Correspondence 0001013762-23-004685 from Jyong Biotech Ltd. (MENS)
Jyong Biotech Ltd.
Date: Oct. 18, 2023 · CIK: 0001954488 · Accession: 0001013762-23-004685
AI Filing Summary & Sentiment
File numbers found in text: 333-274042
Referenced dates: September 14, 2023
Show Raw Text
CORRESP
1
filename1.htm
DLA Piper UK LLP Beijing Representative Office
20th Floor, South Tower, Beijing Kerry Center
1 Guanghua Road, Chaoyang District
Beijing 100020, China
T +86 10 8520 0600
F +86 10 8520 0700
W www.dlapiper.com
October 18, 2023
Via EDGAR
Division of Corporation Finance
Office of Life Sciences
Securities and Exchange Commission
Washington, D.C. 20549
Attn.:
Ibolya Ignat
Mary Mast
Doris Stacey Gama
Joe McCann
Re:
Jyong Biotech Ltd.
Response to the Staff’s Comments on
Amendment No. 1 to the Registration Statement on Form F-1
Filed on August 17, 2023 (File No. 333-274042)
Dear Sir and Madam:
On behalf of our client, Jyong
Biotech Ltd., a Cayman Islands exempted company (the “Company”), we submit to the staff (the “Staff”)
of the Securities and Exchanges Commission (the “Commission”) this letter setting forth the Company’s responses
to the comments contained in the Staff’s letter dated September 14, 2023 on the Company’s registration statement on Form F-1
filed on August 17, 2023 (the “Registration Statement”). Concurrently with the submission of this letter, the
Company is filing amendment No.1 to Registration Statement (the “Amendment No.1”) via EDGAR to the Commission.
The Staff’s comments
are repeated below in bold and are followed by the Company’s responses. We have included page references in the Amendment No.1 where
the language addressing a particular comment appears. Capitalized terms used but not otherwise defined herein have the meanings set forth
in the Amendment No.1.
Prospectus Summary
Overview, page 1
1.
We note your response to prior comment 1. Please revise the Summary to explain briefly the term “carotenoid” in order to provide context for your use of the term “carotenoid chylomicrons.”
In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on pages 1, 2, 75 and 99 in accordance with the Staff’s instructions.
2.
We note your revised disclosure in response to prior comment 2. Please revise to identify the active constituents in your lead botanical drug candidate, MCS-2. Similarly, disclose the active constituents contained in your other clinical stage botanical drug candidate, PCP, which is “essentially the same in terms of composition of active ingredients” as MCS-2.
In response to the Staff’s
comments, the Company has revised the disclosure in the Amendment No.1 on pages 1, 2, 75, 76, 99 and 100 in accordance with the
Staff’s instructions.
3.
We note your disclosures here and elsewhere indicating that you have “patented active pharmaceutical ingredients.” Please revise to clarify, if true, that your patents cover certain compositions of carotenoids and chylomicrons.
In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on page 122 in accordance with the Staff’s instructions.
4.
We note your revised disclosure on page 2 in response to prior comment 2. Regarding your submission of comparative data of API-1 and API-2 for U.S. FDA’s review, please disclose the feedback, if any, that FDA provided to you concerning this submission.
In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on page 2 in accordance with the Staff’s instructions.
We have been involving in legal proceedings in the ordinary course
of our business..., page 28
5.
We note your revised disclosure in the first paragraph indicating that the lawsuit, if not settled, is likely to result in an outcome unfavorable to you. With reference to your disclosure on page F-27, please discuss the financial impact of the lawsuit. To the extent that you presently do not have resources available to pay the settlement or judgment, please revise your liquidity and capital resources discussion accordingly.
In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on pages 28, 30, 82, 124 and 125 in accordance with the Staff’s
instructions.
Botanicals are favored, page 95
6.
With a view to disclosure, please tell us how many botanical drug products to date have received FDA approval. To the extent that only a limited number of botanical drug products are FDA approved, please revise this section to disclose this information and similarly highlight this information in the Summary to convey the novelty and/or challenges of receiving approval for a botanical drug.
In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on page 98 in accordance with the Staff’s instructions.
Suppliers, page 117
7.
Please revise to explain whether you use one or more suppliers for API-1. Provide the same information for API-2. Also discuss the types of raw materials that you source from suppliers. For instance, please discuss whether your suppliers provide you with whole plants and/or with certain carotenoids or chylomicrons.
In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on pages 2 and 120 in accordance with the Staff’s instructions.
Regulations, page 123
8.
Please revise your discussion of FDA Regulation and Product Approval to address regulatory issues and technical challenges that are unique to botanical drug products as compared to nonbotanical drugs. In this regard, we refer to the information contained in FDA’s “Botanical Drug Development: Guidance for Industry” available at: https://www.fda.gov/files/drugs/published/Botanical-Drug-Development--Guidance-for-Industry.pdf
In response to the Staff’s comments,
the Company has revised the disclosure in the Amendment No.1 on page 127 in accordance with the Staff’s instructions.
If you have any questions
regarding the Amendment No.1, please contact the undersigned by phone at (+86) 10 8520 0616 or via e-mail at yang.ge@dlapiper.com.
Very truly yours,
/s/ Yang Ge
Yang
Ge
cc:
Yang Ge