君實生物(01877.HK)抗體療法獲FDA授權用於暴露後預防COVID-19
君實生物(01877.HK)公佈,近日,FDA(美國食品藥品監督管理局)擴大埃特司韋單抗1,400毫克及巴尼韋單抗700毫克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。
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。
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,禮來製藥從公司引進埃特司韋單抗在大中華地區以外地區的權益。至今,雙抗體療法已在全球超過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。
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