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麗珠醫藥(01513.HK)新冠疫苗Ⅲ期臨牀試驗獲巴基斯坦批准
格隆匯 10-26 23:01

格隆匯10月26日丨麗珠醫藥(01513.HK)公吿,近日,公司控股附屬公司珠海市麗珠單抗生物技術有限公司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”(以下簡稱“V-01”)Ⅲ期臨牀試驗的批准函件,批准V-01作為加強針的序貫免疫在完成2劑滅活疫苗接種的18週歲及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。V-01全球Ⅲ期多中心臨牀試驗目前進展順利,針對上述兩種不同臨牀試驗方案已完成多個國家臨牀試驗的申報工作,本次在巴基斯坦獲批開展加強針的臨牀試驗,成功獲批上市後將為全球加強針免疫提供疫苗支持。根據公開信息,V-01是巴基斯坦首個獲批開展加強針Ⅲ期臨牀方案的疫苗。

截至目前,麗珠單抗在V-01項目累計直接投入的研發費用約為人民幣25,291.58萬元。

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