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康泰生物(300601.SZ):CDE啟動凍幹人用狂犬病疫苗(人二倍體細胞)註冊現場核查
格隆匯 01-23 17:47

格隆匯1月23日丨康泰生物(300601.SZ)公佈,公司全資子公司北京民海生物科技有限公司(簡稱“民海生物”)近日收到國家藥監局藥品審評中心(簡稱“藥審中心”)出具的《藥審中心關於啟動凍幹人用狂犬病疫苗(人二倍體細胞)註冊現場核查的通知》,根據《藥品註冊管理辦法》有關規定,藥審中心需對民海生物申報註冊的凍幹人用狂犬病疫苗(人二倍體細胞)(受理號:CXSS2101046)啟動藥品註冊核查(藥學)。

凍幹人用狂犬病疫苗(人二倍體細胞)用於預防狂犬病。狂犬病是由狂犬病毒引起的一種人獸共患的急性傳染病,臨牀表現為特有的恐水、怕風、嚥肌痙攣、進行性癱瘓等,一旦有症狀出現,病死率接近100%。接種狂犬病疫苗是控制和預防狂犬病的有效方式。

民海生物研發的凍幹人用狂犬病疫苗(人二倍體細胞)採用人二倍體細胞製備,臨牀結果表明具有良好的安全性、免疫原性和免疫持久性。國內對狂犬病疫苗的需求量較大,該疫苗市場前景良好。

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