兆科眼科-B2024 年报

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 Report of Directors74董事會報告 Consolidated Statement of Profit or Loss andOther Comprehensive Income118綜合損益及其他全面收益表 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 ZhangMr. Chen Yu(resigned on April 8, 2024) 202448 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 Lam EXECUTIVE COMMITTEE Dr. Li Xiaoyi(Chairman)Mr. Dai XiangrongDr. Lau Lit Fui(CSO)Dr. Albert Tsai Jr.(CMO) COMPANY SECRETARY Ms. Yau Suk Yan(fellow of The Hong Kong Institute ofCertified Public Accountants) AUDITOR KPMGCertified Public AccountantsPublic Interest Entity Auditor registered in accordance withthe Accounting and Financial Reporting Council Ordinance8th Floor, Prince’s Building10 Chater RoadCentralHong Kong 108 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 Kirkland & Ellis26/F, Gloucester TowerThe Landmark15 Queen’s Road CentralCentral, Hong Kong 1526 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 Computershare Hong Kong Investor Services LimitedShops 1712–171617th Floor, Hopewell Center183 Queen’s Road EastWanchaiHong Kong 183171712–1716 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, I am pleased to present Zhaoke Ophthalmology’ s full-year results for2024. Throughout the year we remained steadfast in our commitmentto our mission, achieving substantial progress in our core areas offocus. Critically, we have seen significant advancements in the clinicaldevelopment of our three flagship innovative drug assets – NVK002,Cyclosporine A (“CsA”) Ophthalmic Gel, and TAB014 – all of which are nowundergoing regulatory process. In addition, our commercialization effortshave reached key milestones, strengthening our position in the ophthalmicdrug market. 2024NVK002ATAB014 2024NVK0022025NVK002IIIChina CHAMP20248202410 As a dedicated ophthalmic drug developer, Zhaoke Ophthalmology isfocused on improving visual health both in China and globally. In 2024, wesubmitted an Abbreviated New Drug Application (“ANDA”) for NVK002,a low-dose atropine eye drop designed to control myopia progression inchildren and adolescents. We are pleased to share that, at the beginningof 2025, the National Medical Products Administration (“NMPA”) acceptedour ANDA for review. Additionally, our two-year Phase III clinical trial ofNVK002 (“China CHAMP”), completed the last-patient-last-visit in August2024, with positive topline results announced in October 2024. We lookforward to continuing our leadership in the market as the second marketplayer to develop a high-quality atropine drug for children suffering frommyopia in China. Chairman and CEO Statement A20248IIIIIIA In parallel, our self-developed treatment for dry eye disease, CsAOphthalmic Gel, received regulatory approval from the NMPA in August2024 to proceed with a Phase III clinical trial, based on the recentlyupdated Technical Guidelines for Clinical Trials for Dry Eyes. We arealso preparing to resubmit the New Drug Application (“NDA”) for CsAOphthalmic Gel. Furthermore, we are pleased to report that TAB014, our treatment for wet(neovascular) age-related macular degeneration (“wAMD”), successfullycompleted its Phase III clinical trial in September 2024. The trial metall primary and key secondary endpoints, and we are now preparing tosubmit a Biologics License Application (“BLA”) for TAB014. TAB014wAMDIII20249TAB014 In addition to these flagship achievements, we have made notableprogress with other promising drug assets. In January 2024, we receivedInvestigational New Drug (“IND”) approval for BRIMOCHOL™ PF andCARBACHOL™ PF, our innovative presbyopia trea