康泰生物(300601.SZ):b型流感嗜血桿菌結合疫苗獲藥品補充申請批件
格隆匯3月31日丨康泰生物(300601.SZ)公佈,公司全資子公司北京民海生物科技有限公司(“民海生物”)近日收到國家藥品監督管理局簽發的《藥品補充申請批件》。根據《中華人民共和國藥品管理法》及有關規定,經審查,民海生物申報的b型流感嗜血桿菌結合疫苗Ⅳ期臨牀研究符合藥品註冊的有關要求,批准此次補充申請。
b型流感嗜血桿菌結合疫苗適用於3月齡嬰兒-5週歲兒童,接種本疫苗後,可使機體產生體液免疫應答,用於預防由b型流感嗜血桿菌引起的侵襲性感染(包括腦膜炎、肺炎、敗血症、蜂窩組織炎、關節炎、會厭炎等)。
b型流感嗜血桿菌結合疫苗完成Ⅳ期臨牀研究並獲得藥品補充申請批件,是公司進一步提高b型流感嗜血桿菌結合疫苗上市後研究和實施質量的結果。b型流感嗜血桿菌結合疫苗是公司已經上市銷售的疫苗產品,此次獲得補充申請批件對公司的經營業績不會產生重大影響。
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