君實生物(688180.SH/1877.HK):美國全面恢復分發埃特司韋單抗及巴尼韋單抗雙抗體療法
格隆匯9月3日丨君實生物(688180.SH/1877.HK)公佈,近日,美國食品藥品監督管理局(“FDA”)及應急準備與反應助理部長辦公室(ASPR)宣佈,根據FDA對最近獲得的SARS-CoV-2變異病毒數據的評估,其宣佈在緊急使用授權(EUA)094授權的條件下,可以在美國所有州、地區和司法管轄區使用bamlanivimab和etesevimab的聯合療法。 此前,2021年8月27日,其已宣佈,根據緊急使用授權(EUA)094,對授權使用bamlanivimab和etesevimab的授權使用進行了修訂。經修訂後,恢復埃特司韋單抗(etesevimab,JS016/ LY-CoV016)及巴尼韋單抗(bamlanivimab,LY-CoV555)雙抗體療法(“雙抗體療法”)在美國的運輸及分發,美國已獲授權的州將可以立即直接訂購。
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