騰盛博藥-B(02137.HK):國家藥監局批准中國首個用於治療新冠肺炎創新中和抗體聯合療法
格隆匯12月9日丨騰盛博藥-B(02137.HK)發佈公吿,國家藥監局已批准公司的單克隆中和抗體安巴韋單抗 ╱ 羅米司韋單抗的聯合療法(此前為 BRII-196/BRII-198聯合療法)上市申請,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(COVID-19)患者。其中,青少年(12-17歲,體重≥40kg)適應症人羣為附條件批准。
該批准標誌着中國首個在自主研發並通過隨機、雙盲和安慰劑對照試驗而獲批的 SARS-CoV-2治療方案,代表了中國及全球一流科學家和臨牀研究人員之間有共同使命的合作伙伴關係,其中包括髮現了這些中和抗體候選藥物的清華大學及深圳市第三人民醫院,以及支持並領導ACTIV-2試驗的美國國立衞生研究院及愛滋病臨牀試驗組。
此外,公司正在全球其它成熟和新興市場積極推進安巴韋單抗╱羅米司韋單抗聯合療法的註冊申請工作,初步重點是確保在開展過臨牀試驗的國家以及在獲取高效治療方面存在重大差距的國家推進市場準入。在中國,公司正在開展進一步研究,旨在評估安巴韋單抗╱羅米司韋單抗聯合療法在免疫抑制人羣中的預防免疫增強作用。
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