兆科眼科-B2025 年报

CONTENTS Corporation Information2公司資料Chairman and CEO Statement5主席兼行政總裁報告Operation Highlights8營運摘要Management Discussion and Analysis9管理層討論及分析Profiles of Directors and Senior Management36董事及高級管理層履歷Corporate Governance Report46企業管治報告Report of Directors73董事會報告Independent Auditor’s Report105獨立核數師報告Consolidated Statement of Profit or Loss114綜合損益表Consolidated Statement of Profit or Loss andOther Comprehensive Income115綜合損益及其他全面收益表Consolidated Statement of Financial Position116綜合財務狀況表Consolidated Statement of Changes in Equity117綜合權益變動表Consolidated Statement of Cash Flows118綜合現金流量表Notes to the Financial Statements120財務報表附註Definitions213釋義 Corporate Information BOARD OF DIRECTORS Executive Directors Dr. Li Xiaoyi(Chairman of the Board and CEO)Mr. Dai Xiangrong Non-executive Directors Ms. Leelalertsuphakun WaneeMs. Tiantian Zhang Independent Non-executive Directors Mr. Wong Hin WingProf. Lo Yuk LamMr. Liew Fui Kiang AUTHORIZED REPRESENTATIVES Dr. Li XiaoyiMs. Yau Suk Yan AUDIT COMMITTEE Mr. Wong Hin Wing(Chairman)Mr. Liew Fui KiangMs. Tiantian Zhang REMUNERATION COMMITTEE Prof. Lo Yuk Lam(Chairman)Ms. Tiantian ZhangMr. Wong Hin Wing NOMINATION COMMITTEE Dr. Li Xiaoyi(Chairman)Mr. Wong Hin WingProf. Lo Yuk Lam INVESTMENT COMMITTEE Mr. Wong Hin Wing(Chairman)Dr. Li XiaoyiProf. Lo Yuk LamMs. Tiantian Zhang (appointed on August 28, 2025) 2025828 EXECUTIVE COMMITTEE Dr. Li Xiaoyi(Chairman)Mr. Dai XiangrongDr. Lau Lit Fui(CSO) COMPANY SECRETARY Ms. Yau Suk Yan(fellow of The Hong Kong Institute ofCertified Public Accountants) AUDITOR 108 KPMGCertified Public AccountantsPublic Interest Entity Auditor registered in accordance withthe Accounting and Financial Reporting Council Ordinance8th Floor, Prince’s Building10 Chater RoadCentralHong Kong REGISTERED OFFICE Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands PRINCIPAL PLACE OF BUSINESSIN THE PRC 1 No. 1 Meide 3rd RoadPearl River Industrial ParkNansha DistrictGuangzhouGuangdong ProvincePRC Corporate Information HONG KONG LEGAL ADVISOR 1513 King & Wood13/F, Gloucester TowerThe Landmark15 Queen’s Road CentralCentralHong Kong PRINCIPAL PLACE OF BUSINESS INHONG KONG 312W7716 Unit 716, 7/F, Building 12WPhase 3, Hong Kong Science ParkShatin, Hong Kong PRINCIPAL SHARE REGISTRAR ANDTRANSFER OFFICE Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands HONG KONG SHARE REGISTRAR 183171712–1716 Computershare Hong Kong Investor Services LimitedShops 1712–171617th Floor, Hopewell Center183 Queen’s Road EastWanchaiHong Kong STOCK CODE 6622 6622 zkoph.com COMPANY’S WEBSITE zkoph.com Chairman and CEO Statement Dr. Li Xiaoyi李小羿博士 Chairman of the Board and CEO董事會主席兼行政總裁 Dear Shareholders, 2025 was defined by disciplined execution and measurable advancementacrossour business.We progressed multiple late-stage assets,strengthened our regulatory position across key markets, and continuedbuilding the commercial infrastructure required to support long-termgrowth. 2025 Importantly, this progress was not isolated to one program. It was broad-based across our portfolio. PIPELINE EXECUTION All three of our flagship assets reached meaningful regulatory milestonesin China: •(NVK002) •Atropine Sulphate Eye Drops (NVK002) The ANDA of the 0.01% formulation was accepted for review by theNMPA in January 2025, followed by NDA acceptance for the 0.02%dosage in July. Together, these filings position us strongly in therapidly expanding pediatric myopia management market. 0.01%202510.02%7 Chairman and CEO Statement •Cyclosporine A (CsA) Ophthalmic Gel • 20255 The re-submitted NDA was accepted in May 2025, advancing ourfirst wholly self-developed innovative drug toward commercializationin moderate to severe dry eye disease. •Bevacizumab Intravitreal Injection (TAB014) •(TAB014) (wAMD)20256 The BLA submission for wet age-related macular degeneration(wAMD) was accepted in June 2025, marking a significant step inthe development of our biologics platform. In parallel, we have made important strides with our innovative assets.Our partner received FDA approval for the presbyopia drug BRIMOCHOL™PF in January 2026, and we have finished patient recruitment for thePhase II trial in China, with full data expected in the first quarter of 2026.Additionally, our PAN-90806 for wAMD received IND approval from theNMPA in November 2025, showcasing the strength of our mid-stagepipeline. BRIMOCHOL™PF20261FDAII2026wAMDPAN-90806202511 EXPANDING BEYOND CHINA Our regulatory and development momentum extended internationally. In the United States, we received FDA clearance to initiate a Phase III trialfor CsA Ophthalmic Gel and were granted Orphan Drug Designation for ourproprietary melphalan formulation targeting pediat