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SEC Comment Letter 0000000000-23-011336 to Zhengye Biotechnology Holding Ltd (ZYBT)

Zhengye Biotechnology Holding Ltd
Date: Oct. 17, 2023 · CIK: 0001975641 · Accession: 0000000000-23-011336

AI Filing Summary & Sentiment

Date
October 17, 2023
Author
Not clearly detected
Form
UPLOAD
Company
Zhengye Biotechnology Holding Ltd

Letter

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

FirstName LastNameSonglin Song Comapany NameZhengye Biotechnology Holding Limited October 17, 2023 Page 2 FirstName LastNameSonglin Song Zhengye Biotechnology Holding Limited October 17, 2023 Page 2 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

FirstName LastNameSonglin Song Comapany NameZhengye Biotechnology Holding Limited October 17, 2023 Page 3 FirstName LastName 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, Division of Corporation Finance Office of Life Sciences cc: Ying Li, Esq.

Show Raw Text
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

 FirstName LastNameSonglin Song
 Comapany NameZhengye Biotechnology Holding Limited
 October 17, 2023 Page 2
 FirstName LastNameSonglin Song
Zhengye Biotechnology Holding Limited
October 17, 2023
Page 2
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

 FirstName LastNameSonglin Song
 Comapany NameZhengye Biotechnology Holding Limited
 October 17, 2023 Page 3
 FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc:       Ying Li, Esq.