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騰盛博藥-B(2137.HK)新冠病毒聯合療法提交FDA緊急使用授權,患者治療窗口期最長10天,住院和死亡風險降低78%
格隆匯 10-09 10:44
格隆匯10月9日丨騰盛博藥-B(2137.HK)今日宣佈,向美國 FDA提交其在研的SARS-CoV-2聯合療法BRII-196/BRII-198緊急使用授權(EUA)申請。這意味着支持EUA申請的數據將滾動提交給FDA,以最終確保註冊申請儘快獲批。此申請基於美國國立衞生研究院(NIH)支持的ACTIV-2/3期臨牀試驗積極結果,結果顯示與安慰劑相比,早期開始接受治療(症狀出現後5天內),與晚期開始接受治療(症狀出現後6至10天內)的COVID-19門診患者均顯示臨牀獲益,其住院和死亡風險達到統計學顯著性降低。其住院和死亡風險降低78%,具有統計學顯著意義,並且其安全性優於安慰劑。騰盛博藥計劃在完成EUA提交、審查和批准後,與FDA密切合作,進一步推進BRII-196/BRII-198聯合療法後續的註冊獲批工作。我們注意到,公司也已在中國國家藥品監督管理局(NMPA),以及中國香港衞生署提交BRII-196/BRII-198聯合療法的新藥臨牀試驗申請(IND)並獲得批准,並在中國開展了2期臨牀研究,旨在評估BRII-196/BRII-198聯合療法的藥代動力學和安全性,評估更低劑量BRII-196/BRII-198聯合療法治療COVID-19的有效性。
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