【中国生物制药:TDI01混悬液新适应症被CDE纳入突破性治疗药物程序】金十数据6月16日讯,中国生物制药(01177.HK)董事会宣布,本集团开发的1类创新药TDI01混悬液“ROCK2抑制剂”已被中国国家药品监督管理局药品审评中心(CDE)纳入突破性治疗药物程序,用于治疗既往经过1线不超过5线系统治疗的中重度慢性移植物抗宿主病。Ib/II期临床研究结果显示,在经过1-5线既往治疗的中重度cGVHD患者中,TDI01展示出显著的疗效潜力和良好的安全性。该研究结果已在第51届欧洲血液与骨髓移植学会年会以口头报告的形式公布。
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