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創勝集團-B(06628.HK):奕安濟世已順利通過TST001生產的歐盟質量受權人審計
格隆匯 04-21 17:46

格隆匯4月21日丨創勝集團-B(06628.HK)宣佈,公司全資附屬公司杭州奕安濟世生物藥業有限公司("奕安濟世")已於2022年4月13日順利通過歐盟質量受權人審計,QP認證聲明已於2022年4月21日簽發。

TST001為全球正在開發的針對Claudin18.2的最先進的抗體療法之一,該審計是TST001一個包括歐盟地區在內的全球三期臨牀試驗申請準備工作中重要的一部份,以及未來TST001的全球商業化。一位經驗豐富的QP審計官參考EudraLexVolume4(歐盟GMP)法規及ICH指引,對質量保證體系、生產及物流管理、設備及廠房設施、QC實驗室、包裝及貼標進行了全面、系統且深入的審查。由於受到新冠疫情影響,此次歐盟QP審計以遠程視頻的方式進行。

此次審計概無任何關鍵或重大缺陷,且QP高度認可公司健全而成熟的質量管理體系(以確保該體系符合GMP要求)、程序及記錄的質量以及全面的風險評估及緩解措施。

執行副總裁兼首席運營官葉峯博士表示:"通過歐盟QP審計是歐盟申報的關鍵,這表明我們創勝集團完全有能力生產和交付符合歐盟GMP(藥品生產質量管理規範)相關規定的產品,有資質提供歐洲臨牀試驗的樣品。這對於我們快速推進TST001的全球臨牀戰略至關重要。"

公司全資附屬公司奕安濟世於2018年獲得藥品生產許可證,具備商業化生產能力,且同時符合中、美、歐GMP要求。截至2022年第一季度,該GMP生產基地已經運營4年,承接內外部項目的五十餘批GMP批次生產,成功率100%。

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