君實生物(01877.HK)：FDA擴大埃特司韋單抗及巴尼韋單抗雙抗體療法緊急使用授權範圍至12歲以下人羣
格隆匯12月5日丨君實生物(01877.HK)宣佈，美國食品藥品監督管理局("FDA")擴大埃特司韋單抗(JS016/LY-CoV016)及巴尼韋單抗(LY-CoV555)雙抗體療法("雙抗體療法")的緊急使用授權範圍，新增用於特定高風險兒科人羣(從出生至12歲以下)的輕中度新型冠狀病毒肺炎("COVID-19")治療及暴露後預防。截至公吿日期，雙抗體療法是全球首個且唯一獲緊急使用授權覆蓋12歲以下人羣的中和抗體療法，可為全年齡段的高風險人羣提供治療和預防COVID-19的選擇。
2021年2月，雙抗體療法已獲得FDA緊急使用授權用於治療伴有進展為重度COVID-19及╱或住院風險的12歲及以上輕中度COVID-19患者。2021年9月，雙抗體療法獲得FDA緊急使用授權用於12歲及以上高風險人羣的暴露後預防以防止新型冠狀病毒感染，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乃基於BLAZE-1研究(NCT04427501)中兒科與嬰兒患者的安全性和有效性數據。BLAZE-1是一項II/III期臨牀試驗，旨在研究雙抗體療法用於伴有進展為嚴重疾病風險的輕中度COVID-19患者的治療。根據該臨牀試驗的每日症狀記錄，對於接受埃特司韋單抗1,400毫克及巴尼韋單抗700毫克雙抗體療法的受試者，其症狀完全緩解的中位時間為7天，而對於基於體重給藥的受試者，其症狀完全緩解的中位時間為5天。無兒科受試者因COVID-19死亡或住院。
假病毒及真病毒的研究均顯示雙抗體療法在對抗全球關注的主流變異毒株Delta(B.1.617.2/AY.3)突變型試驗中保持了中和活性。
此外，根據公司合作伙伴Eli Lilly and Company("禮來製藥")的統計，截至公吿日期，已有超過700,000名患者接受了雙抗體療法或巴尼韋單抗治療，在疫情最嚴重的時期潛在防止了超過35,000例住院和至少14,000例死亡發生。
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