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中生製藥(01177.HK):治療纖維化創新藥“TDI01”獲CDE批准開展臨牀試驗
格隆匯 10-28 12:08

格隆匯10月28日丨中國生物製藥(01177.HK)宣佈,集團自主研發的治療纖維化創新藥“TDI01”已獲得中華人民共和國國家藥品監督管理局藥品評審中心(“CDE”)批准開展臨牀試驗,用於特發性肺纖維化的治療。該創新藥於今年初已獲美國食品藥品監督管理局批准了試驗用新藥申請,目前正在當地進行人體臨牀試驗給藥中。

TDI01是全新靶點、高選擇性的Rho/Rho相關捲曲螺旋形成蛋白激酶2(ROCK2)抑制劑,國家十三五重大新藥創制品種。纖維化領域存在巨大的未滿足的臨牀需求,目前全球範圍內尚缺乏有效治療纖維化藥物。全新機制的TDI01可通過高選擇性地抑制ROCK2信號通路,發揮抑制纖維化進展、抗炎和免疫調節等多重作用,在肺纖維化、肝纖維化等領域具有較好的治療潛力。

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