康泰生物(300601.SZ):13價肺炎球菌多糖結合疫苗獲批上市
格隆匯9月10日丨康泰生物(300601.SZ)宣佈,公司全資子公司北京民海生物科技有限公司(簡稱“民海生物”)今日收到國家藥品監督管理局簽發的有關13價肺炎球菌多糖結合疫苗的《藥品註冊證書》。
13價肺炎球菌多糖結合疫苗適用於2月齡-5週歲嬰幼兒和兒童,接種本疫苗後,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)。民海生物自主研發的13價肺炎球菌多糖結合疫苗為全球首創的雙載體13價肺炎球菌多糖結合疫苗,採用兩種載體蛋白(破傷風類毒素/白喉類毒素)與肺炎球菌莢膜多糖結合,取得了較好的臨牀結果。
13價肺炎球菌多糖結合疫苗是全球暢銷的重磅疫苗品種,2020年輝瑞公司該產品全球銷售額約58.5億美元。公司是全球第三家獲得13價肺炎球菌多糖結合疫苗藥品註冊證書的企業,該疫苗的獲批上市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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