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United States securities and exchange commission logo
November 28, 2023
Songlin Song
Chief Executive Officer
Zhengye Biotechnology Holding Limited
No.1 Lianmeng Road, Jilin Economic & Technical Development Zone
Jilin City, Jilin Province, China
Re: Zhengye
Biotechnology Holding Limited
Amendment No. 2 to
Draft Registration Statement on Form F-1
Submitted November
17, 2023
CIK No. 0001975641
Dear Songlin Song:
We have reviewed your amended draft registration statement and have
the following
comments.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to this
letter and your amended
draft registration statement or filed registration statement, we may
have additional comments.
Amendment No. 2 to Draft Registration Statement on Form F-1
Use of Proceeds, page 51
1. We note your response
to our prior comment 2 and the addition of the "total" row in the
table that shows the
types of R&D projects the operating entity plans to conduct. Please
amend to ensure that
the total amounts are properly captured, or otherwise advise.
Management's Discussion and Analysis of Financial Condition and Results
of Operations
Results of Operations
Operating expenses, page 65
2. Please describe and
quantify research and development costs for individual projects
sponsored by the
Government of Jilin Province PRC, as discussed on pages 98-103.
Songlin Song
FirstName LastNameSonglin Song
Zhengye Biotechnology Holding Limited
Comapany 28,
November NameZhengye
2023 Biotechnology Holding Limited
November
Page 2 28, 2023 Page 2
FirstName LastName
Industry
Analysis of Domestic Top Players' Pet Vaccine Portfolio, page 80
3. We note your response to our prior comment 6 regarding the structure
and results of your
clinical trials. You state you are currently analyzing the test
results and conclusions for
project Feline Rhinotracheitis, Feline Rhino conjunctivitis and Feline
Panleukopenia
Triple Inactivated Vaccine. Please revise your disclosure to include a
description of the
trials that were conducted, including the structure of such trials.
4. We note your disclosure that your clinical trials demonstrated that
your vaccines
associated with batch numbers 2022005 and 2021024 were "safe and
effective." Please
tell us whether safety and efficacy determinations are solely within
the purview of certain
Chinese regulatory authorities. If so, please revise your disclosure
to remove such claims
or advise.
R&D, page 94
5. We note your disclosure regarding the strategic cooperation framework
agreement that the
operating entity entered into with Shanghai Veterinary Research
Institute, and the
subsequently executed Memorandum associated with this agreement.
Please revise your
disclosure here to note the duration of the agreement as well as the
termination provisions
of the agreement.
Notes to the Unaudited Condensed Consolidated Financial Statements
2. Summary of Significant Accounting Policies
Basis of presentation, page F-32
6. Please provide disclosure required by Rule 3.03(d) of Regulation S-X.
Research and development expenses , page F-36
7. Please provide disclosure for your research and development activities
as required by
ASC 730-20-50, particularly a description and quantification of key
terms governing the
multiple research projects sponsored by the government of Jilin
Province PRC, as
discussed on pages 98-103.
8. Intangible Assets, Net, page F-43
8. Please expand your disclosure to describe and quantify the intangible
assets licensed
under your agreements with Harbin Veterinary Research Institute, China
Agricultural
University and China Institute of Veterinary Drug Control, as
discussed on pages 95-98.
Songlin Song
FirstName LastNameSonglin Song
Zhengye Biotechnology Holding Limited
Comapany 28,
November NameZhengye
2023 Biotechnology Holding Limited
November
Page 3 28, 2023 Page 3
FirstName LastName
Please contact Franklin Wyman at 202-551-3660 or Daniel Gordon at
202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Doris Stacey Gama at 202-551-3188 or Joshua Gorsky at 202-551-7836 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Ying Li, Esq.