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智飛生物(300122.SZ):凍乾重組結核疫苗進入Ⅱa期臨牀試驗
格隆匯 02-11 17:53

格隆匯2月11日丨智飛生物(300122.SZ)公佈,公司近日獲悉由公司全資子公司安徽智飛龍科馬生物製藥有限公司研發的凍乾重組結核疫苗(AEC/BC02)已完成I期臨牀研究工作,結果初步顯示該疫苗具有良好的安全性和耐受性。目前該產品已完成Ⅱa期臨牀試驗準備工作,開始受試者篩選,正式啟動Ⅱa期臨牀試驗。

結核病是由結核分枝桿菌感染引起的慢性傳染病,根據世界衞生組織評估,結核潛伏感染人羣約17億,約佔人口總數的四分之一,結核潛伏感染人羣的篩查與預防是世衞終結結核病戰略最重要的組成部分。2015年WHO提出“終止結核病策略”,其目標是到2035年全球結核病發病率下降到10/10萬以下,首次提出了要在高危人羣中系統開展LTBI的檢測和預防性干預,減少結核發病;並指出如果結核潛伏感染問題不解決,終止結核病目標不可能實現。

凍乾重組結核疫苗(AEC/BC02)擬用於18週歲及以上結核桿菌潛伏感染人羣預防發生結核病,屬於預防用生物製品1類。截至本公吿披露日,經查詢國家藥品監督管理局網站,目前國內外市場無同類疫苗上市銷售。若本項目研發進展順利,將與公司結核矩陣產品(注射用母牛分枝桿菌(微卡)等)形成協同效應,為民眾提供更多元化的免疫選擇。

本疫苗Ⅱa期臨牀試驗採取隨機、盲法、對照設計,評價凍乾重組結核疫苗(AEC/BC02)的安全性、耐受性和免疫原性,於2022年2月10日在湖南省衡陽市衡東縣啟動Ⅱa期臨牀試驗。

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