復星醫藥(02196.HK)控股子公司獲美國FDA藥品臨牀試驗批準
格隆匯5月9日丨復星醫藥(02196.HK)公告,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司上海菌濟健康科技有限公司(以下簡稱“菌濟健康”)收到美國FDA(即美國食品藥品監督管理局)關於同意LBP-ShC4開展臨牀試驗的批準。菌濟健康擬於條件具備後開展LBP-ShC4的I期臨牀試驗。
LBP-ShC4爲集團(即公司及控股子公司/單位,下同)自主研發的活體生物治療產品,擬用於治療雄激素脫髮(AGA)。截至2025年4月,集團現階段針對LBP-ShC4的累計研發投入約爲人民幣0.17億元(未經審計)。截至本公告日期(2025年5月9日),於全球範圍內尚無用於治療雄激素脫髮(AGA)的活體生物治療產品(包括單藥或聯合治療方案)獲批上市。
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