0000000000-25-003729.txt : 20250703 0000000000-25-003729.hdr.sgml : 20250703 20250408083606 ACCESSION NUMBER: 0000000000-25-003729 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20250408 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Zai Lab Ltd CENTRAL INDEX KEY: 0001704292 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences EIN: 000000000 STATE OF INCORPORATION: E9 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD SEC FILE NUMBER: 001-38205 BUSINESS ADDRESS: STREET 1: 4560 JINKE ROAD STREET 2: BLDG. 1, 4F, PUDONG CITY: SHANGHAI STATE: F4 ZIP: 201210 BUSINESS PHONE: 862161632588 MAIL ADDRESS: STREET 1: 4560 JINKE ROAD STREET 2: BLDG. 1, 4F, PUDONG CITY: SHANGHAI STATE: F4 ZIP: 201210 PUBLIC REFERENCE ACCESSION NUMBER: 0001628280-25-008409 LETTER 1 filename1.pdf begin 644 filename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M?_./7U& M\'=(FC:L"0N]CP;:!184-)[U?:Q7*0+_+<&^TB3Z?1H)I[H&H72]%ALG!>T&'4D3Q6;>0D MWH6(B(B(B(C\#R$E*._*ZYHTMI-&A(VU6%UF9HZ2NH[NXUWDF_0J30SC7?2@ M2/PJR4F7@_Z0[[I\;JQ-+AKZI5%*M5AKM M8BFK_J&*TG K[6(IUA>-=I&!4&HO<:W[\*2UW]+ZHM$N\G+7=*C+,3]OTSEJ M%R(B(B(B(E+)Q34K^EA%QM]\$9_+TI0O8F,68S7:A,$\.N8K;4NS%EN-[$Z69N?#(:9LD.3<.0L[:)O:O9DT]1>NUB*]<5W:A?+ M9^N+W(@?4-,,>KB:7O3:Q5)TF%^?I",&[@&L&R,+;T/15\L%J1-HI#8&-\VB_I8WC9!%S,DPI;5:!P% MR8+C1AOZYL46OFHL0UB&Q^Z<)F7ZA+ TIN;K1-6I DX]3:PU&MUF8U.Q86BZ M*+NN)AL=,NSAANS>K(KZ^]-!HN&XG#L7J[&368KS2VI0=$*?4V;M1+"RR+RK MV'4TMQ!U#CF9$$=$1$1$1$1^-H0=V)*/6XX[W.7D<2')E9@HP(#$T"C P,# P,# P,# @-C4U M,S4@9B *,# P,# P,CF4@,30^/@HE:51E>'0M0V]R92TW+C(N- HE:51E G>'0M<&1F2%1-3"TT+C N- IS=&%R='AR968*,CDR,C8*)25%3T8* end TEXT-EXTRACT 2 filename2.txt 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