中國生物製藥(01177.HK):創新藥"TDI01"向美國FDA提交試驗用新藥申請並獲受理
格隆匯2月3日丨中國生物製藥(01177.HK)宣佈,公司附屬公司北京泰德製藥股份有限公司自主研發的治療纖維化創新藥"TDI01"已向美國食品藥品監督管理局("FDA")提交試驗用新藥申請並獲得受理。獲得FDA的正式批准後,集團將在美國開展TDI01的臨牀試驗。
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,目前開展臨牀試驗的適應症為非酒精性脂肪肝炎、肺纖維化。纖維化是由於損傷或長期炎症而形成的纖維結締組織或瘢痕組織。在肝、肺和腎纖維化中,瘢痕組織失控會逐漸導致器官結構破壞和功能減退,乃至衰竭,對人類的生命和健康造成極大威脅。TDI01可通過抑制ROCK2,同時具有抑制纖維化進程、抗炎和免疫調節作用,對纖維化發生發展各個環節均有治療作用。
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