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兆科眼科-B(06622.HK):環孢素A眼凝膠通過國家藥監局的藥品註冊及臨牀試驗現場核查以及廣東省藥品監督管理局的GMP符合性檢查
格隆匯 01-31 06:26

格隆匯1月31日丨兆科眼科-B(06622.HK)發佈公吿,環孢素A眼凝膠(公司主要候選藥物之一)已通過國家藥監局的藥品註冊及臨牀試驗現場核查。有關核查核實環孢素A研究及開發過程以及第III期臨牀試驗中的原始記錄及資料。第III期臨牀試驗乃迄今就中至嚴重程度乾眼症在中國進行的最大型臨牀試驗。

公司亦通過廣東省藥品監督管理局的生產質量管制規範(“GMP”)審查,確認公司已就環孢素A落實GMP管理框架、核心團隊、全面的分析儀器、設備及設施、管理完善的存檔系統以及妥善運作的生產及質量系統。

通過上述全部三項核查標誌着公司為環孢素A眼凝膠取得最終監管審批及商業化的重要里程碑。此外,核查結果理想亦證明公司的研發及臨牀開發能力以及質量管理系統實力強勁。

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