復星醫藥(600196.SH):GC101獲批開展用於隱性營養不良型大皰性表皮鬆解症患者難以癒合的體表傷口的移植治療的臨牀試驗
格隆匯11月14日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海精繕生物科技有限責任公司(以下簡稱“精繕科技”)收到國家藥品監督管理局關於同意GC101用於隱性營養不良型大皰性表皮鬆解症(Recessive Dystrophic Epidermolysis Bullosa,RDEB)患者難以癒合的體表傷口的移植治療的臨牀試驗批准。精繕科技擬於條件具備後於中國境內(不包括港澳台地區,下同)開展I期臨牀試驗。
產品為公司及控股子公司自主研發的細胞和基因治療產品,屬於1類治療用生物製品,擬主要用於治療隱性營養不良型大皰性表皮鬆解症(RDEB)。RDEB是一種單基因遺傳病,根據《關於公佈第一批罕見病目錄的通知》(國衞醫發[2018]10號),系罕見病。截至本公吿日,於全球範圍內尚無同類用於RDEB治療的產(藥)品獲批上市。
截至2022年10月,公司及控股子公司現階段針對該產品累計研發投入約為人民幣3300萬元(未經審計)。
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