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智飛生物(300122.SZ):智飛綠竹的重組B羣腦膜炎球菌疫苗進入Ⅰ期臨牀試驗
格隆匯 07-19 17:49

格隆匯7月19日丨智飛生物(300122.SZ)公佈,公司近日獲悉由全資子公司北京智飛綠竹生物製藥有限公司(簡稱“智飛綠竹”)自主研發的重組B羣腦膜炎球菌疫苗(大腸桿菌)(簡稱“重組B羣腦膜炎球菌疫苗”)在廣西壯族自治區疾病預防控制中心開展Ⅰ期臨牀試驗。

流行性腦脊髓膜炎(流腦)是由腦膜炎奈瑟菌引起的急性化膿性腦膜炎,具有起病急、進展快、傳染性強、病死率高、致殘率高等特點,絕大多數流腦由A羣、B羣、C羣、W135羣和Y羣腦膜炎球菌引起。當前,B羣腦膜炎球菌已成為引起主要發達國家侵襲性腦膜炎疾病的主要病原體。公司的重組B羣腦膜炎球菌疫苗項目採用重組技術,可以預防由B羣腦膜炎球菌引起的流行性腦脊髓膜炎,市場前景廣闊。公司已於2022年12月14日公吿該產品獲得國家藥品監督管理局授予的《臨牀試驗通知書》。

目前,境外已有兩款B羣腦膜炎球菌疫苗產品上市,而智飛綠竹自主研發的重組B羣腦膜炎球菌疫苗(大腸桿菌)為國內首款進入臨牀試驗階段的產品,國內尚無其他B羣腦膜炎球菌疫苗項目進入臨牀研究階段或獲批上市。

重組B羣腦膜炎球菌疫苗的Ⅰ期臨牀試驗在廣西壯族自治區疾病預防控制中心啟動,評價該疫苗的安全性、耐受性指標並進行初步免疫原性探索。

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