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康泰生物(300601.SZ):口服五價重配輪狀病毒減毒活疫苗(Vero細胞)開啓Ⅲ期臨牀試驗
格隆匯 04-09 15:49

格隆匯4月9日丨康泰生物(300601.SZ)公佈,公司和全資子公司北京民海生物科技有限公司(簡稱“民海生物”)研發的口服五價重配輪狀病毒減毒活疫苗(Vero細胞)已完成Ⅲ期臨牀試驗準備工作,開啓Ⅲ期臨牀試驗,並於近日成功完成首例受試者入組。

口服五價重配輪狀病毒減毒活疫苗(Vero細胞)適用於6周齡至32周齡嬰兒,用於預防感染輪狀病毒導致的嬰幼兒胃腸炎,該產品包含了國內輪狀病毒導致胃腸炎的主要病毒血清型(G1、G2、G3、G4和G9)。

輪狀病毒疫苗爲全球主要疫苗品種之一,分爲單價疫苗和多價疫苗。經查詢國家藥品監督管理局網站,目前國內已上市的有蘭州生物製品研究所有限責任公司的單價口服輪狀病毒活疫苗及口服三價重配輪狀病毒減毒活疫苗(Vero細胞)、MerckSharp&DohmeLLC的口服五價重配輪狀病毒減毒活疫苗(Vero細胞)。

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