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Correspondence 0001213900-24-002029 from Zhengye Biotechnology Holding Ltd (ZYBT)

Zhengye Biotechnology Holding Ltd
Date: Jan. 9, 2024 · CIK: 0001975641 · Accession: 0001213900-24-002029

AI Filing Summary & Sentiment

Referenced dates: December 27, 2023

Date
January 9, 2024
Author
/s/ Songlin Song
Form
CORRESP
Company
Zhengye Biotechnology Holding Ltd

Letter

Zhengye Biotechnology Holding Limited

January 9, 2024

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

U.S. Securities and Exchange Commission

100 F Street, NE

Washington, D.C., 20549

Attention: Franklin Wyman

Daniel Gordon

Doris Stacey Gama

Joshua Gorsky

Re: Zhengye Biotechnology Holding Limited

Amendment No. 3 to Draft Registration Statement on Form F-1

Submitted December 14, 2023

CIK No. 0001975641

Ladies and Gentlemen:

This letter is in response to the letter dated December 27, 2023, from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) addressed to Zhengye Biotechnology Holding Limited (the “Company,” “we” and “our”). For ease of reference, we have recited the Commission’s comments in this response and numbered them accordingly. A registration statement on Form F-1 (the “Registration Statement”) is being submitted to accompany this letter.

Amendment No. 3 to Draft Registration Statement on Form F-1

Cover Page

1. You state you “have filed with the CSRC the filing documents” and that “except for the Supplementary Material Request issued by the CSRC regarding your planned overseas listing on September 26, 2023” you and the operating entity have not received any inquiry regarding your planned overseas listing from the CSRC or any other PRC governmental authorities. Please update your disclosure to clarify whether you have provided the Supplementary Material Request or otherwise advise.

In response to the Staff’s comments, we revised our disclosure on the cover page of the Registration Statement to provide that the Company submitted supplementary materials to the CSRC on October 16, 2023.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Results of Operations

Operating expenses, page 65

2. We acknowledge the information provided in your response to comment 2. Please expand your discussion of operating expenses to describe and quantify the major costs within each expense caption and key factors causing changes in these expenses for each period presented. In particular for research and development expenses, quantify total spending for each research and development project in your collaboration with the Government of Jilin Province PRC, as discussed on pages 98-103.

In response to the Staff’s comments, we revised our disclosure on page 65 of the Registration Statement to describe and quantify the major costs within each expense caption and key factors causing changes in these expenses for each period presented. We also quantified the spending for each research and development project subsidized by the Government of Jilin Province, the PRC, on the same page.

Industry

Analysis of Domestic Top Players’ Pet Vaccine Portfolio, page 80

3. We note your response to prior comment 3 and reissue in part. Please revise your disclosure to include a clear description of the trial structure for project Feline Rhinotracheitis, Feline Rhino conjunctivitis and Feline Panleukopenia Triple Inactivated Vaccine.

In response to the Staff’s comments, we revised our disclosure on page 81 of the Registration Statement to include a description of the trial structure for project Feline Rhinotracheitis, Feline Rhino conjunctivitis and Feline Panleukopenia Triple Inactivated Vaccine.

R&D, page 94

4. We note your response to our prior comment 5. We also note that the memorandum was signed on April 3, 2018. Please clarify if the termination provisions remained the same and if the duration of the agreement was extended. If so, please include the updated duration or otherwise advise.

In response to the Staff’s comments, we revised our disclosure on page 95 of the Registration Statement to provide that the memorandum does not extend the duration of the strategic cooperation framework agreement, nor does it contain any provisions regarding its own duration or termination.

Notes to the Unaudited Condensed Consolidated Financial Statements

2. Summary of Significant Accounting Policies

Research and development expenses, page F-36

5. We acknowledge the information in your response to prior comment 7. Please expand your disclosure to describe and quantify terms governing your funding commitments to these third parties, including the estimated commitment amount and duration of the funding period, as well as terms governing your access to intellectual property developed under these collaborations. Also, explain the basis for your assertion that “no research project agreement should be accounted in accordance with ASC 730-20,” including how these collaborations differ from arrangements described in ASC 730-20-05. Refer us to the technical guidance upon which your relied and revise your disclosure accordingly.

In response to the Staff’s comments, we revised our disclosure on page F-37 of the Registration Statement to provide that the cooperative agreements with third parties do not contain any funding commitments items, and both parties may collectively apply for and jointly own the intellectual property rights derived from the research and development projects, if any. We also explain on the same page that the Company recognized the governmental grants as other income-government subsidy rather than accounting for them in accordance with ASC 730-20.

In responding to your comments, the Company acknowledges that:

● the Company is responsible for the adequacy and accuracy of the disclosure in the filing;

● Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and

● the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

We appreciate the assistance the Staff has provided with its comments. If you have any questions, please do not hesitate to call our counsel, Ying Li, Esq., of Hunter Taubman Fischer & Li LLC, at (212) 530-2206.

Very truly yours,
/s/ Songlin Song

Show Raw Text
CORRESP
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filename1.htm

Zhengye Biotechnology Holding Limited

January 9, 2024

Via EDGAR

Division of Corporation Finance

Office of Life Sciences

U.S. Securities and Exchange Commission

100 F Street, NE

Washington, D.C., 20549

    Attention:
    Franklin Wyman

    Daniel Gordon

    Doris Stacey Gama

    Joshua Gorsky

    Re:
    Zhengye Biotechnology Holding Limited

    Amendment No. 3 to Draft Registration Statement on Form F-1

    Submitted December 14, 2023

    CIK No. 0001975641

Ladies and Gentlemen:

This letter is in response to the letter dated
December 27, 2023, from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”)
addressed to Zhengye Biotechnology Holding Limited (the “Company,” “we” and “our”). For ease of reference,
we have recited the Commission’s comments in this response and numbered them accordingly. A registration statement on Form F-1 (the
“Registration Statement”) is being submitted to accompany this letter.

Amendment No. 3 to Draft Registration Statement
on Form F-1

Cover Page

1. You state you “have filed with the
CSRC the filing documents” and that “except for the Supplementary Material Request issued by the CSRC regarding your planned
overseas listing on September 26, 2023” you and the operating entity have not received any inquiry regarding your planned overseas
listing from the CSRC or any other PRC governmental authorities. Please update your disclosure to clarify whether you have provided the
Supplementary Material Request or otherwise advise.

In response to the Staff’s comments, we
revised our disclosure on the cover page of the Registration Statement to provide that the Company submitted supplementary materials to
the CSRC on October 16, 2023.

Management’s Discussion and Analysis
of Financial Condition and Results of Operations

Results of Operations

Operating expenses, page 65

2. We acknowledge the information provided
in your response to comment 2. Please expand your discussion of operating expenses to describe and quantify the major costs within each
expense caption and key factors causing changes in these expenses for each period presented. In particular for research and development
expenses, quantify total spending for each research and development project in your collaboration with the Government of Jilin Province
PRC, as discussed on pages 98-103.

In response to the Staff’s comments, we
revised our disclosure on page 65 of the Registration Statement to describe and quantify the major costs within each expense caption and
key factors causing changes in these expenses for each period presented. We also quantified the spending for each research and development
project subsidized by the Government of Jilin Province, the PRC, on the same page.

Industry

Analysis of Domestic Top Players’ Pet
Vaccine Portfolio, page 80

3. We note your response to prior comment 3
and reissue in part. Please revise your disclosure to include a clear description of the trial structure for project Feline Rhinotracheitis,
Feline Rhino conjunctivitis and Feline Panleukopenia Triple Inactivated Vaccine.

In response to the Staff’s comments, we
revised our disclosure on page 81 of the Registration Statement to include a description of the trial structure for project Feline Rhinotracheitis,
Feline Rhino conjunctivitis and Feline Panleukopenia Triple Inactivated Vaccine.

R&D, page 94

4. We note your response to our prior comment
5. We also note that the memorandum was signed on April 3, 2018. Please clarify if the termination provisions remained the same and if
the duration of the agreement was extended. If so, please include the updated duration or otherwise advise.

In response to the Staff’s comments, we
revised our disclosure on page 95 of the Registration Statement to provide that the memorandum does not extend the duration of the strategic
cooperation framework agreement, nor does it contain any provisions regarding its own duration or termination.

Notes to the Unaudited Condensed Consolidated
Financial Statements

2. Summary of Significant Accounting Policies

Research and development expenses, page F-36

5. We acknowledge the information in your response
to prior comment 7. Please expand your disclosure to describe and quantify terms governing your funding commitments to these third parties,
including the estimated commitment amount and duration of the funding period, as well as terms governing your access to intellectual property
developed under these collaborations. Also, explain the basis for your assertion that “no research project agreement should be accounted
in accordance with ASC 730-20,” including how these collaborations differ from arrangements described in ASC 730-20-05. Refer us
to the technical guidance upon which your relied and revise your disclosure accordingly.

In response to the Staff’s comments, we
revised our disclosure on page F-37 of the Registration Statement to provide that the cooperative agreements with third parties do not
contain any funding commitments items, and both parties may collectively apply for and jointly own the intellectual property rights derived
from the research and development projects, if any. We also explain on the same page that the Company recognized the governmental grants
as other income-government subsidy rather than accounting for them in accordance with ASC 730-20.

In responding to your comments, the Company acknowledges
that:

 ● the
Company is responsible for the adequacy and accuracy of the disclosure in the filing;

 ● Staff
comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to
the filing; and

 ● the
Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities
laws of the United States.

We appreciate the assistance the Staff has provided
with its comments. If you have any questions, please do not hesitate to call our counsel, Ying Li, Esq., of Hunter Taubman Fischer &
Li LLC, at (212) 530-2206.

    2

Very truly yours,

    /s/ Songlin Song

    Name:
    Songlin Song

    Title:
    Chief Executive Officer

cc: Ying Li, Esq.

Hunter Taubman Fischer & Li LLC

3