康寧傑瑞製藥-B(09966.HK)附屬已通過歐盟品質受權人現場檢查
格隆匯2月7日丨康寧傑瑞製藥-B(09966.HK)公佈,公司的全資附屬公司江蘇康寧傑瑞生物製藥有限公司(江蘇康寧傑瑞)於2020年2月3日已通過歐盟品質受權人(Qualified Person)的現場檢查。
公告顯示,本次現場檢查是為了準備KN035(集團發明的一種抗PD-L1重組人源化單域抗體)的全球臨牀試驗穩定供藥和後續商業化生產。歐盟品質受權人主要針對江蘇康寧傑瑞位於蘇州工業園區生物醫藥生產基地的品質管制體系及生產現場的設備設施進行全面、嚴格、系統的檢查。檢查範圍包括位於蘇州工業園區生物納米園內的生產車間、倉庫及相關支持體系,以及位於蘇州工業園區方洲路175號新建的倉庫和品質控制實驗室。
據悉,該生產基地此前已順利通過中國江蘇省藥品監督管理局的現場檢查,並獲頒《藥品生產許可證》。此次順利通過歐盟品質受權人的現場檢查標誌着江蘇康寧傑瑞的生產、倉儲及相關支持體系和品質管制體系進一步完善,生產能力進一步擴大,為全球臨牀試驗穩定供藥和後續商業化生產打下了堅實的基礎。
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