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智飛生物(300122.SZ)獲得四價流感病毒裂解疫苗Ⅲ期臨牀試驗總結報吿
格隆匯 06-16 12:35

格隆匯6月16日丨智飛生物(300122.SZ)公佈,公司近日接到全資子公司安徽智飛龍科馬生物製藥有限公司的上報,獲悉其研發的四價流感病毒裂解疫苗獲得了Ⅲ期臨牀試驗總結報吿。根據《深圳證券交易所上市公司自律監管指引第4號——創業板行業信息披露》規定,現將主要內容公吿如下:

一、基本情況

疫苗名稱:四價流感病毒裂解疫苗臨牀批件號:2017L00218研究方法:隨機、盲法、同類疫苗對照的臨牀試驗

二、同類產品的市場情況

截至公吿日,經查詢國家藥品監督管理局網站,國內正式獲批上市的流感疫苗中,有7款為四價流感病毒裂解疫苗。

三、試驗結論

該疫苗具有良好的免疫原性及安全性,全面達到臨牀試驗預設目標,在安全性和有效性方面均非劣效於對照疫苗,且符合《季節性流感病毒疫苗臨牀研究技術指導原則》中有效性與安全性評價的設計要求。

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