君實生物(01877.HK)：埃特司韋單抗及巴尼韋單抗雙抗體療法獲FDA緊急使用授權用於暴露後預防COVID-19
格隆匯9月17日丨君實生物(01877.HK)公佈，近日，美國食品藥品監督管理局(“FDA”)擴大埃特司韋單抗(etesevimab，JS016/ LY-CoV016)1400毫克及巴尼韋單抗(bamlanivimab，LY-CoV555)700毫克雙抗體療法(“雙抗體療法”)的緊急使用授權範圍，新增用於特定人羣暴露後預防以防止新型冠狀病毒感染。
2021年2月，雙抗體療法已獲得FDA的緊急使用授權用於治療伴有進展為重度新型冠狀病毒肺炎(“COVID-19”)及/或住院風險的12 歲及以上輕中度COVID-19患者。此次緊急使用授權擴大範圍後，雙抗體療法新增用於12歲及以上的高風險人羣，包括未完全接種COVID-19疫苗或預期完全接種疫苗後無法產生足夠的免疫應答，且其已暴露於新型冠狀病毒感染者或處於高暴露風險的機構環境(包括療養院或監獄)中的人羣。
此次擴大緊急使用授權範圍是基於BLAZE-2研究(NCT04497987)的數據，該研究與美國國立衞生研究院(NIH)國家過敏和傳染病研究所(NIAID)及COVID-19 預防網絡(CoVPN)合作進行，招募了美國各地的長期護理機構(通常被稱為療養院)的住客和工作人員。
此外，在假病毒及真病毒的研究中，雙抗體療法在對抗Alpha(B.1.1.7)突變型及Delta(B.1.617.2/AY.3)突變型試驗中均保持了中和活性。
埃特司韋單抗是一種重組全人源單克隆中和抗體，以高親和力特異性結合SARS-CoV-2 表面刺突蛋白受體結合域，並能有效阻斷病毒與宿主細胞表面受體ACE2的結合。研發團隊在天然的人類IgG1抗體中引入點突變以消除不良效應。公司與中國科學院微生物研究所共同開發埃特司韋單抗後，Eli Lilly and Company(“禮來製藥”)從公司引進埃特司韋單抗在大中華地區(包括中國大陸、香港特別行政區、澳門特別行政區及台灣地區)以外地區的權益。公司將繼續主導該藥物在大中華地區的開發。截至公吿披露日，雙抗體療法已經在全球超過12 個國家和地區獲得緊急使用授權，公司已完成埃特司韋單抗針對新型冠狀病毒感染者的國際多中心Ib/II 期臨牀研究(NCT04780321)。
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