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康泰生物(300601.SZ):13價肺炎球菌結合疫苗正式納入優先審評品種
格隆匯 01-20 12:42

格隆匯1月20日丨康泰生物(300601.SZ)公佈,近日,國家藥品監督管理局藥品審評中心網站信息顯示,公司全資子公司北京民海生物科技有限公司研發的13價肺炎球菌結合疫苗已正式納入優先審評品種。根據國家優先審評審批的規定,國家藥品監督管理局藥品審評中心對納入優先審評審批的藥品註冊申請,將優先配置資源進行審評。

13價肺炎球菌結合疫苗用於嬰幼兒和兒童,接種後可使機體產生免疫應答,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)。13價肺炎球菌結合疫苗是世界上最暢銷的疫苗品種之一,目前國內上市的13價肺炎球菌結合疫苗由輝瑞公司生產,2018年輝瑞13價肺炎球菌結合疫苗全球銷額約58億美元。

13價肺炎球菌結合疫苗的新藥生產註冊申請已獲得國家藥品監督管理局出具的《受理通知書》,詳見公司於2019年12月9日在巨潮資訊網披露的《關於13價肺炎球菌結合疫苗申請新藥生產註冊獲得受理的公告》(公告編號:2019-108)。目前,公司13價肺炎球菌結合疫苗正在國家藥品監督管理局藥品審評中心進行技術審評,後續還需經臨牀試驗現場核查、生產現場檢查等程序方可獲得批准。

公司表示,該次13價肺炎球菌結合疫苗被納入優先審評品種對公司近期業績不會產生重大影響,未來該疫苗獲批上市銷售,將對公司經營業績產生積極的影響。13價肺炎球菌結合疫苗審評審批進度及取得藥品生產註冊批件的時間具有一定的不確定性。

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