兆科眼科-B中期报告 2024

Contents目錄 Financial Summary Chairman and CEO Statement8 Management Discussion and Analysis Overview13 Financial Review Other Information Independent Review Report Consolidated Statement of Profit or Loss and Other Comprehensive Income74 Consolidated Statement of Financial Position75 Consolidated Statement of Changes in Equity77 Condensed Consolidated Cash Flow Statement78 Notes to the Unaudited Interim Financial Report80 Definitions Corporate Information BOARD OF DIRECTORS Executive Directors Dr. Li Xiaoyi(Chairman and CEO)Mr. Dai Xiangrong Non-executive Directors Ms. Leelalertsuphakun WaneeMs. Tiantian ZhangMr. Chen Yu(Note) 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 202448202448 Note:Mr. Chen Yu resigned as a non-executive Director onApril 8, 2024. Please refer to the announcement of theCompany in respect of the resignation of non-executiveDirector dated April 8, 2024 for details. 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 Instituteof Certified Public Accountants) HONG KONG LEGAL ADVISER 1526 Kirkland & Ellis26/F, Gloucester TowerThe Landmark15 Queen’s Road CentralCentralHong Kong AUDITOR KPMGCertified Public Accountants and Public InterestEntity Auditor registered in accordance with theAccounting and Financial Reporting CouncilOrdinance8th 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 PRINCIPAL PLACE OF BUSINESSIN HONG KONG 312W7716 Unit 716, 7/F, Building 12WPhase 3, Hong Kong Science ParkShatin, Hong Kong PRINCIPAL SHARE REGISTRARAND TRANSFER 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 COMPANY WEBSITE zkoph.com zkoph.com (1) (1)NON-HKFRS MEASURES Non-HKFRS adjusted loss for the period is defined as lossfor the period adjusted by adding back equity-settledshare-based payment expenses. The following tablereconciles our non-HKFRS adjusted loss for the periodwith our loss for the period. Chairman and CEO Statement Dear Shareholders, I am pleased to announce Zhaoke Ophthalmology’sinterim results for the first six months of 2024.D e s p i t ea c h a l l e n g i n g m a c r o e c o n o m i c a n dgeopolitical environment, I am encouraged by thesolid progress the Company has made in both R&Dand commercial activities across multiple markets. 2024 At Zhaoke Ophthalmology, we are dedicated toresearching, developing and commercializing acomprehensive drug portfolio of both innovativeand generic assets for front- and back-of-the-eye diseases. Earlier this year, we submittedan Abbreviated New Drug Application (ANDA)for our flagship candidate NVK002, a low-doseatropine eye drop for myopia progression controlin children and adolescents. We are encouragedby the progress this is making, and are currentlypreparing the supplementary information requiredfor the formal acceptance of our ANDA. In addition,our two-year Phase III clinical trial of NVK002, orChina CHAMP, completed the last-patient-last-visitin August 2024. NVK002NVK002IIIChina CHAMP20248 We continue to be well positioned to be second tomarket, and thereby to significantly improve thequality of life for the millions of children in Chinasuffering from myopia. AIIIIIICOSMO We also made steady progress with our self-developed innovative drug for dry eye disease(DED),CsA Ophthalmic Gel.Having obtainedregulatory approval for an Investigational New Drug(IND) application, we will shortly begin a new PhaseIII trial. Meanwhile, we are conducting further datamining and post-hoc analysis on the previouslycompleted Phase III clinical trial, or COSMO, andwe plan to apply for a pre-NDA discussion with theCenter for Drug Evaluation (CED) of the NationalMedical Products Administration (NMPA) regardingthe post-hoc analysis data, and to resubmit ourNDA in the near future. NVK002ABRIMOCHOL PFCARBACHOL PFIII20241 In