智飛生物(300122.SZ):三價流感病毒裂解疫苗(ZFA02佐劑)獲得臨牀試驗批准通知書
格隆匯4月1日丨智飛生物(300122.SZ)公佈,公司於近日獲悉,由全資子公司安徽智飛龍科馬生物製藥有限公司(簡稱“智飛龍科馬”)研發的三價流感病毒裂解疫苗(ZFA02佐劑)(簡稱“佐劑三價流感疫苗”)獲得國家藥品監督管理局藥物臨牀試驗批准通知書(通知書編號:2025LP00953),同意開展預防疫苗相關型別流感病毒引起的流行性感冒的臨牀試驗。公司將根據臨牀試驗批准通知書的要求,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,國內暫無佐劑流感疫苗正式獲批上市。海外有Seqirus公司的佐劑流感疫苗獲批上市使用。公司的佐劑三價流感疫苗臨牀試驗申請獲得批准,是公司新型佐劑技術平台的應用,是公司聚焦創新技術、增強核心攻關的成果。若本項目進展順利,將進一步豐富公司病毒類疫苗品種,並與公司已獲批上市的四價流感病毒裂解疫苗、處於申報上市階段的三價流感病毒裂解疫苗、四價流感病毒裂解疫苗(兒童型),及獲批臨牀試驗的四價流感病毒裂解疫苗(ZFA02佐劑)形成協同效應,完善公司產品佈局,強化公司的市場競爭力。
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