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康希諾生物-B(06185.HK):四價腦膜炎球菌結合疫苗新藥註冊申請獲受理
格隆匯 11-22 12:07

格隆匯11月22日丨康希諾生物-B(06185.HK)宣佈,中國國家藥監局已於2019年11月22日受理公司為其A羣、C羣、Y羣和W135羣腦膜炎球菌結合疫苗(“MCV4”)的新藥註冊申請。這是繼Ad5-EBOV(一種5型腺病毒載體埃博拉病毒病疫苗)及MCV2(A羣及C羣MCV,用於預防感染腦膜炎奈瑟球菌(Lta)的疫苗)後,公司獲得國家藥監局受理的第三款新藥註冊申請,併為MCV4在中國首次獲受理的新藥註冊申請。

公司的在研MCV4為中國預防腦膜炎的潛在首創疫苗,具備安全性及良好的耐受性,在三個月至六歲的年齡組中顯示出良好的免疫原性。

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