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君實生物(01877.HK)澄清雙抗體療法並非撤回其在美國緊急使用授權
君實生物(01877.HK)公佈,對於有媒體報道指,埃特司韋單抗(etesevimab,JS016) 1,400mg和巴尼韋單抗(bamlanivimab,LY-CoV555) 700mg雙抗體療法在美國被停止分發。公司澄清,美國疾控中心(CDC)近日監測到SARS-CoV-2的P.1/Gamma突變型及B.1.351/Beta突變型在美國的總比例已超過11%並呈上升趨勢,美國政府相關部門於6月25日宣佈在美國暫停供應雙抗體療法直至另行通知,上述暫停供應雙抗體療法並非撤回其在美國的緊急使用授權(EUA)。

公司指,過去數月內美國各地區SARS-CoV-2各突變類型所佔比例變化較快,未來雙抗體療法仍有可能在美國恢復使用。公司合作夥伴美國禮來公司將繼續在除大中華地區外的其他區域與監管機構持續溝通,確保適當的患者可獲得雙抗體療法治療。

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