卡拉制药 2025年度报告

☒ANNUAL REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025OR For the transition period fromtoCommission file number 001-38150 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 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 Section13 or 15(d) of the Securities Exchange Act of 1934 during the preceding12months (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 past90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of RegulationS-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 growthcompany. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the ExchangeAct. 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 inthe 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 Rule12b-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 Common Stock held by non-affiliates of the registrant was approximately $24.6 million, based on the closing price of the registrant’s common stock on June 30, 2025. There were 929,491,578 shares of common stock, par value $0.001 per share, outstanding as of April 10, 2026. Table of Contents Special Note Regarding Forward-Looking Statements and Industry Data2Risk Factor Summary4 PART I Item 1.Business5Item 1A.Risk Factors29Item 1B.Unresolved Staff Comments83Item 1C.Cybersecurity83Item 2.Properties85Item 3.Legal Proceedings85Item 4.Mine Safety Disclosures85 PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities86Item 6.[Reserved]86Item 7.Management’s Discussion and Analysis of Financial Condition and Results ofOperations87Item 7A.Quantitative and Qualitative Disclosures About Market Risk107Item 8.Financial Statements and Supplementary Data107Item 9.Changes in and Disagreements With Accountants on Accounting and FinancialDisclosure107Item 9A.Controls and Procedures108Item 9B.Other Information109Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections110 PARTIII Item 10.Directors, Executive Officers and Corporate Governance110Item 11.Executive Compensation113Item 12.Security Ownership of Certain Beneficial Owners and Management and RelatedStockholder Matters131Item 13.Certain Relationships and Related Transactions, and Director Independence133Item 14.Principal Accountant Fees and Services136 PARTIV Item 15.Exhibits and Financial Statement Schedules137Item 16.Form 10-K Summary142Signatures142 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA This Annual Report on Form 10-K contains forward-looking statements that involve substantialrisks and uncertainties. All statements, other than statements of historical fact, contained in this AnnualReport on Form 10-K, including statements regarding our strategy, future operations, future financialposition, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expe