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United States securities and exchange commission logo
October 17, 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. 1 to
Draft Registration Statement on Form F-1
Submitted September
28, 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.
Draft Registration Statement on Form F-1, submitted September 28, 2023
Prospectus Summary
Our Corporate Structure, page 2
1. We note your response
to our prior comment 2 and reissue in part. Please include a
discussion of how the
Cybersecurity Review Measures and the Anti-Monopoly Law may
impact the Company's
ability to accept foreign investments or list on a U.S. or other
foreign exchange if you
were found to be subject to such regulatory action.
Use of Proceeds, page 51
2. We note your response
to our prior comment 5 and your revised disclosure beginning on
page 51, including the
table detailing the R&D projects and the expected proceeds to be
used for each, and your
intention to use 30% of the net proceeds or RBM90,055,00 or
US$13,056,748 to
conduct the listed R&D projects including completing various clinical
Songlin Song
FirstName LastNameSonglin Song
Zhengye Biotechnology Holding Limited
Comapany
October 17,NameZhengye
2023 Biotechnology Holding Limited
October
Page 2 17, 2023 Page 2
FirstName LastName
trials and obtaining Registration Certificates of New Veterinary
Drugs. We also note your
disclosure in the table that the total proceeds that are expected to
be used by the operating
entity in this fashion appear to exceed RBM90,055,00 or US$13,056,748.
Please reconcile
your disclosure in this regard, or advise.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Key Components of Results of Operations
Research and development expenses , page 60
3. We acknowledge the information provided in your expanded disclosure
but continue to
have difficulty in understanding the accounting treatment for your
collaboration activities.
Please provide an accounting analysis for activities under your
collaboration
arrangements with Shanghai Veterinary Research Institute, Harbin
Veterinary Research
Institute, China Agricultural University/China Institute of Veterinary
Drug Control
and Jilin Province/Jilin University. Refer us to the technical
analysis upon which you
relied, including your consideration of guidance in ASC 808. In this
regard, describe the
nature and extent of patent cross licensing between the collaborator
and operating entity
and contractual terms governing these licensing activities under your
collaboration
arrangements. Also, demonstrate how proceeds "expected to be paid to
collaborator"
and "proceeds expected to be used by the operating entity" for
individual R&D projects
sum to the corresponding totals of RMB90.05 million and
USD$13,056,748, as presented
on page 51. Revise your disclosures accordingly.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 61
4. We note your response to our prior comment 9. Please also provide the
RMB to
USD conversion for fiscal year end 2021 in the consolidated results of
operations table so
that investors can make proper comparisons.
Industry
Analysis of Domestic Top Players' Product Portfolio, page 72
5. We note your response to our prior comment 13. We reissue our comment
in full. Please
revise your disclosure to identify the names of the companies listed
in Frost & Sullivan s
analysis. In the alternative, please provide us with a more detailed
analysis as to why you
believe the names of the companies should be excluded from the
prospectus.
Analysis of Domestic Top Players' Pet Vaccine Portfolio, page 77
6. We note your response to our prior comment 16. Please also include a
description of the
structure of the trials conducted.
Products, page 82
7. We note your response to our prior comment 24 and reissue. Please
provide further details
Songlin Song
Zhengye Biotechnology Holding Limited
October 17, 2023
Page 3
about the research the operating entity is conducting with regard to
Feline Infectious
Peritonitis Subunit Vaccine, Feline Leukemia and Feline Immunodeficiency
Disease
Duplex mRNA Vaccine, and Feline GnRH Immunocontraceptive Vaccine.
8. We note your response to our prior comment 25 and your revised disclosure
on page 85
noting that the operating entity has completed clinical trials for Feline
Herpes virus, Feline
Calicivirus and Feline Panleukopenia Triple Vaccine, Inactivated, and
that its application
for a Registration Certificate of New Veterinary Drugs for "this vaccine
has been received
by the Ministry of Agriculture and Rural Affairs of the PRC on February
20, 2023."
Please revise your disclosure to describe the current status of the
operating entity's
application. Additionally, please disclose the structure of the clinical
trials and what
results, if any, were observed.
R&D, page 90
9. We note your response to our prior comment 31 and your revised disclosure
regarding the
material terms of your various collaboration agreements. Please revise
your disclosure in
this section further to state the total aggregate amount to date that has
been paid pursuant
to each agreement, as you disclose on page 80.
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,
FirstName LastNameSonglin Song
Division of Corporation
Finance
Comapany NameZhengye Biotechnology Holding Limited
Office of Life Sciences
October 17, 2023 Page 3
cc: Ying Li, Esq.
FirstName LastName