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國際醫學(000516.SZ)參股公司下屬企業幹細胞新藥獲臨牀試驗默示許可
格隆匯 05-05 16:16

格隆匯5月5日丨國際醫學(000516.SZ)發佈公告,近日,公司參股的北京漢氏聯合生物技術股份有限公司下屬企業天津昂賽細胞基因工程有限公司(以下簡稱“天津昂賽”) 自主研發的治療用生物製品,幹細胞Ⅰ類新藥“注射用間充質幹細胞(臍帶)” 獲得國家藥品監督管理局臨牀試驗默示許可。

注射用間充質幹細胞(臍帶)由天津昂賽自主研製,屬於幹細胞藥物,來源於正常人臍帶組織,用於治療難治性急性移植物抗宿主病(graft-versus-host disease,GvHD)。移植物抗宿主病是異基因造血幹細胞移植後最主要的併發症,是一種多系統損害(皮膚、食管、胃腸,肝臟等)全身性疾病。間充質幹細胞的免疫調節特性為其作為臨牀治療GvHD提供了可能。

該公司將嚴格執行國家藥品監督管理局現行的臨牀試驗規範,制定科學合理的臨牀試驗方案,積極推進該品種的臨牀試驗工作,公司將對該藥品的後續審評進展情況及時披露。

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