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華蘭疫苗(301207.SZ):凍幹b型流感嗜血桿菌結合疫苗獲得藥物臨牀試驗批準通知書

格隆匯8月13日丨華蘭疫苗(301207.SZ)公佈,公司於近日收到國家藥品監督管理局覈準簽發的關於凍幹b型流感嗜血桿菌結合疫苗(簡稱“Hib疫苗”)的《藥物臨牀試驗批準通知書》。

流感嗜血桿菌爲革蘭氏陰性桿菌,是兒童急性下呼吸道感染最主要的病原菌之一,分爲有莢膜型和無莢膜型,兩者均可引發感染。無莢膜型菌株常可引發中耳炎和鼻竇炎等疾病。主要由鼻咽部定植細菌在鄰近部位傳播所致;繼發於血流侵襲的感染通常由莢膜型菌株引起。有莢膜的菌株根據莢膜多糖的化學成分來進行分類,迄今已發現6種血清型,其中,約95%的侵襲性流感嗜血桿菌疾病由b型引起。

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,公司正在研發以組分百白破爲基礎的聯合疫苗,Hib疫苗爲其中的組成部分,作爲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爲基礎的聯合疫苗的註冊申報。

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