中國生物製藥(01177.HK)新藥申請獲FDA受理
中國生物製藥(01177.HK)公布,附屬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的臨床試驗。
公告指,TDI01是全新靶點、高選擇性的Rho/Rho相關捲曲螺旋形成蛋白激(酉每)2(ROCK2)抑制劑,目前開展臨床試驗的適應症為非酒精性脂肪肝炎、肺纖維化。
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