智飛生物(300122.SZ):輪狀病毒滅活疫苗獲批臨牀試驗
格隆匯 9 月 23日丨智飛生物(300122.SZ)公佈,公司於2020年9月22日收到全資子公司北京智飛綠竹生物製藥有限公司(“智飛綠竹”或“子公司”)報告,由智飛綠竹研發的輪狀病毒滅活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:2020LP00507),同意該品進行臨牀試驗,其臨牀試驗申請於2020年6月24日獲得受理。子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。
輪狀病毒(Rotavirus,RV)是導致全球嬰幼兒嚴重腹瀉病的主要病原體之一,在我國也有極高的發病率,估計每年有超過1千萬例的輪狀病毒腹瀉發生,造成嚴重的醫療和經濟負擔。輪狀病毒感染引起腹瀉至今仍沒有特異有效的治療方法,而疫苗已成為最有效的手段。目前上市使用的輪狀病毒疫苗系口服活病毒疫苗。該項目輪狀疫苗採用滅活方式製備,以注射免疫方式誘導產生保護,是一種創新思路開發的預防輪狀病毒的疫苗。該疫苗申報註冊分類為預防用生物製品1類。
若該疫苗品種順利進展,將有利於公司病毒類疫苗品種的豐富,有助於優化產品結構、產業佈局和主營業務的全面發展,增強公司長期盈利能力。
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