Belite Bio Inc ADR 2026年年度报告和过渡报告

TABLE OF CONTENTS PARTI ITEM1.Identity of Directors, Senior Management and Advisers7ITEM2.Offer Statistics and Expected Timetable7ITEM3.Key Information7ITEM4.Information On the Company75ITEM4A.Unresolved Staff Comments137ITEM5.Operating And Financial Review and Prospects137ITEM6.Directors, Senior Management and Employees151ITEM7.Major Shareholders and Related Party Transactions163ITEM8.Financial Information165ITEM9.The Offer and Listing166ITEM10.Additional Information167ITEM11.Quantitative And Qualitative Disclosures About Market Risk182ITEM12.Description Of Securities Other Than Equity Securities182PARTIIITEM13.Defaults, Dividend Arrearages and Delinquencies186ITEM14.Material Modifications to The Rights of Security Holders and Use of Proceeds186ITEM15.Controls And Procedures186ITEM16A.Audit Committee Financial Expert188ITEM16B.Code of Ethics188ITEM16C.Principal Accountant Fees and Services188ITEM16D.Exemptions from the Listing Standards for Audit Committees188ITEM16E.Purchases of Equity Securities by the Issuer and Affiliated Purchasers188ITEM16F.Change in Registrant’s Certifying Accountant189ITEM16G.Corporate Governance190ITEM16H.Mine Safety Disclosure190ITEM16I.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections190ITEM 16J.Insider Trading Policy191ITEM16K.Cybersecurity192PartIII ITEM17.Financial StatementsITEM18.Financial StatementsITEM19.Exhibits ABOUT THIS ANNUAL REPORT Unless otherwise indicated or the context otherwise requires, references in this annual report on Form20-F (the “AnnualReport”) to: ●“ADRs” are to the American depositary receipts that may evidence the ADSs;●“ADSs” are to our American depositary shares, each of which represents one of our ordinary share;●“AUD” are to the legal currency of Australia;●“Belite,” “we,” “us,” “our company,” “Company,” and “our” are to Belite Bio, Inc, a Cayman Islands exemptedcompany with limited liability and its subsidiaries;●“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;●“CHF” are to the legal currency of Switzerland;●“Exchange Act” are to the United States Securities Exchange Act of 1934, as amended;●“EMA” are to European Medicines Agency;●“FDA” are to U.S. Food and Drug Administration;●“HK$” are to the legal currency of Hong Kong;●“IND” are to Investigational New Drug Application;●“JPY” are to the legal currency of Japan;●“Latest Practicable Date” are to February28, 2026;●“PMDA” are to Pharmaceuticals and Medical Devices Agency;●“SEC” are to the United States Securities and Exchange Commission;●“NMPA” are to National Medical Products Administration;●“NTD” are to the legal currency of Taiwan;●“RMB” are to the legal currency of the PRC;●“Securities Act” are to the Securities Act of 1933, as amended;●“shares” or “ordinary shares” are to our ordinary shares, par value US$0.0001 per share;●“TGA” are to Therapeutic Goods Administration of Australia;●“US$,” “U.S. dollars,” “$,” and “dollars” are to the legal currency of the United States; and●“U.S. GAAP” are to the generally accepted accounting principles of the United States. Unless otherwise stated, all of our financial information presented in this Annual Report has been prepared in accordancewith U.S. GAAP. Any discrepancies in any table between totals and sums of the amounts listed are due to rounding. Unlessotherwise indicated, or the context otherwise requires, references in this Annual Report to financial and operational data for aparticularyear refer to the fiscalyear of our company ended December31 of thatyear. Our reporting currency is the U.S. dollar. The functional currency of the Company’s subsidiaries located in the UnitedStates, Hong Kong and Switzerland is U.S. dollars. The functional currency of the Company’s subsidiary located in Australiais AUD, the functional currency of the Company’s subsidiary located in China is RMB, the functional currency of theCompany’s subsidiary located in Taiwan is NTD, and the functional currency of the Company’s subsidiary located in Japan isJPY. TRADEMARKS, SERVICE MARKS AND TRADE NAMES The “Belite Bio” and “倍亮生物” names and logos are our trademarks, trade names and service marks. The othertrademarks, trade names and service marks appearing in this Annual Report are the property of their respective owners. Wedo not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsementor sponsorship of us by, any other companies. Solely for convenience, the trademarks, service marks, logos, copyrights and trade names referred to in this AnnualReport are without the ® and ™ symbols. Such references are not intended to indicate, in any way, that we will not assert, tothe fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks,logos, copyrights and trade names or that the applicable owner will not assert its rights to these tradem