百济神州 2025年度报告

FORM10-K c/o BeOne Medicines I GmbH94 Aeschengraben 27Basel 4051Switzerland(Address of principal executive offices, including zip code) Securities registered pursuant to Section12(b)of the Act: *Included in connection with the registration of the American Depositary Shares (“ADSs”) with the U.S. Securities and Exchange Commission. The ordinary shares are not listed for trading in theUnited States but are listed for trading on The Stock Exchange of Hong Kong Limited (“HKEx”). Securities registered pursuant to Section12(g)of the Act: The RMB shares are ordinary shares of the registrant issued to permitted investors in the People’s Republic of China and listed and traded onthe STAR Market in Renminbi. The RMB shares are not listed for trading in the United States or on the HKEx and are not fungible with the ordinary shares listed on the HKEx or the ADSsrepresenting the ordinary shares listed on Nasdaq, and in no event will any RMB shares be able to be converted into the ordinary shares listed on the HKEx or the ADSs listed on Nasdaq, or vice Indicate by check mark if the registrant is a well‑known seasoned issuer, as defined in Rule405 of the Securities Act.Yes☒No☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section13 or Section15(d)of the Exchange Act.Yes☐No☒ Indicate by check mark whether the registrant: (1)has filed all reports required to be filed by Section13 or 15(d)of the Securities Exchange Act of 1934 during the preceding 12months (or for suchshorter period that the registrant was required to file such reports), and (2)has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S‑T (§ 232.405 of this chapter)during the preceding 12months (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 growth company. See the definitionsof “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b‑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 financial accounting standardsprovided pursuant to Section 13(a) of the Exchange Act.☐ 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 topreviously 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 the registrant’s executive officersduring the relevant recovery period pursuant to §240.10D-1(b).☐ As of June30, 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 the form of ADSs, eachrepresenting 13 ordinary shares, held by non‑affiliates of the registrant was approximately $14.7 billion, based upon the closing price of the registrant’s ADSs on the Nasdaq Global Select Market onJune30, 2025. Table of Contents As of February13, 2026, 1,442,259,810 ordinary shares, par value $0.0001 per share, were outstanding, of which 714,971,127 ordinary shares were held in the form of 54,997,779 ADSs, and DOCUMENTS INCORPORATED BY REFERENCE The registrant intends to filea definitive proxy statement pursuant to Regulation14A within 120days of the end of the fiscalyear ended December31, 2025. Portions of such definitive proxystatement are incorporated by reference into PartIII of this Annual Report on Form10‑K. BeOne MedicinesLtd.Annual Report on Form10‑KTABLE OF CONTENTS PARTIItem1.Business3Item1A.Risk Factors59Item1B.Unresolved Staff Comments118Item 1C.Cybersecurity118Item2.Properties120Item3.Legal Proceedings120Item4.Mine Safety Disclosures120PARTIIItem5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities121Item6.Reserved125Item7.Management’s Discussion and Analysis of Financial Condition and Results of Operations126Item7A.Quantitative and Qualitative Disclosures About Market Risk139Item8.Financial Statements and Supplementary Data141Item9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure197Item9A.Controls and Procedures197Item9B.Other Information198Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections198PARTIIIItem10.Directors, Executive Officers and Corporate Governance199Item11.Executive Compensation199Item12.Security Ownership of Certain Beneficial Own