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康泰生物(300601.SZ):乙肝疫苗獲得藥品補充申請批件
格隆匯 06-24 11:56

格隆匯6月24日丨康泰生物(300601.SZ)宣佈,公司近日收到國家藥品監督管理局簽發的《藥品補充申請批件》,公司的重組乙型肝炎疫苗(釀酒酵母)(包括10μg/0.5ml/支、20μg/1.0ml/支、60μg/1.0ml/支三種規格)生產場地變更已獲批准,由“深圳市南山區科技工業園科發路6號”變更至“深圳市光明區馬田街道薯田埔路18號”。

重組乙型肝炎疫苗(釀酒酵母)(下稱“乙肝疫苗”)是用於預防乙型肝炎病毒引起感染的疫苗,公司生產的乙肝疫苗包括10μg/0.5ml/支、20μg/1.0ml/支、60μg/1.0ml/支三種規格,涵蓋了國內上市乙肝疫苗的全部規格,其中公司是國內唯一生產60μg/1.0ml/支規格乙肝疫苗的企業。

公司表示,此次獲得乙肝疫苗的藥品補充申請批件,標誌着公司已成功完成乙肝疫苗生產場地的變更,光明疫苗研發生產基地的生產車間可正式用於乙肝疫苗的生產。公司具有充足的乙肝疫苗生產能力,可持續穩定的向市場提供符合註冊質量標準的疫苗。

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