智飛生物(300122.SZ):吸附無細胞百白破(組分)b型流感嗜血桿菌(結合)聯合疫苗獲得臨牀試驗批準通知書
格隆匯5月16日丨智飛生物(300122.SZ)公佈,公司於近日獲悉,由全資子公司北京智飛綠竹生物製藥有限公司(簡稱“智飛綠竹”)研發的吸附無細胞百白破(組分)b型流感嗜血桿菌(結合)聯合疫苗(簡稱“組分百白破-Hib四聯疫苗”)獲得國家藥品監督管理局藥物臨牀試驗批準通知書(通知書編號:2025LP01316),同意開展預防百日咳桿菌、白喉桿菌、破傷風梭狀芽孢桿菌及b型流感嗜血桿菌引起的感染性疾病的臨牀試驗。公司將根據臨牀試驗批準通知書的要求,儘快開展相關臨牀試驗工作。
截至目前,經查詢國家藥品監督管理局網站,國內有1款無細胞百白破b型流感嗜血桿菌聯合疫苗上市銷售,採用共純化技術製備。智飛綠竹研製的組分百白破-Hib四聯疫苗相比共純化工藝,百日咳升級了百日咳抗原純化及配製工藝,系採用三個單獨純化的百日咳有效抗原組分聯合白喉、破傷風、Hib有效組分配製的質量均一的疫苗產品,可替代免疫規劃疫苗中的百白破疫苗。目前,國內暫無組分百白破-Hib四聯疫苗獲批上市,市場前景廣闊。
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