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麗珠醫藥(1513.HK)附屬新冠疫苗獲巴基斯坦藥監局批準進行Ⅲ期臨牀試驗
阿思達克 10-27 08:42
麗珠醫藥(1513.HK)公佈,附屬公司麗珠單抗收到巴基斯坦藥品監督管理局簽發的關於麗珠單抗研發的「重組新型冠狀病毒融合蛋白疫苗」(V-01)Ⅲ期臨牀試驗的批準函件,批準V-01作爲加強針的序貫免疫在完成2劑滅活疫苗接種的18歲或以上健康成年人中的保護效力、安全性和免疫原性的國際多中心、隨機、雙盲、安慰劑對照的Ⅲ期臨牀試驗。 V-01已完成多個國家臨牀試驗的申報工作,臨牀試驗方案主要包括基礎免疫、加強針序貫免疫等。
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