復星醫藥(02196.HK)子公司用於治療RDEB臨床試驗獲批
復星醫藥(02196.HK)公布,子公司精繕科技用於隱性營養不良型大皰性表皮松解症(Recessive Dystrophic Epidermolysis Bullosa,RDEB)的移植治療的臨床試驗,獲國家藥品監督管理局同意及批准,並計劃在條件具備後於內地(不包括港澳台地區)開展I期臨床試驗。
該產品為集團自主研發的細胞和基因治療產品,屬於1類治療用生物制品,擬主要用於治療隱性營養不良型大皰性表皮松解症(RDEB)。
集團表示,截至今年10月,現階段針對該產品累計研發投入約3,300萬元人民幣(未經審計)。
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