Exhibit 5.2
2000 Pennsylvania Avenue NW
Suite 3000
Washington, DC 20006
www.ofwlaw.com
Phone: (202)789-1212 ● Fax (202)234-3550
Benjamin L. England - Principal
Direct 202-518-6330
bengland@ofwlaw.com
December 18, 2024
BY ELECTRONIC MAIL
Fu-Feng Kuo
CEO
Health Ever Bio-Tech Co., Ltd.
23F-3, No. 95, Sec. 1, Xintai 5th Rd., Xizhi Dist.
New Taipei City, Taiwan 221416
ff.kuo@hebiotech.com
| Re: | FORM F-1 Registration Statement Under The Securities Act Of 1933 For Jyong Biotech Ltd. (“Jyong”) |
Beginning January 10, 2024, you engaged Olsson Frank Weeda Terman Matz PC (OFW) to review the Form F-1 Registration Statement Under The Securities Act Of 1933 for Jyong Biotech Ltd. (“F-1”). Specifically, OFW was tasked with proposing edits to the draft F-1 to ensure that it would accurately represent, in our opinion, the correspondence between and history of the botanical drug substance MCS-2 before the U.S. Food and Drug Administration (“FDA”). After a series of reviews and edits OFW has now evaluated version eight (8) of the F-1, dated December 18, 2024, representing a revised draft of the original draft F-1, dated February 10, 2024. After our review of various comments and questions received from the Securities and Exchange Commission, in our opinion, version eight of the F-1 (“F-1A8”) accomplishes the original goal of this engagement.
Over the course of its review, OFW focused solely on issues related to MCS-2, the history of MCS-2 with the FDA, representations of how FDA regulates new drugs, and the administrative process FDA undertakes to review and approve new drugs. To that end, OFW did not substantively review or propose edits to any other information in any of the successive versions of the draft F-1 and offers no opinion regarding such other information.
| December 18, 2024 |  |
| Page 2 |
The following correspondence between Jyong and FDA was made available to us to review, which is relevant to this opinion:
| December 17, 2021 | Cover letter from Health Ever Bio-Tech, Co. Ltd. (“HEB”) to FDA accompanying HEB’s resubmitted New Drug Application (“NDA”) for MCS-2 |
| February 22, 2022 | Letter from FDA to HEB |
| June 7, 2022 | Mid-Cycle Communication from FDA to HEB |
| September 14, 2022 | Late Cycle Meeting Minutes prepared by FDA |
| November 30, 2022 | HEB withdrawal of resubmitted NDA |
| December 12, 2022 | FDA Acknowledge Withdrawal Unapproved Application letter to HEB |
| April 14, 2023 | HEB meeting request to FDA |
| June 26, 2023 | FDA written response to HEB meeting request |
| December 12, 2023 | HEB meeting request to FDA |
| December 26, 2023 | FDA response granting meeting request to meeting |
| May 14, 2024 | HEB Type-B Pre-NDA Meeting Request |
| May 23, 2024 | FDA HEB Type-B Meeting Request Denied |
In our opinion, based upon our review of the documents identified above, the statements in version eight (8) of the F-1 (F-1A8) dated December 18, 2024, as to the status of MCS-2 before the FDA and the history of the review of MCS-2 by the FDA, are accurate. Based upon our experience, the statements in version eight (8) of the F-1 (F-1A8) dated December 18, 2024, with respect to its representations of how FDA regulates new drugs and the administrative process FDA undertakes to review and approve new drugs are also accurate.
OFW offers no opinion as to the accuracy or truthfulness of any other statements in version eight (8) of the F-1 (F-1A8), dated December 18, 2024.
| Sincerely, | |
| | |
| /s/ Benjamin L. England, Esq. | |
| Benjamin L. England, Esq. | |
