君實生物(01877.HK):VV116對比PAXLOVID早期治療輕中度COVID-19的III期註冊臨牀研究達到主要研究終點
格隆匯5月23日丨君實生物(01877.HK)發佈公吿,公司控股子公司上海君拓生物醫藥科技有限公司與蘇州旺山旺水生物醫藥有限公司合作開發的產品口服核苷類抗SARS-CoV-2藥物VV116片(項目代號:JT001/VV116,「VV116」)在一項對比奈瑪特韋片╱利托那韋片(即PAXLOVID)用於輕中度新型冠狀病毒肺炎(「COVID-19」)早期治療的III期註冊臨牀研究(NCT05341609)達到方案預設的主要終點。公司將於近期與監管部門溝通遞交新藥上市申請事宜。
NCT05341609研究是一項多中心、單盲、隨機、對照III期臨牀研究,旨在評價VV116對比奈瑪特韋片 ╱ 利托那韋片(即PAXLOVID)用於輕中度COVID-19患者早期治療的有效性和安全性。該項研究由上海交通大學醫學院附屬瑞金醫院寧光院士擔任主要研究者,實際入組822例患者,主要研究終點為至持續臨牀恢復的時間,次要研究終點包括截至第28天發生COVID-19進展(定義為進展為重度╱危重COVID-19或全因死亡)的受試者百分比等。該臨牀研究結果顯示,VV116用於輕中度COVID-19的早期治療達到臨牀方案預設的主要終點。
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