兆科眼科-B中期报告 2025

Contents目錄 Financial Summary Chairman and CEO Statement Other Information Independent Review Report Consolidated Statement of Profit or Loss Consolidated Statement of Financial Position Consolidated Statement of Changes in Equity Condensed Consolidated Cash Flow Statement Notes to the Unaudited Interim Financial Report Definitions Corporate Information BOARD OF DIRECTORS Executive Directors Dr. Li Xiaoyi(Chairman 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 202571 Mr. Wong Hin Wing(Chairman)Prof. Lo Yuk LamMs. Tiantian Zhang (appointed on July 1, 2025) 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 1513 King & Wood Mallesons13/F, Gloucester TowerThe Landmark15 Queen’s Road CentralCentralHong Kong AUDITOR 108 KPMGCertified Public Accountants and Public InterestEntity Auditor registered in accordance with theAccounting and Financial Reporting CouncilOrdinance8th 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 PRINCIPAL PLACE OF BUSINESSIN HONG KONG Unit 716, 7/F, Building 12WPhase 3, Hong Kong Science ParkShatin, Hong Kong 312W7716 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 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 WEBSITE zkoph.com Note: (1) (1)NON-HKFRS ACCOUNTING STANDARDS MEASURES Non-HKFRS Accounting Standards adjusted loss for theperiod is defined as loss for the period adjusted by addingback equity-settled share-based payment expenses. Thefollowing table reconciles our non-HKFRS AccountingStandards adjusted loss for the period with our loss forthe period. Chairman and CEO Statement Dear Shareholders, It is with great pride and optimism that I share ourperformance for the first half of 2025, the mostfruitful period since our listing on the Hong KongStock Exchange. This achievement reflects thehard work and dedication of our entire team, aswell as the enduring trust and support of you, ourshareholders. 2025 2025 We made remarkable progress across multipledimensions of our business, further strengtheningour leadership in ophthalmic drug development.Withthe global capital environment steadilyimproving in the first six months of 2025, we areseeing clear validation of our strategic prioritiesand growth trajectory. O u rR & D p r o g r a m s c o n t i n u e t o d e l i v e rtransformationalresults.We reached criticalmilestones in advancing our pipeline, with threecoredrug candidates now at the New DrugApplication (“NDA”) stage; a testament to ourunwavering commitment to innovation and patientimpact: •Atropine Sulphate Eye Drops (NVK002)for myopia progression control: •(NVK002) o202510.01% oIn January 2025, the 0.01% dosageA b b r e v i a t e dN e w D r u g A p p l i c a t i o n(“ANDA”)was accepted for reviewb yt h e N a t i o n a l M e d i c a l P r o d u c t sAdministration of China (“NMPA”). o202570.02% oIn July 2025, the NDA for the 0.02%dosage was also accepted, marking amajor regulatory breakthrough. • •Cyclosporine A (“CsA”) Ophthalmic Gelfor moderate to severe dry eye disease: o20255 oThe re-NDA was accepted by the NMPAin May 2025 following extensive R&Defforts. •B e v a c i z u m a bI n t r a v i t r e a l I n j e c t i o n(TAB014)for wet age-related maculardegeneration (“wAMD”): •wAMD(TAB014) o20256wAMD oO u rB i o l o g i c a l L i c e n s e A p p l i c a t i o n(“BLA”) was accepted by the NMPA inJune 2025 – a landmark developmentgiven wAMD’s status as a leading causeof vision loss in older adults. 4IIIBRIMOCHOL™ PFII In April, we also successfully recruited the firstpatient for the additional Phase III clinical trial ofCsA Ophthalmic Gel, as well as for the Phase IIclinical trial of BRIMOCHOL™ PF in China. PAN-90806PA