港股異動 | 創勝集團-B(6628.HK)高開6.73% 子公司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4月22日丨創勝集團-B(6628.HK)高開6.73%,報6.98港元,總市值31億港元。該公司昨日宣佈,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。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。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。

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