SecProbe.io

<DOCUMENT>
<TYPE>TEXT-EXTRACT
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<FILENAME>filename2.txt
<TEXT>
 April 28, 2025

Yajing Chen
Chief Financial Officer
Zai Lab Limited
4560 Jinke Road
Bldg. 1, 4th Floor
Pudong
Shanghai, China

 Re: Zai Lab Limited
 Form 10-K for Fiscal Year Ended December 31, 2024
 Filed February 27, 2025
 File No. 001-38205
Dear Yajing Chen:

 We have completed our review of your filing. We remind you that the
company and
its management are responsible for the accuracy and adequacy of their
disclosures,
notwithstanding any review, comments, action or absence of action by the staff.

 Sincerely,

 Division of Corporation
Finance
 Office of Life Sciences
</TEXT>
</DOCUMENT>

CORRESP
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 Document SIDLEY SIDLEY AUSTIN LLP 1501 K STREET, N.W. WASHINGTON, D.C. 20005 +1 202 736 8000 +1 202 736 8711 FAX +1 202 736 8715 SVONALTHANN@SIDLEY.COM April 18, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn:    Chris Edwards Tyler Howes Kevin Vaughn Jenn Do Re:    Zai Lab Limited Form 10-K for Fiscal Year Ended December 31, 2024 Filed February 27, 2025 File No. 001-38205 Ladies and Gentlemen:     On behalf of our client, Zai Lab Limited, an exempted company incorporated in the Cayman Islands (the “Company”), we submit to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) this letter setting forth the Company’s response to the comment contained in the Staff’s letter dated April 8, 2025 on the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (“Annual Report”). The Staff’s comment is repeated below in italics and is followed by the Company’s response. Defined terms used but not defined herein have the meanings assigned to such terms in the Annual Report. Form 10-K for Fiscal Year Ended December 31, 2024 General 1. We note the changes to your disclosure appearing at the outset of your annual report, in Item 1. Business and Item 1A. Risk Factors relating to legal and operational risks associated with operating in China. It is unclear to us that there have been changes in the regulatory environment in the PRC since our prior 10-K review completed on June 10, 2022, warranting revised disclosure to mitigate the challenges you face and related disclosures. The Sample Letters to China-Based Companies sought specific disclosure Sidley Austin (DC) LLP is a Delaware limited liability partnership doing business as Sidley Austin LLP and practicing in affiliation with other Sidley Austin partnerships. Page 2 relating to the risk that the PRC government may intervene in or influence your operations at any time, or may exert control over operations of your business, which could result in a material change in your operations and/or the value of your securities. We remind you that, pursuant to federal securities rules, the term “control” (including the terms “controlling,” “controlled by,” and “under common control with”) as defined in Securities Act Rule 405 means “the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, or otherwise.” We do not believe that your revised disclosure conveys the same risk. In future filings, please restore your disclosures in these areas to the disclosures as they existed in prior filings. For example, and without limitation, we note that your disclosure in your Annual Report on Form 10-K does not (i) state that the PRC government may intervene in or influence your operations at any time; (ii) explain how cash is transferred through your organization; and (iii) discuss the regulatory systems affecting your business in China. Response: The Company acknowledges the Staff’s comment. With respect to risks arising from the potential that the PRC government may intervene in or influence the Company’s operations at any time, the Company respectfully submits that it will make the following updates in its future disclosures on Form 10-K in response (together with such additional updates that the Company deems appropriate due to the passage of time or changing circumstances): The Chinese government may intervene in or influence our business, which could result in a material change in our operations, strategy, research and development activities, commercial activities, business, financial condition, results of operations, and prospects , and the value of our securities . The Chinese government has significant oversight and discretion over the conduct of our business and may intervene or influence our operations at any time as the government deems appropriate to further regulatory, political, and societal goals. The Chinese government has published policies that significantly affect certain industries, such as the education and internet industries, and it may in the future release regulations or policies regarding the life sciences industry that could require us to seek permission from Chinese authorities to continue to operate our business or that may affect our strategy, research and development activities, or commercial activities, which may adversely affect our business, financial condition, results of operations, and prospects , and the value of our securities, including potentially making those securities worthless . Furthermore, recent Page 3 statements made by the Chinese government have indicated an intent to increase the government’s oversight and control over securities offerings of companies with significant operations in mainland China that are to be conducted in foreign markets, including the United States, as well as foreign investment in China-based issuers. Any such action by the Chinese government could significantly limit or completely hinder our ability to offer or continue to offer our securities to our investors and could cause the value of our securities to significantly decline or become worthless. With regard to the disclosures in the Annual Report regarding how cash is transferred through the Company’s organization, we respectfully bring the Staff’s attention to the disclosures under the heading “Dividends and Other Distributions” on page 23 of the Annual Report and under the heading “We may rely on dividends and other distributions on equity paid by our Chinese subsidiaries to fund any cash and financing requirements we may have, and any limitation on the ability of our Chinese subsidiaries to make payments to us could have a material adverse effect on our business operations” on page 31 of the Annual Report. The Company has updated these disclosures since the annual report on Form 10-K for the year ended December 31, 2021 (the “2021 Annual Report”) for the purpose of eliminating duplicative disclosure and refocusing the disclosure on the potential impact to the Company of the relevant regulations that represent material risks, rather than on a fulsome and detailed explanation of the history of the regulations. Furthermore, the Company has retained and updated the explanation regarding cash flows through the Company. Consequently, the Company respectfully submits that the disclosure in the Annual Report complies with sample comments 4 and 9 of the Staff’s Sample Letter to China-Based Companies. Specifically, the Company respectfully submits that the existing disclosure provides a description of how cash is transferred through its organization; describes transfers, dividends, or distributions that have been made to date between the Company and its subsidiaries, quantifying the amount where applicable; and describes restrictions on foreign exchange and its ability to transfer cash between entities, across borders, and to U.S. investors. The Company’s corporate structure currently contains no VIEs (as disclosed under the heading “Zai Lab Limited is not a Chinese operating company, but a holding company incorporated in the Cayman Islands” prior to Item 1 of the Annual Report), and to date the Company has never declared or paid dividends on its ordinary shares (as disclosed in Item 5 on page 76 of the Annual Report), nor have there been any such dividends or other distributions from the Company’s Chinese subsidiaries to its subsidiaries located in or outside of mainland China (as disclosed on page 23 of the Annual Report). With respect to the disclosures in the Annual Report regarding the regulatory systems affecting the Company’s business in China, we respectfully draw the Staff’s attention to the disclosures under the heading “We are or may be required to obtain certain permissions from Chinese Page 4 authorities to operate in mainland China, transfer certain scientific data, and issue our securities to foreign investors” prior to Item 1 in the Annual Report. The Company has updated these disclosures since the 2021 Annual Report for the purpose of eliminating duplicative disclosure and refocusing the disclosure on the potential impact to the Company of the relevant regulations that represent material risks, rather than on a fulsome and detailed explanation of the history of the regulations. Furthermore, the Company has enhanced this description as compared to the 2021 Annual Report with additional detail regarding the risk arising from regulations on approvals required to transfer scientific data abroad or to foreign parties and to address risks arising from updates to the Trial Measures. The Company also respectfully draws the Staff’s attention to additional disclosures regarding the regulatory systems affecting the Company’s business in China, including without limitation those under the following headings: • Government Regulation, pages 13-18 • The Chinese government may intervene in or influence our business, which could result in a material change in our operations, strategy, research and development activities, commercial activities, business, financial condition, results of operations, and prospects, page 27 • We are required to obtain certain approvals and licenses from Chinese authorities to operate our Chinese subsidiaries, page 29 • Under Chinese laws and regulations, we may be required by the CSRC or other Chinese regulatory authorities to obtain approval or follow certain procedures to issue our securities to foreign investors, and we cannot predict whether or when we will be able to obtain such approval or complete such procedures, page 29 • We may face further restrictions (or even prohibitions) on our ability to transfer our scientific data abroad if Chinese regulators impose new restrictions (or change their interpretation of existing restrictions) on life sciences companies like us and the scientific data we obtain, generate, and maintain, page 55 The Company respectfully submits that the disclosures described above comply with sample comment 8 of the Staff’s Sample Letter to China-Based Companies. Specifically, the Company respectfully submits that the existing disclosure provides a description of the material permissions or approvals that the Company and its subsidiaries are required to obtain from Chinese authorities to operate its business and to issue securities to foreign investors, including those permissions required under the CSRC, the CAC, and other governmental agencies; an affirmative statement that no application for any such material license or permit has been denied; and the consequences to the Company and its investors if the Company and its subsidiaries do not receive or maintain such permissions or approvals or inadvertently conclude that such permissions or approvals are not required, or if applicable laws, regulations, or interpretations change and the Company is required to obtain such permissions or approvals in the future. Page 5 Nonetheless, the Company respectfully submits that it will make the following updates in its future disclosures on Form 10-K (together with such additional updates that the Company deems appropriate due to the passage of time or changing circumstances): We are required to obtain certain approvals and licenses from Chinese authorities to operate our Chinese subsidiaries. The Chinese government has exercised, and may continue to exercise, substantial influence or control over virtually every sector of the Chinese economy through regulation and state ownership. For example, to conduct our business activities in mainland China, each of our Chinese subsidiaries is required to obtain a business license from the local counterpart of the SAMR. Our ability to operate in mainland China could be undermined if our Chinese subsidiaries are not able to obtain or maintain required approvals from Chinese authorities to operate in mainland China. Each of our Chinese subsidiaries has obtained a valid business license from the local counterpart of the SAMR, and no application for any such license has been denied. The central or local governments could impose new, stricter regulations or interpretations of existing regulations that could require additional expenditures and efforts on our part to comply with such regulations or interpretations. If in the future our Chinese subsidiaries do not receive or maintain required approvals, such as because we inadvertently conclude that approvals are not required or because of changes in applicable laws and regulations or interpretations of such laws and regulations, the operations of our Chinese subsidiaries, and as a result our business, results of operations, financial condition, and prospects, could be adversely affected , and the value of our securities could significantly decline or become worthless . Thank you for your consideration in reviewing the above responses. Please contact Sara von Althann of Sidley Austin LLP at (202) 736-8715 with any questions or further comments regarding the responses to the Staff’s comments. Sincerely, /s/ Sara von Althann Sara von Althann cc:    Yajing Chen     Bruce Blefeld     Aslynn Hogue

<DOCUMENT>
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<TEXT>
 April 8, 2025

Yajing Chen
Chief Financial Officer
Zai Lab Limited
4560 Jinke Road
Bldg. 1, 4th Floor
Pudong
Shanghai, China

 Re: Zai Lab Limited
 Form 10-K for Fiscal Year Ended December 31, 2024
 Filed February 27, 2025
 File No. 001-38205
Dear Yajing Chen:

 We have reviewed your filing and have the following comment.

 Please respond to this letter within ten business days by providing the
requested
information or advise us as soon as possible when you will respond. If you do
not believe
our comment applies to your facts and circumstances, please tell us why in your
response.

 After reviewing your response to this letter, we may have additional
comments.

Form 10-K for Fiscal Year Ended December 31, 2024
General

1. We note the changes to your disclosure appearing at the outset of your
annual report,
 in Item 1. Business and Item 1A. Risk Factors relating to legal and
operational risks
 associated with operating in China. It is unclear to us that there have
been changes in
 the regulatory environment in the PRC since our prior 10-K review
completed on June
 10, 2022, warranting revised disclosure to mitigate the challenges you
face and related
 disclosures. The Sample Letters to China-Based Companies sought specific
disclosure
 relating to the risk that the PRC government may intervene in or
influence your
 operations at any time, or may exert control over operations of your
business, which
 could result in a material change in your operations and/or the value of
your
 securities. We remind you that, pursuant to federal securities rules,
the term control
 (including the terms controlling, controlled by, and
under common control
 with ) as defined in Securities Act Rule 405 means the possession,
direct or indirect,
 April 8, 2025
Page 2

 of the power to direct or cause the direction of the management and
policies of a
 person, whether through the ownership of voting securities, by contract,
or
 otherwise. We do not believe that your revised disclosure conveys the
same risk. In
 future filings, please restore your disclosures in these areas to the
disclosures as they
 existed in prior filings. For example, and without limitation, we note
that your
 disclosure in your Annual Report on Form 10-K does not (i) state that
the PRC
 government may intervene in or influence your operations at any time;
(ii) explain
 how cash is transferred through your organization; and (iii) discuss the
regulatory
 systems affecting your business in China.
 We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence
of action by the staff.

 Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494
if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tyler Howes at 202-551-3370 or Chris Edwards at 202-551-6761 with any
other
questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
</TEXT>
</DOCUMENT>

United States securities and exchange commission logo
March 5, 2024
Yajing Chen
Chief Financial Officer
Zai Lab Ltd
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong, Shanghai, China 201210
Re:Zai Lab Ltd
Form 10-K for Fiscal Year Ended December 31, 2022
File No. 001-38205
Dear Yajing Chen:
            We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Disclosure Review Program
cc:       Aslynn Hogue

CORRESP
1
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Document

 SIDLEY AUSTIN LLP

1501 K STREET, N.W.

WASHINGTON, D.C. 20005

+1 202 736 8000

+1 202 736 8711 FAX

AMERICA  •  ASIA PACIFIC  •  EUROPE

+1 202 736 8387

SBARROS@SIDLEY.COM

February 16, 2024

VIA EDGAR

U.S. Securities and Exchange Commission
Division of Corporation Finance

Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549

Attn:        Jennifer Gowetski

                Andrew Mew

Re:        Zai Lab, Ltd.

        Amendment No. 1 to Form 10-K for Fiscal Year Ended December 31, 2022

        Response dated January 5, 2024

        File No. 001-38205

Ladies and Gentlemen:

On behalf of our client, Zai Lab, Limited, an exempted company incorporated in the Cayman Islands (the “Company”), we submit to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) this letter setting forth the Company’s responses to the comment contained in the Staff’s letter dated January 16, 2024 on the Company’s Amendment No. 1 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and the Company’s response dated January 5, 2024. To assist your review, the Staff’s comment is repeated in italics and is followed by the Company’s response.

Amendment No. 1 to Form 10-K for Fiscal Year Ended December 31, 2022

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections, page 3

1.Your response to prior comment 2 indicates that you relied upon information provided in response to the D&O Questionnaires and that you are not aware of any current members of your board who are officials of the Chinese Communist Party.  Although your response indicates that you did not consider affiliations that predated your board members’ tenure on your board, we note your disclosure that there are no officials of the Chinese Communist Party who are members of your board.

•Please tell us in more detail how you considered the profile of Mr. Kai-Xian Chen. In particular, we note he is a Member of the Chief Specialists Board and Deputy Chief Technical Officer of the major science and technology projects “innovative drugs and modernization of traditional Chinese medicine” and “Innovative Drug Research & Development,” where he participated in the organization and promotion of new drug research and development for China’s 10th - 13th Five Year Plans. We further note Mr. Chen was a Principal Scientist

Sidley Austin (DC) LLP is a Delaware limited liability partnership doing business as Sidley Austin LLP and practicing in affiliation with other Sidley Austin partnerships.

Securities and Exchange Commission    - 1 -    February 16, 2024

for two National Basic Research Programs by the Ministry of Science and Technology as well as a Member of the National Committee of the Chinese People’s Political Consultative Conference.  Please describe his various roles and provide us with your analysis of whether any of those roles at any point in time made him a CCP official.

•Please also tell us how you considered whether Mr. Chen has any current or prior memberships on, or affiliations with, committees of the Chinese Communist Party that are not addressed in his biography on page 11 of your proxy statement.

•Please tell us whether Mr. Chen is a member of the Chinese Communist Party.

Response to Comment 1:

Consideration of Professor Chen’s profile and his various roles in our analysis as to whether these roles made him a CCP official

The Company’s practice with respect to verifying the profile of all directors is to have such individuals submit completed D&O Questionnaires to the Company along with a certification as to the truthfulness and accuracy of their responses to the D&O Questionnaire.   The Company followed this practice to verify Professor Kai Xian Chen’s profile.  In his response to the D&O Questionnaire, Professor Chen confirmed to the Company that he is not an official of the Chinese Communist Party (the “CCP”).

Following receipt of the Staff’s January 16 letter, the Company and its external legal counsel met with Professor Chen to discuss his previous and current roles and affiliations.  Professor Chen’s certification in his response to our D&O Questionnaire that he is not an official of the CCP was confirmed in our subsequent discussion with him following receipt of the Staff’s January 16 letter. The Company also conducted an independent search of available media relating to Professor Chen’s biography.  Based on these actions, the Company has confirmed that Professor Chen is not an official of the CCP nor has he been a CCP official during his tenure with the Company’s Board of Directors (the “Board”).

The Company notes that the term “CCP official” is not defined under the laws, rules, or regulations of the People’s Republic of China (“China”).  The term “CCP official” is also not defined under the Holding Foreign Company’s Accountable Act (the “HFCAA”) and related SEC rules.  In determining that Professor Chen is not a CCP official, the Company considered references to the term in the HFCAA and related SEC rules, as well as definitions of the term used by third-party sources, institutions of the Chinese government, and guidance from our local counsel in China, the Zhonglun Law Firm.  While Professor Chen has held various prominent research and academic positions, those positions have been only as a scientific advisor. At no time has Professor Chen held any positions with the government of China with decision-making authority within the CCP.  In addition, Professor Chen confirmed to us that he has never been an official of the CCP.

Securities and Exchange Commission    - 2 -    February 16, 2024

Below is certain additional information considered by the Company in relation to positions highlighted in the Staff’s January 16 letter and otherwise held by Professor Chen and referenced in his biography as provided on page 11 of the proxy statement:

•Professor Chen has held and continues to hold research positions within project-based advisory initiatives of various organizations relating to the Chinese bio-pharmaceutical industry:

◦As noted in the Staff’s January 16 letter, Professor Chen assisted in administering the major science and technology projects “innovative drugs and modernization of traditional Chinese medicine” and “Innovative Drug Research & Development” since 2001, including by participating in the organization and promotion of new drug research and development for China’s 10th - 13th Five Year Plans.  None of these are official positions within the CCP, government authorities, state-owned enterprises, or other public institutions within China.

◦Prior to joining the Company’s Board of Directors, Professor Chen held roles as a Principal Scientist for two National Basic Research Programs administered by the Ministry of Science and Technology from 1998 to 2009. Professor Chen was the President of the Shanghai Association for Science and Technology, an academic organization whose primary purpose is to promote collaboration and exchange between scientists and which occasionally provides advice with respect to local level government initiatives in the science and technology industry, from 2011 to 2018.

◦Prior to serving on the Company’s Board, Professor Chen was a member of the National Committee of the Chinese People’s Political Consultative Conference (the “Consultative Conference”) from 2007 to 2017. Professor Chen served as a member of the group focused on the science and technology industry, and was one of approximately 2,000 members, of the Consultative Conference, which was an advisory body formed for the purpose of proposing reforms. In this role, Professor Chen provided proposals relating to pharmaceutical drug research and development in China, such as proposals for reforms in the regulatory approval processes in the Chinese biopharmaceutical industry. Professor Chen ceased to be a member of the Consultative Conference in 2017.

•Similarly, before joining the Company’s Board, Professor Chen held positions within academia. Professor Chen was the President of Shanghai University of Traditional Chinese Medicine (“SUTCM”), a public university, from 2005 to 2014. Professor Chen was Deputy Director General and ultimately the Director General of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences (“SIMM”), an academic and research organization focused on the research and development of new and generic pharmaceutical products. He held these roles between 1993 to 2004. Professor Chen is currently a professor at SIMM. SUTCM and SIMM are well-known educational and research institutions. Similar to many of the leading public universities and research-oriented institutions in the United States, neither SUTCM nor SIMM have policy-making authority, and neither are considered to be government agencies of China.

Securities and Exchange Commission    - 3 -    February 16, 2024

Committee memberships or affiliations

The Company has not identified any current or prior memberships or affiliations for Professor Chen beyond those disclosed in his biography on page 11 of our proxy statement that should be considered in connection with its analysis of whether Professor Chen is an official of the CCP. During the meeting between the Company, its external counsel, and Professor Chen, external counsel specifically asked Professor Chen whether he holds any current or prior memberships or affiliations that are not addressed in his biography on page 11 of our proxy statement that should be considered as part of its analysis of whether Professor Chen is an official of the CCP. Professor Chen confirmed that he does not hold and has not held any such committee memberships or affiliations.

Membership with the Chinese Communist Party

Professor Chen is a member of the CCP. Third-party sources estimate that the CCP has approximately 97 million adult members, and another 184 million people under the age of 18 belong to the CCP’s Young Pioneers and Youth League. As these statistics reveal, membership with the CCP is not uncommon in China, and such membership does not cause Professor Chen to be an official of the CCP.

*    *    *

Our additional diligence further confirms the appropriateness of our reliance on Professor Chen’s certification in his D&O questionnaire response that he is not an official of the CCP and supports our disclosure that there are no officials of the Chinese Communist Party who are members of our Board. We hope that the foregoing has been responsive to the Staff’s comments. If you have any questions about this letter or require any further information, please call Sara von Althann of Sidley Austin LLP at (202) 736-8715 or Sonia Barros of Sidley Austin LLP at (202) 736-8387.

Sincerely,

/s/ Sonia Barros
Sonia Barros

cc:      Yajing Chen

F. Ty Edmondson

    Bruce Blefeld

    Aslynn Hogue

CORRESP
1
filename1.htm

Document

 SIDLEY AUSTIN LLP

1501 K STREET, N.W.

WASHINGTON, D.C. 20005

+1 202 736 8000

+1 202 736 8711 FAX

AMERICA  •  ASIA PACIFIC  •  EUROPE

+1 202 736 8387

SBARROS@SIDLEY.COM

January 31, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attn:    Jennifer Gowetski

Andrew Mew

Re:    Zai Lab Ltd

Amendment No. 1 to Form 10-K for Fiscal Year Ended December 31, 2022

Response dated January 5, 2024

File No. 001-38205

Ladies and Gentlemen:

On behalf of our client, Zai Lab Limited, an exempted company incorporated in the Cayman Islands (the “Company”), we acknowledge receipt of the comment contained in the letter of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated January 16, 2024, and relating to Amendment No. 1 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “January 16, 2024 Comment Letter”).

The January 16, 2024 Comment Letter requests that the Company respond within ten business days or advise the Staff when the Company will respond. As communicated to the Staff orally, the Company hereby requests an extension to respond by February 16, 2024. This additional time will enable the necessary internal review related to the Company’s response to the January 16, 2024 Comment Letter.

Sidley Austin (DC) LLP is a Delaware limited liability partnership doing business as Sidley Austin LLP and practicing in affiliation with other Sidley Austin partnerships.

Page 2

Thank you for your consideration in reviewing the above request. Please contact Sara von Althann of Sidley Austin LLP at (202) 736-8715 or Sonia Barros of Sidley Austin LLP at (202) 736-8387 with any questions or further comments regarding the responses to the Staff’s comments.

Sincerely,

/s/ Sonia Barros

Sonia Barros

cc:    Yajing Chen

    Bruce Blefeld

    Aslynn Hogue

United States securities and exchange commission logo
January 16, 2024
Yajing Chen
Chief Financial Officer
Zai Lab Ltd
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong, Shanghai, China 201210
Re:Zai Lab Ltd
Amendment No. 1 to Form 10-K for Fiscal Year Ended December 31, 2022
Response dated January 5, 2024
File No. 001-38205
Dear Yajing Chen:
            We have reviewed your January 5, 2024 response to our comment letter and have the
following comment.
            Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this letter, we may have additional comments. Unless
we note otherwise, any references to prior comments are to comments in our December 21,
2023 letter.
Amendment No. 1 to Form 10-K for Fiscal Year Ended December 31, 2022
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections, page 3
1.Your response to prior comment 2 indicates that you relied upon information provided in
response to the D&O Questionnaires and that you are not aware of any current members
of your board who are officials of the Chinese Communist Party.  Although your response
indicates that you did not consider affiliations that predated your board members’ tenure
on your board, we note your disclosure that there are no officials of the Chinese
Communist Party who are members of your board.

•Please tell us in more detail how you considered the profile of Mr. Kai-Xian Chen.
In particular, we note he is a Member of the Chief Specialists Board and Deputy
Chief Technical Officer of the major science and technology projects “innovative

 FirstName LastNameYajing Chen
 Comapany NameZai Lab Ltd
 January 16, 2024 Page 2
 FirstName LastName
Yajing Chen
Zai Lab Ltd
January 16, 2024
Page 2
drugs and modernization of traditional Chinese medicine” and “Innovative Drug
Research & Development,” where he participated in the organization and promotion
of new drug research and development for China’s 10th - 13th Five Year Plans. We
further note Mr. Chen was a Principal Scientist for two National Basic Research
Programs by the Ministry of Science and Technology as well as a Member of
the National Committee of the Chinese People’s Political Consultative Conference.
Please describe his various roles and provide us with your analysis of whether any of
those roles at any point in time made him a CCP official.

•Please also tell us how you considered whether Mr. Chen has any current or prior
memberships on, or affiliations with, committees of the Chinese Communist Party
that are not addressed in his biography on page 11 of your proxy statement.

•Please tell us whether Mr. Chen is a member of the Chinese Communist Party.
            Please contact Jennifer Gowetski at 202-551-3401 or Andrew Mew at 202-551-3377 with
any other questions.
Sincerely,
Division of Corporation Finance
Disclosure Review Program
cc:       Aslynn Hogue

CORRESP
1
filename1.htm

Document

 SIDLEY AUSTIN LLP

1501 K STREET, N.W.

WASHINGTON, D.C. 20005

+1 202 736 8000

+1 202 736 8711 FAX

AMERICA •  ASIA PACIFIC  •  EUROPE

+1 202 736 8387

SBARROS@SIDLEY.COM

January 5, 2023

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attn:    Jennifer Gowetski

Andrew Mew

Re:    Zai Lab Ltd

Form 10-K for Fiscal Year Ended December 31, 2022

Response dated December 4, 2023

File No. 001-38205

Ladies and Gentlemen:

    On behalf of our client, Zai Lab Limited, an exempted company incorporated in the Cayman Islands (the “Company”), we submit to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) this letter setting forth the Company’s response to the comments contained in the Staff’s letter dated December 21, 2023 on the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “Annual Report”). The Staff’s comments are repeated below in italics and are followed by the Company’s response. Defined terms used but not defined herein have the meanings assigned to such terms in the Annual Report.

Form 10-K for Fiscal Year Ended December 31, 2022

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections, page 158

1.We note your statement that you reviewed public filings, material contracts and director and officer questionnaires in connection with your required submission under paragraph (a). Please supplementally describe any additional materials that were reviewed and tell us whether you relied upon any legal opinions or third party certifications such as affidavits as the basis for your submission. In your response, please provide a similarly detailed discussion of the materials reviewed and legal opinions or third party certifications relied upon in connection with the required disclosures under paragraphs (b)(2) and (3).

Response:

The Company acknowledges the Staff’s comment and respectfully submits that it did not review materials other than the public filings, material contracts and director and officer questionnaires previously described, nor did it rely upon any legal opinions or third party certifications such as affidavits as the basis for its submissions under paragraph (a).

Sidley Austin (DC) LLP is a Delaware limited liability partnership doing business as Sidley Austin LLP and practicing in affiliation with other Sidley Austin partnerships.

Page 2

Additionally, the Company respectfully makes reference to the response set forth in its letter dated September 20, 2023 to comment 1 of the Staff’s letter dated September 13, 2023, quoted below:

For the purpose of making these determinations [under Item 9C(b)(2) through (5) of Form 10-K], the Company reviewed its material contracts and relied upon the Schedules 13D and 13G and the amendments thereto filed by the Company’s shareholders. The Company believes such reliance is reasonable and sufficient because major shareholders are legally obligated to file beneficial ownership schedules with the Commission. In addition, the Company respectfully submits that its annual director and officer questionnaire (“D&O Questionnaire”) solicits information regarding its directors’ outside affiliations. The Company relied upon information provided in response to its D&O Questionnaire in making the above statement that there is no foreign government representative on the Company’s board of directors. The Company respectfully submits that it did not rely upon any legal opinions or third-party certifications such as affidavits as the basis for its determination.

The Company affirms the above response, and submits that it did not review materials other than the public filings, material contracts and director and officer questionnaires previously described, nor did it rely upon any legal opinions or third party certifications such as affidavits as the basis for its submissions under paragraphs (b)(2) or (b)(3) of Item 9C of Form 10-K.

2.In order to clarify the scope of your review, please supplementally describe the steps you have taken to confirm that none of the members of your board or the boards of your consolidated foreign operating entities are officials of the Chinese Communist Party. For instance, please tell us how the board members’ current or prior memberships on, or affiliations with, committees of the Chinese Communist Party factored into your determination. In addition, please tell us whether you have relied upon third party certifications such as affidavits as the basis for your disclosure.

Response:

As noted in response to comment 1, the Company respectfully submits that its D&O Questionnaire solicited information regarding its directors’ outside affiliations and specifically requested directors to indicate whether they were officials of the Chinese Communist Party. The Company relied upon information provided in response to its D&O Questionnaires, where each director of the Company confirmed that he/she was not an official of the Chinese Communist Party. In addition, the Company is not aware of any current members of its board or the boards of its consolidated foreign operating entities who are officials of the Chinese Communist Party or are members of any committee of the Chinese Communist Party. In making this determination, the Company did not consider affiliations of its board members or board members of its consolidated foreign operating entities that predated such persons’ tenure on the boards of the Company or its consolidated foreign operating entities. The Company also did not rely upon any third party certifications or affidavits in making such determinations. Finally, the Company did not take any

Page 3

additional steps to confirm that none of the members of the Company’s board or the boards of the Company’s consolidated foreign operating entities are officials of the Chinese Communist Party.

Thank you for your consideration in reviewing the above responses. Please contact Sara von Althann of Sidley Austin LLP at (202) 736-8715 or Sonia Barros of Sidley Austin LLP at (202) 736-8387 with any questions or further comments regarding the responses to the Staff’s comments.

Sincerely,

/s/ Sonia Barros

Sonia Barros

cc:    Yajing Chen

    Bruce Blefeld

    Aslynn Hogue

United States securities and exchange commission logo
December 21, 2023
Yajing Chen
Chief Financial Officer
Zai Lab Ltd
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong, Shanghai, China 201210
Re:Zai Lab Ltd
Form 10-K for Fiscal Year Ended December 31, 2022
Response dated December 4, 2023
File No. 001-38205
Dear Yajing Chen:
            We have reviewed your December 4, 2023 response to our comment letter and have the
following comments.
            Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this letter, we may have additional comments. Unless
we note otherwise, any references to prior comments are to comments in our November 17,
2023 letter.
Form 10-K for Fiscal Year Ended December 22, 2022
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections, page 158
1.We note your statement that you reviewed public filings, material contracts and director
and officer questionnaires in connection with your required submission under paragraph
(a).  Please supplementally describe any additional materials that were reviewed and tell
us whether you relied upon any legal opinions or third party certifications such as
affidavits as the basis for your submission.  In your response, please provide a similarly
detailed discussion of the materials reviewed and legal opinions or third party
certifications relied upon in connection with the required disclosures under paragraphs
(b)(2) and (3).
2.In order to clarify the scope of your review, please supplementally describe the steps you

 FirstName LastNameYajing Chen
 Comapany NameZai Lab Ltd
 December 21, 2023 Page 2
 FirstName LastName
Yajing Chen
Zai Lab Ltd
December 21, 2023
Page 2
have taken to confirm that none of the members of your board or the boards of your
consolidated foreign operating entities are officials of the Chinese Communist Party.  For
instance, please tell us how the board members’ current or prior memberships on, or
affiliations with, committees of the Chinese Communist Party factored into your
determination. In addition, please tell us whether you have relied upon third party
certifications such as affidavits as the basis for your disclosure.
            Please contact Jennifer Gowetski at 202-551-3401 or Andrew Mew at 202-551-3377 with
any other questions.
Sincerely,
Division of Corporation Finance
Disclosure Review Program
cc:       Aslynn Hogue

CORRESP
1
filename1.htm

Document

 SIDLEY AUSTIN LLP

1501 K STREET, N.W.

WASHINGTON, D.C. 20005

+1 202 736 8000

+1 202 736 8711 FAX

AMERICA  •  ASIA PACIFIC  •  EUROPE

+1 202 736 8387

SBARROS@SIDLEY.COM

December 4, 2023

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attn:    Jennifer Gowetski

Andrew Mew

Re:    Zai Lab Ltd

Form 10-K for Fiscal Year Ended December 31, 2022

Response dated September 20, 2023

File No. 001-38205

Ladies and Gentlemen:

    On behalf of our client, Zai Lab Limited, an exempted company incorporated in the Cayman Islands (the “Company”), we submit to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) this letter setting forth the Company’s response to the comment contained in the Staff’s letter dated November 17, 2023 on the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (“Annual Report”). The Staff’s comment is repeated below in italics and is followed by the Company’s response. Defined terms used but not defined herein have the meanings assigned to such terms in the Annual Report.

Form 10-K for Fiscal Year Ended December 31, 2022

General

1.We note your response to prior comment 1 and continue to believe that you should provide the documentation required by Item 9C of Form 10-K. Additionally, please amend your Form 10-K to provide the disclosures required under Item 9C(b) of Form 10-K. Refer to the Staff Statement on the Holding Foreign Companies Accountable Act and the Consolidated Appropriations Act, 2023, available on our website at https://www.sec.gov/corpfin/announcement/statement-hfcaa-040623.

Response:

The Company acknowledges the Staff’s comment and proposes to amend its Form 10-K for the year ended December 31, 2022. The Company has attached a draft of the amendment on Form 10-K/A, including new Exhibit 99.1, as Exhibit A hereto.

Thank you for your consideration in reviewing the above responses. Please contact Sara von Althann of Sidley Austin LLP at (202) 736-8715 or Sonia Barros of Sidley Austin LLP at (202)

Sidley Austin (DC) LLP is a Delaware limited liability partnership doing business as Sidley Austin LLP and practicing in affiliation with other Sidley Austin partnerships.

Page 2

736-8387 with any questions or further comments regarding the responses to the Staff’s comments.

Sincerely,

/s/ Sonia Barros

Sonia Barros

cc:    Yajing Chen

    Bruce Blefeld

    Aslynn Hogue

Exhibit A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

__________________________

FORM 10-K/A

Amendment No.1

__________________________

(Mark One)

x Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the fiscal year ended: December 31, 2022

Or

o Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Commission file number: 001-38205

__________________________

ZAI LAB LIMITED

(Exact Name of Registrant as Specified in its Charter)

__________________________

Cayman Islands 98-1144595

(State or Other Jurisdiction of
Incorporation or Organization) (I.R.S. Employer
Identification No.)

4560 Jinke Road

Bldg. 1, Fourth Floor
Pudong

Shanghai, China

 201210

314 Main Street

4th Floor, Suite 100

Cambridge, MA, USA

 02142

(Address of Principal Executive Offices) (Zip Code)

+86 21 6163 2588

+1 857 706 2604

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class  Trading Symbol(s)  Name of each exchange on which registered

American Depositary Shares, each representing 10 Ordinary Shares, par value $0.000006 per share  ZLAB  The Nasdaq Global Market

Ordinary Shares, par value $0.000006 per share*

  9688  The Stock Exchange of Hong Kong Limited

__________________________

*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not registered or listed for trading in the United States but are listed for trading on the Stock Exchange of Hong Kong Limited.

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No o

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes o No x

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:

Large accelerated filer x Accelerated Filer o

Non-accelerated filer o Smaller reporting company o

    Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. x

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. o

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of June 30, 2022, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the ordinary shares, including in the form of American Depositary Shares (“ADSs”), each representing ten ordinary shares, held by non-affiliates of the registrant was approximately $3.2 billion, based upon the closing price of the registrant’s ADSs on the Nasdaq Global Market of $34.68 on June 30, 2022.

As of February 28, 2023, 979,087,430 ordinary shares, par value $0.000006 per share, were outstanding, of which 743,576,320 ordinary shares were held in the form of ADSs.

EXPLANATORY NOTE

Zai Lab Limited (the “Company”) is filing this Form 10-K/A (“Amendment No. 1”) to its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, originally filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2023 (the “2022 Annual Report on Form 10-K”) to amend Item 9C and include Exhibit 99.1 in response to comments received from the SEC staff.

In addition, as required by Rule 12b-15 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), new certifications by the Company’s principal executive officer and principal financial officer are filed herewith as exhibits to this Amendment No. 1, under Item 15 hereof, pursuant to Rule 13a-14(a) or 15d-14(a) of the Exchange Act. Since no financial statements have been included in this Amendment No. 1 and this Amendment No. 1 does not contain or amend any disclosure with respect to Items 307 and 308 of Regulation S-K, paragraphs 3, 4 and 5 of the certifications have been omitted. The Company is also not including new certifications under Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350) (Section 906 of the Sarbanes-Oxley Act of 2002), as no financial statements are being filed with this Amendment No. 1.

This Amendment No. 1 speaks as of the original filing date of the 2022 Annual Report on Form 10-K and reflects only the changes to the cover page, Item 9C of Part II, and Item 15 of Part IV, including the addition of Exhibit 99.1 and the inclusion of the certifications required under Section 302 of The Sarbanes-Oxley Act of 2002. Apart from those changes discussed above, this Amendment No. 1 does not, and does not purport to, amend, update, or restate the information in any other item of the 2022 Annual Report on Form 10-K or reflect any events that have occurred after the filing of the 2022 Annual Report on Form 10-K. The 2022 Annual Report on Form 10-K continues to speak as of the date of the original filing. Accordingly, this Amendment No. 1 should be read in conjunction with the 2022 Annual Report on Form 10-K and the Company’s other SEC filings.

Unless the context requires otherwise, references in this Amendment No. 1 to “Zai Lab,” the “Company,” “we,” “us,” and “our” refer to Zai Lab Limited, a holding company, and its subsidiaries, on a consolidated basis; and references to “Zai Lab Limited” refer to Zai Lab Limited, a holding company.

Part II

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

As we discussed in Disclosures Relating to Our Chinese Operations and Item 1A. Risk Factors, in March 2022, SEC staff conclusively identified the Company under the Holding Foreign Companies Accountable Act (“HFCAA”) because our prior auditor, Deloitte Touche Tohmatsu Certified Public Accountants LLP, which filed an audit report with our last annual report, was located in mainland China, a jurisdiction where the U.S. Public Company Accounting Oversight Board (“PCAOB”) had determined that it was unable to inspect or investigate completely because of restrictions imposed by Chinese authorities.

In May 2022, the Company engaged KPMG LLP, an auditor located in the United States that is inspected by the PCAOB, as our independent registered public accounting firm for the fiscal year ending December 31, 2022, including for the Company’s internal controls over financial reporting. In addition, in December 2022, the PCAOB vacated its determination that it was unable to inspect and investigate PCAOB-registered public accounting firms in mainland China. As a result, the Company no longer retained a registered public accounting firm that the PCAOB had determined it is unable to inspect or investigate completely because of a position taken by an authority in the foreign jurisdiction, and the SEC staff have stated that there are no issuers currently at risk of having their securities subject to a trading prohibition under the HFCAA.

As of the filing date of the 2022 Annual Report on Form 10-K and as of the date hereof, the Company has determined, on behalf of Zai Lab Limited and its consolidated foreign operating entities, that:

•Based on a review of Schedules 13D and 13G and the amendments thereto filed by the Company’s shareholders, the Company is not aware of any owners of the Company’s ordinary shares that are governmental entities in the Cayman Islands. All of the Company’s consolidated operating subsidiaries are wholly owned, directly or indirectly, by Zai Lab Limited.

•Based on a review of Schedules 13D and 13G and the amendments thereto filed by the Company’s shareholders, the Company is not aware of any governmental entities in the People’s Republic of China that have a controlling financial interest in the Company. As noted above, all of the Company’s consolidated operating subsidiaries are wholly owned, directly or indirectly, by Zai Lab Limited.

•Based on a review of the annual director and officer questionnaires completed by each of the Company’s directors, there are no officials of the Chinese Communist Party who are members of the Company’s Board of Directors, or of any equivalent governing body of any of the Company’s consolidated operating subsidiaries.

•Neither the Company’s Sixth Amended and Restated Memorandum and Articles of Association, nor the organizational documents of its consolidated operating subsidiaries, contains any charter of the Chinese Communist Party, including the text of any such charter.

PART IV

Item 15. Exhibits, Financial Statement Schedules

No financial statements or schedules are filed with this Amendment No. 1.

The exhibits filed as part of this Amendment No. 1 are set forth on the Exhibit Index below.

Exhibit
Number  Exhibit Title

3.1  Sixth Amended and Restated Memorandum and Articles of Association of Zai Lab Limited (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K (File No. 001-38205) filed on June 22, 2022)

4.1  Form of Deposit Agreement (incorporated by reference to Exhibit 4.1 to Amendment No. 2 to our Registration Statement on Form F-1 (File No. 333-219980) filed on September 1, 2017)

4.2  Form of American Depositary Receipt (incorporated by reference to Form 424B3 (File No. 333-220256) filed on March 30, 2022)

4.3  Registrant’s Specimen Certificate for Ordinary Shares (incorporated by reference to Exhibit 4.1 to our Registration Statement on Form S-8 (File No. 333-264800) filed on May 9, 2022)

4.4  Third Amended and Restated Shareholders Agreement between Zai Lab Limited and other parties named therein dated June 26, 2017 (incorporated by reference to Exhibit 4.4 to our Registration Statement on Form F-1 (File No. 333-219980) filed on August 15, 2017)

4.5  Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act

10.1#  Zai Lab Limited 2015 Omnibus Equity Incentive Plan as amended on February 3, 2016 and April 10, 2016 (incorporated by reference to Exhibit 10.1 to Amendment No. 2 to our Registration Statement on Form F-1 (File No. 333-219980) filed on September 1, 2017)

10.2#  Zai Lab Limited 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.22 to Amendment No. 2 to our Registration Statement on Form F-1 (File No. 333-219980) filed on September 1, 2017)

10.3#  Zai Lab Limited 2022 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K (File No. 001-38205) filed on June 22, 2022)

10.4#  Form Restricted Share Unit Award Agreement (incorporated by reference to Exhibit 10.2 to our Quarterly Report on Form 10-Q (File No. 001-38205) filed on November 9, 2022)

10.5#  Form Restricted Stock Award Agreement (incorporated by reference to Exhibit 10.3 to our Quarterly Report on Form 10-Q (File No. 001-38205) filed on November 9, 2022)

10.6#  Form of Non-Statutory Stock Option Award Agreement (incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q (File No. 001-38205) filed on November 9, 2022)

10.7#  Non-Employee Director Compensation Policy

10.8#  Zai Lab Limited 2017 Cash Bonus Plan (incorporated by reference to Exhibit 10.11 to Amendment No. 2 to our Registration Statement on Form F-1 (File No. 333-219980) filed on September 1, 2017)

10.9+

  Collaboration, Development and License Agreement by and between Tesaro, Inc. and Zai Lab (Shanghai) Co., Ltd. dated September 28, 2016 (incorporated by reference to Exhibit 10.2 to our Reg

United States securities and exchange commission logo
November 17, 2023
Yajing Chen
Chief Financial Officer
Zai Lab Ltd
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong, Shanghai, China 201210
Re:Zai Lab Ltd
Form 10-K for Fiscal Year Ended December 31, 2022
Response dated September 20, 2023
File No. 001-38205
Dear Yajing Chen:
            We have reviewed your September 20, 2023 response to our comment letter and have the
following comment.
            Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this letter, we may have additional comments. Unless
we note otherwise, any references to prior comments are to comments in our September 13,
2023 letter.
Form 10-K for Fiscal Year Ended December 31, 2022
General
1.We note your response to prior comment 1 and continue to believe that you
should provide the documentation required by Item 9C of Form 10-K. Additionally,
please amend your Form 10-K to provide the disclosures required under Item 9C(b) of
Form 10-K. Refer to the Staff Statement on the Holding Foreign Companies Accountable
Act and the Consolidated Appropriations Act, 2023, available on our website at
https://www.sec.gov/corpfin/announcement/statement-hfcaa-040623.

 FirstName LastNameYajing Chen
 Comapany NameZai Lab Ltd
 November 17, 2023 Page 2
 FirstName LastName
Yajing Chen
Zai Lab Ltd
November 17, 2023
Page 2
            Please contact Jennifer Gowetski at 202-551-3401 or Andrew Mew at 202-551-3377 with
any other questions.
Sincerely,
Division of Corporation Finance
Disclosure Review Program
cc:       Aslynn Hogue

CORRESP
1
filename1.htm

Document

 SIDLEY AUSTIN LLP

1501 K STREET, N.W.

WASHINGTON, D.C. 20005

+1 202 736 8000

+1 202 736 8711 FAX

AMERICA •  ASIA PACIFIC  •  EUROPE

+1 202 736 8387

SBARROS@SIDLEY.COM

September 20, 2023

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attn:    Jennifer Gowetski

Andrew Mew

Re:    Zai Lab Ltd

Form 10-K for Fiscal Year Ended December 31, 2022

File No. 001-38205

Ladies and Gentlemen:

    On behalf of our client, Zai Lab Limited, an exempted company incorporated in the Cayman Islands (the “Company”), we submit to the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) this letter setting forth the Company’s responses to the comment contained in the Staff’s letter dated September 13, 2023 on the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (“Annual Report”). The Staff’s comment is repeated below in italics and is followed by the Company’s response. Defined terms used but not defined herein have the meanings assigned to such terms in the Annual Report.

Form 10-K for Fiscal Year Ended December 31, 2022

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections, page 158

1.We note that during your fiscal year 2022 you were identified by the Commission pursuant to Section 104(i)(2)(A) of the Sarbanes-Oxley Act of 2002 (15 U.S.C. 7214(i)(2)(A)) as having retained, for the preparation of the audit report on your financial statements included in the Form 10-K, a registered public accounting firm that has a branch or office that is located in a foreign jurisdiction and that the Public Company Accounting Oversight Board had determined it is unable to inspect or investigate completely because of a position taken by an authority in the foreign jurisdiction. Please provide the documentation required by Item 9C of Form 10-K or tell us why you are not required to do so. Additionally, please amend your Form 10-K to provide the disclosures required under Item 9C(b) of Form 10-K. Refer to the Staff Statement on the Holding Foreign Companies Accountable Act and the Consolidated Appropriations Act, 2023, available on our website at https://www.sec.gov/corpfin/announcement/statement-hfcaa-040623.

Sidley Austin (DC) LLP is a Delaware limited liability partnership doing business as Sidley Austin LLP and practicing in affiliation with other Sidley Austin partnerships.

Page 2

Response:

The Company respectfully submits that it determined that the disclosures and documentation required under Item 9C of Form 10-K were either included prominently within the Annual Report, or were not material, as described in more detail below.

First, the Company respectfully observes that, on April 18, 2022, the Audit Committee of the Board of Directors of the Company approved (i) the engagement of KPMG LLP, a U.S. auditor (“KPMG U.S.”), as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2022, and the Company’s internal controls over financial reporting, and (ii) the dismissal of Deloitte Touche Tohmatsu Certified Public Accountants LLP and Deloitte Touche Tohmatsu (together, “Deloitte China”) as the Company’s independent registered public accounting firm and auditor, respectively. As a result of the appointment of KPMG U.S. and the dismissal of Deloitte-China in May 2022, the Company no longer retained a registered public accounting firm that the Public Company Accounting Oversight Board (“PCAOB”) had determined it is unable to inspect or investigate completely because of a position taken by an authority in the foreign jurisdiction. The Company’s shareholders ratified the engagement of KPMG U.S. at the Company’s annual shareholders’ meeting in June 2022. Consequently, the Company believed that documentation responsive to Item 9C(a) of Form 10-K was not material.

Additionally, the Company respectfully submits that it provided prominent disclosure in its Annual Report that is directly responsive to Item 9C(b)(1) of Form 10-K, including on page v under the heading “Disclosures Relating to Our Chinese Operations — In order to list our securities in the United States, we must continue to comply with the Holding Foreign Companies Accountable Act (“HFCAA”).” There, the Company specifically disclosed that:

In order to list our securities in the United States, we must continue to comply with the Holding Foreign Companies Accountable Act (“HFCAA”).

Because our prior auditor, which filed an audit report with our last annual report, was located in mainland China, a jurisdiction where the U.S. Public Company Accounting Oversight Board (“PCAOB”) had determined that it was unable to inspect or investigate completely because of restrictions imposed by Chinese authorities, U.S. Securities and Exchange Commission (“SEC”) staff conclusively identified us under the HFCAA in March 2022. . . . In May 2022, the Company engaged KPMG, an auditor located in the United States that is inspected by the PCAOB, as our independent registered public accounting firm.

In addition, the Company included detailed disclosure of related risks in its Risk Factors, including on pages 73-74.

Furthermore, with regard to the disclosures in Item 9C(b)(2) through (5) of Form 10-K, as of the filing date of the Annual Report and as of the date hereof, the Company has determined that it is not owned or controlled by a governmental entity in mainland China, the Company is not a party to any material contracts with such a foreign governmental party, and there is no foreign government representative on the Company’s board of directors. As a result, the Company indicated that these requirements were “Not applicable” in the Annual Report.

Page 3

For the purpose of making these determinations, the Company reviewed its material contracts and relied upon the Schedules 13D and 13G and the amendments thereto filed by the Company’s shareholders. The Company believes such reliance is reasonable and sufficient because major shareholders are legally obligated to file beneficial ownership schedules with the Commission. In addition, the Company respectfully submits that its annual director and officer questionnaire (“D&O Questionnaire”) solicits information regarding its directors’ outside affiliations. The Company relied upon information provided in response to its D&O Questionnaire in making the above statement that there is no foreign government representative on the Company’s board of directors. The Company respectfully submits that it did not rely upon any legal opinions or third-party certifications such as affidavits as the basis for its determination.

Therefore, with regard to Items 9C(b)(2) through (5) of Form 10-K, the Company respectfully submits that it has determined that, as of the filing date of the Annual Report and as of the date hereof, it had and has nothing material to disclose. Specifically, the Company respectfully submits the below information with respect to itself and its consolidated operating subsidiaries.

•Based on a review of Schedules 13D and 13G and the amendments thereto filed by the Company’s shareholders (as described above), the Company is not aware of any owners of the Company’s ordinary shares that are governmental entities in the Cayman Islands. All of the Company’s consolidated operating subsidiaries are wholly owned, directly or indirectly, by Zai Lab Limited.

•Based on a review of Schedules 13D and 13G and the amendments thereto filed by the Company’s shareholders (as described above), the Company is not aware of any governmental entities in the People’s Republic of China that have a controlling financial interest in the Company. As noted above, all of the Company’s consolidated operating subsidiaries are wholly owned, directly or indirectly, by Zai Lab Limited.

•There are no officials of the Chinese Communist Party who are members of the Company’s Board of Directors, or of any equivalent governing body of any of the Company’s consolidated operating subsidiaries.

•Neither the Company’s Sixth Amended and Restated Memorandum and Articles of Association, nor the organizational documents of its consolidated operating subsidiaries, contains any charter of the Chinese Communist Party, including the text of any such charter.

The Company respectfully submits that it did not rely upon any legal opinions or third-party certifications such as affidavits as the basis for the above statements.

On the basis of the foregoing, the Company respectfully submits that no amendments to its Annual Report are required to provide information material to investors, and that filing such an amendment may confuse investors and create an undue hardship for the Company. However, the Company undertakes to include disclosures responsive to Item 9C of Form 10-K in future periodic reports filed under the Securities Exchange Act of 1934, as amended, to the extent required.

Page 4

Thank you for your consideration in reviewing the above responses. Please contact Sara von Althann of Sidley Austin LLP at (202) 736-8715 or Sonia Barros of Sidley Austin LLP at (202) 736-8387 with any questions or further comments regarding the responses to the Staff’s comments.

Sincerely,

/s/ Sonia Barros

Sonia Barros

cc:    Yajing Chen

    Bruce Blefeld

    Aslynn Hogue

United States securities and exchange commission logo
September 13, 2023
Yajing Chen
Chief Financial Officer
Zai Lab Ltd
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong, Shanghai, China 201210
Re:Zai Lab Ltd
Form 10-K for Fiscal Year Ended December 31, 2022
File No. 001-38205
Dear Yajing Chen:
            We have limited our review of your filing to the submission and/or disclosures as
required by Item 9C of Form 10-K and have the following comment.  In our comment, we may
ask you to provide us with information so we may better understand your disclosure.
            Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond.
            After reviewing your response to this comment, we may have additional comments.
Form 10-K for Fiscal Year Ended December 31, 2022
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections, page 158
1.We note that during your fiscal year 2022 you were identified by the Commission
pursuant to Section 104(i)(2)(A) of the Sarbanes-Oxley Act of 2002 (15 U.S.C.
7214(i)(2)(A)) as having retained, for the preparation of the audit report on your financial
statements included in the Form 10-K, a registered public accounting firm that has a
branch or office that is located in a foreign jurisdiction and that the Public Company
Accounting Oversight Board had determined it is unable to inspect or investigate
completely because of a position taken by an authority in the foreign jurisdiction. Please
provide the documentation required by Item 9C of Form 10-K or tell us why you are not
required to do so. Additionally, please amend your Form 10-K to provide the disclosures
required under Item 9C(b) of Form 10-K. Refer to the Staff Statement on the Holding
Foreign Companies Accountable Act and the Consolidated Appropriations Act, 2023,
available on our website at https://www.sec.gov/corpfin/announcement/statement-hfcaa-
040623.

 FirstName LastNameYajing Chen
 Comapany NameZai Lab Ltd
 September 13, 2023 Page 2
 FirstName LastName
Yajing Chen
Zai Lab Ltd
September 13, 2023
Page 2
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Please contact Jennifer Gowetski at 202-551-3401 or Andrew Mew at 202-551-3377 with
any questions.
Sincerely,
Division of Corporation Finance
Disclosure Review Program
cc:       Aslynn Hogue

United States securities and exchange commission logo
June 10, 2022
Billy Cho
Chief Financial Officer
Zai Lab Ltd
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong
Shanghai, China
Re:Zai Lab Ltd
Form 10-K for Fiscal Year Ended December 31, 2021
Filed March 1, 2022
File No. 001-38205
Dear Mr. Cho:
            We have completed our review of your filing.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Thomas Danielski

CORRESP
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 ROPES & GRAY LLP

PRUDENTIAL TOWER

800 BOYLSTON STREET

BOSTON, MA 02199-3600

WWW.ROPESGRAY.COM

 May 3, 2022

 VIA
EDGAR

 U.S. Securities and Exchange Commission

Division of Corporation Finance

 Office of Life Sciences

100 F Street, N.E.

 Washington, D.C. 20549

Attention:

 Tracie Mariner

 Kevin Vaughn

Jason Drory

 Jeffrey Gabor

Re:

 Zai Lab, Ltd.

 Form 10-K for Fiscal Year Ended December 31, 2021

 Filed March 1, 2022

File No. 001-38205

 Ladies and Gentlemen:

On behalf of Zai Lab, Ltd. (the “Company”), we are hereby providing the following response to the comment letter from the staff of
the Division of Corporate Finance, Office of Life Science (the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated April 19, 2022 related to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “Form 10-K”). To assist your review, we have presented the text of the Staff’s comment in italics below. The
response and information described below are based upon information provided to us by the Company.

 Form 10-K
for Fiscal Year Ended December 31, 2021

 Disclosures Relating to our Chinese Operations, page ii

1. Please provide prominent disclosure here discussing whether your auditor is subject to the determinations announced by the PCAOB on
December 16, 2021 and whether and how the Holding Foreign Companies Accountable Act (the “HFCAA”) and related regulations will affect your company, including disclosing that you were identified by the Commission under
the HFCAA. Also, disclose that the United States Senate passed the Accelerating Holding Foreign Companies Accountable Act, which, if enacted, would decrease the number of non-inspection years from three years
to two, thus reducing the time period before your securities may be prohibited from trading or delisted.

Securities and Exchange Commission

 -
 2
 -

May 3, 2022

 Response to Comment 1:

The Company acknowledges the Staff’s comment and advises the Staff that it will provide prominent disclosure of such information at the
onset of Part 1 of the Company’s Form 10-Q for the quarter ending March 31, 2022. Unless there are changes in relevant law or regulations, or in interpretations thereof that would necessitate changes
to the below, we will add the following disclosure in response to this comment:

 Because the majority of our operations are in mainland
China and our auditor has been located in mainland China, a jurisdiction where the U.S. Public Company Accounting Oversight Board (“PCAOB”) is currently unable to conduct inspections without the approval of Chinese authorities, there have
been concerns regarding oversight of the audits of our financial statements filed with the SEC. In March 2022, SEC staff conclusively identified us under the Holding Foreign Companies Accountable Act (“HFCAA”) as an issuer that uses an
auditor that the PCAOB is unable to inspect or investigate completely. Although in April 2022 our Audit Committee approved the engagement of KPMG LLP (“KPMG”), a U.S. auditor that is subject to inspection by the PCAOB, as our independent
public accounting firm for the fiscal year ending December 31, 2022, KPMG is in the process of concluding its standard client evaluation procedures, including obtaining approval from the Hong Kong Stock Exchange to audit the
Company’s consolidated financial statements submitted to the Hong Kong Stock Exchange. If for any reason we continue to fail to meet the audit requirements of the HFCAA for three consecutive years, the HFCAA requires the SEC to prohibit the
trading of our securities on a national securities exchange, including Nasdaq, or on over-the-counter markets in the United States. In addition, the U.S. Senate and U.S.
House of Representatives have each passed bills, which, if enacted, would decrease the number of non-inspection years from three consecutive years to two, thus reducing the time period before our securities
may be prohibited from trading on a U.S. securities exchange or delisted from Nasdaq. The foregoing could adversely affect the market price of our ordinary shares and/or ADSs and our ability to raise capital effectively.

Auditors of companies that are registered with the SEC and traded publicly in the United States, including our independent registered public
accounting firm, are required to be registered with the PCAOB and to undergo regular inspections by the PCAOB to assess their compliance with the laws of the United States and applicable professional standards. Because our current auditor is located
in mainland China, a jurisdiction where the PCAOB is currently unable to conduct inspections without the approval of Chinese authorities, our auditor is not currently inspected by the PCAOB.

Securities and Exchange Commission

 -
 3
 -

May 3, 2022

 PCAOB inspections of auditors located outside of mainland China and Hong Kong have at times
identified deficiencies in those auditors’ audit procedures and quality control procedures, which may be addressed as part of the PCAOB’s inspection process to improve future audit quality. The lack of PCAOB inspections of audit work
undertaken in mainland China and Hong Kong prevents the PCAOB from regularly evaluating our auditor’s audits and its quality control procedures. As a result, investors are deprived of the benefits of PCAOB inspections, which could result in
limitations or restrictions on our access to the U.S. capital markets.

 Furthermore, in recent years, the U.S. Congress and regulatory
authorities have continued to express concerns about challenges in their oversight of financial statement audits of U.S.-listed companies with significant operations in China. As part of this continued focus on access to audit and other information
currently protected by national law, in particular under Chinese law, the United States enacted the HFCAA in December 2020. The HFCAA requires the SEC to identify issuers that have filed an annual report with an audit report issued by a registered
public accounting firm that is located in a foreign jurisdiction and that the PCAOB has determined it is unable to inspect or investigate completely because of a restriction imposed by a non-U.S. authority in
the auditor’s local jurisdiction (a “Commission-Identified Issuer”). Under the HFCAA, if the SEC conclusively identifies an issuer as a Commission-Identified Issuer for three consecutive years, the SEC is required to prohibit the
trading of the issuer’s securities on a national securities exchange or through any other method that is within the jurisdiction of the SEC to regulate, including
over-the-counter markets in the United States. Our securities may be prohibited from trading on the Nasdaq or other U.S. stock exchanges if our auditor is not inspected
by the PCAOB for three consecutive years, and this ultimately could result in our ADSs being delisted.

 Furthermore, in June 2021, the U.S.
Senate passed the Accelerating Holding Foreign Companies Accountable Act (“AHFCAA”), which, if enacted, would amend the HFCAA and require the SEC to prohibit an issuer’s securities from trading on any U.S. stock exchanges if its
auditor is not subject to PCAOB inspections for two consecutive years (as opposed to the three years under the HFCAA). In February 2022, the U.S. House of Representatives passed the America Creating Opportunities for Manufacturing Pre-Eminence in Technology and Economic Strength (COMPETES) Act of 2022 (the “America COMPETES Act”), which similarly would amend the HFCAA to shorten the number of
non-inspection years from three years to two years. The America COMPETES Act, however, includes a broader range of legislation than the AHFCA Act in response to the U.S. Innovation and Competition Act passed
by the U.S. Senate in 2021. The U.S. House of Representatives and the U.S. Senate will need to agree on amendments to these respective bills to allow the legislature to pass their amended bills before the President can sign the bill into law. It is
unclear if or when either of these bills will be signed into law.

Securities and Exchange Commission

 -
 4
 -

May 3, 2022

 In September 2021, the PCAOB adopted PCAOB Rule 6100, Board Determinations Under the Holding
Foreign Companies Accountable Act, which provides a framework for the PCAOB to use when determining whether the PCAOB is unable to inspect or investigate completely a registered public accounting firm located in a foreign jurisdiction because of a
position taken by one or more authorities in that jurisdiction for the purposes of the HFCAA. PCAOB Rule 6100 establishes the manner of the PCAOB’s determinations; the factors the PCAOB will evaluate and the documents and information it will
consider when assessing whether a determination is warranted; the form, public availability, effective date, and duration of such determinations; and the process by which the PCAOB will reaffirm, modify or vacate any such determinations. In November
2021, the SEC announced that it had approved Rule 6100.

 In December 2021, the SEC adopted amendments to finalize rules implementing the
submission and disclosure requirements in the HFCAA for Commission-Identified Issuers, which became effective on January 10, 2022. In addition, the PCAOB issued a Determination Report, pursuant to PCAOB Rule 6100, which found that the PCAOB is
unable to inspect or investigate completely registered public accounting firms headquartered in mainland China and Hong Kong because of positions taken by Chinese authorities in those jurisdictions. The SEC began to identify Commission-Identified
Issuers for fiscal years beginning after December 18, 2020. A Commission-Identified Issuer will be required to comply with the submission and disclosure requirements in the annual report for each year in which it was so identified. If an issuer
is identified as a Commission-Identified Issuer based on its annual report for the fiscal year ended December 31, 2021, the issuer will be required to comply with the submission or disclosure requirements in its annual report for the fiscal
year ended December 31, 2022.

 In March 2022, SEC staff conclusively identified the Company as a Commission-Identified Issuer. In
April 2022 the Audit Committee of our Board of Directors approved the engagement of KPMG, an auditor located in the United States that is inspected by the PCAOB, as our independent registered public accounting firm for the fiscal year ending
December 31, 2022 for the annual consolidated financial statements of the Company filed with the SEC and the Company’s internal controls over financial reporting in accordance with the Exchange Act. KPMG will also be engaged to audit the
consolidated financial statements of the Company for the year ending December 31, 2022 submitted to the Hong Kong Stock Exchange in accordance with the Rules Governing the Listing of Securities of the Hong Kong Stock Exchange, subject to the
Company’s receipt of the approval from the Hong Kong Stock Exchange and the FRC. Even though such approval is expected to be administrative in nature, if such approval is rejected by the Hong Kong Stock Exchange or the FRC, or, for some reason,
we are not able to enter into an engagement agreement with KPMG, the Company would need to engage another auditor that is inspected by the PCAOB in order to comply with the audit requirements of the HFCAA. Additionally, even if KPMG is approved as
our auditor by the Hong Kong Stock Exchange and the FRC, there remains a risk that the CSRC or another Chinese governmental agency could limit or prohibit our ability to use KPMG as our auditor. The foregoing could adversely affect the market price
of our ordinary shares and/or ADSs and our ability to raise capital effectively.

Securities and Exchange Commission

 -
 5
 -

May 3, 2022

 While we understand that there appears to be ongoing, constructive dialogue among the CSRC,
the SEC and the PCAOB regarding permitting the inspection of PCAOB-registered accounting firms in China, there can be no assurance that the U.S. and Chinese governments ultimately reach an agreement on these matters, or that we will be able to
comply with requirements imposed by U.S. regulators, Nasdaq, the CSRC, or other Chinese regulators. If for any reason we continue to be identified as a Commission-Identified Issuer that uses an auditor not subject to PCAOB inspection for three
consecutive years or, if the AHFCAA or the America COMPETES Act is passed, two consecutive years, our ADSs may be delisted from Nasdaq as a result. Delisting of our ADSs would force holders of our ADSs to sell their ADSs or convert them into our
ordinary shares. Further, we may be prohibited from listing our ADSs on another U.S. securities exchange. The market price of our ordinary shares and/or ADSs could be adversely affected as a result of anticipated negative impacts of such legislative
or executive actions upon, as well as negative investor sentiment toward, companies with significant operations in mainland China and Hong Kong that are listed in the United States, regardless of whether such actions are implemented and regardless
of our actual operating performance.

 *    *    *

Securities and Exchange Commission

 -
 6
 -

May 3, 2022

 We hope that the foregoing has been responsive to the Staff’s comments. If you have any
questions about this letter or require any further information, please call my office at (617) 235-4961.

Very truly yours,

/s/ Thomas J. Danielski

Thomas J. Danielski

cc:
 F. Ty Edmondson

Billy Cho

United States securities and exchange commission logo
April 19, 2022
Billy Cho
Chief Financial Officer
Zai Lab Ltd
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong
Shanghai, China
Re:Zai Lab Ltd
Form 10-K for Fiscal Year Ended December 31, 2021
Filed March 1, 2022
File No. 001-38205
Dear Mr. Cho:
            We have reviewed your filing and have the following comment.  In our comment, we
may ask you to provide us with information so we may better understand your disclosure.
            Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this comment, we may have additional comments.
Form 10-K for Fiscal Year Ended December 31, 2021
Disclosures Relating to Our Chinese Operations, page ii
1.Please provide prominent disclosure here discussing whether your auditor is subject to the
determinations announced by the PCAOB on December 16, 2021 and whether and how
the Holding Foreign Companies Accountable Act (the "HFCAA") and related regulations
will affect your company, including disclosing that you were identified by the
Commission under the HFCAA. Also, disclose that the United States Senate passed the
Accelerating Holding Foreign Companies Accountable Act, which, if enacted, would
decrease the number of non-inspection years from three years to two, thus reducing the
time period before your securities may be prohibited from trading or delisted.

 FirstName LastNameBilly Cho
 Comapany NameZai Lab Ltd
 April 19, 2022 Page 2
 FirstName LastName
Billy Cho
Zai Lab Ltd
April 19, 2022
Page 2
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            You may contact Tracie Mariner at 202-551-3744 or Kevin Vaughn at 202-551-3494 if
you have questions regarding comments on the financial statements and related matters.  Please
contact Jason Drory at 202-551-8342 or Jeffrey Gabor at 202-551-2544 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Thomas Danielski

CORRESP
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CORRESP

 ROPES & GRAY LLP

 PRUDENTIAL TOWER

800 BOYLSTON STREET

 BOSTON, MA 02199-3600

WWW.ROPESGRAY.COM

 January 14, 2022

 VIA
EDGAR

 U.S. Securities and Exchange Commission

Division of Corporation Finance

 Office of Life Sciences

100 F Street, N.E.

 Washington, D.C. 20549

Attention:         Tracie Mariner

Kevin Vaughn

 Re:                    Zai Lab, Ltd.

                         Form 10-K for Fiscal Year Ended December 31, 2020

                         Response
dated November 9, 2021

                         File No. 001-38205

 Ladies and Gentlemen:

On behalf of Zai Lab, Ltd. (the “Company”), we provide the following responses to the comment letter from the staff of the Division
of Corporate Finance, Office of Life Science (the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated December 10, 2021 related to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 (the “Form 10-K”) and the Company’s response dated November 9, 2021. To assist your review, we have
presented the text of the Staff’s comments in italics below. The responses and information described below are based upon information provided to us by the Company.

Form 10-K for Fiscal Year Ended December 31, 2020

Part I

 Item 1. Business, page 1

1. At the onset of Part 1, please disclose prominently that you are not a Chinese operating company but a Cayman Islands holding company that
conducts its operations through wholly owned subsidiaries based in China and that investors will not hold direct investments in the Chinese operating companies. Your disclosure should acknowledge that Chinese regulatory authorities could disallow
this structure, which would likely result in a material change in your operations and/or value of your ADSs, including that it could cause the value of such securities to significantly decline or become worthless.

Securities and Exchange Commission

 -
 2
 -

January 14, 2022

 Response to Comment 1:

The Company acknowledges the Staff’s comment and advises the Staff that it will provide prominent disclosure of such risks at the onset of
Part 1 of the Company’s Form 10-K for the year ending December 31, 2021. Unless there are changes in relevant law or regulations, or in interpretations thereof that would necessitate changes to the
below, we will add the following disclosure at the onset of Part 1 of the Company’s Form 10-K for the year ending December 31, 2021:

We are not a Chinese operating company, but a holding company incorporated in the Cayman Islands. As a holding company, we conduct a
substantial portion of our operations through wholly-owned subsidiaries based in China. Investors will not hold direct investments in our Chinese operating companies. In July 2021, the Chinese government provided new guidance on China-based
companies raising capital outside of China, including through arrangements called variable interest entities, or VIEs. Currently, our corporate structure contains no VIEs, and the life sciences industry in which we operate is not subject to foreign
ownership limitations in China. However, there are uncertainties with respect to the Chinese legal system and there may be changes in laws, regulations and policies, including how those laws, regulations, and policies will be interpreted or
implemented. If, in the future, the Chinese government determines that our corporate structure does not comply with Chinese regulations, or if Chinese regulations change or are interpreted differently, the value of our ADSs or ordinary shares may
decline in value or become worthless.

 2. We note your response to prior comment two and disclosure on your Form
10-Q for the quarterly period ending September 30, 2021 (the “2021 Q3 Form 10-Q”) and reissue in part. On page 1 of the 2021 Q3 Form 10-Q under the heading “Usage of Terms,” we note that you provide the domicile of each subsidiary. However, please expand your disclosure to include the entity (including the domicile) in which investors
are purchasing their interest. In addition, we note your disclosure, on page 1, stating that references in the quarterly report on Form 10-Q to “Zai Lab,” the “Company,” “we,”
“us,” and “our” refer to Zai Lab Limited, a holding company, and its subsidiaries, on a consolidated basis. However, we note you refer to Zai Lab Limited and its subsidiaries as the “Group” throughout the filing. Please
revise your disclosure to be consistent throughout.

 Response to Comment 2:

The Company acknowledges the Staff’s comment and advises the Staff that, in future filings, the Company will revise its disclosure to
clarify the entities that it refers to throughout the filing and will revise the “Note on Company Usage of Terms” section of the Company’s Form 10-K for the year ending December 31, 2021 as
follows:

Securities and Exchange Commission

 -
 3
 -

January 14, 2022

 Note on Company-Usage of Terms

Unless the context requires otherwise, references in this Annual Report on Form 10-K to “Greater
China” refers to mainland China, Hong Kong, Macau, and Taiwan and “China” refers to mainland China and references in this Annual Report on Form 10-K to “Zai Lab,” the
“Company,” “we,” “us,” and “our” refer to Zai Lab Limited, a Cayman Islands holding company, and its subsidiaries, on a consolidated basis and references to “Zai Lab Limited” refer to Zai Lab
Limited, a holding company. Zai Lab Limited is the entity in which investors are purchasing their interest.

 Our operating subsidiaries
comprise of Zai Lab (Hong Kong) Limited, domiciled in Hong Kong; Zai Auto Immune (Hong Kong) Limited, domiciled in Hong Kong; Zai Anti Infectives (Hong Kong) Limited, domiciled in Hong Kong; Zai Lab (Shanghai) Co., Ltd., domiciled in China; Zai Lab
International Trading (Shanghai) Co., Ltd., domiciled in China; Zai Lab (Suzhou) Co., Ltd., domiciled in China; Zai Biopharmaceutical (Suzhou) Co., Ltd., domiciled in China; Zai Lab Trading (Suzhou) Co., Ltd., domiciled in China; Zai Lab (Taiwan)
Limited, domiciled in Taiwan; Zai Lab (US) LLC, domiciled in the United States. Additionally, as of the date of this Annual Report on Form 10-K, Zai Auto Immune (Hong Kong) Limited and Zai Anti Infectives
(Hong Kong) Limited have non-substantial business operations.

 Item 1A. Risk Factors, page 61

3. We note your response to prior comment three and your updated risk factor disclosure on page 50 of your 2021 Q3 Form
10-Q and reissue in part. Please address the following regarding your response to prior comment three:

•

 Please disclose the consequences to you and your investors if you inadvertently conclude that approvals are
not required, or applicable laws, regulations, or interpretations change.

•

 Regarding your disclosure that you are required to get certain approvals from Chinese authorities before
transferring certain scientific data abroad or to foreign parties, please revise to more clearly disclose whether have you have received all requisite permissions and whether any permissions have been denied.

Response to Comment 3:

 The Company
acknowledges the Staff’s comment and advises the Staff that it will update the disclosures to address the points above in the Company’s Form 10-K for the year ending December 31, 2021. Unless
there are changes in relevant law or regulations, or in interpretations thereof that would necessitate changes to the below, we will add the following risk factors in response to this comment three:

Securities and Exchange Commission

 -
 4
 -

January 14, 2022

 We are not currently required to obtain approval or prior permission from the China
Securities Regulatory Commission (CSRC) or any other Chinese regulatory authority under the Chinese laws and regulations currently in effect to issue securities to foreign investors. However, as there are uncertainties with respect to the Chinese
legal system and changes in laws, regulations and policies, including how those laws and regulations will be interpreted or implemented, there can be no assurance that we will not be subject to such requirements, approvals or permissions in the
future. We are required to obtain approvals and permissions from Chinese authorities in connection with our general business activities currently conducted in China.

The Chinese government has exercised, and may continue to exercise, substantial influence or control over virtually every sector of the Chinese
economy through regulation and state ownership. Our ability to operate in China could be undermined if our Chinese subsidiaries are not able to obtain or maintain approvals to operate in China. The central or local governments could impose new,
stricter regulations or interpretations of existing regulations that could require additional expenditures and efforts on our part to ensure our compliance with such regulations or interpretations.

As of the date of this Annual Report on Form 10-K, we are not required to obtain approval or prior
permission from the CSRC or any other Chinese regulatory authority under the Chinese laws and regulations currently in effect to issue securities to foreign investors. However, as there are uncertainties with respect to the Chinese legal system and
changes in laws, regulations and policies, including how those laws, regulations, and policies will be interpreted or implemented, there can be no assurance that we will not be subject to such requirements, approvals or permissions in the future. We
are required to obtain certain approvals from Chinese authorities in order to operate our Chinese subsidiaries. We are also required to obtain certain approvals from Chinese authorities before transferring certain scientific data abroad or to
foreign parties or entities established or actually controlled by them.

 If our Chinese subsidiaries do not receive or maintain approvals,
inadvertently conclude that approvals needed for their business are not required or if there are changes in applicable laws (including regulations) or interpretations of laws and our Chinese subsidiaries are required but unable to obtain approvals
in the future, then such changes or need for approvals (if not obtained) could adversely affect the operations of our Chinese subsidiaries, including limiting or prohibiting the ability of our Chinese subsidiaries to operate, and the value of our
ADSs or ordinary shares could significantly decline or become worthless.

 To operate our general business activities currently conducted in
China, each of our Chinese subsidiaries is required to obtain a business license from the local counterpart of the State Administration for Market Regulation, or SAMR. Each of our Chinese subsidiaries has obtained a valid business license from the
local counterpart of the SAMR, and no application for any such license has been denied.

Securities and Exchange Commission

 -
 5
 -

January 14, 2022

 The Regulations on Mergers and Acquisitions of Domestic Enterprises by Foreign Investors, or
the M&A Rules, appear to require that offshore special purpose vehicles, controlled by Chinese companies or individuals formed for the purpose of seeking a public listing on an overseas stock exchange through acquisitions of Chinese domestic
companies or assets in exchange for the shares of the offshore special purpose vehicles, obtain CSRC approval prior to publicly listing their securities on an overseas stock exchange.

Based on the Chinese laws and regulations currently in effect, we are currently not required to obtain
pre-approval from the CSRC to conduct a public offering in foreign capital markets, subject to interpretation of the existing Chinese laws, regulations, and policies by the Chinese government authorities.
However, there is uncertainty as to how the M&A Rules will be interpreted or implemented by Chinese government agencies, including the CSRC. Additionally, new laws, rules and regulations or detailed implementations and interpretations of new or
existing laws, rules, or regulations relating to the M&A Rules by Chinese regulators may change our conclusion about the effect of the M&A Rules on us. We cannot, therefore, assure investors that we will not need to potentially obtain in the
future the pre-approval from the CSRC or other government agencies prior to conducting a public offering in a foreign capital market.

Furthermore, on July 6, 2021, the General Office of the Central Committee of the Communist Party of China and the General Office of the
State Council jointly promulgated the Opinions on Strictly Cracking Down on Illegal Securities Activities in Accordance with the Law, pursuant to which Chinese regulators are required to accelerate rulemaking related to the overseas issuance and
listing of securities, and update the existing laws and regulations related to data security, cross-border data flow, and management of confidential information. Numerous regulations, guidelines and other measures have been or are expected to be
adopted under the umbrella of or in addition to the Cyber Security Law and Data Security Law. As there are still uncertainties regarding the interpretation and implementation of such regulatory guidance, we cannot assure investors that we will be
able to comply with new regulatory requirements relating to our future overseas capital-raising activities, and we may become subject to more stringent requirements with respect to matters including data privacy and cross-border investigation and
enforcement of legal claims.

Securities and Exchange Commission

 -
 6
 -

January 14, 2022

 Based on the above and our understanding of the Chinese laws and regulations currently in
effect, we were not required to submit an application to the CSRC or Cyberspace Administration of China, or the CAC, for the listing and trading of our ADSs on the Nasdaq. However, there remains significant uncertainty as to the enactment,
interpretation and implementation of regulatory requirements related to overseas securities offerings and other capital markets activities. If it is determined in the future that the approval of the CSRC, the CAC or any other regulatory authority is
required for offerings of our equity securities, we may face sanctions by the CSRC, the CAC or other Chinese regulatory agencies. These regulatory agencies may impose fines and penalties on our operations in China, limit our ability to pay dividends
outside of China, limit our operations in China, delay or restrict the repatriation of the proceeds from our initial public offering into China or take other actions that could have a material adverse effect on our business, financial condition,
results of operations and prospects, as well as the trading price of our ADSs and ordinary shares. In addition, if the CSRC, the CAC or other regulatory agencies later promulgate new rules requiring that we obtain their approvals for any future
public offerings, we may be unable to obtain a waiver of such approval requirements, if and when procedures are established to obtain such a waiver. Any uncertainties and/or negative publicity regarding such an approval requirement could have a
material adverse effect on the trading price of our ADSs and the ordinary shares, including potentially making those ADSs and ordinary shares worthless.

We may face further restrictions (or even prohibitions) on our ability to transfer our scientific data abroad if Chinese regulators
impose new restrictions (or change their interpretation of existing restrictions) on life sciences companies like us and the scientific data we obtain, generate, and maintain.

The General Office of the State Council passed the Scientific Data Administrative Measures in March 2018, which provides a regulatory framework
for the collection, submission, retention, exploitation, confidentiality and security of scientific data. Scientific data is defined as data generated from basic research, applied research, experiments and developments in the fields of natural

CORRESP
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CORRESP

 December 17, 2021

VIA EDGAR

 U.S. Securities and Exchange
Commission

 Division of Corporation Finance

 Office of Life
Sciences 100 F Street, N.E.

 Washington, D.C. 20549

Attention:

Tracie Mariner

Kevin Vaughn

Re:

Zai Lab, Ltd.

Form 10-K for Fiscal Year Ended December 31, 2020

Response dated November 9, 2021

File No. 001-38205

 Ladies and Gentlemen:

On behalf of Zai Lab, Ltd. (the “Company”), we are hereby providing the following responses to the comment letter from the staff of
the Division of Corporate Finance, Office of Life Science (the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated December 10, 2021 related to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 (the “Form 10-K”) and the Company’s response dated November 9, 2021. To assist your review, we have
presented the text of the Staff’s comment in italics below. The responses and information described below are based upon information provided to us by the Company.

Form 10-K for Fiscal Year Ended December 31, 2020

Part I

 Item 1. Business, page 1

1. At the onset of Part 1, please disclose prominently that you are not a Chinese operating company but a Cayman Islands holding company that conducts its
operations through wholly owned subsidiaries based in China and that investors will not hold direct investments in the Chinese operating companies. Your disclosure should acknowledge that Chinese regulatory authorities could disallow this structure,
which would likely result in a material change in your operations and/or value of your ADSs, including that it could cause the value of such securities to significantly decline or become worthless.

 Securities and Exchange Commission

 -2-

December 17, 2021

 Response to Comment 1:

The Company acknowledges the Staff’s comment and advises the Staff that it will provide prominent disclosure of such risks at the onset of
Part 1 of the Company’s Form 10-K for the year ending December 31, 2021.

 2. We note your response to
prior comment two and disclosure on your Form 10-Q for the quarterly period ending September 30, 2021 (the “2021 Q3 Form 10-Q”) and reissue
in part. On page 1 of the 2021 Q3 Form 10-Q under the heading “Usage of Terms,” we note that you provide the domicile of each subsidiary. However, please expand your disclosure to include the entity
(including the domicile) in which investors are purchasing their interest. In addition, we note your disclosure, on page 1, stating that references in the quarterly report on Form 10-Q to “Zai Lab,”
the “Company,” “we,” “us,” and “our” refer to Zai Lab Limited, a holding company, and its subsidiaries, on a consolidated basis. However, we note you refer to Zai Lab Limited and its subsidiaries as the
“Group” throughout the filing. Please revise your disclosure to be consistent throughout.

 Response to Comment 2:

The Company acknowledges the Staff’s comment and advises the Staff that, in future filings, the Company will expand its disclosure to
include the entity (including the domicile) in which investors are purchasing their interest and will revise its disclosure to clarify the entities that it refers to throughout the filing.

Item 1A. Risk Factors, page 61

 3. We note your
response to prior comment three and your updated risk factor disclosure on page 50 of your 2021 Q3 Form 10-Q and reissue in part. Please address the following regarding your response to prior comment
three:

•

 Please disclose the consequences to you and your investors if you inadvertently conclude that approvals are
not required, or applicable laws, regulations, or interpretations change.

•

 Regarding your disclosure that you are required to get certain approvals from Chinese authorities before
transferring certain scientific data abroad or to foreign parties, please revise to more clearly disclose whether have you have received all requisite permissions and whether any permissions have been denied.

Securities and Exchange Commission

-3-

December 17, 2021

 Response to Comment 3:

The Company acknowledges the Staff’s comment and advises the Staff that it will update the disclosures to address the points above in the
Company’s Form 10-K for the year ending December 31, 2021.

 4. We note your response
to prior comment four and updated disclosure on pages 2-3 of your 2021 Q3 Form 10-Q. As requested in the prior comment, please include the disclosures requested in the
comment as a separate risk factor as well.

 Response to Comment 4:

The Company acknowledges the Staff’s comment and advises the Staff that it will include the disclosures requested in the comment as a
separate risk factor in the Company’s Form 10-K for the year ending December 31, 2021.

5. We note your response to prior comment seven. As requested in the prior comment, please expand the disclosures in your risk factors. For
example, on page 49 of your 2021 Q3 Form 10-Q, expand your disclosures to state that the Chinese government may intervene or influence your operations at any time, which could result in a material change in
your operations and/or the value of your ADSs and any action by the Chinese government to exert more oversight and control over offerings that are conducted overseas and/or foreign investment in China-based issuers could significantly limit or
completely hinder your ability to offer or continue to offer securities to investors and cause the value of such securities to significantly decline or be worthless.

Response to Comment 5:

 The Company
acknowledges the Staff’s comment and advises the Staff that it will expand its disclosures in its risk factors to state that the Chinese government may intervene or influence its operations at any time in the Company’s Form 10-K for the year ending December 31, 2021.

 6. We note your response to prior comment eight and
updated disclosure on page 45 of your 2021 Q3 Form 10-Q. As requested in the prior comment, please expand your risk factor disclosure to explain to what extent you believe that you are compliant with the
regulations or policies that have been issued by the CAC to date.

 Response to Comment 6:

The Company acknowledges the Staff’s comment and advises the Staff that it will expand its risk factor disclosure to explain to what
extent we believe that it is compliant with the regulations or policies that have been issued by the CAC in the Company’s Form 10-K for the year ending December 31, 2021.

Securities and Exchange Commission

-4-

December 17, 2021

 7. Please revise both the risk factors summary and the Risk Factors section to move
forward the risks related to doing business in the PRC so that such risks are prominently disclosed within each section in relation to other identified material risks.

Response to Comment 7:

 The Company
acknowledges the Staff’s comment and advises the Staff that it will revise both the Risk Factors Summary and the Risk Factors sections to move forward the risks related to doing business in the PRC in the Company’s Form 10-K for the year ending December 31, 2021.

 * * *

Securities and Exchange Commission

-5-

December 17, 2021

 We hope that the foregoing has been responsive to the Staff’s comments. If you have any
questions about this letter or require any further information, please call my office at (617) 235-4961.

 Very truly yours,

 /s/ Thomas J. Danielski

 Thomas J. Danielski

cc:
 F. Ty Edmondson

Billy Cho

United States securities and exchange commission logo
December 10, 2021
Billy Cho
Chief Financial Officer
Zai Lab, Ltd.
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong
Shanghai, China
Re:Zai Lab, Ltd.
Form 10-K for Fiscal Year Ended December 31, 2020
Response dated November 9, 2021
File No. 001-38205
Dear Mr. Cho:
            We have reviewed your November 9, 2021 response to our comment letter and have the
following comments.  In some of our comments, we may ask you to provide us with information
so we may better understand your disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional
comments.  Unless we note otherwise, our references to prior comments are to comments in our
September 29, 2021 letter.
Form 10-K for Fiscal Year Ended December 31, 2020
Part I
Item 1. Business, page 1
1.At the onset of Part 1, please disclose prominently that you are not a Chinese operating
company but a Cayman Islands holding company that conducts its operations through
wholly owned subsidiaries based in China and that investors will not hold direct
investments in the Chinese operating companies.  Your disclosure should acknowledge
that Chinese regulatory authorities could disallow this structure, which would likely result
in a material change in your operations and/or value of your ADSs, including that it could
cause the value of such securities to significantly decline or become worthless.

 FirstName LastNameBilly Cho
 Comapany NameZai Lab, Ltd.
 December 10, 2021 Page 2
 FirstName LastName
Billy Cho
Zai Lab, Ltd.
December 10, 2021
Page 2
2.We note your response to prior comment two and disclosure on your Form 10-Q for the
quarterly period ending September 30, 2021 (the “2021 Q3 Form 10-Q”) and reissue in
part.  On page 1 of the 2021 Q3 Form 10-Q under the heading "Usage of Terms," we note
that you provide the domicile of each subsidiary.  However, please expand your disclosure
to include the entity (including the domicile) in which investors are purchasing their
interest.  In addition, we note your disclosure, on page 1, stating that references in the
quarterly report on Form 10-Q to “Zai Lab,” the “Company,” “we,” “us,” and “our” refer
to Zai Lab Limited, a holding company, and its subsidiaries, on a consolidated basis.
However, we note you refer to Zai Lab Limited and its subsidiaries as the "Group"
throughout the filing.  Please revise your disclosure to be consistent throughout.
Item 1A. Risk Factors, page 61
3.We note your response to prior comment three and your updated risk factor disclosure on
page 50 of your 2021 Q3 Form 10-Q and reissue in part.  Please address the following
regarding your response to prior comment three:
•Please disclose the consequences to you and your investors if you inadvertently
conclude that approvals are not required, or applicable laws, regulations, or
interpretations change.
•Regarding your disclosure that you are required to get certain approvals from Chinese
authorities before transferring certain scientific data abroad or to foreign parties,
please revise to more clearly disclose whether have you have received all requisite
permissions and whether any permissions have been denied.
4.We note your response to prior comment four and updated disclosure on pages 2-3 of
your 2021 Q3 Form 10-Q.  As requested in the prior comment, please include the
disclosures requested in the comment as a separate risk factor as well.
5.We note your response to prior comment seven.  As requested in the prior comment,
please expand the disclosures in your risk factors.  For example, on page 49 of your 2021
Q3 Form 10-Q, expand your disclosures to state that the Chinese government may
intervene or influence your operations at any time, which could result in a material change
in your operations and/or the value of your ADSs and any action by the Chinese
government to exert more oversight and control over offerings that are conducted overseas
and/or foreign investment in China-based issuers could significantly limit or completely
hinder your ability to offer or continue to offer securities to investors and cause the value
of such securities to significantly decline or be worthless.
6.We note your response to prior comment eight and updated disclosure on page 45 of
your 2021 Q3 Form 10-Q.  As requested in the prior comment, please expand your risk
factor disclosure to explain to what extent you believe that you are compliant with the
regulations or policies that have been issued by the CAC to date.

 FirstName LastNameBilly Cho
 Comapany NameZai Lab, Ltd.
 December 10, 2021 Page 3
 FirstName LastName
Billy Cho
Zai Lab, Ltd.
December 10, 2021
Page 3
7.Please revise both the risk factors summary and the Risk Factors section to move forward
the risks related to doing business in the PRC so that such risks are prominently disclosed
within each section in relation to other identified material risks.
            You may contact Tracie Mariner at 202-551-3744 or Kevin Vaughn at 202-551-3494 if
you have questions regarding comments on the financial statements and related matters.  Please
contact Jason Drory at 202-551-8342 or Jeffrey Gabor at 202-551-2544 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Thomas Danielski

CORRESP
1
filename1.htm

CORRESP

ROPES & GRAY LLP

PRUDENTIAL TOWER

800 BOYLSTON STREET

BOSTON, MA 02199-3600

WWW.ROPESGRAY.COM

 November 9, 2021

VIA EDGAR

 U.S. Securities and Exchange Commission

 Division of Corporation Finance

 Office of Life Sciences

 100 F Street, N.E.

 Washington, D.C. 20549

Attention:
 Tracie Mariner

 Kevin Vaughn

Re:
 Zai Lab, Ltd.

 Form 10-K for Fiscal Year Ended December 31, 2020

 Filed March 1, 2021

 File No. 001-38205

Ladies and Gentlemen:

 On half of Zai Lab, Ltd.
(the “Company”), we are hereby providing the following responses to the comment letter from the staff of the Division of Corporate Finance, Office of Life Science (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) dated September 29, 2021 related to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 (the “Form
10-K”). To assist your review, we have presented the text of the Staff’s comment in italics below. The responses and information described below are based upon information provided to us by the
Company.

 Form 10-K for Fiscal Year Ended December 31, 2020

Part I

 Item 1. Business, page 1

1. At the onset of Part 1, provide prominent disclosure about the legal and operational risks associated with being based in or having the majority of the
company’s operations in China. Your disclosure should make clear whether these risks could result in a material change in your operations and/or the value of your ADSs or could significantly limit or completely hinder your ability to offer or
continue to offer securities to investors and cause the value of such securities to significantly decline or be worthless. Your disclosure should address how recent statements and regulatory actions by China’s government, such as those related
data security or anti-monopoly concerns, has or may impact the company’s ability to conduct its business, accept foreign investments, or list on an U.S. or other foreign exchange. Your Business section should address, but not necessarily be
limited to, the risks highlighted in Part 1.

Securities and Exchange Commission

 -
 2
 -

November 9, 2021

 Response to Comment 1:

The Company acknowledges the Staff’s comment and has supplemented its disclosure on pages 1-2 of
the Company’s Form 10-Q for the quarterly period ending September 30, 2021 (the “2021 Q3 Form 10-Q”) to add a risk factor to disclose the legal and
operational risks associated with being based in or having the majority of the Company’s operations in China. The Company will also provide prominent disclosure of such risks at the onset of Part 1 and the Business section of the Company’s
Form 10-K for the year ending December 31, 2021.

 2. At the onset of Part 1, clearly disclose how you will
refer to the holding company and subsidiaries when providing the disclosure throughout the document so that it is clear to investors which entity the disclosure is referencing and which subsidiaries or entities are conducting the business
operations. Refrain from using terms such as “we” or “our” when describing activities or functions of a subsidiary with a different domicile than the holding company. Disclose clearly the entity (including the domicile) in which
investors are purchasing their interest.

 Response to Comment 2:

The Company acknowledges the Staff’s comment and advises the Staff that, in future filings, beginning with the Company’s 2021 Q3 Form
10-Q, the Company will refrain from using terms such as “we” or “our” when describing activities or functions of a subsidiary with a different domicile than the holding company. The Company
has also supplemented its disclosure on page 1 of the Company’s 2021 Q3 Form 10-Q to disclose the Company’s subsidiaries that are conducting the business operations.

3. On page 1 and as a separate risk factor under Item 1A, disclose each permission that you or your subsidiaries are required to obtain from Chinese
authorities to operate and issue these securities to foreign investors, including approvals needed to transfer scientific data as discussed on page 89. State whether you or your subsidiaries are covered by permissions requirements from the CSRC, CAC
or any other entity, and state affirmatively whether you have received all requisite permissions and whether any permissions have been denied, including those related to the transfer of scientific data.

Response to Comment 3:

 The Company
acknowledges the Staff’s comment and has supplemented its disclosure on pages 2, 26-27, 50 of the Company’s 2021 Q3 Form 10-Q to disclose each permission that
the Company or the Company’s subsidiaries are required to obtain from Chinese authorities to operate and issue securities to foreign investors. The Company will also include such risk factor on page 1 of the Company’s Form 10-K for the year ending December 31, 2021.

Securities and Exchange Commission

 -
 3
 -

November 9, 2021

 4. In your Business section and as a separate risk factor, provide a clear description of how cash is
transferred through your organization. Disclose your intentions to distribute earnings or settle amounts owed. Quantify any cash flows and transfers of other assets by type that have occurred between the holding company and its subsidiaries and
direction of transfer. Quantify any dividends or distributions that a subsidiary has made to the holding company, which entity made such transfer, and their tax consequences. Similarly quantify dividends or distributions made to U.S. investors, the
source, and their tax consequences. Describe any restrictions on foreign exchange and your ability to transfer cash between entities, across borders, and to U.S. investors. Describe any restrictions and limitations on your ability to distribute
earnings from your businesses, including subsidiaries, to the parent company and U.S. investors.

 Response to Comment 4:

The Company acknowledges the Staff’s comment and has supplemented its disclosure on pages 2-3 of the
Company’s 2021 Q3 Form 10-Q to include a separate risk factor with a clear description of how cash is transferred through the Company’s organization and the other additional information. The Company
will also provide such disclosures in the Business section of the Company’s Form 10-K for the year ending December 31, 2021.

Summary of Significant Risk Factors, page iii

 5. In
your summary of risk factors, disclose the risks that your corporate structure and being based in or having the majority of the company’s operations in China poses to investors. In particular, describe the significant regulatory, liquidity, and
enforcement risks with cross-references to the more detailed discussion of these risks in your risk factor disclosure. For example, specifically discuss risks arising from the legal system in China, including risks and uncertainties regarding the
enforcement of laws and that rules and regulations in China can change quickly with little advance notice; and the risk that the Chinese government may intervene or influence your operations at any time, or may exert more control over offerings
conducted overseas and/or foreign investment in China-based issuers, which could result in a material change in your operations and/or the value of your ADSs. Acknowledge any risks that any actions by the Chinese government to exert more oversight
and control over offerings that are conducted overseas and/or foreign investment in China-based issuers could significantly limit or completely hinder your ability to offer or continue to offer securities to investors and cause the value of such
securities to significantly decline or be worthless.

 Response to Comment 5:

The Company acknowledges the Staff’s comment and has supplemented its disclosure on page 52 of the Company’s 2021 Q3 Form 10-Q to incorporate additional disclosure of the risks that the Company’s corporate structure and being based in or having the majority of the Company’s operations in China poses to investors. The Company
will also include such risk factor in the Company’s Form 10-K for the year ending December 31, 2021.

Securities and Exchange Commission

 -
 4
 -

November 9, 2021

 Item 1A. Risk Factors, page 61

6. Revise your risk factors to acknowledge that if the PRC government determines that your offshore corporate structure does not comply with PRC
regulations, or if these regulations change or are interpreted differently in the future, your shares may decline in value or become worthless if you are unable to assert your contractual control rights over the assets of your PRC subsidiaries that
conduct all or substantially all of your operations.

 Response to Comment 6:

The Company acknowledges the Staff’s comment and has supplemented its disclosure on page 50 of the Company’s 2021 Q3 Form 10-Q its risk factor disclosures to incorporate this additional information. The Company will also include such risk factor in the Company’s Form 10-K for the year ending December 31, 2021.

7. Given the Chinese government’s significant oversight and discretion over the conduct of your business, please revise to separately highlight the
risk that the Chinese government may intervene or influence your operations at any time, which could result in a material change in your operations and/or the value of your ADSs. Also, given recent statements by the Chinese government indicating an
intent to exert more oversight and control over offerings that are conducted overseas and/or foreign investment in China-based issuers, acknowledge the risk that any such action could significantly limit or completely hinder your ability to offer or
continue to offer securities to investors and cause the value of such securities to significantly decline or be worthless.

 Response to Comment 7:

 The Company acknowledges the Staff’s comment and advises the Staff that it has included such disclosure in Item 1A. Risk Factors
with the Company’s Form 10-Q for the quarterly period ending June 30, 2021. The Company also expanded its risk factor disclosures on pages 49 and 52 of the Company’s 2021 Q3 Form 10-Q to further highlight the risk that the Chinese government may intervene or influence the Company’s operations at any time, which could result in a material change in the Company’s operations and/or
the value of the Company’s ADSs and acknowledge the risk that any such action could significantly limit or completely hinder the Company’s ability to offer or continue to offer securities to investors and cause the value of such securities
to significantly decline or be worthless. The Company will also include such risk factor in the Company’s Form 10-K for the year ending December 31, 2021.

8. In light of recent events indicating greater oversight by the Cyberspace Administration of China over data security, particularly for companies seeking
to list on a foreign exchange, please revise your disclosure to explain how this oversight impacts your business and your offering and to what extent you believe that you are compliant with the regulations or policies that have been issued by the
CAC to date.

Securities and Exchange Commission

 -
 5
 -

November 9, 2021

 Response to Comment 8:

The Company acknowledges the Staff’s comment and advises the Staff that it has included such disclosure in Item 2. Management’s
Discussion and Analysis of Financial Conditions and Results of Operations – Recent Developments – Recent Regulatory Developments and Item 1A. Risk Factors with the Company’s Form 10-Q for the
quarterly period ending June 30, 2021. The Company also expanded its existing disclosures on page 28 of the Company’s 2021 Q3 Form 10-Q to further explain how Cyberspace Administration of
China’s oversight impacts our business and our compliance with the regulations or policies that have been issued by the Cyberspace Administration of China to date. The Company will also include such risk factor in the Company’s Form 10-K
for the year ending December 31, 2021.

 *    *     *

Securities and Exchange Commission

 -
 6
 -

November 9, 2021

 We hope that the foregoing has been responsive to the Staff’s comments. If you have any
questions about this letter or require any further information, please call my office at (617) 235-4961.

 Very truly yours,

 /s/ Thomas J. Danielski

 Thomas J. Danielski

cc:
 F. Ty Edmondson

Billy Cho

United States securities and exchange commission logo
September 29, 2021
Billy Cho
Chief Financial Officer
Zai Lab, Ltd.
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong
Shanghai, China
Re:Zai Lab, Ltd.
Form 10-K for Fiscal Year Ended December 31, 2020
Filed March 1, 2021
File No. 001-38205
Dear Mr. Cho:
            We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Form 10-K for Fiscal Year Ended December 31, 2020
Part I
Item 1. Business, page 1
1.At the onset of Part 1, provide prominent disclosure about the legal and operational risks
associated with being based in or having the majority of the company’s operations in
China.  Your disclosure should make clear whether these risks could result in a material
change in your operations and/or the value of your ADSs or could significantly limit or
completely hinder your ability to offer or continue to offer securities to investors and
cause the value of such securities to significantly decline or be worthless.  Your disclosure
should address how recent statements and regulatory actions by China’s government, such
as those related data security or anti-monopoly concerns, has or may impact the
company’s ability to conduct its business, accept foreign investments, or list on an U.S. or

 FirstName LastNameBilly Cho
 Comapany NameZai Lab, Ltd.
 September 29, 2021 Page 2
 FirstName LastNameBilly Cho
Zai Lab, Ltd.
September 29, 2021
Page 2
other foreign exchange. Your Business section should address, but not necessarily be
limited to, the risks highlighted in Part 1.
2.At the onset of Part 1, clearly disclose how you will refer to the holding company and
subsidiaries when providing the disclosure throughout the document so that it is clear to
investors which entity the disclosure is referencing and which subsidiaries or entities are
conducting the business operations.  Refrain from using terms such as “we” or “our” when
describing activities or functions of a subsidiary with a different domicile than the holding
company.  Disclose clearly the entity (including the domicile) in which investors are
purchasing their interest.

3.On page 1 and as a separate risk factor under Item 1A, disclose each permission that you
or your subsidiaries are required to obtain from Chinese authorities to operate and issue
these securities to foreign investors, including approvals needed to transfer scientific data
as discussed on page 89.  State whether you or your subsidiaries are covered by
permissions requirements from the CSRC, CAC or any other entity, and state
affirmatively whether you have received all requisite permissions and whether any
permissions have been denied, including those related to the transfer of scientific data.
4.In your Business section and as a separate risk factor, provide a clear description of how
cash is transferred through your organization.  Disclose your intentions to distribute
earnings or settle amounts owed.  Quantify any cash flows and transfers of other assets by
type that have occurred between the holding company and its subsidiaries and direction of
transfer.  Quantify any dividends or distributions that a subsidiary has made to the holding
company, which entity made such transfer, and their tax consequences.  Similarly quantify
dividends or distributions made to U.S. investors, the source, and their tax consequences.
Describe any restrictions on foreign exchange and your ability to transfer cash between
entities, across borders, and to U.S. investors.  Describe any restrictions and limitations on
your ability to distribute earnings from your businesses, including subsidiaries, to the
parent company and U.S. investors.
Summary of Significant Risk Factors, page iii
5.In your summary of risk factors, disclose the risks that your corporate structure and being
based in or having the majority of the company’s operations in China poses to investors.
In particular, describe the significant regulatory, liquidity, and enforcement risks with
cross-references to the more detailed discussion of these risks in your risk factor
disclosure.   For example, specifically discuss risks arising from the legal system in China,
including risks and uncertainties regarding the enforcement of laws and that rules and
regulations in China can change quickly with little advance notice; and the risk that the
Chinese government may intervene or influence your operations at any time, or may exert
more control over offerings conducted overseas and/or foreign investment in China-based
issuers, which could result in a material change in your operations and/or the value of
your ADSs.  Acknowledge any risks that any actions by the Chinese government to exert

 FirstName LastNameBilly Cho
 Comapany NameZai Lab, Ltd.
 September 29, 2021 Page 3
 FirstName LastName
Billy Cho
Zai Lab, Ltd.
September 29, 2021
Page 3
more oversight and control over offerings that are conducted overseas and/or foreign
investment in China-based issuers could significantly limit or completely hinder your
ability to offer or continue to offer securities to investors and cause the value of such
securities to significantly decline or be worthless.
Item 1A. Risk Factors, page 61
6.Revise your risk factors to acknowledge that if the PRC government determines that your
offshore corporate structure does not comply with PRC regulations, or if these regulations
change or are interpreted differently in the future, your shares may decline in value or
become worthless if you are unable to assert your contractual control rights over the assets
of your PRC subsidiaries that conduct all or substantially all of your operations.
7.Given the Chinese government’s significant oversight and discretion over the conduct of
your business, please revise to separately highlight the risk that the Chinese government
may intervene or influence your operations at any time, which could result in a material
change in your operations and/or the value of your ADSs.  Also, given recent statements
by the Chinese government indicating an intent to exert more oversight and control over
offerings that are conducted overseas and/or foreign investment in China-based issuers,
acknowledge the risk that any such action could significantly limit or completely hinder
your ability to offer or continue to offer securities to investors and cause the value of such
securities to significantly decline or be worthless.
8.In light of recent events indicating greater oversight by the Cyberspace Administration of
China over data security, particularly for companies seeking to list on a foreign exchange,
please revise your disclosure to explain how this oversight impacts your business and your
offering and to what extent you believe that you are compliant with the regulations or
policies that have been issued by the CAC to date.

            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            You may contact Tracie Mariner at (202) 551-3744 or Kevin Vaughn at (202) 551-
3494 if you have questions regarding comments on the financial statements and related matters.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

United States securities and exchange commission logo
October 30, 2020
Billy Cho
Chief Financial Officer
Zai Lab Ltd
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong
Shanghai, China 201210
Re:Zai Lab Ltd
Form 20-F for the fiscal year ended December 31, 2019
Filed April 29, 2020
File No. 001-38205
Dear Mr. Cho:
            We have completed our review of your filing.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

CORRESP
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zlab-corresp.DOCX.htm

ROPES & GRAY LLP

PRUDENTIAL TOWER

800 BOYLSTON STREET

BOSTON, MA  02199-3600

WWW.ROPESGRAY.COM

September 18, 2020

VIA FEDEX AND EDGAR

Re:Zai Lab Ltd

Form 20-F for the fiscal year ended December 31, 2019

Filed April 29, 2020

File No. 001-38205

Vanessa Robertson

Christine Torney

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Dear Ms. Robertson and Ms. Torney:

On behalf of Zai Lab Limited (the “Company”), we are hereby providing the following responses to the comment letter from the staff of the Division of Corporation Finance, Office of Life Sciences (the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated September 9, 2020 related to the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2019. To assist your review, we have presented the text of the Staff’s comment in italics below. The response and information described below are based upon information provided to us by the Company.

Form 20-F for the period ended December 31, 2019

Exhibits 12.1 and 12.2, page 1

1.

The SEC rules under Section 302 of the Sarbanes-Oxley Act require that the language of the 302 certification not be altered. Item 601(b)(31) states that the certification must be provided exactly as stated therein. We note certain differences between the language in paragraphs 4 and 5 of your disclosure and the language that is required. Please amend your Form 20-F to include revised certifications as appropriate.

Response to Comment: The Company acknowledges the Staff’s comment and confirms that the Company filed an amendment to its Form 20-F for the fiscal year ended December 31, 2019 to include revised certifications in accordance with Item 601(b)(31).

Zai Lab Limited

Item 4. Information on the Company

Overview of the License Agreements, page 98

2.

For your license agreements with Incyte, Deciphera and Novocure, please disclose when the royalty term is currently expected to expire.

Response to Comment: The Company acknowledges the Staff’s comment and confirms that in future filings with the Commission the Company will disclose when the royalty terms of the Company’s license agreements with Incyte, Deciphera and Novocure are expected to expire.

*            *             *            *            *

Please do not hesitate to call me at 617-235-4961 with any questions or further comments

Sincerely,

/s/ Thomas J. Danielski

Thomas J. Danielski

cc:

F. Ty Edmondson

Billy Cho

-2-

United States securities and exchange commission logo
September 9, 2020
Billy Cho
Chief Financial Officer
Zai Lab Ltd
4560 Jinke Road
Bldg. 1, Fourth Floor
Pudong
Shanghai, China 201210
Re:Zai Lab Ltd
Form 20-F for the fiscal year ended December 31, 2019
Filed April 29, 2020
File No. 001-38205
Dear Mr. Cho:
            We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Form 20-F for the fiscal year ended December 31, 2019
Exhibits 12.1 and 12.2, page 1
1.The SEC rules under Section 302 of the Sarbanes-Oxley Act require that the language of
the 302 certification not be altered. Item 601(b)(31) states that the certification must be
provided exactly as stated therein. We note certain differences between the language in
paragraphs 4 and 5 of your disclosure and the language that is required. Please amend
your Form 20-F to include revised certifications as appropriate.
Item 4. Information on the Company
Overview of the License Agreements, page 98
2.For your license agreements with Incyte, Decipher and Novocure, please disclose when

 FirstName LastNameBilly Cho
 Comapany NameZai Lab Ltd
 September 9, 2020 Page 2
 FirstName LastName
Billy Cho
Zai Lab Ltd
September 9, 2020
Page 2
the royalty term is currently expected to expire.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            You may contact Vanessa Robertson at 202-551-3649 or Christine Torney at 202-551-
3652 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

CORRESP
1
filename1.htm

CORRESP

 J.P. Morgan Securities LLC

383 Madison Avenue

 New York, New York 10179

Citigroup Global Markets Inc.

 388 Greenwich Street

New York, New York 10013

 Jefferies LLC

520 Madison Avenue

 New York, New York 10022

Leerink Partners LLC

 One Federal Street, 37th Floor

Boston, Massachusetts 02110

 August 31, 2018

 Securities and Exchange Commission

 Division of Corporation
Finance

 100 F Street, N.E.

 Washington, D.C. 20549-7010

Attn:    Jeffrey Gabor

Re:    Zai Lab Limited

 Registration Statement on Form F-1 (File
No. 333-227159)

 Ladies and Gentlemen:

In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several
underwriters, hereby join in the request of Zai Lab Limited (the “Company”) for acceleration of the effective date of the above-named Registration Statement so that it becomes effective at 4:00 PM, Eastern Time, on September 5,
2018 or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Davis Polk & Wardwell LLP, may orally request by telephone call that such Registration Statement be declared effective.

Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that we expect to effect the
following distribution of the Company’s Preliminary Prospectus dated August 31, 2018:

•

 approximately 2,291 copies to prospective underwriters, dealers, institutional investors and individuals.

 We, the undersigned, as representatives of the several underwriters, have complied and will comply with the
requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.

 Very truly yours,

J.P. MORGAN SECURITIES LLC

CITIGROUP GLOBAL MARKETS INC.

JEFFERIES LLC

 LEERINK PARTNERS LLC

By:

J.P. MORGAN SECURITIES LLC

By:

 /s/ Gautham Baliga

Name:

Gautham Baliga

Title:

Vice President

By:

CITIGROUP GLOBAL MARKETS INC.

By:

 /s/ Nicholas Jennings

Name:

Nicholas Jennings

Title:

Vice President

By:

JEFFERIES LLC

By:

 /s/ Matthew Kim

Name:

Matthew Kim

Title:

Managing Director

By:

LEERINK PARTNERS LLC

By:

 /s/ John I. Fitzgerald, Esq.

Name:

John I. Fitzgerald, Esq.

Title:

Managing Director

 [Signature Page to Acceleration Request]

CORRESP
1
filename1.htm

CORRESP

 Zai Lab Limited

4560 Jinke Road

 Bldg. 1,
Fourth Floor

 Pudong, Shanghai, China 201210

August 31, 2018

 VIA EDGAR CORRESPONDENCE AND FACSIMILE

 Jeffrey Gabor

 Division of Corporation Finance

Securities and Exchange Commission

 100 F Street, N.E.

Washington, D.C. 20549

Re:

Zai Lab Limited (CIK: 0001704292)

Registration Statement on Form F-1 (File No. 333-227159)

 Ladies and Gentlemen:

 In
accordance with Rule 461 of Regulation C (“Rule 461”) of the General Rules and Regulations under the Securities Act of 1933, as amended, Zai Lab Limited (the “Company”) hereby requests that the effectiveness of the
above-referenced Registration Statement on Form F-1 (the “Registration Statement”) be accelerated to and that the Registration Statement become effective at 4:00 p.m., Eastern Time, on
September 5, 2018, or as soon thereafter as practicable.

 If there is any change in the acceleration request set forth above, the Company will
promptly notify you of the change, in which case the Company may be making an oral request of acceleration of the effectiveness of the Registration Statement in accordance with Rule 461. The request may be made by an executive officer of the Company
or by any attorney from the Company’s U.S. counsel, Davis Polk & Wardwell LLP.

 The Company understands that J.P. Morgan Securities LLC,
Citigroup Global Markets Inc., Jefferies LLC and Leerink Partners LLC, the representatives of the underwriters of the offering, have joined in this request in a separate letter filed with the Securities and Exchange Commission today.

[Signature page follows]

Very truly yours,

Zai Lab Limited

By:

 /s/ Samantha Du

Name:

Samantha Du

Title:

Chief Executive Officer

CORRESP
1
filename1.htm

CORRESP

 J.P. Morgan Securities LLC

383 Madison Avenue

 New York, New York 10179

Citigroup Global Markets Inc.

 390 Greenwich Street

New York, New York 10013

 Leerink Partners LLC

One Federal Street, 37th Floor

 Boston, MA 02110

September 15, 2017

 Securities and Exchange
Commission

 Division of Corporation Finance

 100 F Street,
N.E.

 Washington, D.C. 20549-7010

Attn:
Suzanne Hayes / Vanessa Robertson

 James Rosenberg / Chris Edwards

Re:
Zai Lab Limited

 Registration Statement on Form F-1, as amended (File No. 333-219980)

 Registration Statement on Form 8-A (File No. 001-38205)

Ladies and Gentlemen:

 In accordance with Rule
461 under the Securities Act of 1933, as amended (the “Act”), we, as representative of the several underwriters, hereby join in the request of Zai Lab Limited (the “Company”) for acceleration of the effective date
of the above-named Registration Statement so that it becomes effective at 4:00 PM, Eastern Daylight Time, on September 19, 2017 or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Ropes & Gray LLP,
may orally request by telephone call that such Registration Statement be declared effective.

 Pursuant to Rule 460 under the Act, we, as
representatives of the several underwriters, wish to advise you that we have effected the following distribution of the Company’s Preliminary Prospectus dated September 1, 2017:

(i)
Dates of distribution: September 1, 2017 through the date hereof

(ii)
Number of prospective underwriters to which the preliminary prospectus was furnished: 3

(iii)
Number of prospectuses furnished to investors: approximately 3,000

(iv)
Number of prospectuses distributed to others, including the Company, the Company’s counsel, independent accountants, and underwriters’ counsel: approximately 50

We, the undersigned, as representative of the several underwriters, have complied and will comply with the requirements of Rule 15c2-8 under
the Securities Exchange Act of 1934, as amended.

 Very truly yours,

J.P. MORGAN SECURITIES LLC

 CITIGROUP GLOBAL MARKETS INC.

LEERINK PARTNERS LLC

By:

J.P. MORGAN SECURITIES LLC

By:

/s/ David Ke

Name:

David Ke

Title:

Vice President

By:

CITIGROUP GLOBAL MARKETS INC.

 By:

/s/ Russell Chong

Name:

Russell Chong

Title:

Managing Director

By:

LEERINK PARTNERS LLC

 By:

/s/ John I. Fitzgerald

Name:

John Fitzgerald

Title:

Managing Director

CORRESP
1
filename1.htm

CORRESP

 Zai Lab Limited

4560 Jinke Road

 Bldg. 1, Fourth
Floor

 Pudong

 Shanghai, China
201210

 September 15, 2017

 Securities
and Exchange Commission

 Division of Corporation Finance

 100
F Street, N.E.

 Washington, D.C. 20549

Attention:

Suzanne Hayes / Vanessa Robertson

James Rosenberg / Chris Edwards

Re:
Zai Lab Limited

Registration Statement on Form F-1, as amended (File No. 333-219980)

Registration Statement on Form 8-A (Registration No. 001-38205)

Ladies and Gentlemen:

 Pursuant to Rule 461 of
Regulation C (“Rule 461”) promulgated under the Securities Act of 1933, as amended, Zai Lab Limited (the “Company”) hereby requests that the effectiveness of the above-referenced Registration Statement on Form F-1 (the “F-1 Registration Statement”) be accelerated to, and that the Registration Statement become effective at, 4:00 pm Eastern Daylight Time on
September 19, 2017, or as soon thereafter as practicable.

 The Company also requests that the Registration Statement on Form 8-A under the Securities Exchange Act of 1933, as amended, covering the American depositary shares representing ordinary shares of the Company (the “Registration Statement on Form
8-A,” together with the F-1 Registration Statement, the “Registration Statements”), be declared effective concurrently with the F-1 Registration Statement.

 If there is any change in the acceleration request set forth above, the
Company will promptly notify you of the change, in which case the Company may be making an oral request of acceleration of the effectiveness of the Registration Statements in accordance with Rule 461. Such request may be made by an executive officer
of the Company or by any attorney from the Company’s U.S. counsel, Ropes & Gray LLP.

 The Company understands that J.P.
Morgan Securities LLC, Citigroup Global Markets Inc. and Leerink Partners LLC, on behalf of the prospective underwriters of the offering, have joined in this request in a separate letter delivered to you today.

The Company hereby acknowledges the following:

•

should the Securities and Exchange Commission (the “Commission”) or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the filing effective, it does not
foreclose the Commission from taking any action with respect to the filing;

•

the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the
disclosure in the filing; and

•

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

 [Signature page follows]

 -2-

Very truly yours,

Zai Lab Limited

By:

 /s/ Samantha Du

Name:

Samantha Du

Title:

Chief Executive Officer

CORRESP
1
filename1.htm

CORRESP

 ROPES & GRAY LLP

 PRUDENTIAL TOWER

800 BOYLSTON STREET

 BOSTON, MA 02199-3600

WWW.ROPESGRAY.COM

 FOIA Confidential Treatment Request

The entity requesting confidential treatment is

 Zai Lab
Limited

 4560 Jinke Road

 Bldg. 1, 4F

Pudong, Shanghai, 201210, China

 Attn: Samantha
Du

 +86 21 6163 2588

 Patrick O’Brien

 617-951-7527

617-235-0392 fax

patrick.obrien@ropesgray.com

 August 22, 2017

 VIA
EDGAR AND HAND DELIVERY

 CONFIDENTIAL

 Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Mail Stop 4546

Attention:  Suzanne Hayes

Vanessa Robertson

 Jim
Rosenberg

 Chris Edwards

Office of Healthcare and Insurance

Re:  Zai Lab Limited

Registration Statement on Form F-1 (File
No. 333-219980)

 Dear Ms. Hayes:

On behalf of Zai Lab Limited (the “Company”), set forth below is information in response to Comment #20 contained in the
letter dated June 28, 2017 from Suzanne Hayes of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to Samantha Du, the Company’s Chief Executive Officer, with respect to
the Company’s Form F-1, File No. 333-219980 (the “Registration Statement”) that was filed with the Commission. The supplemental response set
forth below is based upon information provided to Ropes & Gray LLP by the Company.

*****Confidential material redacted and separately filed with the Securities and Exchange Commission.

CONFIDENTIAL TREATMENT REQUESTED BY ZAI LAB LIMITED

Confidential treatment has been requested for portions of this letter. The copy filed herewith omits the information subject to the
confidentiality request. Omissions are designated as [***]. A complete version of this letter has been separately filed with the Securities and Exchange Commission.

On behalf of the Company, we advise you as follows:

20.     Once you have an estimated offering price or range, please explain to us how you determined the fair value of
the ordinary shares underlying your equity issuances and the reasons for any differences between the recent valuations of your ordinary shares leading up to the IPO and the estimated offering price. This information will help facilitate our review
of your accounting for equity issuances including stock compensation and beneficial conversion features.

Response:    To provide additional context and further information for the Staff’s consideration, the Company
supplementally advises the Staff that, based on discussions with the Company’s board of directors and input provided by the underwriters, the Company currently anticipates that the price range for this offering is expected to be within the
range of $[***] to $[***] per American depositary share, or ADS, before giving effect to a reverse stock split of the Company’s ordinary shares. The Company currently expects each ADS to represent one ordinary share.

The estimated price range is based on a number of factors, including the Company’s prospects and the prospects for the Company’s
industry, the general condition of the securities markets, the recent market prices of, and the demand for, publicly traded stock of generally comparable companies and preliminary discussions with the underwriters regarding potential valuations of
the Company. The actual price range to be included in a subsequent amendment to the Registration Statement has not yet been determined and will not be established until shortly before printing the preliminary prospectus for the offering, taking into
account all relevant market factors at that time. However, the Company believes that the estimated price range will not be subject to significant change.

We confirm on behalf of the Company that, prior to circulating copies of the preliminary prospectus in connection with this offering, the
Company will file a pre-effective amendment to the Registration Statement that will include all information other than information that may be excluded in reliance upon Rule 430A of Regulation C, and the
actual price range to be included in such amendment will comply with the Staff’s interpretation regarding the parameters of a bona fide price range.

As disclosed in the Registration Statement under the heading “Management’s discussion and analysis of financial condition and
results of operations—Critical accounting policies and significant judgments and estimates—Fair value of our ordinary shares,” the Company estimates the fair value of the Company’s ordinary shares using both income and market
approaches.

 -2-

*****Confidential material redacted and separately filed with the Securities and Exchange Commission.

CONFIDENTIAL TREATMENT REQUESTED BY ZAI LAB LIMITED

Income approaches to valuation incorporate discounted cash flow estimates while market-based approaches use the Company’s private equity financing
transaction with independent third parties to determine valuation.

 Grant Date Fair Value Determinations

August 25, 2016 and December 6, 2016 Option Grants. The Company obtained a third-party valuation
of its ordinary shares, which resulted in an estimated fair value of $1.34 per share. In determining the fair value of the ordinary shares, the third-party valuation applied a discounted cash flow analysis to conclude equity value of the
Company’s securities, and then adopted an option-pricing method to allocate the equity value between preferred shares and ordinary shares. This valuation was considered by the Company in its determination of the fair value of ordinary shares of
$1.34 per share for options granted on August 25, 2016 and December 6, 2016. Among the qualitative factors considered by the Company in determining fair value of the Company’s ordinary shares were the following:

•

The Company received $53.1 million in April 2016 from the issuance of 23,838,588 Series B-2 preferred shares at $2.2275 per share. The difference in the value between the
ordinary shares and the Series B-2 preferred shares was primarily due to the significant rights and preferences associated with the Series B-2 preferred shares.

•

Since the Company had not yet formally started any initial public offering preparation, in estimating the initial public offering probability, one of the key assumptions in the equity allocation analysis, the Company
considered an initial public offering probability to be 20%.

 May 12, 2017 Option Grants. The
Company obtained a third-party valuation of its ordinary shares, which resulted in an estimated fair value of $1.60 per share. In determining the fair value of the ordinary shares, the third-party valuation adopted a market approach by referring to
transaction price of the Company’s private equity financing transaction with independent third parties to conclude the equity value of the Company’s securities, and then adopted the option-pricing method to allocate the equity value
between preferred shares and ordinary shares. This valuation was considered by the Company in its determination of the fair value of ordinary shares of $1.60 per share for options granted on May 12, 2017. Among the qualitative factors
considered by the Company in determining fair value of the Company’s ordinary shares were the following:

•

In March 2017, TESARO Inc., or Tesaro, received marketing approval for niraparib from the United States Food and Drug Administration, or the FDA, and was commercially launched in the United States in April 2017. The
approval of niraparib makes it more likely that the Company would obtain approval from the China Food and Drug Administration, or the CFDA, of its clinical trial application, or CTA, of niraparib as a Category 1 drug. Approval of the CTA is a
prerequisite to initiating clinical trials. In addition, as a Category 1 drug, niraparib will be entitled to an expedited new drug approval process. The Company previously entered into a collaboration, development and license agreement with Tesaro
under which the Company obtained an exclusive sub-license under certain patents and know-how that Tesaro licensed from Merck, Sharp & Dohme Corp. and Merck
Corp. to develop, manufacture, use, sell, import and commercialize Tesaro’s proprietary PARP inhibitor, niraparib, in mainland China, Hong Kong and Macau.

 -3-

*****Confidential material redacted and separately filed with the Securities and Exchange Commission.

CONFIDENTIAL TREATMENT REQUESTED BY ZAI LAB LIMITED

•

The Company initiated Phase II clinical trials for two late stage drug candidates, ZL-2301 and fugan, and has recently recruited patients for clinical trials for these drug
candidates.

•

In April 2017, the Company entered into a license and collaboration agreement with Paratek Bermuda, Ltd., a subsidiary of Paratek Pharmaceuticals, Inc., or Paratek, under which the Company obtained an exclusive license
under certain patents and know-how of Paratek Bermuda Ltd. to develop, manufacture, use, sell, import and commercialize omadacycline in mainland China, Hong, Macau and Taiwan.

•

The Company selected investment bankers for a contemplated initial public offering and scheduled an organizational meeting in March 2017.

•

The third-party valuation included an initial public offering probability of 65% compared to 20% for the August 25, 2016 and December 6, 2016 option grants. These percentages changed primarily as a result of
the Company’s selection of investment bankers for a contemplated initial public offering in March 2017 and it becoming very actively engaged in preparing its draft Registration Statement on Form F-1.

 Estimated Initial Public Offering Price

The estimated price range for this offering was determined with reference to several quantitative and qualitative factors. The Company, based
on discussions with the Company’s board of directors and input provided by the underwriters, determined the estimated price range to be within the range of $[***] to $[***] per ADS, before giving effect to a reverse stock split of the
Company’s ordinary shares. The Company currently expects each ADS to represent one ordinary share. As noted above, the Company’s estimate of fair value of its ordinary shares was $1.60 as of May 12, 2017. The Company notes that, as is
typical in initial public offerings, the price range for this offering was not derived using a formal determination of fair value, but was determined in consultation with the underwriters based upon the factors discussed herein. The factors
considered in setting the price range for this offering included:

•

an analysis of the typical valuation ranges seen in recent initial public offerings for companies in the Company’s industry;

•

the general condition of the securities market and the recent market prices of, and the demand for, publicly traded stock of generally comparable companies;

•

an assumption that there would be a receptive public trading market for pre-commercial biotechnology companies such as the Company; and

•

an assumption that there would be sufficient demand for the Company’s ADSs to support an offering of the size contemplated by the Company based on the response to and feedback from the Company’s Testing-the-Waters meetings.

 -4-

*****Confidential material redacted and separately filed with the Securities and Exchange Commission.

CONFIDENTIAL TREATMENT REQUESTED BY ZAI LAB LIMITED

In addition, the Company believes that the difference in value reflected between the midpoint of the estimated price range for this offering of
$[***] per ADS, and the Company’s determination of the fair value of the Company’s ordinary shares on May 12, 2017 was primarily the result of the following subsequent events and circumstances:

•

The continued advancement of niraparib, the Company’s lead drug candidate, including approval of its clinical trial application, or CTA, as a Category 1 drug by the CFDA in July 2017. Approval of the CTA is a
prerequisite to initiating clinical trials. In addition, as a Category 1 drug, niraparib will be entitled to an expedited new drug approval process.

•

The Company has progressed in recruiting patients for its clinical trials of ZL-2301 and fugan.

•

The Company received $30.0 million in June 2017 from the issuance of 11,993,763 Series C preferred shares at $2.50 per share.

•

Paratek’s July 2017 announcement of positive top-line data from a second Phase III clinical trial comparing omadacycline to linezolid in the treatment of ABSSSI, in which the
study met all of its primary and secondary endpoints required to support approval for this indication by the FDA and the European Medicines Agency. Paratek’s successful clinical trial results will make it more likely that the Company’s
clinical trials for omadacycline will be successful.

•

The estimated price range for this offering is based only upon a scenario in which the Company completes this offering and is not probability weighted, in contrast to the Company’s prior valuations of the
Company’s ordinary shares, which considered multiple potential outcomes and resulted in a lower value of the Company’s ordinary shares than the estimated price range for this offering. For the May 12, 2017 option grants, the
Company’s considerations included a third-party valuation in which the probability weighting for an initial public offering was 65%.

•

The Company’s currently outstanding convertible preferred stock has substantial economic rights and preferences superior to the Company’s ordinary shares. The initial public offering price assumes the
conversion of the Company’s convertible preferred stock to ordinary shares upon the completion of this offering and the corresponding elimination of such superior economic rights and preferences.

•

The significant benefits the Company expects to accrue as a result of becoming publicly traded through the initial public offering, including (i) a substantial increase in the Company’s cash position after
receiving the net proceeds from the initial public offering, (ii) becoming fully funded through the anticipated completion of all Phase III clinical trials of niraparib, its lead drug candidate, (iii) an anticipated improved ability of the
Company to raise equity and debt capital going forward, and at a lower expected cost of capital and with reduced borrowing costs, as a result of being a publicly traded company, and (iv) the expected increased attractiveness of the
Company’s equity as a currency to raise capital, compensate employees and explore other strategic transactions.

•

The Company has taken several steps towards the completion of an initial public offering, including:

 -5-

*****Confidential material redacted and separately filed with the Securities and Exchange Commission.

CONFIDENTIAL TREATMENT REQUESTED BY ZAI LAB LIMITED

○

on May 31, 2017 the Company confidentially submitted its Registration Statement with the Commission and on August 15, 2017 the Company publicly filed its Registration Statement with the Commission;

○

the board of directors appointed two additional independent members to serve on the board of directors and approved various equity and governance policies that will become effective upon the closing of this offering;
and

○

in anticipation of this offering, the board of directors approved the Company’s fourth amended and restated memorandum and articles of association, which will be effective upon the closing of this offering

 The Company believes that the increase between the fair value of its ordinary shares as of May 12, 2017 and the
anticipated price range for this offering is reasonable based on the above referenced factors.

 Because of the financially sensitive
nature of the estimated price range, the Company requests confidential treatment under 17 C.F.R. § 200.83 of the contents of this letter and has submitted a separate request for confidential treatment in accordance therewith to the
Commission’s Office of Freedom and Information Privacy Act Operations. Pursuant to Rule 418 under

July 21, 2017

Samantha Du
Chief Executive Officer
Zai Lab Limited
4560 Jinke Rd
Bldg.1, Fourth Floor
Pudong
Shanghai, China 201210

Re: Zai Lab Limited
Amendment No. 2 to the
Draft Registration Statement on Form F -1
Submitted July 11, 2017
  CIK No. 0001704292

Dear Dr. Du:

We have reviewed your amended draft registration statement and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.

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 our comments apply 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 these comments and your
amended draft registra tion statement or filed registration statement, we may have additional
comments.

Form F -1
Capitalization, page 67

1. Please refer to your response to prior comment 17. Your response that the warrants will
expire upon the completion of the offering to the extent unexercised (following notice of
the offering) is not consistent with your disclosure on pages F -25 and II -2 which states
that if not previously exercised, the warrants shall expire on the earlier of (i) the sixth
anniversary of the issue date or (i i) ninety days prior to the date on which the Company
consummates an initial public offering.   Please advise.

Samantha Du
Zai Lab Limited
July 21, 2017
Page 2

 Management’s discussion and analysis of financial condition and results of operations
Critical accounting policies and significant judgments an d estimates
Fair value of our ordinary shares, page 75

2. Please refer to your response to prior comment 19. You disclose on page 75 that you first
applied appropriate methodologies “such as” the income approach/discounted cash flow.
On page 76 you disclose that the equity value was determined based on the income
approach and “other appropriate valuation methodologies”.   If more than one method was
used, please clarify in your disclosure the name of the other method(s) and how the other
methods were used to d etermine fair value.

Overview of our licensing agreements, page 127

3. We note your response to comment 25.  However, your response does not comply with
our prior comment.  Please revise your description of the material terms for each of your
license agreements to disclose the aggregate maximum potential payments that you may
be required to pay upon achievement of development, regulatory and/or commercial
milestones. In relation to your request for confidential treatment with respect to the
license agr eements, please note that we are generally willing to grant confidential
treatment for individual milestone payments provided that the aggregate amount of such
payments is disclosed in the prospectus.

Item 7. Recent sales of unregistered securities, page II-1

4. Please refer to Item 9 regarding your June 26, 2017 private placement of 11,993,763
Series C preferred shares for an aggregate consideration of $30,000,000. Please tell us
why you have not reflected these shares as outstanding in various places throu ghout your
filing where you discuss outstanding shares. Further tell us why you neither reflect them
in the capitalization on a pro forma basis on page 67 nor in your discussion of liquidity
and capital resources in MD&A on page 80.

You may contact Vanes sa Robertson at (202) 551 -3649 or Jim Rosenberg at (202) 551 -
3679 if you have questions regarding comments on the financial statements and related matters.
Please contact Chris Edwards at (202) 551 -6761 or Suzanne Hayes at (202) 551 -3675 with any
other qu estions.

Sincerely,

 /s/ Suzanne Hayes

Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
Cc: Patrick O’Brien, Esq.

Mail Stop 4546
June 28, 2017

Dr. Samantha Du
Chief Executive Officer
Zai Lab Limited
4560 Jinke Rd
Bldg.1, Fourth Floor
Pudong
Shanghai, China 201210

Re: Zai Lab Limited
Draft Registration Statement on Form S -1
Submitted May 31, 2017
  CIK No. 0001704292

Dear Dr. Du:

We have reviewed your draft registration statement  and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.

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 our comments apply to your facts and circumst ances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in response to these  comments  and your
amended draft registration statement or filed registration statement,  we may have additional
comments.

General

1. Please supplementally provide us with copies of all written communications, as defined
in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your
behalf, present to potential investors in relian ce on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.

2. We note that you intend to request confidential treatment for several exhibits. We will
send comments on your application for confidential treatment under s eparate cover.

Dr. Samantha Du
Zai Lab Limited
June 28, 2017
Page 2

 Prospectus summary, page 1
Our innovative pipeline, page 2

3. The table of your pipeline product candidates on page 2, 94 and 96 should reflect the
actual, and not the anticipated, status of your pipeline candidates as of the latest
practicable date. For example, the table currently suggests that ZL -2306 is currently in
Phase 3 trials for breast cancer and ovarian cancer, but the footnotes to the table suggest
that Phase 3 trials have not been initiated.

4. Please revise the pipeline ta ble to remove the internal discovery programs. Because you
have not identified a product candidate for these programs, it is premature to include
them in a product pipeline table.

5. Please revise the column reflecting the commercial rights to more clearly i ndicate where
you have commercialization rights.

6. Please remove the column reflecting the partner clinical stage since that information does
not correlate to the status of your pipeline products within the regulatory framework in
China.

7. Please explain the  relevance of the statement that your planned Phase III studies for
niraparib are expected to be similar in design to Tesaro’s clinical studies of niraparib.

8. We note your statement that you expect to commercialize niraparib for the treatment of
ovarian ca ncer in Hong Kong and Macau during the second half of 2018 after being
approved by the FDA and EMA.  It is not appropriate to assume your product candidate
will obtain regulatory approval.  Please revise to clarify whether it currently has EMA
approval.  I f it does not, please clarify that you hope to commercialize the product
candidate in these jurisdictions, if you are able to obtain regulatory approval.

Industry, page 4

9. In your discussion of the CFDA regulatory outlook, please balance the disclosure to
reflect that the implementation of CFDA reform is uncertain and the impact this may
have on your strategy.

Risks associated with our business, page 6

10. In the first bullet point, please quantify your losses for the most recent fiscal year.

The offering , page 9

11. Please disclose what percentage of your total share capital will be held by the public
immediately after the offering.

Dr. Samantha Du
Zai Lab Limited
June 28, 2017
Page 3

Risk factors, page 12
Reimbursement may not be available for our drug candidates in China…, page 28

12. We note your statement th at niraparib is unlikely to be included on National Drug
Reimbursement List. Please tell us why niraparib is not expected to be included and the
criteria you must satisfy for inclusion on the NDRL.

Uncertainties with respect to the PRC legal system…, page  38

13. Please explain how the proposed Foreign Investment Law as currently proposed would
impact your corporate structure, corporate governance practice and business operations.

The depositary for our ADSs will give us a discretionary proxy, page 59

14. Please  reconcile the inclusion of this risk with your disclosure under “Voting Rights” on
page 199 that the depositary will vote or attempt to vote only as ADS holders instruct and
will not itself exercise any voting discretion.

Use of Proceeds, page 65

15. Please  clarify whether your current expectations are to complete the niraparib Phase III
studies, the omadacycline Phase III studies and the ZL -2301 Phase II/III studies with the
proceeds from this offering.

Capitalization, page 67

16. Please tell us why the pre ferred shares and warrant liabilities are not included in your
Total Capitalization amount in the table.

17. Please tell us why it is appropriate to include the exercise of warrants to purchase
preferred shares in the pro forma. Please explain how these exerc ises are factually
supportable and directly attributable to your offering.

18. It appears that your pro forma should reflect total shareholders’ equity and a positive total
capitalization rather than deficits. Please revise accordingly.

Management’s discussion and analysis of financial condition and results of operations
Critical accounting policies and significant judgments and estimates
Share -based compensation, page 74

19. You disclose the use the binomial option pricing model in determining the estim ated fair
value of options granted. However, please expand your policy to explain how you
estimated the fair value of the underlying ordinary shares and include the following:

Dr. Samantha Du
Zai Lab Limited
June 28, 2017
Page 4

 The methods that management used to determine the fair value of the Company’s
shares and the nature of the material assumptions involved,
 The extent to which the estimates are considered highly complex and subjective, and
 The estimates will not be necessary to determine the fair value of new awards once
the ADSs begin trading.

20. Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the ordinary shares underlying your equity issuances and the
reasons for any differences between the recent valuations of your ordinary shares leading
up to the IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features.

Results of Operations
Research and development expen ses, page 77

21. Please revise your disclosure to include the amount of external research and development
expense for niraparib incurred during the year ended December 31, 2015. Please disclose
that no other program individually represents a significant amoun t of these expenses in
2015 or 2016; otherwise disclose the program(s) and amounts incurred.

Liquidity and capital resources, page 79

22. Please disclose the impact on your liquidity and on your ability to pay dividends related
to the restrictions from receiving funds from your PRC subsidiary as discussed in Note 13
to the consolidated financial statements. Include in your disclosure, the am ount of funds
currently restricted from being received from the subsidiary.

JOBS Act exemptions and foreign private issuer status, page 85

23. You disclose that you have elected not to take advantage of the extended transition period
for complying with new or revised accounting standards.  Please expand your disclosure
to include a statement that the election is irrevocable.

Business, page 92

24. We note that you expect to complete the construction of your large molecule facility in
the first half of 2018. Pl ease disclose the estimated costs to complete this facility and how
you intend to finance the construction.

Dr. Samantha Du
Zai Lab Limited
June 28, 2017
Page 5

 Overview of our licensing agreements, page 125

25. For each of the license agreements described in this section, please disclose the aggregate
milestone payments that are payable under the agreement.

Management, page 170
Other key employees and advisors, page 172

26. Please explain the role of your scientific advisory board and clarify, here or in the
appropriate section of your filing, how members  of the board are compensated.

You may contact Vanessa Robertson at (202) 551 -3649 or Jim Rosenberg at (202) 551 -
3679 if you have questions regarding comments on the financial statements and related matters.
Please contact Chris Edwards at (202) 551 -6761 or Suzanne Hayes at (202) 551 -3675 with any
other questions.

Sincerely,

 /s/ Suzanne Hayes

Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance

Cc: Patrick O’Brien, Esq.
Ropes & Gray, LLP