李氏大藥廠(00950.HK)附屬已完成TAB014第I期臨牀測試
格隆匯1月13日丨李氏大藥廠(00950.HK)公告，公司的間接非全資附屬公司China Ophthalmology Focus Limited已完成TAB014的第I期臨牀測試，此研究的最後一名患者於2019年12月2日招募。
TAB014臨牀第I期研究的目的是評估其對罹患原發性或複發性脈絡膜新生血管(CNV)繼發性病變濕性老年性黃斑部病變(wAMD)的患者的安全性及藥物代謝動力學概況。目前正在進行臨牀數據收集和分析，而第III期臨牀前研究的申請將提交予中國國家藥品監督管理局藥品審評中心(CDE)。於向CDE諮詢後，COPFL計劃啟動TAB014治療wAMD的第III期臨牀研究項目。
TAB014是一種單克隆抗體產品，可用於治療濕性老年性黃斑部病變(wAMD)、視網膜靜脈阻塞(RVO)、脈絡膜新生血管(CNV)以及其他眼部疾病。東曜藥業有限公司於2017年1月向COPFL的全資附屬公司，兆科(廣州)眼科藥物有限公司授予其在中國獨家開發和商業化權利。
COPFL是本公司的間接非全資附屬公司。其A輪融資已於2019年6月完成集資五千萬美元，出資人包括着名投資者Coyot InvestmentPte.Ltd.、Panacea Venture Healthcare FundI,L.P.、Smart RocketLtd.及Vertex Profit InternationalLtd.。COPFL專門從事眼科藥物的開發、製造及營銷。通過其全資附屬公司兆科(廣州)眼科藥物有限公司在廣州南沙建設最先進的開發及生產設施。該設施能夠內部開發及日後商品化21種以上專利產品以及高端仿製藥(從臨牀前到註冊階段不等)，行銷中國和東盟市場。其產品組合多樣化，既包括小分子及生物製劑，也包括新藥及仿製藥，涵蓋從乾眼症候羣、青光眼、濕性老年性黃斑部病變、糖尿病性視網膜病到角膜炎症性疾病的各種眼科適應症。它是中國目前唯一根據所有適用的GMP標準(即中國國家藥品監督管理局、藥品檢查合作計劃(PIC/S)、歐洲藥品評價局(EMEA)、日本醫藥食品局及美國食品藥品監督管理局(FDA))設計及興建的眼科藥物現代化設施。
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