先聲藥業(02096.HK):對中國輕中度COVID-19成年患者,先諾欣可加快症狀恢復、縮短病程
格隆匯1月18日丨先聲藥業(02096.HK)公吿,於2024年1月18日,《新英格蘭醫學雜誌》(The New England Journal of Medicine,2022年度影響因子:158.5)在線發表了集團3CL口服創新藥先諾欣(先諾特韋片╱利托那韋片組合包裝)用於輕中度COVID-19成年患者的II/III期、雙盲、隨機、安慰劑對照臨牀試驗(NCT05506176)的完整數據(DOI:10.1056/NEJMoa2301425)。
2022年8月19日至2022年12月16日,該研究於中國35個研究中心共納入1,208例患者,其中先諾欣組(750mg先諾特韋+100mg利托那韋,每日2次,共5天)603例,安慰劑組605例。結果顯示,對中國輕中度COVID-19成年患者,先諾欣可加快症狀恢復,縮短病程,快速、大幅降低病毒載量,且安全耐受性良好。
該研究中納入患者年齡中位數為35歲,1,092例(95.9%)患者已完成首次疫苗接種,其中874例(76.7%)患者接受過加強劑量。同時該研究覆蓋了不同的奧密克戎變異株,證明了先諾欣在實際臨牀中的應用價值。
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