兆科眼科-B2023 年报

2023 ANNUAL REPORT年報 CONTENTS Chairman and CEO Statement5主席兼行政總裁報告 Operation Highlights10營運摘要 Management Discussion and Analysis11管理層討論及分析 Report of Directors76董事會報告 Independent Auditor’s Report109獨立核數師報告 Consolidated Statement of Profit or Loss andOther Comprehensive Income119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 ZhangMs. Cai Li(resigned on November 27, 2023)Mr. Chen Yu(resigned on April 8, 2024) 20231127202448 Independent Non-executive Directors Mr. Wong Hin WingProf. Lo Yuk LamMr. Liew Fui Kiang AUTHORIZED REPRESENTATIVES Dr. Li XiaoyiMs. Yau Suk Yan AUDIT COMMITTEE 2023112720231127 Mr. Wong Hin Wing(Chairman)Ms. Cai Li(resigned on November 27, 2023)Mr. Liew Fui KiangMs. Tiantian Zhang(appointed on November 27, 2023) 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)Ms. Feng Xinyan(CBO & CFO)Dr. Albert Tsai Jr.(CMO) 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 1526 Kirkland & Ellis26/F, Gloucester TowerThe Landmark15 Queen’s Road CentralCentral, Hong 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 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 I am pleased to announce Zhaoke Ophthalmology’s results for the full year2023. As with all businesses, these results were achieved in a challengingmacroeconomic and geopolitical environment. Despite this externalcontext, at Zhaoke Ophthalmology we have remained diligently committedto our mission and successfully achieved numerous milestones across ourfocus areas. 2023 In 2023 we began our commercialization journey and established solidgroundwork for the future launch of our blockbuster products. Withsignificant opportunities still on the table for eye disease treatments, we’repoised to capitalize on the insights gained from our early commercialefforts. Our focus is to amplify our commercial capabilities across thewhole spectrum of channels, ensuring we’re at the forefront of the market. 2023 Turning to our R&D programs, we further refined our priorities and madesolid progress with our core assets. We achieved exciting results from ourlow-dose atropine clinical trial and strengthened our position in the low-dose atropine race in China. We also finished patient enrolment for ourTAB014 Phase III trial and completed ANDA submissions for almost allof our glaucoma franchise as well as for Epinastine. At the same time,our global partners continued advancing their own clinical programs,with Vyluma, Inc.’s atropine program under FDA NDA review and VisusTherapeutics, Inc. announcing positive results from the first Phase IIIstudy of its presbyopia product. TAB014IIIVyluma, Inc.FDAVisusTherapeutics, Inc.III Chairman and CEO Statement In addition to these accomplishments, it would be remiss of me not torecord the hurdle we encountered in the NDA process for CsA OphthalmicGel. Following a series of productive consultations, the regulatoryauthorities requested we provide additional supporting information. Giventhe strict timetable of the NDA process, and after prudent consideration,we decided to voluntarily withdraw our application and will resubmitthe NDA once this supplementary documentation is complete to oursatisfaction. A While inevitably disappointing, this experience has sharpened our abilitiesin this critical area. The Chinese ophthalmology space has seen few NDAapplications for inn