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康泰生物(300601.SZ):凍幹b型流感嗜血桿菌結合疫苗獲批上市
格隆匯 06-08 14:21

格隆匯6月8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《藥品註冊證書》。根據《中華人民共和國藥品管理法》《中華人民共和國疫苗管理法》及有關規定,經審查,民海生物申報的凍幹b型流感嗜血桿菌結合疫符合藥品注冊的有關要求,批准註冊,發給藥品註冊證書,具體情況如下:

凍幹b型流感嗜血桿菌結合疫苗適用於2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)

對於多糖結合類疫苗,凍幹製劑的疫苗具有較好的穩定性,方便存放和運輸,產品有效期較長,在同類產品中具有一定優勢。國內上市的b型流感嗜血桿菌結合疫苗分為凍幹劑型和液體劑型,凍幹劑型為進口產品。公司是首家獲得凍幹b型流感嗜血桿菌結合疫苗藥品註冊證書國內企業,將進一步豐富公司的產品梯隊,提高公司的市場競爭力

凍幹b型流感嗜血桿菌結合疫苗已通過北京市藥品監督管理局GMP合性檢查,公司將按照相關要求開展生產工作,積極做好產品上市準備,產品獲得國家藥品監督管理局生物製品批簽發證明後可上市銷售。產品的上市時間具有一定的不確定性,敬請廣大投資者謹慎決策,注意投資風險。

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