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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________________________
FORM 10-K/A
Amendment No.1
__________________________
(Mark One)
xAnnual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the fiscal year ended: December 31, 2022
Or
oTransition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Commission file number: 001-38205
__________________________
Zai Lab logo.jpg
ZAI LAB LIMITED
(Exact Name of Registrant as Specified in its Charter)
__________________________
Cayman Islands98-1144595
(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 classTrading Symbol(s)Name of each exchange on which registered
American Depositary Shares, each representing 10 Ordinary Shares, par value $0.000006 per shareZLABThe Nasdaq Global Market
Ordinary Shares, par value $0.000006 per share*
9688The 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 filerxAccelerated Filero
Non-accelerated fileroSmaller reporting companyo
  Emerging growth companyo
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.

Audit Firm IDAuditor NameAuditor Location
185KPMG LLPNew York, NY



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 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
4.1
4.2
4.3
4.4
4.5
10.1#
10.2#
10.3#
10.4#
10.5#
10.6#
10.7#
10.8#
10.9+
10.10


Exhibit
Number		Exhibit Title
10.11+
10.12+
10.13+
10.14+
10.15+
10.16+
10.17^
10.18^
10.19^
10.20^
10.21^
10.22^
10.23^
10.24^
10.25^


Exhibit
Number		Exhibit Title
10.26^
10.27^
10.28^
10.29^
10.30^
10.31#
10.32#
10.33#
10.34#
10.35#
10.36#
10.37#
10.38#
10.39#
10.40#
10.41#


Exhibit
Number		Exhibit Title
10.42#
10.43
10.44
10.45
16.1
21.1
23.1
23.2
31.1
31.2
31.3
31.4
32.1
32.2
99.1
101.INS
Inline XBRL Instance Document-the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definitions Linkbase Document
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)


#    Management contract or compensatory plan, contract, or arrangement
+    Confidential treatment has been granted as to certain portions, which portions have been omitted and submitted separately to the Securities and Exchange Commission.
^    Certain confidential information contained in this exhibit has been omitted because it (i) is not material and (ii) would be competitively harmful if publicly disclosed.



SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized.
ZAI LAB LIMITED
Date: December 22, 2023
By:/s/ Samantha (Ying) Du
Name:Samantha (Ying) Du
Title:Chief Executive Officer



Exhibit 31.3
Certification by the Principal Executive Officer
Pursuant to Exchange Act Rule 13a-14(a),
As Adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Samantha (Ying) Du, certify that:
1. I have reviewed Amendment No. 1 to this Annual Report on Form 10-K for the year ended December 31, 2022 of Zai Lab Limited; and
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.
Date: December 22, 2023
/s/ Samantha (Ying) Du
Samantha (Ying) Du
Chief Executive Officer
(Principal Executive Officer)




Exhibit 31.4
Certification by the Principal Financial Officer
Pursuant to Exchange Act Rule 13a-14(a),
As Adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Yajing Chen, certify that:
1. I have reviewed Amendment No. 1 to this Annual Report on Form 10-K for the year ended December 31, 2022 of Zai Lab Limited; and
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.
Date: December 22, 2023
/s/ Yajing Chen
Yajing Chen
Chief Financial Officer
(Principal Financial and Accounting Officer)





Exhibit 99.1
Supplemental Submission Pursuant to Item 9C(a) of Form 10-K
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
In March 2022, 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, the staff of the Securities and Exchange Commission (“SEC”) conclusively identified Zai Lab Limited (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 proactively engaged KPMG LLP, an auditor located in the United States that is inspected by the PCAOB, as the Company’s 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 date of filing of the Annual Report on Form 10-K for the year ended December 31, 2022, and as of the date hereof, the Company has determined that it is not owned or controlled by a governmental entity in the People’s Republic of China and that no governmental entity in the People’s Republic of China, directly or indirectly, possesses the power to direct or cause the direction of the management and policies of the Company or has a controlling financial interest in the Company. Specifically, the Company has determined the following:
•Based on a review of its material contracts, the Company is not a party to any material contracts with such a foreign governmental party.
•Based on a review of the Schedules 13D and 13G and amendments thereto filed by the Company’s shareholders, the Company has no major shareholders that are owned or controlled by governmental entities in the People’s Republic of China. The Company believes reliance on a review of such Schedules 13D and 13G and amendments thereto is reasonable and sufficient, because major shareholders are legally obligated to file beneficial ownership schedules with the SEC.
•Based on a review of the annual director and officer questionnaires (each, a “D&O Questionnaire”) completed and submitted to the Company by its directors and executive officers, there is no foreign government representative or official of the Chinese Communist Party on the Company’s Board of Directors.



v3.23.4
Cover Page - USD ($)
$ in Billions
 12 Months Ended
Dec. 31, 2022
Feb. 28, 2023
Jun. 30, 2022
Document Information [Line Items]      
Document Type 10-K/A    
Document Annual Report true    
Document Period End Date Dec. 31, 2022    
Current Fiscal Year End Date --12-31    
Document Transition Report false    
Entity File Number 001-38205    
Entity Registrant Name ZAI LAB LIMITED    
Entity Incorporation, State or Country Code E9    
Entity Tax Identification Number 98-1144595    
Entity Address, Address Line One 4560 Jinke Road    
Entity Address, Address Line Two Bldg. 1, Fourth Floor Pudong    
Entity Address, City or Town Shanghai    
Entity Address, Country CN    
Entity Address, Postal Zip Code 201210    
City Area Code 86 21    
Local Phone Number 6163 2588    
Entity Well-known Seasoned Issuer Yes    
Entity Voluntary Filers No    
Entity Current Reporting Status Yes    
Entity Interactive Data Current Yes    
Entity Filer Category Large Accelerated Filer    
Entity Small Business false    
Entity Emerging Growth Company false    
ICFR Auditor Attestation Flag true    
Entity Shell Company false    
Entity Public Float     $ 3.2
Amendment Flag false    
Document Fiscal Period Focus FY    
Entity Central Index Key 0001704292    
Document Fiscal Year Focus 2022    
Auditor Firm ID 185    
Auditor Name KPMG LLP    
Auditor Location New York, NY    
American Depositary Shares      
Document Information [Line Items]      
Title of 12(b) Security American Depositary Shares, each representing 10 Ordinary Shares, par value $0.000006 per share    
Trading Symbol ZLAB    
Security Exchange Name NASDAQ    
Entity Common Stock, Shares Outstanding   743,576,320  
Common Stock      
Document Information [Line Items]      
Title of 12(b) Security Ordinary Shares, par value $0.000006 per share    
Trading Symbol 9688    
Entity Common Stock, Shares Outstanding   979,087,430  
v3.23.4
Audit Information
 12 Months Ended
Dec. 31, 2022
Audit Information [Abstract]  
Auditor Firm ID 185
Auditor Name KPMG LLP
Auditor Location New York, NY
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