure, the amount of the subject matter applicable to small claims procedure is raised, the trial time for small claims procedure is limited to three months and certain types of cases, such as cases of personal relation, are excluded from application of small claims procedure; and (vi) the jurisdiction of judicial conformation of a mediation agreement is further clarified and the parties to a mediation agreement are given more options in terms of choosing the people’s court for judicial conformation.

Table of Contents

Collecting and Using China-Sourced Human Genetic Resources and Derived Data

On March 4, 2022, the Ministry of Science and Technology (MOST) issued Answers to Frequently Asked Questions Regarding Human Genetic Resources (HGRs) Administration, or the Q&A Series I. The Q&A Series I provides short answers to 30 frequently asked questions relating to the collection, preservation, utilization and external provision of China-sourced HGRs. For example, the Q&A Series I clarifies that a notification filing with the Human Genetic Resources Administration Office of China, or HGRAC, is required for purpose of transferring China-sourced HGRs to regulatory authorities in other jurisdictions.

On March 22, 2022, the Ministry of Science and Technology (MOST) issued the Draft Implementing Rules of the Regulation on the Administration of Human Genetic Resources (Draft for Comment), or the Draft Implementing Rules, which closely scrutinizes all HGRs-related activity from upstream collection of HGR materials to downstream exploitation and external provision of the HGR materials and data derived therefrom (“HGR data”). The Draft Implementing Rules are intended to provide operational details and clarify questions that have emerged in the past few years after the Regulation on the Administration of Human Genetic Resources became effective. Under the Draft Implementing Rules, clinical studies conducted for purpose of obtaining marketing authorization for drugs and medical devices in China, if not involving the export of HGR materials, will be eligible for a notification filing (as opposed to the advance approval) if the HGR materials are collected by sites, and processed by sites or an onshore third-party lab specified in the clinical trial protocol. The Draft Implementing Rules provide clearer guidance on how to allocate the intellectual property derived from a Sino-foreign cooperative research utilizing China-Sourced HGRs. The Draft Implementing Rules enumerate situations where a security review is required for external provision or utilization in an open manner of HGR data, such as external provision or utilization in an open manner of HGR data about important genetic pedigrees, HGR data from specific regions, and exome sequencing and genome sequencing information of over 500 individuals.

On April 15, 2022, MOST issued Answers to Frequently Asked Questions Regarding Human Genetic Resources Administration (Q&A Series II), or the Q&A Series II. The Q&A Series II provide formal written reply to 5 frequently asked questions relating to the collection, preservation, utilization and external provision of China-Sourced HGRs. The Q&A Series II specifies that collection, external provision or utilization in an open manner of the data related to clinical practices, patient demographics, lab tests, medical images, etc. that do not carry genetic attributes will not be regulated as collection, external provision or utilization in an open manner of HGR data. The Q&A Series II stipulates that no advance approval for Sino-foreign cooperative research is required for a research utilizing China-Sourced HGRs, if the foreign entity who provides funding support will not substantially participate in the research and have any access to or ownership of the research data and research results.

Auxiliary Rules for the Regulations on Supervision and Administration of Medical Devices

On March 18, 2021, the State Council ~~passed~~published new Regulations on Supervision and Administration of Medical ~~Device Regulations (State Council Order #739),~~Devices, or Order ~~#739, to replace the existing Medical Device Regulations (State Council Order #680), or Order #680. Order #739 was published by the National Medical Products Administration (NMPA) and~~739, which became effective on June 1, 2021. ~~Order #739 largely follows~~This

top-level

medical device administrative regulation contains a number of important changes, the ~~legislative structure~~practical effects of which will be implemented in corresponding auxiliary regulations and rules. Recently, a series of regulations have been amended accordingly to support the implementation of Order ~~#680. We, as the Chinese legal agent for Optune~~739 in China, are subject to the statutory compliance requirements under Order #739. The following updates from Order #739 we believe are the most relevant to our compliance obligations and our business operations in China:

~~hinese legal agent~~

. Under Order #739, foreign device MAHs will still need to appoint a Chinese legal entity to submit regulatory applications and correspond with regulatory authorities. Nevertheless, the local appointees may only need to play a secondary role to assist the foreign device MAHs in the performance of compliance obligations under Order #739.

~~Table of Contents~~

~~iabilities for~~

~~non-compliance~~

~~. Order #739 significantly increases MAH’s liabilities for~~

~~non-compliance.~~

Order #739 also introduces personal liability on the legal representatives, main responsible persons, directly responsible supervisors or other personnel of MAHs. While Order #680 does not differentiate the liability of local legal agents from the foreign device MAHs, Order #739 makes it clear that local appointees will assume a lesser degree of liability compared to the foreign device MAHs. If local appointees fail to perform the statutory responsibilities and obligations on behalfterms of the ~~MAHs, they will be subject to administrative fines up to RMB 0.5 million,~~production, distribution and ~~their responsible personnel will only be subject to a five-year debarment. In comparison, foreign MAHs who refuse to fulfill the administrative penalties may be subject to a~~

~~ten-year~~

~~import ban.~~

clinical trials of medical devices.

~~AH system~~

~~. The MAH system will be rolled out nationwide. MAHs will be responsible~~Measures for the ~~safety~~Supervision and ~~effectiveness~~Administration of the Production of Medical Devices

On May 1, 2022, a revised version of the Measures for the Supervision and Administration of the Production of Medical Devices, or Order 53, promulgated by the State Administration for Market Regulation, or SAMR, became effective. All medical device manufacturing activities within China should comply with Order 53. Order 53 clarifies the responsibilities and obligations of medical device registrants/ record-filing applicants and their ~~products during the entire~~entrusted manufacturers where applicable. Order 53 also establishes a medical device reporting system with an aim to improve administration of medical device production. The reporting system consists of several types of report, including annual self-inspection report, production product ~~life cycle. They must establish a quality management system and ensure its effectiveness, define and implement a post-approval study and risk control plan, conduct adverse event monitoring and~~variety report, production conditions change report,

~~re-evaluation,~~re-production

~~establish and implement the product tracing~~report and recall ~~system,~~ and ~~fulfill other statutory obligations imposed by~~disposal report. The medical device registrants/ record-filing applicants and/or the ~~NMPA.~~

medical device manufacturers need to submit corresponding reports to the local relevant Medical Product Administrations in accordance with Order 53.

EMeasures for the Supervision and Administration of the Distribution of Medical Devices

~~ncouraging innovations~~

. As a core theme of its drafting philosophy, Order #739 encourages innovations in medical device technologies and will continue to allow the “fast track approval process” to accelerate the product launch timeline for innovative devices. Under Order #739, imported medical devices that are

~~“first-in-class”~~

~~and have Chinese invention patent(s) covering their core technologies do not need to be approved outside of China before the NMPA’s marketing authorization.~~

~~linical evidence~~

. The NMPA will allow versatile clinical evidence to demonstrate product safety and effectiveness. Such evaluation can be based on clinical study data or analysis of clinical literature and clinical data on predicate devices.

~~xpanded access~~

. Expanded access to investigational devices will be made available for patients in the study sites upon ethics committee approval and the patients’ giving informed consent, provided that the investigational devices are used for critical, life-threatening diseases without an effective treatment method and can confer clinical benefits on patients based on medical judgment.

~~To implement Order #739, from March to June of 2021, the NMPA also published draft administrative regulations on the registration, manufacturing, distribution, Good Clinical Practices and~~

~~company-led~~

~~type tests for medical devices for public comment.~~

~~PRC Biosecurity Law~~

On ~~April 15, 2021, the PRC Biosecurity Law took effect.~~

~~PRC Patent Law~~

~~On June~~May 1, ~~2021, the fourth amendment to the PRC Patent Law took effect.~~

On July 3, 2021, the Implementing Measure to Early-Stage Resolution Mechanism for Pharmaceutical Patent Disputes (Tentative) (the “Measures”), jointly issued by the NMPA and the China National Intellectual Property Administration jointly, took effect. The Measures give practical guidance on the patent linkage system in China, where the drug originators are permitted to list on a public registration system certain patents that are relevant to approved drugs. Generic and biosimilar drug applicants must then make certifications when applying for drug approval in respect of the listed patents. Where the certification is a type IV certification which alleges the invalidity of the listed patents or alleges that the scope of the listed patents does not cover the generic or biosimilar drug that is the subject of the drug approval application, drug originators have an opportunity to pursue administrative or judicial litigation to determine patent infringement prior to commercial sale, and in the case of chemical generics, obtain a

~~9-month~~

approval stay on the chemical generic drug approval application. Upon successful litigation prior to the approval of the generic or biosimilar drug, the drug originators may delay the grant of the approval of a chemical generic drug until after patent expiry or have the approval of a biosimilar drug be conditioned upon patent expiry.

~~PRC Data Security and Cybersecurity~~

In June 2021, China’s top legislative body, the National People’s Congress, passed the Data Security Law (DSL). Being the first comprehensive data security legislation in China, the DSL will take effect on September 1, 2021, and it covers a wide range of issues relating to the collection, storage, processing, use, provision, transaction and publication of data. The DSL provides that the data processing activities must be conducted based on “data classification and hierarchical protection system” for the purpose of data protection. The DSL has extraterritorial effect and it applies to any data processing activities outside China if such activities would be detrimental to the national security or public interest of China or the interests of Chinese citizens or organizations.

~~In July 2021, the Cyberspace Administration of China published~~2022, a revised ~~draft~~version of the Measures ~~on Cybersecurity Review, expanding~~for the ~~cybersecurity review~~Supervision and Administration of the Distribution of Medical Devices, or Order 54, promulgated by SAMR came into effect. All medical device distribution activities within China should comply with Order 54. Under Order 54, explicit regulatory requirements were introduced to ~~data processing operators in possession~~distributors of ~~personal information~~medical devices. For example, Order 54 requires medical device distributors to establish quality management system and adopt quality control measures covering the total process of ~~over 1 million users if the operators intend~~distribution and submit annual self-inspection reports to ~~list their securities in a foreign country.~~local relevant Medical Product Administrations.

~~Also, recently,~~

Good Practices for Medical Device Clinical Trials

On May 1, 2022, a revised version of the Good Practices for Medical Device Clinical Trials, or 2022 Medical Device GCP, jointly released by the NMPA and the National ~~People’s Congress released~~Health Commission, came into effect. Going forward, all medical device clinical trials that haven’t passed ethical review by May 1, 2022 should be conducted in compliance with the ~~second consultation draft~~2022 Medical Device GCP, if they are conducted for purpose of applying for medical device registration. The 2022 Medical Device GCP specifies responsibilities of each party participating in a medical device clinical trial, in particular the responsibilities of the ~~Personal Information Protection Law.~~sponsor. The ~~draft proposes a comprehensive set~~2022 Medical Device GCP no longer requires clinical trials of ~~data privacy and protection requirements that apply~~medical devices to ~~the processing of personal information and expands data protection compliance obligations~~be conducted in two or more clinical trial institutions. This will make it easier for medical device companies to cover the processing of personal information of persons by organizations and individuals in China, and the processing of personal information of persons in China outside of China if such processing is for purposes of providing products and services to, or analyzing and evaluating the behavior of, persons in China. The draft also proposes that critical information infrastructure operators and personal information processing entities who process personal information meeting a volume threshold

~~to-be-set~~conduct medical device registration studies.

by Chinese cyberspace regulators are also required to store in China personal information generated or collected in China, and to pass a security assessment administered by Chinese cyberspace regulators for any export of such personal information. Lastly, the draft contains proposals for significant fines for serious violations of up to RMB 50 million or 5% of annual revenues from the prior year.

Factors Affecting our Results of Operations

Research and Development Expenses

We believe our ability to successfully develop product candidates will be the primary factor affecting our long-term competitiveness, as well as our future growth and development. Developing high quality product candidates requires a significant investment of resources over a prolonged period of time, and a core part of our strategy is to continue making sustained investments in this area. As a result of this commitment, our pipeline of product candidates has been steadily advancing and expanding, with twelve late-stage clinical product candidates being investigated as of ~~June 30, 2021.~~March 31, 2022.

~~To date, we~~We have financed our activities primarily through private placements, our initial public offering on Nasdaq in September 2017, multiple

follow-on

offerings and a secondary listing on the Hong Kong Stock Exchange ~~of Hong Kong and multiple~~

~~follow-on~~

~~offerings.~~in September 2020. Through ~~June 30, 2021,~~March 31, 2022, we have raised approximately $164.6 million infrom private equity financing and approximately $2,462.7 million in net proceeds after deducting underwriting commissions and the offering expenses payable by us infrom our initial public offering, ~~our~~

follow-on

offerings and secondary ~~listing and our~~

~~follow-on~~

~~offerings.~~listing. Our operations have consumed substantial amounts of cash since inception. The net cash used in our operating activities was ~~$235.3~~$87.1 million and ~~$92.3~~$169.5 million, for the ~~six~~three months ended ~~June 30,~~March 31, 2022 and 2021, ~~and June 30, 2020,~~ respectively. We expect our expenditures to increase significantly in connection with our ongoing activities, particularly as we advance the clinical development of our twelve late-stage clinical product candidates, ~~and continue~~ research and ~~development of~~develop our ~~clinical~~clinical- and

~~pre-clinical-~~pre-clinical-stage

~~stage~~ product candidates and initiate additional clinical trials of, and seek regulatory approval for, these and other future product candidates. These expenditures include:

expenses incurred for ~~payments to~~ contract research organizations ~~(“CROs”)~~(CROs), contract manufacture organizations ~~(“CMOs”)~~(CMOs), investigators and clinical trial sites that conduct our clinical studies;

employee compensation related expenses, including salaries, benefits and equity compensation expenses;

expenses for licensors;

the cost of acquiring, developing and manufacturing clinical study materials;

facilities ~~depreciation~~ and other expenses, which include office leases and other overhead expenses;

costs associated with

pre-clinical

activities and regulatory operations;

expenses associated with the construction and maintenance of our manufacturing facilities; and

costs associated with operating as a public company.

Selling, General and Administrative Expenses

Our selling, general and administrative expenses consist primarily of personnel compensation and related costs, including share-based compensation for commercial and administrative personnel. Other selling, general and administrative expenses include product distribution and promotion costs, professional service fees for legal, intellectual property, consulting, auditing and tax services as well as other direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies used in selling, general and administrative activities. We anticipate that our selling, general and administrative expenses will increase in future periods to support increases in our commercial and research and development activities and as we continue to commercialize, develop and manufacture our products and assets. These increases will likely include increased headcount, increased ~~share~~share-based compensation charges, increased product distribution and promotion costs, expanded infrastructure and increased costs for insurance. We also anticipate to incur ~~increased~~additional legal, compliance, accounting and investor and public relations expenses associated with being a public company.

Table of Contents

Our Ability to Commercialize Our Product Candidates

As of ~~June 30, 2021,~~March 31, 2022, twelve of our product candidates are in late-stage clinical development and various others are in clinical and

pre-clinical

development in Greater China and the United States. Our ability to generate revenue from our product candidates is dependent on our receipt of regulatory approvals for and successful commercialization of such products, which may never occur. Certain of our product candidates may require additional

pre-clinical

and/or clinical development, regulatory approvals in multiple jurisdictions, manufacturing supply, substantial investment and significant marketing efforts before we generate any revenue from product sales.

~~Table of Contents~~

Our License Arrangements

Our results of operations have been, and we expect them to continue to be, affected by our licensing, collaboration and development agreements. We are required to make upfront payments upon our entry into such agreements and milestone payments upon the achievement of certain development, regulatory and commercial milestones for the relevant products under these agreements as well as tiered royalties based on the net sales of the licensed products. These upfront payments and milestone payments upon the achievement of certain development and regulatory milestones are recorded in research and development expense in our unaudited condensed consolidated financial statements and totaled ~~$269.2 million for the six months ended June 30, 2021~~nil and ~~$98.0~~$171.3 million for the three months ended ~~June 30, 2021. The upfront payments~~March 31, 2022 and ~~milestone payments are recorded in research and development expense and was $51.7 million for the six months ended June 30, 2020 and $42.5 million for the three months ended June 30, 2020.~~

~~Key Components of Results of Operations~~

~~Taxation~~

~~Cayman Islands~~

Zai Lab Limited is incorporated in the Cayman Islands. The Cayman Islands currently levies no taxes on profits, income, gains or appreciation earned by individuals or corporations. In addition, our payment of dividends, if any, is not subject to withholding tax in the Cayman Islands. For more information, see “Taxation—Material Cayman Islands Taxation” in our Annual Report on Form

~~10-K~~

~~for the year ended December~~March 31, ~~2020.~~

~~People’s Republic of China~~

Our subsidiaries incorporated in China are governed by the EIT Law and regulations. Under the EIT Law, the standard EIT rate is 25% on taxable profits as reduced by available tax losses. Tax losses may be carried forward to offset any taxable profits for up to following five years. For more information, see “Taxation—Material People’s Republic of China Taxation” in our Annual Report on Form

~~10-K~~

~~for the year ended December 31, 2020.~~

~~Hong Kong~~

~~Our subsidiaries incorporated in Hong Kong are subject to~~

~~two-tiered~~

~~tax rates for the six months ended June 30,~~ 2021, and 2020 on assessable profits earned in Hong Kong where the profits tax rate for the first HK$2 million of assessable profits is subject to profits tax rate of 8.25% and the assessable profits above HK$2 million is subject to profits tax rate of 16.5%. Our subsidiaries incorporated in Hong Kong did not have assessable profit for the six months ended June 30, 2021 and 2020.respectively.

Results of Operations

The following table sets forth a summary of our consolidated results of operations for the periods indicated. This information should be read together with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report. Our operating results in any period are not necessarily indicative

Three Months Ended March 31, 2022 Compared to Three Months Ended March 31, 2021

Revenues

Total revenues consist of the ~~results that may be expected for any future period.~~following:

Three months ended June 30,

Six months ended June 30,


2021

2020

2021

2020

(in thousands, except share and per share data)
Comprehensive Loss Data:

Revenue
   $ 36,935    $ 10,995    $ 57,038    $ 19,213
Expenses:

Cost of sales
   (10,868 )    (2,896 )    (18,373 )    (4,980 )
Research and development
   (142,224 )    (68,307 )    (346,076 )    (102,049 )
Selling, general and administrative
   (54,414 )    (23,758 )    (90,252 )    (42,472 )








Loss from operations
   $ (170,571 )    $ (83,966 )    $ (397,663 )    $ (130,288 )
Interest income
   244    1,227    458    2,882
Interest expenses
   —      (55 )    —      (114 )
Other income (expense), net
   7,406    2,434    1,179    (691 )








Loss before income tax and share of loss from equity method investment
   $ (162,921 )    $ (80,360 )    $ (396,026 )    $ (128,211 )
Income tax expense
   —      —      —      —
Share of loss from equity method investment
   (403 )    (269 )    (208 )    (406 )








Net loss attributable to ordinary shareholders
   $ (163,324 )    $ (80,629 )    $ (396,234 )    $ (128,617 )
Weighted-average shares used in calculating net loss per ordinary share, basic and diluted
   93,045,531    74,738,563    90,723,132    73,847,551
Net loss per share, basic and diluted
   $ (1.76 )    $ (1.08 )    $ (4.37 )    $ (1.74 )


	Three months ended March 31,
(in thousands)	2022		%		2021		%
Revenues:
Product revenue, net	$	46,095		98.7	$	20,103		100.0
Collaboration revenue		629		1.3		—		—

Total	$	46,724		100.0	$	20,103		100.0

Product Revenue, net

Our product revenue is primarily derived from the sales of ZEJULA, Optune, QINLOCK, and NUZYRA in mainland China and Hong Kong. The amount of revenue of ZEJULA for the three months ended March 31, 2022 and March 31, 2021, respectively, was adjusted by the normal process in mainland China to compensate distributors for products recently sold at prices prior to the NRDL implementation. The following table disaggregates net revenue by product for the three months ended March 31, 2022 and 2021, respectively:


(in thousands)	Three months ended March 31,
(in thousands)	2022		%		2021		%
ZEJULA	$	29,597		64.2	$	12,606		62.7
Optune		12,797		27.8		7,130		35.5
QINLOCK		2,959		6.4		367		1.8
NUZYRA		742		1.6		—		—

Total product revenue, net	$	46,095		100.0	$	20,103		100.0

~~Three Months Ended June 30, 2021 Compared to Three Months Ended June 30, 2020~~Collaboration revenue

~~Revenue~~

~~Our~~Collaboration revenue ~~is derived from the sale of ZEJULA, Optune and QINLOCK in China and Hong Kong. The following table disaggregates net revenue~~increased by ~~product~~$0.6 million to $0.6 million for the three months ended ~~June 30,~~March 31, 2022 from nil for the three months ended March 31, 2021 ~~and 2020:~~from the collaborative arrangement with Huizheng (Shanghai) Pharmaceutical Technology Co., Ltd.

Cost of Sales

Three Months Ended June 30,

(in thousands)

2021

%

2020

%

ZEJULA
   $ 23,366    63.3    $ 7,446    67.7
Optune
   9,535    25.8    3,549    32.3
QINLOCK
   4,034    10.9    —      —








Total product revenue—Net
   $ 36,935    100.0    $ 10,995    100.0

Cost of sales increased by $8.1 million to $15.6 million for the three months ended March 31, 2022 from $7.5 million for the three months ended March 31, 2021 primarily due to increasing sales volume, product costs and higher royalties during the three months ended March 31, 2022.

Research and Development Expenses

The following table sets forth the components of our research and development expenses for the ~~periods~~respective period indicated.


	Three Months Ended June 30,
(in thousands)	2021		%		2020		%		Three months ended March 31,
Research and Development Expenses:
(in thousands)									2022		%		2021		%
(in thousands)
Personnel compensation and related costs	$	17,282		12.1	$	11,596		17.0	$	24,802		46.1	$	12,697		6.2
Licensing fees		97,966		68.9		42,480		62.2		—		—		171,282		84.0
Payment to CROs/CMOs/Investigators		19,618		13.8		9,982		14.6
CROs/CMOs/Investigators expenses										23,550		43.7		15,526		7.6
Other costs		7,358		5.2		4,249		6.2		5,502		10.2		4,347		2.2

Total	$	142,224		100.0	$	68,307		100.0	$	53,854		100.0	$	203,852		100.0

Research and development expenses ~~increased~~decreased by ~~$73.9~~$150.0 million to ~~$142.2~~$53.9 million for the three months ended ~~June 30, 2021~~March 31, 2022 from ~~$68.3~~$203.9 million for the three months ended ~~June 30, 2020. The increase~~March 31, 2021 primarily due to:

a decrease of $171.3 million in ~~research~~licensing fees in connection with the upfront and ~~development expenses included~~milestone fee paid for licensing agreement due to no new licensing for the ~~following:~~three months ended March 31, 2022; offset by

~~$5.7~~an increase of $12.1 million ~~for increased~~in personnel compensation and related costs ~~which was~~ primarily attributable to increased employee compensation costs due to ~~hiring of more personnel~~headcount growth during the three months ended ~~June 30, 2021~~March 31, 2022 and the grants of new share options and vesting of restricted shares to certain ~~employees;~~

~~$55.5 million for increased licensing fees in connection with the upfront payments for new licensing agreements as well as certain milestone fees;~~employees, and

~~$9.6~~an increase of $8.0 million ~~for increased payments to CROs, CMOs and investigators~~in CROs/CMOs/Investigators expenses in the three months ended ~~June 30, 2021~~March 31, 2022 as we advanced our drug candidate pipeline.

The following table summarizes our research and development expenses by program for the three months ended ~~June 30,~~March 31, 2022 and 2021, ~~and 2020,~~ respectively:


	Three Months Ended June 30,
(in thousands)	2021		%		2020		%		Three months ended March 31,
Research and Development Expenses:
(in thousands)									2022		%		2021		%
(in thousands)
Clinical programs	$	93,433		65.7	$	52,003		76.1	$	22,852		42.4	$	186,256		91.4
Pre-clinical programs		28,545		20.1		2,227		3.3		2,565		4.8		2,500		1.2
Unallocated research and development expenses		20,246		14.2		14,077		20.6		28,437		52.8		15,096		7.4

Total	$	142,224		100.0	$	68,307		100.0	$	53,854		100.0	$	203,852		100.0

~~During~~

Research and development expenses attributable to clinical programs decreased by $163.4 million from $186.3 million during the three months ended ~~June 30,~~March 31, 2021 ~~65.7% and 20.1%~~(which included the licensing fees of ~~our total research and development expenses were attributable~~$171.3 million) to ~~clinical programs and~~

~~pre-clinical~~

~~programs, respectively. During~~$22.9 million during the three months ended ~~June 30, 2020, 76.1% and 3.3% of our total research~~March 31, 2022. Research and development expenses ~~were~~ attributable to ~~clinical programs and~~

pre-clinical

programs ~~respectively.~~remained relatively consistent during the three months ended March 31, 2022 compared to the three months ended March 31, 2021. Although we manage our external research and development expenses by program, we do not allocate our internal research and development expenses by program because our employees and internal resources may be engaged in projects for multiple programs at any given time.

Selling, General and Administrative Expenses

The following table sets forth the components of our selling, general and administrative expenses for the ~~periods~~respective period indicated.


	Three Months Ended June 30,
(in thousands)									Three months ended March 31,
(in thousands)	2021		%		2020		%		2022		%		2021		%
Selling, General and Administrative Expenses:
Personnel compensation and related costs		30,060		55.2		14,040		59.1	$	38,203		67.0	$	23,412		65.3
Professional service fees		4,806		8.8		2,543		10.7		7,433		13.0		3,583		10.0
Other costs		19,548		36.0		7,175		30.2		11,355		20.0		8,843		24.7

Total	$	54,414		100.0	$	23,758		100.0	$	56,991		100.0	$	35,838		100.0

Selling, general and administrative expenses increased by ~~$30.7~~$21.2 million to ~~$54.4~~$57.0 million for the three months ended ~~June 30, 2021~~March 31, 2022 from ~~$23.8~~$35.8 million for the three months ended ~~June 30, 2020. The increase in general and administrative expenses included the following:~~March 31, 2021 primarily due to:

~~$16.0~~an increase of $14.8 million ~~for increased~~in personnel compensation and related costs which was primarily attributable to increased commercial and administrative personnel costs due to ~~hiring of more personnel~~headcount growth during the three months ended ~~June 30, 2021~~March 31, 2022 and the grants and vesting of ~~new~~ share options and ~~vesting of~~ restricted shares to certain employees;

~~$2.3~~an increase of $3.9 million ~~for increased~~in professional service ~~fee,~~fees mainly attributable to our increased legal, compliance, accounting and investor and public relations expenses associated with being a public ~~company;~~company and in connection with sales of ZEJULA, Optune, QINLOCK and NUZYRA in mainland China and Hong Kong after our commercial launch of these four commercialized products; and

~~$12.4~~an increase of $2.5 million ~~for increased~~in other costs mainly including selling, rental, and administrative expenses ~~primary~~primarily attributable to the commercial operation in mainland China, Hong Kong, and ~~China.~~Taiwan.

Interest Income

Interest income ~~decreased by $1.0~~were $0.2 million toand $0.2 million for the three months ended ~~June 30,~~March 31, 2022 and 2021, ~~from $1.2~~respectively.

Other Expenses, Net

Other expenses decreased by $3.6 million to $2.6 million for the three months ended ~~June 30, 2020 primary due to the decrease of short-term investments balance.~~

~~Interest Expenses~~

~~Interest expenses is nil for the three months ended June 30, 2021, compared to $0.1~~March 31, 2022 from $6.2 million for the three months ended ~~June 30, 2020, as all the short-term borrowings were repaid in 2020.~~

~~Share of loss from equity method investment~~

~~In June 2017, we entered into an agreement with three~~

~~third-parties~~

to launch JING Medicine Technology (Shanghai) Ltd. (“JING”), an entity which provides services for product discovery and development, consultation and transfer of pharmaceutical technology. We recorded loss of $0.4 million and $0.3 million for its portion of JING’s net loss for the three months June 30,March 31, 2021, ~~and 2020, respectively.~~

~~Other Income (Expense), net~~

~~Other income (expense), net increased by $5.0 million for the three months ended June 30, 2021, as compared to the three months ended June 30, 2020,~~ primarily as a result of an increase in foreign exchange gain and ~~partially offset by a decrease~~governmental subsidies net of equity investment loss in ~~governmental subsidies.~~

~~Net Loss Attributable to Ordinary Shareholders~~

As a result of the foregoing, we had net loss attributable to ordinary shareholders of $163.3 million for the three months ended June 30, 2021 compared to net loss attributable to ordinary shareholders of $80.6 million for the three months ended June 30, 2020.MacroGenics.

~~Six Months Ended June 30, 2021 Compared to Six Months Ended June 30, 2020~~

~~Revenue~~

Our revenue is derived from the sale of ZEJULA, Optune and QINLOCK in China and Hong Kong. The amount of revenue of ZEJULA for the six months ended June 30, 2021, was adjusted by the normal process in China to compensate distributors for products recently sold at prices prior to the National Reimbursement Drug List (NRDL) implementation. The following table disaggregates net revenue by product for the six months ended June 30, 2021 and 2020:

Six Months Ended June 30,

(in thousands)

2021

%

2020

%

ZEJULA
   $ 35,972    63.1    $ 13,791    71.8
Optune
   16,665    29.2    5,422    28.2
QINLOCK
   4,401    7.7    —      —








Total product revenue—Net
   $ 57,038    100.0    $ 19,213    100.0

~~Research and Development Expenses~~

~~The following table sets forth the components of our research and development expenses for the periods indicated.~~

Six Months Ended June 30,

(in thousands)

2021

%

2020

%

Research and Development Expenses:

Personnel compensation and related costs
   $ 29,979    8.7    $ 21,600    21.2
Licensing fees
   269,248    77.8    51,720    50.7
Payment to CROs/CMOs/Investigators
   35,144    10.1    19,812    19.4
Other costs
   11,705    3.4    8,917    8.7








Total
   $ 346,076    100.0    $ 102,049    100.0

Research and development expenses increased by $244.0 million to $346.1 million for the six months ended June 30, 2021 from $102.0 million for the six months ended June 30, 2020. The increase in research and development expenses included the following:

$8.4 million for increased personnel compensation and related costs which was primarily attributable to increased employee compensation costs, due to hiring of more personnel during the six months ended June 30, 2021 and the grants of new share options and vesting of restricted shares to certain employees;

~~$217.5 million for increased licensing fees in connection with the upfront payments for new licensing agreements as well as certain milestone fees; and~~

~~$15.3 million for increased payment to CROs, CMOs and investigators in the six months ended June 30, 2021 as we advanced our drug candidate pipeline.~~

~~The following table summarizes our research and development expenses by program for the six months ended June 30, 2021 and 2020, respectively:~~

Six Months Ended June 30,

(in thousands)

2021

%

2020

%

Research and Development Expenses:

Clinical programs
   $ 279,689    80.8    $ 72,335    70.9
Pre-clinical
programs
   31,045    9.0    2,915    2.9
Unallocated research and development expenses
   35,342    10.2    26,799    26.2








Total
   $ 346,076    100.0    $ 102,049    100.0

~~During the six months ended June 30, 2021, 80.8% and 9.0% of our total research and development expenses were attributable to clinical programs and~~

~~pre-clinical~~

~~programs, respectively. During the six months ended June 30, 2020, 70.9% and 2.9% of our total research and development expenses were attributable to clinical programs and~~

~~pre-clinical~~

programs, respectively. Although we manage our external research and development expenses by program, we do not allocate our internal research and development expenses by program because our employees and internal resources may be engaged in projects for multiple programs at any given time.

~~Selling, General and Administrative Expenses~~

~~The following table sets forth the components of our selling, general and administrative expenses for the periods indicated.~~

Six Months Ended June 30,

(in thousands)

2021

%

2020

%

Selling, General and Administrative Expenses:

Personnel compensation and related costs
   $ 53,472    59.2    $ 27,082    63.8
Professional service fees
   8,389    9.3    4,570    10.7
Other costs
   28,391    31.5    10,820    25.5








Total
   $ 90,252    100.0    $ 42,472    100.0

Selling, general and administrative expenses increased by $47.8 million to $90.3 million for the six months ended June 30, 2021 from $42.5 million for the six months ended June 30, 2020. The increase in general and administrative expenses included the following:

$26.4 million for increased personnel compensation and related costs which was primarily attributable to increased commercial and administrative personnel costs, due to hiring of more personnel during the six months ended June 30, 2021 and the grants of new share options and vesting of restricted shares to certain employees;

$3.8 million for increased professional service fee, mainly attributable to our increased legal, compliance, accounting and investor and public relations expenses associated with being a public company; and

~~$17.6 million for increased other costs, mainly including selling, rental, and administrative expenses primary attributable to the commercial operation in Hong Kong and China.~~

~~Interest Income~~

Interest income decreased by $2.4 million, to $0.5 million for the six months ended June 30, 2021, from $2.9 million for the six months ended June 30, 2020 primary due to the decrease of short-term investments balance.

~~Interest Expenses~~

~~Interest expenses is nil for the six months ended June 30, 2021, compared to $0.1 million for the six months ended June 30, 2020, as all the short-term borrowings were repaid in 2020.~~

~~Share of loss from equity method investment~~

In June 2017, we entered into an agreement with three third-parties to launch JING Medicine Technology (Shanghai) Ltd., or JING, an entity that will provide services for product discovery and development, consultation and transfer of pharmaceutical technology. We recorded the gain on deemed disposal in this investee of $0.5 million and share of loss of $0.7 million for the six months ended June 30, 2021, and recorded share of loss in this investee of $0.4 million for the six months ended June 30, 2020.

~~Other Income (Expense), net~~

Other income (expense), net increased by $1.9 million for the six months ended June 30, 2021, as compared to the six months ended June 30, 2020, primarily as a result of an increase in foreign exchange gain and partially offset by a decrease in governmental subsidies.

~~Net Loss Attributable to Ordinary Shareholders~~

As a result of the foregoing, we had net loss attributable to ordinary shareholders of $396.2 million for the six months ended June 30, 2021 compared to net loss attributable to ordinary shareholders of $128.6 million for the six months ended June 30, 2020.

Critical Accounting Policies and Significant Judgments and Estimates

We prepare our financial statements in conformity with U.S. GAAP, which requires us to make judgments, estimates and assumptions. We ~~continually~~periodically evaluate these estimates and assumptions based on the most recently available information, our own historical experiences and various other assumptions that we believe to be reasonable under the circumstances. Since the use of estimates is an integral component of the financial reporting process, actual results could differ from our expectations as a result of changes in our estimates. Some of our accounting policies require a higher degree of judgment than others in their application and require us to make significant accounting estimates.

The selection of critical accounting policies, the judgments and other uncertainties affecting application of those policies and the sensitivity of reported results to changes in conditions and assumptions are factors that should be considered when reviewing our financial statements. We believe the following accounting policies involve the most significant judgments and estimates used in the preparation of our financial statements.

Revenue recognition

~~In 2018, we adopted ASC Topic 606 (“ASC 606”),~~

~~Revenue~~Description

~~from~~

~~Contracts~~

~~with~~

~~Customers,~~

in recognition of revenue. Under ASC 606, we recognize revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration expected to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the

~~five-step~~

model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for the goods or services we transfer to the customer. Once a contract is determined to be within the scope of ASC 606 at contract inception, we review the contract to determine which performance obligations we must deliver and which of these performance obligations are distinct. We recognize as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied.

Our revenue is from product sales. We recognize revenue from product sales when we have satisfied the performance obligation by transferring control of the product to the customers. Control of the product generally transfers to the customers when the delivery is made and when title and risk of loss transfers to the customers. Cost of sales mainly consists of the acquisition cost of products and royalty fees.

We have applied the practical expedients under ASC 606 with regard to assessment of financing components and concluded that there is no significant financing component given that the period between delivery of goods and payment is generally one year or less. We have generated product sales revenue since 2018. Our product revenues were primarily generated from the sale of ZEJULA (niraparib), Optune (Tumor Treating Fields) and QINLOCK (ripretinib) to customers.

In mainland China, we sell ~~the~~our products to distributors, who ultimately sell the products to healthcare providers. Based on the nature of the arrangements, the performance obligations are satisfied upon the product’s delivery to distributors.

Judgments and Uncertainties

Rebates are offered to distributors, consistent with pharmaceutical industry practices. The estimated amount of unpaid or unbilled rebates, if any, is recorded as a reduction of revenue. Estimated rebates are determined based on contracted rates, sales volumes and level of distributor inventories. We regularly review the information related to these estimates and adjust the amount accordingly.

~~In Hong Kong,~~

Sensitivity of Estimate to Change

Actual amounts of rebates ultimately paid or billed may differ from our estimates. We will reassess estimates for rebates periodically. If actual results in the future vary from our estimates, we ~~sell~~will adjust these estimates, which would affect net product revenue and earnings in the ~~products~~period such variances become known.

Research and Development Expenses

Description

Research and development expenses are charged to ~~customers, which~~expense as incurred when these expenditures relate to our research and development services and have no alternative future uses.

Preclinical and clinical trial costs are ~~typically healthcare providers such as oncology centers.~~a significant component of our research and development expenses. We ~~utilize~~have a history of contracting with third ~~party for warehousing services. Based~~parties that perform various preclinical and clinical trial activities on behalf of us in the ~~nature~~ongoing development of our product candidates. Expenses related to preclinical and clinical trials are accrued based on our estimates of the ~~arrangement,~~actual services performed by the third parties for the respective period.

Judgments and Uncertainties

The process of estimating our research and development expenses involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated costs incurred for the services when we have ~~determined~~not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a

pre-determined

schedule or when contractual milestones are met; however, some require advanced payments. We make estimates of our expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time.

Sensitivity of Estimate to Change

Although we ~~are a principal in~~do not expect our estimates to be materially different from amounts actually incurred, our understanding of the ~~transaction since we are primarily responsible for fulfilling the promise to provide the products~~status and timing of services performed relative to the ~~customers, maintain inventory risk until delivery~~actual status and timing of services performed may vary and may result in us reporting expenses that are too high or too low in any particular period. To date, we have not made any material adjustments to ~~the customers~~our prior estimates of research and have latitude in establishing the price. Revenue is recognized at the amount to which we expect to be entitled in exchange for the sale of the products, which is the sales price agreed with the customers. Consideration paid to the third party is recognized in operatingdevelopment expenses.

~~We did not recognize any contract assets and contract liabilities as~~

Share-Based Compensation

~~We grant share options and~~

~~non-vested~~

~~restricted shares to eligible employees, management and directors and account for these~~

~~share-based~~

~~awards in accordance with ASC 718,~~

~~Compensation-Stock~~Description

~~Compensatio~~

. Employees’ share-based awards are measured at the grant date fair value of the awards and recognized as expenses (1) immediately at grant date if no vesting conditions are required; or (2) using graded vesting method over the requisite service period, which is the vesting period.

To the extent the required vesting conditions are not met resulting in the forfeiture of the share-based awards, previously recognized compensation ~~expense~~expenses relating to those awards are reversed.

Judgments and Uncertainties

We ~~determined~~determine the fair value of the stock options granted to employees using the Black-Scholes option valuation model.

~~We also grant share~~ Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of our ADS price, (ii) the periods of time over which grantees are expected to hold their options prior to ~~eligible~~

~~non-employees~~

exercise (expected lives), (iii) expected dividend yield on our ADS, and ~~account~~(iv) risk-free interest rates, which are based on quoted U.S. Treasury rates for ~~these~~

~~share-based~~

~~awards~~securities with maturities approximating the options’ expected lives. Expected volatility has been estimated based on actual movements in ~~accordance~~some comparable companies’ stock prices over the most recent historical periods equivalent to the options’ expected lives. Expected lives are principally based on our historical exercise experience with ~~ASC 718,~~

~~Compensation- Stock~~previous option grants. The expected dividend yield is zero as we have never paid dividends and do not currently anticipate paying any in the foreseeable future.

Sensitivity of Estimate to Change

~~Compensation~~

~~Non-employees’~~

~~share-based awards are measured at the grant date~~The assumptions used in this method to determine fair value of ordinary shares consider historical trends, macroeconomic conditions, and projections consistent with the awards and recognized as expenses (1) immediately at grant date if no vesting conditions are required; or (2) using graded vesting method over the requisite service period, which is the vesting period. All transactionsCompany’s operating strategy. Changes in ~~which goods or services are received in exchange for equity instruments are accounted for based~~these estimates can have a significant impact on the ~~fair value~~determination of the consideration received or the fair value of the equity instrument issued, whichever is more reliably measurable. To the extent the required vesting conditions are not met resulting in the forfeiture of the share-based awards, previously recognized compensation expense relating to those awards are reversed. We determined the fair value of the stock ~~options granted to~~

~~non-employees~~

~~using~~options. If factors change or different assumptions are used, the ~~Black-Scholes option valuation model.~~

~~Fair Value Measurements~~

~~We apply ASC Topic 820,~~

~~Fair~~

~~Value~~

~~Measurements~~

~~and~~

~~Discl~~

~~sure~~

~~, or ASC 820, in measuring fair value. ASC 820 defines fair value, establishes a framework~~share-based compensation expenses could be materially different for ~~measuring fair value and requires disclosures to be provided on fair value measurement.~~

~~ASC 820 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:~~

~~Level 1—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.~~

~~Level 2—Include other inputs that are directly or indirectly observable in the marketplace.~~

~~Level 3—Unobservable inputs which are supported by little or no market activity.~~

ASC 820 describes three main approaches, for example, to measure the fair value of assets and liabilities: (1) market approach, (2) income approach and (3) cost approach. The market approach uses prices and other relevant information generated from market transactions involving identical or comparable assets or liabilities. The income approach uses valuation techniques to convert future amounts to a single present value amount. The measurement is based on the value indicated by current market expectations about those future amounts. The cost approach is based on the amount that would currently be required to replace an asset.

Financial instruments of our company primarily include cash, cash equivalents and restricted cash, short-term investment, accounts receivable, prepayments and other current assets, short-term borrowings, accounts payable and other current liabilities. As of each reporting date, the carrying values of cash and cash equivalents, short-term investment, accounts receivable, prepayments and other current assets, short-term borrowings, accounts payable and other current liabilities approximated their fair values due to the short-term maturity of these instruments, and the carrying value of restricted cash approximates its fair value based on the nature of and the assessment of the ability to recover these amounts.any period.

Income Taxes

Current income taxes are provided on the basis of net income for financial reporting purposes, adjusted for income and expense items which are not assessable or deductible for income tax purposes, in accordance with the regulations of the relevant tax jurisdictions. We follow the liability method of accounting for income taxes.

Description

Under this method, deferred tax assets and liabilities are determined based on the temporary differences between the financial statements carrying amounts and tax bases of assets and liabilities by applying enacted statutory tax rates that will be in effect in the period in which the temporary differences are expected to reverse. We record a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more likely than not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rate is recognized in our consolidated financial statements in the period of change.

In accordance with the provisions of ASC 740, Income Taxes, we recognize in our financial statements the benefit of a tax position if the tax position is “more likely than not” to prevail based on the facts and technical merits of the position. Tax positions that meet the “more likely than not” recognition threshold are measured at the largest amount of tax benefit that has a greater than fifty percent likelihood of being realized upon settlement. We estimate our liability for unrecognized tax benefits which are periodically assessed and may be affected by changing interpretations of laws, rulings by tax authorities, changes and/or developments with respect to tax audits, and expiration of the statute of limitations. The ultimate outcome for a particular tax position may not be determined with certainty prior to the conclusion of a tax audit and, in some cases, appeal or litigation process.

Judgments and Uncertainties

We consider positive and negative evidence when determining whether some portion or all of our deferred tax assets will not be realized. This assessment considers, among other matters, the nature, frequency and severity of current and cumulative losses, forecasts of future profitability, the duration of statutory carry-forward periods, our historical results of operations and our tax planning strategies. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Based upon the level of our historical taxable income and projections for future taxable income over the periods in which the deferred tax assets are deductible, we believe it is more likely than not that we will not realize the deferred tax assets resulted from the tax loss carried forward in the future periods.

Sensitivity of Estimate to Change

The actual benefits ultimately realized may differ from our estimates. As each audit is concluded, adjustments, if any, are recorded in our financial statements in the period in which the audit is concluded. Additionally, in future periods, changes in facts, circumstances and new information may require us to adjust the recognition and measurement estimates with regard to individual tax positions. Changes in recognition and measurement estimates are recognized in the period in which the changes occur. As of ~~June 30,~~March 31, 2022 and 2021, ~~and December 31, 2020,~~ we did not have any significant unrecognized uncertain tax positions.

~~Table of Contents~~

B. Liquidity and Capital Resources

~~To date, we~~We have financed our activities primarily through private placements, our September 2017 initial public offering on the Nasdaq stock exchange, various

follow-on

offerings and our September 2020 secondary listing on the Hong Kong Stock Exchange of ~~Hong Kong and multiple~~

~~follow-on~~

~~offerings.~~our ordinary shares and/or ADSs. Through ~~June 30, 2021,~~March 31, 2022, we have raised approximately $164.6 million infrom private equity financing and approximately $2,462.7 million in net proceeds after deducting underwriting commissions and the offering expenses payable by us infrom our initial public offering, ~~subsequent follow-on offerings,~~secondary listing and ~~our secondary listing.~~ subsequent

follow-on

offerings.

Table of Contents

Our operations have consumed substantial amounts of cash since inception. The net cash used in our operating activities was ~~$235.3~~$87.1 million and ~~$92.3~~$169.5 million, for the ~~six~~three months ended ~~June 30,~~March 31, 2022 and 2021, respectively. We have commitments for capital expenditure of $22.3 million as of March 31, 2022, mainly for the purpose of plant construction and ~~2020, respectively.~~installation. We currently are not aware of any events that are reasonably likely to cause a material change in the relationship between costs and revenues.

As of ~~June 30, 2021,~~March 31, 2022, we had cash, cash equivalents, ~~and~~ restricted cash and short-term investment of ~~$1,767.3~~$1,313.0 million. Our expenditures ~~as a company~~are principally focused on research and development and are largely ~~discretionary and as~~discretionary. As such, we believe that our current losses and cash used in operations do not present ~~immediate~~ going concern issues. Based on our current operating plan, we expect that our ~~existing~~cash, cash equivalents, restricted cash and ~~cash equivalents as of August 9, 2021,~~short-term investments will enable us to fund our operating expenses and capital expenditures requirements for at least the next 12 ~~months after the date that the financial statements included in this Quarterly Report are issued.~~months. However, in order to bring to fruition our research and development objectives, we will ultimately need additional funding sources and there can be no assurances that they will be made available.

The following table provides information regarding our cash flows for the ~~six~~three months ended ~~June 30, 2021~~March 31, 2022 and ~~2020:~~2021:


	Six months ended June 30,						Three months ended March 31,
(in thousands)	2021			2020			2022			2021
Net cash used in operating activities	$	(235,348	)	$	(92,319	)	$	(87,127	)	$	(169,500	)
Net cash provided by (used in) investing activities		737,828			(6,521	)
Net cash provided by financing activities		820,949			281,500
Net cash (used in) provided by investing activities								(30,144	)		742,005
Net cash provided by (used in) financing activities								258			(271	)
Effect of foreign exchange rate changes		1,028			12			(130	)		(930	)

Net increases in cash, cash equivalents and restricted cash	$	1,324,457		$	182,672
Net (decreases) increases in cash, cash equivalents and restricted cash							$	(117,143	)	$	571,304

Net cash used in operating activities

During the ~~six~~three months ended ~~June 30, 2021,~~March 31, 2022, our operating activities used ~~$235.3~~$87.1 million of cash, which resulted principally from our net loss of ~~$396.2~~$82.4 million, adjusted for

non-cash

charges of ~~$85.9~~$23.0 million, and cash ~~provided~~used in our operating assets and liabilities of ~~$75.0~~$27.7 million. ~~Our net~~

~~non-cash~~

~~charges during~~During the ~~six~~three months ended ~~June 30,~~March 31, 2021, our operating activities used $169.5 million of cash, which resulted principally from our net loss of $232.9 million, adjusted

for non-cash charges

of $72.1 million, and cash used in our operating assets and liabilities of $8.7 million. The decrease in cash used in operating activities was primarily ~~consisted~~due to the decrease of ~~$62.3 million~~

~~non-cash~~

~~research and development expenses, a $3.0 million depreciation expense, a $17.6 million~~

~~share-based~~

~~compensation expense and a $2.8 million~~

~~non-cash~~

~~lease expense.~~license payments.

Net cash (used in) provided by ~~(used in)~~ investing activities

Net cash used in investing activities was $30.1 million for the three months ended March 31, 2022 compared to net cash provided by investing activities ~~was $737.8~~of $742.0 million for the ~~six~~three months ended ~~June 30, 2021 compared to net cash used in investing activities of $6.5 million for the six months ended June 30, 2020.~~March 31, 2021. The ~~increase~~decrease in cash provided by investing activities was primarily due to the decrease of proceeds from maturity of short-term ~~investments.~~investments during the three months ended March 31, 2022 compared to the three months ended March 31, 2021.

Net cash provided by (used in) financing activities

Net cash provided by financing activities was ~~$820.9~~$0.3 million for the ~~six~~three months ended ~~June 30, 2021~~March 31, 2022 compared to ~~$281.5~~net cash used in financing activities of $0.3 million for the ~~six~~three months ended ~~June 30, 2020.~~March 31, 2021. The increase in cash provided by financing activities was primarily due to the ~~issuance~~reduced payment of ~~ADSs in our~~

~~follow-on~~

public offering costs during the ~~six~~three months ended ~~June 30, 2021.~~March 31, 2022.

C. Research and Development Activities and Expenditures, Including Patents and Licenses ~~etc.~~

Full details of our research and development activities and expenditures are provided in the ~~“Business”~~“Research and ~~“Operating~~Development Expenses” and ~~Financial Review and Prospects”~~“Results of Operations” sections above.

D. Trend Information

Other than as described elsewhere in this Quarterly Report on Form

10-Q,

we are not aware of any trends, uncertainties, demands, commitments or events that are reasonably likely to have a material adverse effect on our revenue, income from continuing operations, profitability, liquidity or capital resources, or that would cause our reported financial information not necessarily to be indicative of future operation results or financial condition.

~~Off-balance~~

~~Sheet Arrangements~~

~~We currently do not engage in trading activities involving~~

~~non-exchange~~

traded contracts or interest rate swap transactions or foreign currency forward contracts. In the ordinary course of our business, we do not enter into transactions involving, or otherwise form relationships with, unconsolidated entities or financial partnerships that are established for the purpose of facilitating

~~off-balance~~

~~sheet arrangements or other contractually narrow or limited purposes.~~

~~F. Tabular Disclosure of Contractual Obligations~~

~~The following table sets forth our contractual obligations as of June 30, 2021. Amounts we pay in future periods may vary from those reflected in the table.~~

(in thousands)

Total

Less than
1 year

1 to 3 years

3 to 5
years

More than
5 years

Purchase Obligations
   $ 28,240    $ 28,191    $ 49    —      —
Operating Lease Obligations
   $ 18,847    $ 6,557    $ 6,180    $ 4,373    $ 1,737

We also have obligations to make future payments to third party licensors that become due and payable on the achievement of certain development, regulatory and commercial milestones as well as tiered royalties on net sales. We have not included these commitments on our balance sheet or in the table above because the commitments are cancellable if the milestones are not complete and achievement and timing of these obligations are not fixed or determinable.

Recently Issued Accounting Standards

For more information regarding recently issued accounting standards, please see ~~“Part II—Item 8—~~“Item 8. Financial Statements and Supplementary ~~Data—Recent~~Data-Recent accounting pronouncements” in our 2021 Annual ~~Report on Form~~

~~10-K~~Report.

~~for the year ended December 31, 2020, as filed with the SEC on March 1, 2021.~~

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are exposed to market risk including foreign exchange risk, credit risk, cash flow interest rate risk and liquidity risk.

Foreign Exchange Risk

Renminbi, or RMB, is not a freely convertible currency. The State Administration of Foreign Exchange, under the authority of the People’s Bank of China ~~(“PBOC”)~~(PBOC), controls the conversion of RMB into foreign currencies. The value of RMB is subject to changes in central government policies and to international economic and political developments affecting supply and demand in the China Foreign Exchange Trading System market. The cash and cash equivalents of ~~our company~~the Company included aggregated amounts of RMB ~~234.0~~371.8 million and RMB ~~155.9~~151.7 million, which were denominated in RMB, ~~as of June 30, 2021~~representing 7% and ~~December 31, 2020, respectively, representing~~ 2% ~~and 5%~~ of the cash and cash equivalents, as of ~~June 30, 2021~~March 31, 2022 and December 31, ~~2020,~~2021, respectively.

Our business mainly operates in mainland China with a significant portion of our transactions settled in RMB, and our financial statements are presented in U.S. dollars. We do not believe that we currently have ~~any~~ significant direct foreign exchange risk and have not used ~~any~~ derivative financial instruments to hedge our exposure to such risk. Although, in general, our exposure to foreign exchange risks should be limited, the value of your investment in our ADSs will be affected by the exchange rate between the U.S. dollar and the RMB because the value of our business is effectively denominated in ~~RMBs,~~RMB, while ADSs will be traded in U.S. dollars.

The value of the RMB against the U.S. dollar and other currencies may fluctuate and is affected by, among other things, changes in Greater China’s political and economic conditions. The conversion of RMB into foreign currencies, including U.S. dollars, has been based on rates set by the PBOC. On July 21, 2005, ~~China~~the Chinese government changed its

decade-old

policy of pegging the value of the RMB to the U.S. dollar. Under the revised policy, the RMB is permitted to fluctuate within a narrow and managed band against a basket of certain foreign currencies. This change in policy resulted in a more than 20% appreciation of the RMB against the U.S. dollar in the following three years. Between July 2008 and June 2010, this appreciation halted, and the exchange rate between the RMB and U.S. dollar remained within a narrow band. In June 2010, the PBOC announced that ~~China’s~~Chinese government would increase the flexibility of the exchange rate, and thereafter allowed the RMB to appreciate slowly against the U.S. dollar within the narrow band fixed by the PBOC. However, in August 2015, the PBOC significantly devalued the RMB.

~~A significant portion of our cash is kept in Hong Kong dollars (HK dollars) as well as U.S. dollars.~~ The value of our ADSs and our ordinary shares will ~~therefore,~~ be affected by the foreign exchange rates between U.S. dollars, HK dollars and the RMB. For example, to the extent that we need to convert U.S. dollars or HK dollars into RMB for our operations or if any of our arrangements with other parties are denominated in U.S. dollars or HK dollars and need to be converted into RMB, appreciation of the RMB against the U.S. dollar or the HK dollar would have an adverse effect on the RMB amount we receive from the conversion. Conversely, if we decide to convert RMB into U.S. dollars or HK dollars for the purpose of making payments for dividends on our ordinary shares or ADSs or for other business purposes, appreciation of the U.S. dollar or the HK dollar against the RMB would have a negative effect on the conversion amounts available to us.

Since 1983, the Hong Kong Monetary Authority (HKMA) has pegged the HK dollar to the U.S. dollar at the rate of approximately HK$7.80 to US$1.00. However, there is no assurance that the HK dollar will continue to be pegged to the U.S. dollar or that the HK dollar conversion rate will remain at HK$7.80 to US$1.00. If the HK dollar conversion rate against the U.S. dollar changes and the value of the HK dollar depreciates against the U.S. dollar, our ~~Group’s~~ assets denominated in HK dollars will be adversely affected. Additionally, if the HKMA were to repeg the HK dollar to, for example, the RMB rather than the U.S. dollar, or otherwise restrict the conversion of HK dollars into other currencies, then our ~~Group’s~~ assets denominated in HK dollars will be adversely affected.

3028

Table of Contents

Credit Risk

~~Our~~

Financial instruments that are potentially subject to significant concentration of credit risk ~~is primarily attributable to the~~consist of cash and cash equivalents, short-term investments, accounts receivable and notes receivable.

The carrying amounts of cash and cash equivalents and short-term ~~investment. The carrying amounts of cash and cash equivalents and~~

~~short-term~~

~~investment~~investments represent the maximum amount of loss due to credit risk. AsWe had cash and cash equivalents of ~~June 30, 2021~~$847.0 million and $964.1 million and short-term investments of $465.3 million and $445.0 million, as of March 31, 2022 and December 31, ~~2020,~~2021, respectively. As of March 31, 2022 and December 31, 2021, all of our cash and cash equivalents and short-term investments were held by major financial institutions located in mainland China and international financial institutions outside of mainland China which we believe are of high credit quality and we ~~will~~ continually monitor the credit worthiness of these financial institutions.

Accounts receivable are typically unsecured and are derived from product sales and collaborative arrangement. We manage credit risk of accounts receivable through ongoing monitoring of the outstanding balances and limit the amount of credit extended based upon payment history and the debtor’s current credit worthiness. Historically, we have collected the receivables from customers within the credit terms with no significant credit losses incurred. As of March 31, 2022, our two largest debtors accounted for approximately 39% of our total accounts receivable collectively.

Certain accounts receivable balances are settled in the form of notes receivable. As of March 31, 2022, such notes receivable included bank acceptance promissory notes that are

non-interest

bearing and due within six months. These notes receivable were used to collect the receivables based on an administrative convenience, given these notes are readily convertible to known amounts of cash. In accordance with the sales agreements, whether to use cash or bank acceptance promissory notes to settle the receivables is at our discretion, and this selection does not impact the agreed contractual purchase prices.

Inflation

In recent years, mainland China has not experienced significant inflation and thus inflation has not had a material impact on our results of operations. Although we have not been materially affected by inflation in the past, we can provide no assurance that we will not be affected in the future by higher rates of inflation in mainland China.

Item 4. Controls and Procedures

Management’s Evaluation of our Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is (1) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.

As of ~~June 30, 2021,~~March 31, 2022, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules

13a-15(e)

and

15d-15(e)

under the ~~Securities~~ Exchange ~~Act of 1934, as amended)~~Act). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial officer have concluded based upon the evaluation described above that, as of ~~June 30, 2021,~~March 31, 2022, our disclosure controls and procedures were effective at ~~the~~a reasonable assurance level.

Changes in Internal Control over Financial Reporting

During the ~~six~~three months ended ~~June 30, 2021,~~March 31, 2022, there have not been any changes in our internal controls over financial reporting (as such item is defined in Rules

13a-15(f)

and

15d-15(f)

promulgated under the ~~Securities~~ Exchange ~~Act of 1934, as amended)~~Act) that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

~~PART II—OTHER INFORMATION~~

Table of Contents

PART

II-OTHER

INFORMATION

Item 1. Legal Proceedings.

We may be, from time to time, subject to claims and suits arising in the ordinary course of business. Although the outcome of these and other claims cannot be predicted with certainty, management does not believe that the ultimate resolution of these matters will have a material adverse effect on our financial position or on our results of operations. We are not currently a party to, nor is our property the subject of, any actual or threatened material legal or administrative proceedings.

Item 1A. Risk Factors.

~~There have been no~~This Quarterly Report on Form

10-Q

should be read in conjunction with our 2021 Annual Report, which describes various material risks and uncertainties to which we are or may become subject. These risks and uncertainties could, directly or indirectly, adversely affect our business, results of operations, financial condition, liquidity, or cash flows and could cause our actual results to differ materially from our past results or the results contemplated by any forward-looking statements we make. We believe the risks described in this section of our Quarterly Report on Form

10-Q

and our 2021 Annual Report are the most significant we face; however, these are not the only risks we face. We face additional risks and uncertainties not currently known to us or that we currently believe are not material.

Material changes from the risk factors set forth in our 2021 Annual Report ~~on Form~~are set forth below:

~~10-K~~

Because the majority of our operations are in mainland China and our auditor has been located in mainland China, a jurisdiction where the PCAOB is currently unable to conduct inspections without the approval of Chinese authorities, there have been concerns regarding oversight of the audits of our financial statements filed with the SEC. In March 2022, SEC staff conclusively identified us under the HFCAA as an issuer that uses an auditor that the PCAOB is unable to inspect or investigate completely. Although in April 2022 our Audit Committee approved the engagement of KPMG, a U.S. auditor that is subject to inspection by the PCAOB, as our independent public accounting firm for the fiscal year ending December 31, 2022, KPMG is in the process of concluding its standard client evaluation procedures, including obtaining approval from the Hong Kong Stock Exchange to audit the Company’s consolidated financial statements submitted to the Hong Kong Stock Exchange. If for any reason we continue to fail to meet the audit requirements of the HFCAA for three consecutive years, the HFCAA requires the SEC to prohibit the trading of our securities on a national securities exchange, including Nasdaq, or on

over-the-counter

markets in the United States. In addition, the U.S. Senate and U.S. House of Representatives have each passed bills, which, if enacted, would decrease the number of

non-inspection

years from three consecutive years to two, thus reducing the time period before our securities may be prohibited from trading on a U.S. securities exchange or delisted from Nasdaq. The foregoing could adversely affect the market price of our ordinary shares and/or ADSs and our ability to raise capital effectively.

non-U.S.

authority in the auditor’s local jurisdiction (a “Commission-Identified Issuer”). Under the HFCAA, if the SEC conclusively identifies an issuer as a Commission-Identified Issuer for three consecutive years, the SEC is required to prohibit the trading of the issuer’s securities on a national securities exchange or through any other method that is within the jurisdiction of the SEC to regulate, including

over-the-counter

markets in the United States. Our securities may be prohibited from trading on the Nasdaq or other U.S. stock exchanges if our auditor is not inspected by the PCAOB for three consecutive years, and this ultimately could result in our ADSs being delisted.

Furthermore, in June 2021, the U.S. Senate passed the AHFCAA, which, if enacted, would amend the HFCAA and require the SEC to prohibit an issuer’s securities from trading on any U.S. stock exchanges if its auditor is not subject to PCAOB inspections for two consecutive years (as opposed to the three years under the HFCAA). In February 2022, the U.S. House of Representatives passed the America COMPETES Act, which similarly would amend the HFCAA to shorten the number of

non-inspection

years from three years to two years. The America COMPETES Act, however, includes a broader range of legislation than the AHFCA Act in response to the U.S. Innovation and Competition Act passed by the U.S. Senate in 2021. The U.S. House of Representatives and the U.S. Senate will need to agree on amendments to these respective bills to allow the legislature to pass their amended bills before the President can sign the bill into law. It is unclear if or when either of these bills will be signed into law.

In December 2021, the SEC adopted amendments to finalize rules implementing the submission and disclosure requirements in the HFCAA for Commission-Identified Issuers, which became effective on January 10, 2022. In addition, the PCAOB issued a Determination Report, pursuant to PCAOB Rule 6100, which found that the PCAOB is unable to inspect or investigate completely registered public accounting firms headquartered in mainland China and Hong Kong because of positions taken by Chinese authorities in those jurisdictions. The SEC began to identify Commission-Identified Issuers for fiscal years beginning after December 18, 2020. A Commission-Identified Issuer will be required to comply with the submission and disclosure requirements in the annual report for each year in which it was so identified. If an issuer is identified as a Commission-Identified Issuer based on its annual report for the fiscal year ended December 31, ~~2020,~~2021, the issuer will be required to comply with the submission or disclosure requirements in its annual report for the fiscal year ended December 31, 2022.

We may be subject to additional approval, filing, and compliance obligations with Chinese authorities in connection with our engagement of KPMG LLP, a U.S. auditor that is subject to PCAOB inspection.

Pursuant to the Draft Archives Rules, released by the CSRC for public comment on April 2, 2022, where Chinese domestic companies (including Chinese domestic companies that are listed outside of China through a overseas holding entity, such as Zai Lab Limited) seek to disclose or provide, or disclose or provide through its overseas holding entity, documents and materials that have a sensitive impact (i.e. be detrimental to national security or the public interest if divulged) or contain state secrets or government department work secrets to relevant entities or individuals including securities companies, other securities service providers and overseas regulators in connection with a securities offering outside of China, such company will be required to complete the relevant approval, filing, and other regulatory procedures. Disclosure of such materials to auditors based outside of China is explicitly included within the scope of the Draft Archives Rules and any such auditors are required under Chinese law to abide by the corresponding approval, filing, and compliance procedures in accordance with relevant Chinese regulations. The Draft Archive Rules are still in draft form and we do not yet know the scope of materials that have a sensitive impact or contain state secrets or government department work secrets, but if the Draft Archives Rules become effective and our auditor’s work papers are determined to be materials that have a sensitive impact or contain state secrets or government department work secrets, our engagement of KPMG LLP may subject us and KPMG LLP to additional approval, filing, and compliance obligations in China under the Draft Archive Rules.

We face risks related to public health crises, including the current

ongoing COVID-19

pandemic, which could have a material adverse effect on our business and results of operations.

Our global operations expose us to risks associated with public health crises, such as epidemics and pandemics, natural catastrophes, such as earthquakes, hurricanes, typhoons, or floods, or other disasters such as fires, explosions and terrorist activity or war that are outside of our control, including government reactions due to such events. Our business operations and those of our suppliers, CROs, CMOs and other contractors may potentially suffer interruptions caused by any of these events.

In December 2019, a respiratory illness caused by a novel strain of coronavirus, SARS-CoV2, causing the Coronavirus Disease 2019, also known

as COVID-19

or coronavirus emerged. Global health concerns relating to

the COVID-19

pandemic have been weighing on the macroeconomic environment and the pandemic has significantly increased economic volatility and uncertainty. The pandemic has resulted in government authorities implementing numerous measures to try to contain the virus, such as travel bans and restrictions, quarantines,

shelter-in-place or stay-at-home

orders and business shutdowns.

Although the

COVID-19

outbreak appeared to have been largely under control within Greater China since the second fiscal quarter of 2020, there have been continuous rebound cases in Greater China, especially in some large cities like Shanghai, Shenzhen and Hong Kong since February 2022 and uncertainties associated with the future developments of the pandemic still exist, which resulted in unpredictable regional quarantines, travel restrictions and shutdown of businesses, which has caused slower recovery of the Chinese economy. In January and February 2022, Shanghai, where our principal executive offices are located, experienced a wave of intermittent government shutdowns in connection with

COVID-19

control measures. From late March 1,2022,

COVID-19

lockdown restrictions were increased and most of the city is subject to a full lockdown. Other cities or regions in China are or may be subject to similar government restrictions. The effect of these restrictive quarantine measures imposed by the Chinese government, which may continue for some indeterminate amount of time, may have a material adverse effect on our business for the remainder of this fiscal year.

The

continued COVID-19

pandemic and related government restrictions could adversely impact our operations and, given the impact it may have on the manufacturing and supply chain, sales and marketing and clinical trial operations of us and our business partners and the ability to advance our research and development activities and pursue development of any of our pipeline products, each of which could have an adverse impact on our business and our financial results.

For example, due to business interruptions to hospitals and treatment centers in mainland China arising in connection with the outbreak

of COVID-19,

some patients have experienced difficulties in accessing hospital care and, as a result, they could have limited or even no access to ZEJULA, Optune, QINLOCK, or NUZYRA. The ability to conduct

in-person

interactions between medical representatives and physicians has also been adversely affected. In addition, we have experienced delays in the enrollment of patients in our clinical trials due to the outbreak

of COVID-19.

Our commercial partners and licensors also have similarly experienced delays in enrollment of patients to their clinical trials due to the outbreak

of COVID-19

in their respective territories. Although so far none of our NDA submissions and acceptances, key clinical development milestones or CTA approvals have been materially delayed, there is no guarantee this will continue to be the case.

Additionally, the

COVID-19

government restrictions and shutdown orders—those currently in effect and which may be effective in the future—could cause us or our commercial partners, licensors, and CMOs to experience delays or interruptions in the ability to manufacture and supply the products we are selling commercially in Greater China. For example, if current COVID-related restrictions in Shanghai continue, such restrictions may impact the distribution and sale of our products within China. These and other government restrictions could limit our and our distributors’ ability to successfully sell our commercial products in Greater China, even if we implement contingent plans. Any or all of these adverse effects arising from

COVID-19

may adversely affect our operations this year and cause the value of the Company to decline, potentially limiting our ability to obtain additional financing on terms acceptable to the Company.

We have taken precautionary measures intended to help minimize the risk of the virus to our employees, including limiting

non-essential

travel, preparing pandemic prevention materials in the office, permitting work from home as appropriate, and providing

COVID-19

testing for our employees. Certain of these measures could negatively affect our business. For instance, if our employees are required to continue to work remotely as a result of local government mandates, company policy updates, or otherwise, absenteeism or employee turnover could increase, or we may experience disruptions to our operations or increased risk of a cybersecurity incident.

There are no comparable recent events that provide guidance as to the effect

the COVID-19

outbreak as a global pandemic may have and, as a result, the ultimate impact of the pandemic is highly uncertain and subject to change, and the actual effects will depend on many factors beyond our control.

Our business and financial results, including our ability to raise capital or raise capital on favorable terms and the market price of our ordinary shares and/or our ADSs, may be adversely affected by the geopolitical factors arising in connection with Russia’s invasion of Ukraine, including particularly how countries like the United States and China choose to respond to this war. As a result, the value of our ordinary shares and ADSs may significantly decline.

Although we do not conduct business in Russia or Ukraine, our business and financial results, including our ability to raise capital or raise capital on favorable terms and the market price of our ordinary shares and/or our ADSs, may be adversely affected by geopolitical factors arising in connection with Russia’s invasion of Ukraine. For example, in connection with this war, the United States and other nations have raised the possibility of secondary sanctions on China, Chinese banks and Chinese businesses that do business with Russia or its allies, including Belarus. We do not conduct business in Russia or Belarus, or with Russian or Belarusian counterparties, but we may be impacted by sanctions if third parties with which we do business, such as customers, suppliers, intermediaries, services providers or banks, are subject to such sanctions or if broader sanctions are imposed. Our business and operations may also be adversely impacted by any actions taken by China in response to the war or any related sanctions or threatened sanctions. If sanctions are imposed or if this war continues or expands, or leads to continued political or economic instability, terrorist activity, or further government actions or increased economic or political tensions between the United States and China, our business and financial results, including our ability to raise capital or raise capital on favorable terms and the market price of our ordinary shares and/or our ADSs, may be adversely impacted and the value of our ADSs and ordinary shares may significantly decline.

We may not be able to access the capital and credit markets on terms that are favorable to us.

We may seek access to the capital and credit markets to supplement our existing funds and cash generated from operations for working capital, capital expenditure and debt service requirements and other business initiatives. The capital and credit markets are experiencing, and have in the past experienced, extreme volatility and disruption, which leads to uncertainty and liquidity issues for both borrowers and investors. That volatility and unpredictability in the financial markets is adversely affecting the access to capital and credit for many life sciences companies, but that risk is currently exacerbated for companies like ours with significant operations in China by factors such as the geopolitical tensions between the U.S. and China, the ongoing war between Russia and Ukraine, and the uncertainty about the duration, scope, and effect of the COVID-19 restrictions imposed by the Chinese government. In the event that these continued adverse market conditions may affect us, we may be unable to obtain adequate capital or credit market financing, obtain that capital or credit on favorable terms, or access such capital or credit in the market(s) or manner most favorable to the Company.

Other Risk Factors

The following is a summary of significant risk factors and uncertainties that may affect our business which are discussed in more detail above and in our 2021 ~~except as follows:~~Annual Report:

The uncertainties in the Chinese legal system could materially and adversely affect us;

Changes in United States and China relations, as well as relations with other countries, and/or regulations may adversely impact our business, our operating results, our ability to raise capital and the market price of our ordinary shares and/or our ~~ADSs.~~

ADSs;

The U.S. government, including the SEC, has made statements and taken certain actions that led to changes to United States and international relations, and will impact companies with connections to the United States or China, including imposing several rounds of tariffs affecting certain products manufactured in China, imposing certain sanctions and restrictions in relation to China and issuing statements indicating enhanced review of companies with significant China-based operations. It is unknown whether and to what extent new legislation, executive orders, tariffs, laws or regulations will be adopted, or the effect that any such actions would have on companies with significant connections to the U.S. or to China, our industry or on us. We conduct preclinical and clinical activities and have business operations both in the United States and China. Any unfavorable government policies on cross-border relations and/or international trade, including increased scrutiny on companies with significant China-based operations, capital controls or tariffs, may affect the competitive position of our drug products, the hiring of scientists and other research and development personnel, the demand for our drug products, the import or export of raw materials in relation to drug development, our ability to raise capital, the market price of our ordinary shares and/or our ADSs or prevent us from selling our drug products in certain countries.

The Chinese government may intervene in or influence our operations at any time, which could result in a material change in our operations and significantly and adversely impact the value of our ADSs and ordinary shares, including potentially making those ADSs or ordinary shares worthless;

Furthermore, the SEC has issued statements primarily focused on companies with significant China-based operations, such as us. For example, on July 30, 2021, Gary Gensler, Chairman of the SEC, issued a Statement on Investor Protection Related to Recent Developments in China, pursuant to which Chairman Gensler stated that he has asked the SEC staff to engage in targeted additional reviews of filings for companies with significant China-based operations. The statement also addressed risks inherent in companies with a Variable Interest Entity, or a VIE structure. We do not have a VIE structure and are not in an industry that is subject to foreign ownership limitations by China. Further, we believe that we have robust disclosures relating to our operations in China, including the relevant risks noted in Chairman Gensler’s statement. However, it is possible that the Company’s periodic reports and other filings with the SEC may be subject to enhanced review by the SEC and this additional scrutiny could affect our ability to effectively raise capital in the United States.

In response to the SEC’s July 30 statement, the China Securities Regulatory Commission (CSRC) announced on August 1, 2021, that “[i]t is our belief that Chinese and U.S. regulators shall continue to enhance communication with the principle of mutual respect and cooperation, and properly address the issues related to the supervision of China-based companies listed in the U.S. so as to form stable policy expectations and create benign rules framework for the market.” While the CSRC will continue to collaborate “closely with different stakeholders including investors, companies, and relevant authorities to further promote transparency and certainty of policies and implementing measures,” it emphasized that it “has always been open to companies’ choices to list their securities on international or domestic markets in compliance with relevant laws and regulations.”

If any new legislation, executive orders, tariffs, laws and/or regulations are implemented, if existing trade agreements are renegotiated or if the U.S. or Chinese governments take retaliatory actions due to the recent U.S.-China tension, such changes could have an adverse effect on our business, financial condition and results of operations, our ability to raise capital and the market price of our ordinary shares and/or our ADSs.

Compliance with China’s new Data Security Law, Measures on Cybersecurity Review (revised draft for public consultation), Personal Information Protection Law (second draft for consultation), regulations and guidelines relating to the multi-level protection scheme and any other future laws and regulations may entail significant expenses and could materially affect our business.

China has implemented or will implement rules and is considering a number of additional proposals relating to data protection. China’s new Data Security Law promulgated by the Standing Committee of the National People’s Congress of China in June 2021, or the Data Security Law, will take effect in September 2021. The Data Security Law provides that the data processing activities must be conducted based on “data classification and hierarchical protection system” for the purpose of data protection and prohibits entities in China from transferring data stored in China to foreign law enforcement agencies or judicial authorities without prior approval by the Chinese government. As the Data Security Law has not yet come into effect, we may need to make adjustments to our data processing practices to comply with this law.

Additionally, China’s Cyber Security Law, requires companies to take certain organizational, technical and administrative measures and other necessary measures to ensure the security of their networks and data stored on their networks. Specifically, the Cyber Security Law provides that China adopt a multi-level protection scheme (MLPS), under which network operators are required to perform obligations of security protection to ensure that the network is free from interference, disruption or unauthorized access, and prevent network data from being disclosed, stolen or tampered. Under the MLPS, entities operating information systems must have a thorough assessment of the risks and the conditions of their information and network systems to determine the level to which the entity’s information and network systems belong—from the lowest Level 1 to the highest Level 5 pursuant to the Measures for the Graded Protection and the Guidelines for Grading of Classified Protection of Cyber Security. The grading result will determine the set of security protection obligations that entities must comply with. Entities classified as Level 2 or above should report the grade to the relevant government authority for examination and approval.

Recently, the Cyberspace Administration of China has taken action against several Chinese internet companies in connection with their initial public offerings on U.S. securities exchanges, for alleged national security risks and improper collection and use of the personal information of Chinese data subjects. According to the official announcement, the action was initiated based on the National Security Law, the Cyber Security Law and the Measures on Cybersecurity Review, which are aimed at “preventing national data security risks, maintaining national security and safeguarding public interests.” On July 10, 2021, the Cyberspace Administration of China published a revised draft of the Measures on Cybersecurity Review, expanding the cybersecurity review to data processing operators in possession of personal information of over 1 million users if the operators intend to list their securities in a foreign country.

It is unclear at the present time how widespread the cybersecurity review requirement and the enforcement action will be and what effect they will have on the life sciences sector generally and the Company in particular. China’s regulators may impose penalties for

~~non-compliance~~

~~ranging from fines or suspension of operations, and this could lead to us delisting from the U.S. stock market.~~

Also, recently, the National People’s Congress released the second consultation draft of the Personal Information Protection Law. The draft proposes a comprehensive set of data privacy and protection requirements that apply to the processing of personal information and expands data protection compliance obligations to cover the processing of personal information of persons by organizations and individuals in China, and the processing of personal information of persons in China outside of China if such processing is for purposes of providing products and services to, or analyzing and evaluating the behavior of, persons in China. The draft also proposes that critical information infrastructure operators and personal information processing entities who process personal information meeting a volume threshold to-be-set by Chinese cyberspace regulators are also required to store in China personal information generated or collected in China, and to pass a security assessment administered by Chinese cyberspace regulators for any export of such personal information. Lastly, the draft contains proposals for significant fines for serious violations of up to RMB 50 million or 5% of annual revenues from the prior year.

Interpretation, application and enforcement of these laws, rules and regulations evolve from time to time and their scope may continually change, through new legislation, amendments to existing legislation and changes in enforcement. Compliance with the Cyber Security Law and the Data Security Law could significantly increase the cost to us of providing our service offerings, require significant changes to our operations or even prevent us from providing certain service offerings in jurisdictions in which we currently operate or in which we may operate in the future. Despite our efforts to comply with applicable laws, regulations and other obligations relating to privacy, data protection and information security, it is possible that our practices, offerings or platform could fail to meet all of the requirements imposed on us by the Cyber Security Law, the Data Security Law and/or related implementing regulations. Any failure on our part to comply with such law or regulations or any other obligations relating to privacy, data protection or information security, or any compromise of security that results in unauthorized access, use or release of personally identifiable information or other data, or the perception or allegation that any of the foregoing types of failure or compromise has occurred, could damage our reputation, discourage new and existing counterparties from contracting with us or result in investigations, fines, suspension or other penalties by Chinese government authorities and private claims or litigation, any of which could materially adversely affect our business, financial condition and results of operations. Even if our practices are not subject to legal challenge, the perception of privacy concerns, whether or not valid, may harm our reputation and brand and adversely affect our business, financial condition and results of operations. Moreover, the legal uncertainty created by the Data Security Law and the recent Chinese government actions could materially adversely affect our ability, on favorable terms, to raise capital, including engaging in

~~follow-on~~

~~offerings of our securities in the U.S. market or the Stock Exchange of Hong Kong.~~

The audit report included in our ~~periodic reports are~~2021 Annual Report was prepared by an auditor who is not inspected by ~~the U.S. Public Company Accounting Oversight Board, or~~ the PCAOB and, as such, you are deprived of the benefits of such inspection, we may be subject to additional Nasdaq listing criteria or other penalties and our ADSs may be delisted from the U.S. stock ~~market.~~

market;

~~Auditors of companies that are registered with~~

Proceedings brought by the SEC ~~and traded publicly in the United States, including the independent registered public~~against China-based accounting firm of our company, must be registered with the PCAOB, and are required by the laws of the United States to undergo regular inspections by the PCAOB to assess their compliance with the laws of the United States and professional standards. Because a substantial portion of our operations are within China, a jurisdiction where the PCAOB is currently unable to conduct inspections without the approval of the Chinese authorities, our auditor is not currently inspected by the PCAOB.

Inspections of auditors conducted by the PCAOB outside China have at times identified deficiencies in those auditors’ audit procedures and quality control procedures, which may be addressed as part of the inspection process to improve future audit quality. The lack of PCAOB inspections of audit work undertaken in China prevents the PCAOB from regularly evaluating our auditor’s audits and its quality control procedures. As afirms could result ~~investors are deprived of the benefits of PCAOB inspections and may lose confidence~~ in our ~~reported~~inability to file future financial ~~information and procedures and the quality of our financial statements.~~

~~As part of a continued regulatory focus~~statements in the United States on access to audit and other information currently protected by national law, in particular China’s, in June 2019, a bipartisan group of lawmakers introduced bills in both houses of the U.S. Congress, which if passed, would require the SEC to maintain a list of issuers for which PCAOB is not able to inspect or investigate the audit work performed by a foreign public accounting firm completely. The proposed Ensuring Quality Information and Transparency for Abroad-Based Listings on Our Exchanges Act prescribes increased disclosure requirements for these issuers and, beginning in 2025, the delisting from U.S. national securities exchanges, such as the Nasdaq, of issuers included on the SEC’s list for three consecutive years. It is unclear if this proposed legislation will be enacted.

Furthermore, there have been recent deliberations within the U.S. government regarding potentially limiting or restricting China-based companies from accessing U.S. capital markets. On May 20, 2020, the U.S. Senate passed the Holding Foreign Companies Accountable Act (HFCA Act), which includes requirements for the SEC to identify issuers whose audit work is performed by auditors that the PCAOB is unable to inspect or investigate completely because of a restriction imposed by

~~a non-U.S. authority~~

~~in the auditor’s local jurisdiction and to prohibit the securities of such issuers that have has three consecutive~~

~~non-inspection~~

years from being traded on U.S. national securities exchanges such as the Nasdaq. The U.S. House of Representatives passed the HFCA Act on December 2, 2020, and the HFCA Act was signed into law on December 18, 2020. On May 13, 2021, the PCAOB issued proposed PCAOB Rule 6100 Board Determinations under the HFCA Act for public comment. The proposed rule provides a framework for making determinations as to whether PCAOB is unable to inspect an audit firm in a foreign jurisdiction, including the timing, factors, bases, publication and revocation or modification of such determinations, and provides that such determinations may be made on a jurisdiction-wide basis in a consistent manner applicable to all firms headquartered in the jurisdiction.

Additionally, in July 2020, the U.S. President’s Working Group on Financial Markets issued recommendations for actions that can be taken by the executive branch, the SEC, the PCAOB or other federal agencies and departmentscompliance with respect to Chinese companies listed on U.S. stock exchanges and their audit firms, in an effort to protect investors in the United States. In response, on November 23, 2020, the SEC issued guidance highlighting certain risks (and their implications to U.S. investors) associated with investments in China-based issuers and summarizing enhanced disclosures the SEC recommends China-based issuers make regarding such risks.

~~On June 22, 2021, the U.S. Senate passed the Accelerating Holding Foreign Companies Accountable Act (AHFCA Act), which amends~~ the requirements of the ~~HFCA Act to require that the SEC identify issuers whose audit work is performed by auditors that the PCAOB is unable to inspect or investigate completely because of a restriction imposed by any~~

~~non-U.S.~~Exchange Act;

~~authority and to prohibit the securities of such issuers that have had two consecutive~~

~~non-inspection~~

~~years from being traded on U.S. national securities exchanges such as the Nasdaq.~~

Under the HFCA Act (and, if passed, the AHFCA Act), our securities may be prohibited from trading on the Nasdaq or other U.S. stock exchanges if our auditor is not inspected by the PCAOB for three consecutive years (or, if the AHFCA Act is passed, two consecutive years), and this ultimately could result in our ADSs being delisted which would materially adversely affect the Company.

~~Table of Contents~~

~~Additionally,~~Compliance with China’s Data Security Law, Cyber Security Law, Cybersecurity Review Measures, Personal Information Protection Law, the Nasdaq has proposed adopting additional listing criteria applicable to companies that primarily operate in jurisdictions where local regulators impose secrecy laws, national security laws or other laws that restrict U.S. regulators from accessing information relating to the issuer, or a Restrictive Market. Under the proposed rule, whether a jurisdiction permits PCAOB inspection would be a factor in determining whether a jurisdiction is deemed by the Nasdaq to be a Restrictive Market. If the Nasdaq adopts this rule, China will likely be determined to be a Restrictive Market and, as a result, the Nasdaq may impose on us additional listing criteria or deny continued listing of our securitiesRegulation on the ~~Nasdaq.~~

~~There can be no assurance that we or~~Administration of Human Genetic Resources, the Biosecurity Law, and any other future laws and regulations may entail significant expenses and could materially affect our ~~auditor will be able~~business. Our failure to comply with requirements imposed by Nasdaq or the U.S. regulators. We are evaluating additional business processes and control changes with the goal of meeting the requirements of the HFCA Act. However, any business processes and control changes that we may implement may not be sufficient or may take time for us to implement and they ultimately may not be successful. We may also be subject to enforcement under the HFCA Act, the rules implementing the act that may be adopted by the SEC, and any other similar legislation that may be enacted into law or executive orders that may be adopted in the future. Although we are committed to complying with the rulessuch laws and regulations ~~applicable~~could lead to ~~listed companies in the United States, we are currently unable to predict the potential impact on~~government enforcement actions and significant penalties against us, materially and adversely impacting our listed status by the rules that may be adopted by the SEC under the HFCA Act (or, if passed, the AHFCA Act). Delisting of our ADSs would force holders of our ADSs to sell their ADSs or convert them into our ordinary shares. Although our ordinary shares are listed in Hong Kong, investors may face difficulties in converting their ADSs into ordinary shares and migrating the ordinary shares to Hong Kong or may incur increased costs or suffer losses in order to do so. The market price of our ADSs could be materially adversely affected as a result of anticipated negative impacts of these rules and executive, regulatory or legislative actions upon, as well as negative investor sentiment towards, companies with significant operations in China that are listed in the United States, regardless of whether these rules and executive, regulatory or legislative actions are implemented and regardless of our actual operating ~~performance. Failure to adopt effective contingency plans may also have a material adverse impact on our business and the price of our ADSs and ordinary shares.~~results;

~~China’s~~The economic, political and social conditions in mainland China, as well as governmental policies, ~~or regulatory actions,~~ could affect the business environment and financial markets in mainland China, our ability to operate our business, our liquidity and our access to ~~capital.~~

capital;

~~Substantially all of~~

If the Chinese government determines that our ~~operations (and all of our commercial operations)~~corporate structure does not comply with Chinese regulations, or if Chinese regulations change or are conducted in China. Accordingly, our business, results of operations, financial condition and prospects may be influenced to a significant degree by economic, political, legal and social conditions in China as well as China’s economic, political, legal and social conditions in relation to the rest of the world. China’s economy differs from the economies of developed countries in many respects, including with respect to the amount of government involvement, level of development, growth rate, and control of foreign exchange and allocation of resources. While China’s economy has experienced significant growth over the past 40 years, growth has been uneven across different regions and among various economic sectors of China. China’s government has implemented various measures to encourage economic development, data protection and allocation of resources. Some of these measures may benefit the overall economy in China but may have a negative effect on us. Our financial condition and results of operations may be adversely affected by government control, perceived government interference and/or changes in tax, cyber and data security, capital investments, cross-border transaction and other regulations that are currently or mayinterpreted differently in the future, the value of our ADSs or ordinary shares may decline in value or become worthless;

The approval of, filing or other procedures with the CSRC or other Chinese regulatory authorities may be ~~applicable~~required in connection with issuing securities to ~~us. Recently,~~foreign investors under Chinese ~~regulators~~law, and, if required, we cannot predict whether we will be able, or how long it will take us, to obtain such approval or complete such filing or other procedures.

We may be exposed to liabilities under the U.S. Foreign Corrupt Practices Act, or FCPA, and Chinese anti-corruption laws, and any determination that we have ~~announced regulatory actions aimed at providing China’s government with greater oversight over certain sectors of China’s economy, including the~~

~~for-profit~~

~~education sector and technology platforms that~~violated these laws could have a ~~quantitatively significant number of users located in China. Although the biotech industry is already highly regulated in China and while there has been no indication to date that such actions~~material adverse effect on our business or ~~oversight would apply to companies that are similarly situated as us and that are pursuing similar portfolios of drug products and therapies as us, China’s government~~our reputation;

Restrictions on currency exchange may ~~in the future take regulatory actions that materially adversely affect the business environment and financial markets in China as they relate to us,~~limit our ability to ~~operate our business, our liquidity~~receive and ~~our access to capital.~~use financing in foreign currencies effectively;

We may rely on dividends and other distributions on equity paid by our Chinese subsidiaries to fund any cash and financing requirements we may have, and any limitation on the ability of our Chinese subsidiaries to make payments to us could have a material and adverse effect on our ability to conduct our business;

~~The uncertainties~~

Chinese regulations relating to the establishment of offshore special purpose companies by residents in ~~the~~mainland China ~~legal system could materially and~~may subject our China resident beneficial owners or our wholly foreign-owned subsidiaries in mainland China to liability or penalties, limit our ability to inject capital into these subsidiaries, limit these subsidiaries’ ability to increase their registered capital or distribute profits to us, or may otherwise adversely affect ~~us.~~

us;

~~On July 6, 2021, the General Office~~

Chinese regulations establish complex procedures for some acquisitions of ~~the Communist Party of~~mainland China Central Committee and the General Office of the State Council jointly issued a document to enhance its enforcement against illegal activities in the securities markets and promote the high-quality development of the capital markets,based companies by foreign investors, which ~~among other things, requires the relevant governmental authorities to strengthen cross-border oversight of~~

~~law-enforcement~~

and judicial cooperation, to enhance supervision over China-based companies listed overseas, and to establish and improve the system of extraterritorial application of the Chinese securities laws. Since this document is relatively new, uncertainties exist in relation to how soon legislative or administrative regulation-making bodies will respond and what existing or new laws or regulations or detailed implementations and interpretations will be modified or promulgated, if any, and the potential impact such modified or new laws and regulations will have on companies like us.

~~It is especially~~could make it more difficult for us to ~~accurately predict~~pursue growth through acquisitions in mainland China;

Chinese manufacturing facilities have historically experienced issues operating in line with established GMPs and international best practices, and passing FDA, NMPA, and EMA inspections, which may result in a longer and costlier current GMP inspection and approval process by the potential impact to the Company of new legal requirements in China because the China legal system is a civil law system based on written statutes. Unlike the common law system, prior court decisions under the civil law system may be citedFDA, NMPA, or EMA for ~~reference but have limited precedential value. In 1979, the~~our Chinese ~~government began to promulgate a comprehensive system of laws~~manufacturing processes and regulations governing economic matters in general. The overall effect of legislation over the past four decades has significantly enhanced the protections afforded to various forms of foreign investments in China. However, China has not developed a fully integrated legal system, and recently enacted laws and regulations may not sufficiently cover all aspects of economic activities in China. In particular, the China legal system is based on written statutes and prior court decisions have limited value as precedents. Since these laws and regulations are relatively new and the China legal system continues to rapidly evolve, the interpretations of many laws, regulations and rules may not be uniform and enforcement of these laws, regulations and rules involves uncertainties. These uncertainties may affect our judgment on the relevance of legal requirements and our ability to enforce our contractual rights or tort claims. In addition, the regulatory uncertainties may be exploited through unmerited or frivolous legal actions or threats in attempts to extract payments orthird-party contract manufacturers;

Our business benefits from ~~us. Furthermore, the China legal system is based in part~~certain financial incentives and discretionary policies granted by local governments. Expiration of, or changes to, these incentives or policies would have an adverse effect on ~~government policies and internal rules, some~~our results of which are not published on a timely basis or at all and may have a retroactive effect. As a result, we may not be aware of our violation of any of these policies and rules until sometime after the violation. In addition, any administrative and court proceedings in China may be protracted, resulting in substantial costs and diversion of resources and management attention.operations;

~~Other Risk Factors~~

~~The following is a summary of significant risk factors and uncertainties that~~It may ~~affect our business which are discussed in more detail in our Annual Report on Form 10-K~~be difficult for ~~the year ended December 31, 2020:~~

~~our ability~~overseas regulators to ~~successfully commercialize ZEJULA, Optune, QINLOCK and any other products and product candidates that we may obtain regulatory approval for;~~conduct investigations or collect evidence within mainland China;

~~the anticipated amount, timing~~If we are classified as a Chinese resident enterprise for Chinese income tax purposes, such classification could result in unfavorable tax consequences to us and ~~accounting of revenues; contingent, milestone, royalty and other payments under licensing, collaboration, and acquisition agreements; tax positions and contingencies; collectability of receivables;~~our

~~pre-approval~~non-Chinese

inventory; cost of sales; research and development costs; compensation and other selling, general and administrative expenses; amortization of intangible assets; foreign currency exchange risk; estimated fair value of assets and liabilities; and impairment assessments;shareholders or ADS holders;

~~expectations,~~We and our shareholders face uncertainties in mainland China with respect to indirect transfers of equity interests in Chinese resident enterprises;

Any failure to comply with Chinese regulations regarding the registration requirements for our employee equity incentive plans may subject us to fines and ~~prospects relating to sales, pricing, growth~~other legal or administrative sanctions, which could adversely affect our business, financial condition and ~~launch~~results of operations;

Certain of our ~~marketed~~investments may be subject to review from the Committee on Foreign Investment in the United States, or CFIUS, which may delay or block a transaction from closing;

Changes in United States and ~~pipeline~~international trade policies and relations, particularly with regard to mainland China, may adversely impact our business and operating results;

It may be difficult to enforce against us or our management in mainland China any judgments obtained from foreign courts;

Failure to renew our current leases or locate desirable alternatives for our leased properties could materially and adversely affect our business;

We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future. To date, we have not generated sufficient revenue from product sales to cover corresponding expenses, and we may never achieve or sustain profitability;

We are invested in the commercial success of our four approved products and our ability to generate product revenues in the near future is highly dependent on the commercial success of each of those products;

We rely on third parties to conduct our

~~the potential impact of increased~~pre-clinical

and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our products or product ~~competition in the markets in which~~candidates and our business could be substantially harmed;

If we ~~compete, including increased competition from new originator therapies, generics, prodrugs~~are unable to obtain and ~~biosimilars of existing~~maintain patent protection for our products and ~~products approved under abbreviated regulatory pathways, including generic~~product candidates through intellectual property rights, or ~~biosimilar versions~~if the scope of ~~our products;~~such intellectual property rights obtained is not sufficiently broad, third parties may compete directly against us;

~~patent terms, patent term extensions, patent office actions~~If we fail to maintain proper internal financial reporting controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired; and ~~expected availability and any period of regulatory exclusivity;~~

the timing, outcome and impact of administrative, regulatory, legal or other proceedings related to our patents and other proprietary and intellectual property rights, tax audits, assessments and settlements, pricing matters, sales and promotional practices, product liability and other matters;

the drivers for growing our business, including our plans and intention to commit resources relating to discovery, research and development programs and business development opportunities as well as the potential benefits and results of certain business development transactions;

~~our ability to finance our operations and business initiatives and obtain funding for such activities;~~

the expectations, development plans and anticipated timelines, including costs and timing of potential clinical trials, filings and approvals of our products, product candidates and pipeline programs, including collaborations with third-parties, as well as the potential therapeutic scope of the development and commercialization of our and our collaborators’ pipeline products;

reputational or financial harm to our business arising from adverse safety events, including product liability claims or lawsuits affecting our or any of our licensors’ marketed products, generic or biosimilar versions of our or any of our licensors’ marketed products or any other products from the same class as one of our or any of our licensors’ products;

unexpected impacts on our business operations including sales, expenses, supply chain, manufacturing, cyber-attacks or other privacy or data security incidents, research and development costs, clinical trials and employees;

the potential impact of measures being taken worldwide designed to reduce healthcare costs and limit the overall level of government expenditures, including the impact of pricing actions and reduced reimbursement for our products;

our manufacturing capacity, use of third-party contract manufacturing organizations, plans and timing relating to changes in our manufacturing capabilities or activities in new or existing manufacturing facilities;

~~lease commitments, purchase obligations and the timing and satisfaction of other contractual obligations;~~

~~the impact of new laws, regulatory requirements, judicial decisions and accounting standards;~~

~~the disruption of our business relationships with our licensors;~~

~~the direct and indirect impact of the~~

~~COVID-19~~

~~pandemic on our business and operations, our and our partners’ ability to effectively travel, as needed, during the~~

~~COVID-19~~

~~pandemic, and the duration and impact of~~

~~COVID-19~~

~~or any of its variants that may affect, precipitate or exacerbate one or more of any of the risks and uncertainties mentioned in this section;~~

~~our ability to effectively manage our growth;~~

~~the disruption in the capital or credit markets which may adversely impact our ability to obtain necessary capital or credit market financing;~~

~~the geopolitical tensions that exist between China and the United States may adversely affect our business, our ability to grow, and our access to necessary capital or credit markets;~~

~~our ability to retain key executives and to attract, retain and motivate personnel; and~~

~~other~~Other risks and uncertainties, including those ~~listed under “Part I—Item 1A—Risk Factors”~~described in ~~our~~the 2021 Annual ~~Report on Form~~

~~10-K~~

~~for the year ended December 31, 2020.~~

Report.

These factors should not be construed as exhaustive and should be read with the other cautionary statements and ~~other~~ information in our 2021 Annual Report ~~on Form~~

~~10-K~~

~~for the year ended December 31, 2020~~ and our other filings with the SEC.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

None.

Item 5. Other Information.

None.

3635


~~Exhibit~~ ~~Number~~		~~Exhibit Title~~

101.SCH*		Inline XBRL Taxonomy Extension Schema Document

101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document

~~101.LAB~~101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document

101.DEF*		Inline XBRL Taxonomy Extension Definitions Linkbase Document

104*		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

*	Filed herewith

**	Furnished herewith

^	~~Certain confidential information contained in this exhibit has been omitted because it (i) is not material and (ii) would be competitively harmful if publicly disclosed.~~

3836

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


			ZAI LAB LIMITED

Dated: ~~August 9, 2021~~	May 10, 2022	By:	/s/ ~~Samantha Du~~
		~~Name:~~	Samantha Du
	Name:	Samantha Du
	Title:	Chief Executive Officer

3937


Exhibit Number		Exhibit Title

~~3.1~~		Fifth Amended and Restated Memorandum of Association of Zai Lab Limited (incorporated by reference to Exhibit 3.1 to our Annual Report on Form 10-K (File No. 001-38205) filed with the SEC on March 1, 2021)

~~3.2~~		Fifth Amended and Restated Articles of Association of Zai Lab Limited (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K (File No. 001-38205) filed with the SEC on June 24, 2021)

~~4.1~~		~~Form of Deposit Agreement (incorporated by reference to Exhibit 4.1 to Amendment No. 2 to our Registration Statement on Form F-1 (File No. 333-219980) filed with the SEC on September 1, 2017)~~

4.2		Form of American Depositary Receipt (incorporated by reference to ~~Exhibit 4.1 to Amendment~~ Form 424B3 (File No. ~~2 to our Registration Statement on Form F-1 (File No. 333-219980)~~333-220256 filed with the SEC on ~~September 1, 2017)~~March 30, 2022)

4.3*4.3		Registrant’s Specimen Certificate for Ordinary Shares

~~4.4~~		~~Third Amended and Restated Shareholders Agreement between Zai Lab Limited and other parties named therein dated June 26, 2017~~ (incorporated by reference to Exhibit ~~4.4~~4.1 to our Registration Statement on Form ~~F-1~~S-8 (File No. ~~333-219980)~~333-264800) filed with the SEC on ~~September 1, 2017)~~May 9, 2022).

~~4.5~~4.5*		Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act ~~(incorporated by reference to Exhibit 4.5 to our Annual Report on Form 10-K (File No. 001-38205) filed with the SEC on March 1, 2021)~~

10.1*		~~Amendment to the Amended and Restated Employment Agreement, dated as of May 7, 2021, by and between Zai Lab (US) LLC and Tao Fu~~

~~10.2*^~~		~~Collaboration and License Agreement, dated as of May 28, 2021, by and between Zai Lab (Hong Kong) Limited and Mirati Therapeutics, Inc.~~

~~10.3*^~~		~~License and Collaboration Agreement, dated as of June 15, 2021, by and between Zai Lab (US) LLC and MacroGenics, Inc.~~

31.1*		Certification of Chief Executive Officer Required by Rule 13a-14(a)

31.2*		Certification of Chief Financial Officer Required by Rule 13a-14(a)

32.1**		Certification of Chief Executive Officer Required by Rule 13a-14(a) and Section 1350 of Chapter 63 of Title 18 of the United States Code

32.2**		Certification of Chief Financial Officer Required by Rule 13a-14(a) and Section 1350 of Chapter 63 of Title 18 of the United States Code

101.INS*		Inline XBRL Instance ~~Document—the~~ Document-the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document


			As of
			June 30, 2021			December 31, 2020
	Notes		$			$
Assets
Current assets:
Cash and cash equivalents		3		1,766,573			442,116
Short-term investments		5		—			744,676
Accounts receivable (net of allowance of $5 and $1 as of June 30, 2021 and December 31 , 2020, respectively)				18,029			5,165
Inventories		6		11,114			13,144
Prepayments and other current assets				12,887			10,935

Total current assets				1,808,603			1,216,036
Restricted cash, non-current		4		743			743
Investments in equity investees		7		1,070			1,279
Prepayments for equipment				1,846			274
Property and equipment, net		8		31,642			29,162
Operating lease right-of-use assets				17,015			17,701
Land use rights, net				7,849			7,908
Intangible assets, net				1,733			1,532
Long term deposits				891			862
Value added tax recoverable				23,823			22,141

Total assets				1,895,215			1,297,638

Liabilities and shareholders’ equity
Current liabilities:
Accounts payable				125,621			62,641
Current operating lease liabilities				6,371			5,206
Other current liabilities		11		61,925			30,196

Total current liabilities				193,917			98,043
Deferred income				17,632			16,858
Non-current operating lease liabilities				11,968			13,392

Total liabilities				223,517			128,293

Commitments and contingencies (Note 17 )				0			0
Shareholders’ equity
Ordinary shares (par value of $0.00006 per share; 500,000,000 shares authorized, 94,758,189 and 87,811,026 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively)				6			5
Additional paid-in capital				2,799,318			1,897,467
Accumulated deficit				(1,109,837	)		(713,603	)
Accumulated other comprehensive loss				(16,865	)		(14,524	)
Treasury Stock (at cost, 6,086 and 0nil shares as of June 30, 2021 and December 31, 2020, respectively)				(924	)		—

Total shareholders’ equity				1,671,698			1,169,345

Total liabilities and shareholders’ equity				1,895,215			1,297,638


	As of
	June 30, 2021		December 31, 2020
	$		$
Payroll		12,474		13,694
Professional service fee		9,610		3,128
Payables for purchase of property and equipment		1,720		788
Accrued rebate to distributors		22,416		7,067
Others (note (i))		15,705		5,519

Total		61,925		30,196


	As of
	June 30, 2021		June 30, 2020
Share options		8,629,440		9,808,561
Non-vested restricted shares		632,535		710,068


(in thousands)	Total		Less than 1 year		1 to 3 years		3 to 5 years		More than 5 years
Purchase Obligations	$	28,240	$	28,191	$	49		—		—
Operating Lease Obligations	$	18,847	$	6,557	$	6,180	$	4,373	$	1,737

Title of each class

Trading
Symbol(s)

~~Trading~~
~~Symbol(s)~~

Name of each exchange
on which registered

American Depositary Shares, each representing 110 Ordinary Share, par value ~~$0.00006~~$0.000006 per share

The Nasdaq Global Market

Ordinary Shares, par value ~~$0.00006~~$0.000006 per share*

The Stock Exchange of Hong Kong Limited