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華蘭生物(002007.SZ):疫苗公司的“凍幹b型流感嗜血桿菌結合疫苗”臨牀試驗申請獲得批准
格隆匯 08-13 16:06

格隆匯8月13日丨華蘭生物(002007.SZ)公佈,2025年8月12日,華蘭生物工程股份有限公司控股子公司華蘭生物疫苗股份有限公司(以下稱“疫苗公司”)收到國家藥品監督管理局下發的《藥物臨牀試驗批准通知書》(通知書編號:2025LP02051),由疫苗公司申報的“凍幹b型流感嗜血桿菌結合疫苗”臨牀試驗申請獲得批准:經審查,2025年5月21日受理的凍幹b型流感嗜血桿菌結合疫苗符合藥品註冊的有關要求,同意開展預防由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、蜂窩織炎、關節炎、會厭炎等)的臨牀試驗。疫苗公司將按照藥物臨牀試驗批准通知書的要求,儘快開展相關臨牀試驗工作。

疫苗公司研發的Hib疫苗系以純化的Hib莢膜多糖與破傷風類毒素蛋白結合而成,採用凍幹劑型,預期可在接種後誘導針對Hib的免疫答應,對接種者提供保護作用。此外,疫苗公司正在研發以組分百白破為基礎的聯合疫苗,Hib疫苗為其中的組成部分,作為未獲批上市的單苗需累積一定的臨牀數據,完成Hib單價疫苗的申報上市,並支持未來以組分百白破為基礎的聯合疫苗的註冊申報。

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