君實生物(01877.HK):重組全人源抗SARS-CoV-2單克隆抗體注射液(JS016)及LY-CoV555雙抗體療法的III期臨牀試驗達到主要研究終點
格隆匯 1 月 26日丨君實生物(01877.HK)宣佈，etesevimab (JS016/LY-CoV016)2,800 mg及bamlanivimab (LY-CoV555) 2,800 mg雙抗體療法("雙抗體療法")顯著降低了近期被確診為新型冠狀病毒肺炎(COVID-19)高重症化風險患者COVID-19相關住院和死亡事件(以下統稱"事件")，達到了BLAZE-1研究III期臨牀試驗的主要研究終點。在1035例患者中，雙抗體治療組事件發生率為2.1%(11例)，安慰劑組事件發生率為7.0%(36例)，表明事件發生風險降低了70%(p=0.0004)。
Etesevimab及bamlanivimab雙抗體療法在所有關鍵次要研究終點上亦顯示出統計學顯着改善，為該療法降低病毒載量並加快症狀緩解提供了有力的證據。在III期試驗中，etesevimab及bamlanivimab雙抗體療法的安全性特徵與評估該等抗體的其他I期、II期及III期試驗觀察結果一致。Etesevimab及bamlanivimab雙抗體治療組的嚴重不良事件報吿頻率與安慰劑組相似。
此外，正在進行BLAZE-4研究的初步結果提供病毒載量及藥效學╱藥代動力學數據，顯示較低劑量(包括etesevimab 1,400 mg及bamlanivimab 700 mg雙抗體療法)與etesevimab 2,800 mg及bamlanivimab 2,800 mg雙抗體療法的效果相似。美國禮來製藥公司("禮來製藥")探索更低劑量的etesevimab和bamlanivimab雙抗體治療，因為低劑量可以最大限度地為更多患者供藥，為皮下給藥提供可能性，且這種潛在的變化旨在簡化給藥和減輕醫療系統的負擔。
禮來製藥已於2020年11月就etesevimab和bamlanivimab雙抗體治療輕中度COVID-19高風險患者向美國食品藥品監督管理局("FDA")提交了緊急使用授權(EUA)申請。FDA目前仍在審核有關請求。
禮來製藥將與安進合作加快生產etesevimab以在全球層面投入使用。預計在2021年中之前，禮來製藥將生產高達100萬劑etesevimab用於雙抗體療法，其中第一季度將完成超過25萬劑的生產。
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