康泰生物(300601.SZ):子公司收到13價肺炎球菌結合疫苗註冊現場檢查通知
格隆匯 11 月 30日丨康泰生物(300601.SZ)公佈,近日,公司全資子公司北京民海生物科技有限公司(“民海生物”)收到國家藥品監督管理局藥品審評中心出具的《藥審中心關於13價肺炎球菌結合疫苗註冊現場檢查的通知》(“通知”),基於技術審評需要,將對民海生物註冊申報的13價肺炎球菌結合疫苗(受理號:CXSS1900046)組織開展註冊現場檢查。
13價肺炎球菌結合疫苗可用於預防由肺炎球菌血清型1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F和23F引起的侵襲性疾病(包括菌血症性肺炎、腦膜炎、敗血症和菌血症)。
民海生物研製的13價肺炎球菌結合疫苗臨牀試驗表明對2月齡-5週歲嬰幼兒和兒童具有良好的免疫原性和安全性,接種後可使機體產生免疫應答。
該通知表明民海生物研製的 13價肺炎球菌結合疫苗的註冊工作取得了重要進展,即將開始註冊現場檢查,待藥品檢驗機構對此次生產的產品抽樣檢定合格且通過國家藥品監督管理局的審評審批後,該產品將可取得藥品註冊批件。若該產品註冊成功,將進一步豐富公司的產品梯隊,增強公司競爭力,強化公司的市場地位。
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