成大生物(688739.SH):ACYW135羣腦膜炎球菌多糖結合疫苗臨牀試驗申請獲受理
格隆匯3月16日丨成大生物(688739.SH)公佈,公司於近日收到國家藥監局核准簽發的受理通知書,ACYW135羣腦膜炎球菌多糖結合疫苗臨牀試驗申請獲得受理。自受理之日起60日內,未收到藥審中心否定或質疑意見的,公司可以按照提交的方案開展臨牀試驗。
公司本次申報的ACYW135羣腦膜炎球菌多糖結合疫苗,是在已獲得臨牀批件的A羣C羣腦膜炎球菌多糖結合疫苗基礎上進行研究開發的。本疫苗可以使機體產生記憶性免疫應答,用於預防A羣、C羣、Y羣、W135羣腦膜炎奈瑟球菌引起的流行性腦脊髓膜炎。本次獲得ACYW135羣腦膜炎球菌多糖結合疫苗的臨牀試驗受理通知書,表明公司在多價流腦結合疫苗領域的研發取得新進展。
流行性腦脊髓膜炎是由腦膜炎奈瑟球菌引起的急性傳染病,具有發病急、進展快、傳染性強、隱性感染率高和病死率高等特點。目前,在國內已上市的同類產品為康希諾生物股份有限公司的ACYW135羣腦膜炎球菌多糖結合疫苗,該品種已於2021年12月批准上市。公司本次申報的ACYW135羣腦膜炎球菌多糖結合疫苗,既有助於豐富公司產品研發管線,又有助於滿足市場需求。
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