兆科眼科-B中期报告 2023

(Incorporated in the British Virgin Islands with limited liabilityand continued in the Cayman Islands) (Stock Code: 6622) Contents目錄 1兆科眼科有限公司中期報告2023PageCorporation Information2Financial Summary6Chairman and CEO Statement8Management Discussion and AnalysisOverview15Business Review20Financial Review39Other Information53Independent Review Report74Consolidated Statement of Profit or Loss and Other Comprehensive Income76Consolidated Statement of Financial Position77Consolidated Statement of Changes in Equity79Condensed Consolidated Cash Flow Statement80Notes to the Unaudited Interim Financial Report82Definitions109 Corporate Information BOARD OF DIRECTORS Executive Directors Dr. Li Xiaoyi(Chairman and CEO)Mr. Dai Xiangrong Non-executive Directors Ms. Leelalertsuphakun WaneeMs. Tiantian ZhangMs. Cai LiMr. Chen Yu 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)Ms. Cai LiMr. Liew Fui Kiang 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 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 net loss for the period is definedas loss and total comprehensive income for the periodadjusted by adding back non-cash adjustment and ofequity-settled share-based payment expenses. Thefollowing table reconciles our Non-HKFRS adjusted netloss for the period with our loss. Chairman and CEO Statement Dear Shareholders, It is with great pleasure that we announce theinterim results for Zhaoke Ophthalmology Limited(“Zhaoke” or the “Company”), reporting ourprogress over the first six months of 2023. Theseresults demonstrate how significant this year willbe for Zhaoke as we continue our dual focus ofimplementing a comprehensive commercializationstrategy in parallel with advancing our late-stageclinical programs. 2023 11.32.33.6®NVK0025.4 During the first six months of this year, Zhaoker e c o r d e dm e a n i n g f u l s a l e s r e v e n u e f o r t h efirsttime,with a total of RMB11.3 million.Specifically, RMB2.3 million was derived throughthe commercialization of Bimataprost Timolo andRMB3.6 million was derived through®serieseye patches. These sales span both traditionalhospitalas well as new digital and physicalchannels, reflecting the potential for the Company’sfuture sales to benefit from a mix of offline andonline channels, and new ways to build brandawareness and service our customers. In addition,we recorded RMB5.4 million of upfront paymentfrom our first out-licensing deal for NVK002 inSouth Korea. III On the R&D side, we continued to solidify ourleadership with advancement of our late-stageprograms (Phase III or later) addressing significantmarket opportunities in major front- and back-of-the-eye diseases. Outlined below are some of thekey highlights of our progress: AGMP •Cyclosporine A (CsA) Ophthalmic Gelpassed on-site inspections and GMPreview As previously reported, the NDA submissionf o rC s A f o r t h e t r e a t m e n t o f D E D w a saccepted for review by the CDE on June 8,2022. In January this year, we announcedt h a ti t h a d p a s s e d t h e N M P A ’ s o n - s i t eregulatory and clinical trial inspections, and aGood Manufacturing Practice (“GMP”) reviewconducted by the Guangdong M