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of Contents](#TOC)\n\n​\n\n​\n\n**UNITED STATES**\n\n**SECURITIES AND EXCHANGE COMMISSION**\n\n**Washington, D.C. 20549**\n\n**FORM ****20-F**\n\n**(Mark One)**\n\n​\n\n**☐**\n\n**REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n​\n\n**OR**\n\n​\n\n**☒**\n\n**ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n​\n\n**For the fiscal year ended****December 31****,****20****25****.**\n\n**OR**\n\n​\n\n**☐**\n\n**TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n​\n\n**OR**\n\n​\n\n**☐**\n\n**SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n​\n\nDate of event requiring this shell company report\n\n**For the transition period from to**\n\nCommission file number: 001-41666\n\n**CASI PHARMACEUTICALS, INC.**\n\n(Exact Name of Registrant as Specified in Its Charter)\n\n**N/A**\n\n(Translation of Registrant’s Name into English)\n\n**Cayman Islands**\n\n(Jurisdiction of Incorporation or Organization)\n\n**1701-1702, China Central Office Tower 1**\n\n**No. 81 Jianguo Road Chaoyang District**\n\n**Beijing****,****100025**\n\n**People’s Republic of China**\n\n(Address of Principal Executive Offices)\n\n**Larry Zhang**\n\n**601 Gateway Blvd****,****Suite 1250****,**\n\n**South San Francisco****,****California****,****94080****,****USA**\n\n******240****-****205-5475**\n\n**Email:****larryz****@casipharmaceuticals.com**\n\n(Name, Telephone, Email and/or Facsimile number and Address of Company Contact Person)\n\nSecurities registered or to be registered pursuant to Section 12(b) of the Act:\n\n**None**\n\n​\n\nSecurities registered or to be registered pursuant to Section 12(g) of the Act:\n\n**Ordinary shares, par value US$0.0001 per share**\n\n(Title of Class)\n\nSecurities for which there is a reporting obligation pursuant to Section 15(d) of the Act:\n\n**None**\n\n(Title of Class)\n\nIndicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report:\n\nAs of December 31, 2025, there were 20,555,873 ordinary shares outstanding, par value US$0.0001 per share.\n\nIndicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒ No\n\nIf this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. ☐ Yes ☒ No\n\n[Table of Contents](#TOC)\n\nNote - Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.\n\nIndicate 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 12 months (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\n\nIndicate 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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No\n\nIndicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.\n\n​\n\nLarge accelerated filer ☐\n\nAccelerated filer ☐\n\nNon-accelerated filer ☒\n\nEmerging growth company ☐\n\n​\n\nIf an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, 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 standards† provided pursuant to Section 13(a) of the Exchange Act. ☐\n\n†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.\n\nIndicate 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 financial reporting 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. ☐\n\nIf 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. ☐\n\nIndicate 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 officers during the relevant recovery period pursuant to §240.10D-1(b). ☐\n\nIndicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:\n\n​\n\nU.S. GAAP ☒\n\nInternational Financial Reporting Standards as issued\nby the International Accounting Standards Board ☐\n\nOther ☐\n\n​\n\nIf “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. ☐ Item 17 ☐ Item 18\n\nIf this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No\n\n(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)\n\nIndicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. ☐ Yes ☐ No\n\n​\n\n​\n\n​\n\n​\n\n[Table of Contents](#TOC)\n\n**TABLE OF CONTENTS**\n\n​\n\n[INTRODUCTION](#INTRODUCTION_82103)\n\n4\n\n[FORWARD-LOOKING STATEMENTS](#FORWARDLOOKINGSTATEMENTS_925056)\n\n5\n\n[PART I](#PARTI_674474)\n\n7\n\n[ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS](#ITEM1IDENTITYOFDIRECTORS_444423)\n\n7\n\n[ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE](#ITEM2OFFERSTATISTICS_38596)\n\n7\n\n[ITEM 3. KEY INFORMATION](#ITEM3KEYINFORMATION_817159)\n\n7\n\n[ITEM 4. INFORMATION ON THE COMPANY](#ITEM4INFORMATIONONTHE_548059)\n\n38\n\n[ITEM 4A. UNRESOLVED STAFF COMMENTS](#ITEM4AUNRESOLVEDSTAFF_84805)\n\n61\n\n[ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS](#ITEM5OPERATINGANDFINANCIAL_223166)\n\n61\n\n[ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES](#ITEM6DIRECTORSSENIOR_786537)\n\n75\n\n[ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS](#ITEM7MAJORSHAREHOLDERS_527728)\n\n86\n\n[ITEM 8. FINANCIAL INFORMATION](#ITEM8FINANCIALINFORMATION_999405)\n\n88\n\n[ITEM 9. THE OFFER AND LISTING](#ITEM9THEOFFERANDLISTING_71023)\n\n89\n\n[ITEM 10. ADDITIONAL INFORMATION](#ITEM10ADDITIONALINFORMATION_892988)\n\n90\n\n[ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](#ITEM11QUANTITATIVEANDQUALITATIVE_310685)\n\n105\n\n[ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES](#ITEM12DESCRIPTIONOFSECURITIES_979592)\n\n105\n\n[PART II.](#PARTII_261657)\n\n107\n\n[ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES](#ITEM13DEFAULTSDIVIDEND_250794)\n\n107\n\n[ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS](#ITEM14MATERIALMODIFICATION_138908)\n\n107\n\n[ITEM 15. CONTROLS AND PROCEDURES](#ITEM15CONTROLS_273058)\n\n107\n\n[ITEM 16. RESERVED](#ITEM16RES_789204)\n\n107\n\n[ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT](#ITEM16AAUDITCOMMITTEE_744472)\n\n107\n\n[ITEM 16B. CODE OF ETHICS](#ITEM16BCODEOF_276083)\n\n108\n\n[ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES](#ITEM16CPRINCIPALACCOUNTANT_419852)\n\n108\n\n[ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES](#ITEM16DEXEMPTIONSFROMTHE_256642)\n\n108\n\n[ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS](#ITEM16EPURCHASESOFEQUITYSECURITIES_15723)\n\n109\n\n[ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT](#ITEM16FCHANGEINREGISTRANTS_324715)\n\n109\n\n[ITEM 16G. CORPORATE GOVERNANCE](#ITEM16GCORPORATEG_729477)\n\n109\n\n[ITEM 16H. MINE SAFETY DISCLOSURE](#ITEM16HMINESAFETYDISCLOSURE_5273)\n\n109\n\n[ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS](#ITEM16IDISCLOSUREREGARDING_293593)\n\n109\n\n[ITEM 16J. INSIDER TRADING POLICIES](#ITEM16J_179943)\n\n109\n\n[ITEM 16K. CYBERSECURITY](#ITEM16K_915916)\n\n109\n\n[PART III.](#PARTIII_858672)\n\n111\n\n[ITEM 17. FINANCIAL STATEMENTS](#ITEM17FINANCIALST_957639)\n\n111\n\n[ITEM 18. FINANCIAL STATEMENTS](#ITEM18FINANCIALSTA_373216)\n\n111\n\n[ITEM 19. EXHIBITS](#ITEM19EXHIBITS_808782)\n\n111\n\n​\n\n​\n\n​\n\n​\n\n3\n\n[Table of Contents](#TOC)\n\n**INTRODUCTION**\n\nUnless otherwise indicated and except where the context otherwise requires, references in this annual report to:\n\n●“Acrotech” are to Acrotech Biopharma Inc., formerly known as Acrotech Biopharma L.L.C.;\n\n●“ANDA” are to abbreviated new drug application;\n\n●“CASI”, “us”, “our Company”, “the Company”, “our” and “we” are to (i) CASI Pharmaceuticals, Inc., an exempted company with limited liability incorporated under the laws of the Cayman Islands  (“CASI Cayman”) and its subsidiaries after the Redomicile Merger, and (ii) CASI Pharmaceuticals, Inc., a Delaware corporation (“CASI Delaware”) and its subsidiaries prior to the Redomicile Merger, in each case as appropriate based on the context;\n\n●“CASI China” are to CASI Pharmaceuticals (China) Co., Ltd.;\n\n●“CASI Wuxi” are to CASI Pharmaceuticals (Wuxi) Co., Ltd.;\n\n●“CASI Biopharmaceuticals” are to CASI Biopharmaceuticals (WUXI) Co., Ltd;\n\n●“CASI Hong Kong” are to CASI Pharmaceuticals Co., Limited;\n\n●“China” or the “PRC” are to the People’s Republic of China, excluding, for the purposes of this annual report only, Hong Kong, Macau and Taiwan;\n\n●“CDE” are to the China Center for Drug Evaluation;\n\n●“cGMP” are to current Good Manufacturing Practice;\n\n●“CTA” are to the Clinical Trial Application;\n\n●“Companies Act” are to the Companies Act (As Revised) of the Cayman Islands;\n\n●“EMA” are to the European Medicines Agency;\n\n●“FDA” are to the U.S. Food and Drug Administration;\n\n●“IND” are to the Investigational New Drug;\n\n●“IRB” are to institutional review board;\n\n●“Juventas” are to Juventas Cell Therapy Ltd.;\n\n●“NMPA” are to the PRC National Medical Products Administration;\n\n●“ordinary shares” are to our ordinary shares, par value US$0.0001 per share;\n\n●“PAT” are to Precision Autoimmune Therapeutics, a company established under the laws of China, in which the Company holds an equity investment;\n\n●“Redomicile Merger” are to a merger between CASI Delaware and CASI Cayman for the purpose of CASI Delaware’s re-domiciliation from the State of Delaware of U.S. to the Cayman Islands, where CASI Delaware merged with and into CASI Cayman with CASI Cayman becoming the surviving entity and the successor issuer;\n\n●“RMB” and “Renminbi” are to the legal currency of China;\n\n●“US$,” “U.S. dollars,” “$” and “dollars” are to the legal currency of the United States; and\n\n●“Wuxi LP” are to Wuxi Huicheng Yuanda Investment Partnership (Limited Partnership) (formerly known as Wuxi Jintou Huicun Investment Enterprise), a limited partnership organized under the laws of the People’s Republic of China.\n\n​\n\n4\n\n[Table of Contents](#TOC)\n\n**FORWARD-LOOKING STATEMENTS**\n\nThis annual report contains forward-looking statements that relate to our current expectations and views of future events. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements are made under the “safe harbor” provisions under Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act and of the U.S. Private Securities Litigations Reform Act of 1995.\n\nYou can identify some of these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “potential,” “continue” or other similar expressions. These forward-looking statements include, among others, statements regarding the timing of our commercial launch of products, clinical trials, our cash position and future expenses, and our future revenues. We have based these forward-looking statements largely on our current expectations and projections about future events that we believe may affect our financial condition, results of operations, business strategy and financial needs.\n\nActual results could differ materially from those currently anticipated due to a number of factors, including: uncertainties related to the going-private proposal made by Dr. Wei-Wu He; uncertainties related to the possibility that the transaction for the divestiture of certain assets in China (the “Transaction”) will not occur as planned if events arise that result in the termination of the Equity and Assets Transfer Agreement, or if one or more of the various closing conditions to the Transaction are not satisfied or waived; the possibility that our plan with respect to our business operations after the consummation of the Transaction can be implemented successfully; our recurring operating losses have raised substantial doubt regarding our ability to continue as a going concern; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. FDA, EMA, NMPA, or other regulatory authorities; our inability to receive approval for renewal of license of our existing products; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in pre-clinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to pre-clinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products and our dependence on third parties; the risks related to our dependence on Juventas to partner with us to co-market CNCT19; risks related to the uncertainty in connection with the ongoing arbitration proceedings between us and Juventas with respect to Juventas’ purported termination of certain CNCT19 license agreements; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; risks relating to interests of our largest shareholder and our Chairman that differ from our other shareholders; risks related to the success of a new manufacturing facility by CASI Wuxi; risks related to the inclusion-status of our drug products in the National Reimbursement Drug List; risks related to the resolution of the clinical hold placed by the FDA on our CID-103, anti-CD38 antibody, Investigational New Drug application for the treatment of AMR; and risks related to our disagreement with Acrotech with respect to the termination of agreements regarding EVOMELA®. Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition.\n\nYou should read this annual report and the documents that we refer to in this annual report and have filed as exhibits to this annual report completely and with the understanding that our actual future results may be materially different from what we expect. Other sections (including “Item 3. Key Information—D. Risk Factors”) of this annual report discuss factors which could adversely impact our business and financial performance. Moreover, we operate in an evolving environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. We undertake no obligation to publicly release the result of any revision of these forward-looking statements to reflect events or circumstances after the date they are made or to reflect the occurrence of unanticipated events. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission (“SEC”), which are available at www.sec.gov.\n\n5\n\n[Table of Contents](#TOC)\n\nYou should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this annual report relate only to events or information as of the date on which the statements are made in this annual report. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.\n\n​\n\n6\n\n[Table of Contents](#TOC)\n\n**PART I**"}