君實生物(01877.HK)新冠藥物獲內地批准上市
君實生物(01877.HK)公布,其控股子公司上海旺實生物醫藥科技申報的口服核(甘)類抗新型冠狀病毒(SARS-CoV-2)1類創新藥氫溴酸氘瑞米德韋片(商品名:民得維,產品代號:VV116/JT001,「VV116」)上市(國藥准字H20230002),用於治療輕中度新型冠狀病毒感染的成年患者。
臨床前研究顯示,VV116對包括奧密克戎在內的新冠病毒原始株和突變株表現出顯著的抗病毒作用,且無遺傳毒性。
此外,研究結果顯示,至期中分析的數據截止日,在1,277例隨機並接受治療的受試者中,VV116相較安慰劑,主要終點從首次給藥至持續臨床症狀消失(11項新冠相關臨床症狀評分=0且持續2天)時間顯著縮短,中位時間差達2天;至持續臨床症狀緩解時間顯著縮短,病毒載量較基線變化等病毒學指標均優於安慰劑組。
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