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康泰生物(300601.SZ):水痘減毒活疫苗申請生產註冊獲得受理
格隆匯 09-14 20:57

格隆匯9月14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(“民海生物”)研發的水痘減毒活疫苗申請生產註冊獲得國家藥品監督管理局出具的《受理通知書》,受理號:CXSS2200078國。

水痘減毒活疫苗系用水痘-帶狀皰疹病毒接種於人二倍體細胞,經培養,收穫病毒液,加入適宜穩定劑凍乾製成。該疫苗適用於12月齡以上健康水痘易感人羣,接種後可刺激機體產生抗水痘-帶狀皰疹病毒的免疫力,用於預防水痘。水痘以呼吸道飛沫和接觸傳播為主,傳染率高,接種水痘疫苗是預防水痘感染的最有效手段,也是非免疫規劃疫苗中接種率最高的疫苗之一。

目前國內已上市水痘減毒活疫苗的廠家包括長春百克生物科技股份公司、上海生物製品研究所有限責任公司、長春祈健生物製品有限公司、科興(大連)疫苗技術有限公司和上海榮盛生物藥業有限公司。臨牀研究表明該產品具有良好的安全性、免疫原性和免疫持久性。

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