再鼎医药 2025年度报告

(Mark One) Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended: December 31, 2025 Or Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 +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: 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No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YesNo 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 12months (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No 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 duringthe preceding 12 months (or for such shorter period that the registrant was required to submit such files). YesNo 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 growthcompany. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.: 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 financialaccounting standards provided pursuant to Section 13(a) of the Exchange Act. 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 financialreporting 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. 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. 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 theregistrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YesNo As of June 30, 2025, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the ordinary shares, including in theform of American Depositary Shares (“ADSs”), each representing ten ordinary shares, held by non-affiliates of the registrant was approximately $3.8billion, based upon theclosing price of the registrant’s ADSs on the Nasdaq Global Market of $34.97 on June 30, 2025. As of February20, 2026, 1,106,407,390 ordinary shares, par value $0.000006 per share, were outstanding, of which 307,140,690 ordinary shares were held in the form of ADSs. DOCUMENTS INCORPORATED BY REFERENCE The registrant intends to file a definitive proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, 2025. Portions of suchdefinitive proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K. Zai Lab Limited2025 Annual Report on Form 10-KTABLE OF CONTENTS PagePART I1Item 1. Business1Item 1A. Risk Factors26Item 1B. Unresolved Staff Comments75Item 1C. Cybersecurity75Item 2. Properties76Item 3. Legal Proceedings77Item 4. Mine Safety Disclosures77PART II78Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities78Item 6. [Reserved]79Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations80Item 7A. Quantitative and Qualitative Disclosures About Market Risk88Item 8. Financial Statements and Supplementary Data90Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure90Item 9A. Controls and Procedures90Item 9B. Other Information91Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections92PART III93Item 10. Directors, Executive Officers and Corporate Governance93Item 11. Executive Compensation93Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters93Item 13. Certain Relationships and Related Transactions, and Director In