UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 30, 2023
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ZAI LAB LIMITED
(Exact name of registrant as specified in its charter)
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Cayman Islands | 001-38205 | 98-1144595 | ||||||
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
4560 Jinke Road Bldg. 1, Fourth Floor, Pudong Shanghai, China | 201210 | ||||
314 Main Street 4th Floor, Suite 100 Cambridge, MA, USA | 02142 | ||||
(Address of principal executive offices) | (Zip Code) |
+86 21 6163 2588
+1 857 706 2604
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former name or former address, if changed since last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | ||||
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | ||||
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | ||||
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
American Depositary Shares, each representing 10 Ordinary Shares, par value $0.000006 per share | ZLAB | The Nasdaq Global Market | ||||||||||||
Ordinary Shares, par value $0.000006 per share* | 9688 | The Stock Exchange of Hong Kong Limited |
*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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
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. ☐
Item 7.01 Regulation FD Disclosure.
On June 30, 2023, Zai Lab Limited (the “Company”), together with its partner argenx BV (“argenx”), announced that China’s National Medical Products Administration has approved the Biologics License Application for VYVGART® (efgartigimod alfa injection), a first-in-class neonatal Fc receptor (FcRn) antagonist, as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The Company has an exclusive license from argenx to develop and commercialize VYVGART in mainland China, Hong Kong, Macau, and Taiwan. .
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | Description | |||||||
99.1 | ||||||||
104 | The cover page of this Current Report on Form 8-K is formatted in Inline XBRL |
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 hereunto duly authorized.
ZAI LAB LIMITED | ||||||||
By: | /s/ F. Ty Edmondson | |||||||
F. Ty Edmondson | ||||||||
Chief Legal Officer & Corporate Secretary | ||||||||
Date: June 30, 2023 |