再鼎医药 2025年季度报告

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN Securities registered pursuant to Section 12(b) of the Act:TradingSymbol(s) Ordinary Shares, par value $0.000006 per shareOrdinary Shares, par value $0.000006 per share*9688 Non-accelerated fileroSmaller reporting companyEmerging growth companyo complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ 486,853,250ordinary shares were held in the form of American Depositary Shares. Quarterly Report on Form 10-QFor the First Quarter of 2025FINANCIAL INFORMATIONFinancial Statements (Unaudited)Condensed Consolidated Balance Sheets as ofMarch 31,2025and December 31, 2024Condensed Consolidated Statements of Operations for the ThreeMonths EndedMarch 31, 2025 and 2024Condensed Consolidated Statements of Comprehensive Loss for the ThreeMonths EndedMarch 31,2025and2024Condensed Consolidated Statements of Shareholders’ Equity for the ThreeMonths EndedMarch 31, 2025and2024Condensed Consolidated Statements of Cash Flows for the ThreeMonths EndedMarch 31,2025 and2024Notes to the Unaudited Condensed Consolidated Financial StatementsManagement’s Discussion and Analysis of Financial Condition and Results of OperationsQuantitative and Qualitative Disclosures about Market RiskControls and ProceduresOTHER INFORMATIONLegal ProceedingsRisk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults upon Senior SecuritiesMine Safety DisclosuresOther InformationExhibits Forward-Looking Statements allocation and investment strategy; clinical development programs and related clinical trials; clinical trial data, data readouts, andpresentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings,and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of ourcollaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; ourprofitability and timeline to profitability; and our future financial and operating results. All statements, other than statements of historicalfact, included in this report are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,”“contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “predict,”“project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or similar expressions. Such statements constituteforward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are notguarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date ofthis report and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated authorities in connection with issuing securities to foreign investors under Chinese law;•Any violation or liability under the U.S. Foreign Corrupt Practices Act or Chinese anti-corruption, anti-bribery, and anti-fraud laws;•Restrictions on currency exchange;•Limitations on the ability of our Chinese subsidiaries to make payments to us;•Chinese requirements on the ability of residents in mainland China to establish offshore special purpose companies;•Chinese regulations regarding acquisitions of companies based in mainland China by foreign investors;•Any issues that our Chinese manufacturing facilities may have with operating in conformity with established GMPs and internationalbest practices, and with passing FDA, NMPA, and EMA inspections;•Expiration of, or changes to, financial incentives or discretionary policies granted by local governments in mainland China; conflict, natural disasters or extreme weather events, and other geopolitical events;•Unfavorable tax consequences to us and our non-Chinese shareholders or ADS holders if we were to be classified as a Chineseresident enterprise for Chinese income tax purposes;•Failure to comply with applicable Chinese, U.S., and Hong Kong regulations that could lead to government enforcement actions,fines, other legal or administrative sanctions, and/or harm to our business or reputation;•Delays or obstacles for closing transactions, such as review by the CFIUS in our investments; •Any inability to obtain or maintain sufficient patent protection for our products and product candidates. These factors should not be construed as exhaustive and should be read with the other cautionary statements and information in ourAnnual Report on Form 10-K for the year ended December 31, 2024 (the “2024 Annual Report”), our Quarterly Reports on