騰盛博藥-B(02137.HK)：美國FDA正在對安巴韋單抗和羅米司韋單抗聯合療法的緊急使用授權申請進行審核
格隆匯7月27日丨騰盛博藥-B(02137.HK)發佈公吿，新的活病毒數據確認其長效新冠單克隆中和抗體安巴韋單抗和羅米司韋單抗聯合療法對新冠病毒奧密克戎BA.4/5及BA.2.12.1亞型變異株保持中和活性。
在美國國立衞生研究院和美國國家過敏和傳染病研究所認證的美國馬里蘭大學實驗室進行的活病毒中和實驗數據預測，在給藥14天后，安巴韋單抗和羅米司韋單抗聯合療法的總血藥濃度仍保持中和超過90%的活病毒所需濃度(Neut99: 0.94 μg/ mL)的170倍以上。因此，其治療作用將至少持續整個治療時間。
相較野生型新冠病毒，奧密克戎BA.4/5及BA.2.12.1亞型變異株刺突蛋白中發現的突變，雖有限地降低了抗體的中和活性，但基於安巴韋單抗和羅米司韋單抗聯合療法的人體藥代動力學數據，預測其用於治療新冠肺炎單次靜脈注射1,000mg安巴韋單抗和1,000mg羅米司韋單抗後的血藥濃度將保持在中和奧密克戎BA.4/5及 BA.2.12.1亞型變異株所需的活性水平之上。
公司副總裁兼傳染病治療領域負責人David Margolis博士表示，“隨着新冠肺炎疫情不斷出現新的變異株，這些數據進一步證實了長效安巴韋單抗和羅米司韋單抗聯合療法的持久性和長效性，鞏固了其作為領先的研究性單克隆抗體療法的地位，並有潛力對全球流行的最主要病毒變異株保持活性。我們正處於疫情的關鍵時刻，新的奧密克戎亞型變異株傳染性更強，為此對安全高效的治療方案仍存在迫切需求。我們將繼續與全球監管機構進行討論，努力為全球有需要的新冠患者提供該創新聯合療法。”
安巴韋單抗和羅米司韋單抗聯合療法於2021年12月8日獲得中國國家藥品監督管理局上市批准，用於治療輕型和普通型且伴有進展為重型(包括住院或死亡)高風險因素的成人和青少年(12-17歲，體重≥40kg)新型冠狀病毒感染患者。其中青少年(12-17歲，體重≥40kg)適應症人羣為附條件批准。該聯合療法於2022年3月15 日獲國家衞生健康委員會批准納入《新型冠狀病毒肺炎診療方案(試行第九版)》，並於2022年7月7日在中國商業化上市。目前美國食品和藥品管理局正在對安巴韋單抗和羅米司韋單抗聯合療法的緊急使用授權申請進行審核。
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