智通财经APP讯，中国生物制药(01177)公布，该集团开发的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(BTD)，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 (cGVHD)。
据悉，TDI01是一种创新、口服、高选择性的ROCK2抑制剂，也是国内首个自主研发的ROCK2抑制剂。 TDI01能够有效抑制促炎性Th17细胞，促进调节性T细胞，并恢复免疫稳态。同时，ROCK2抑制剂直接作用于成纤维细胞的ROCK2靶点，阻断成纤维细胞分化成肌成纤维细胞，并诱导已存在的肌成纤维细胞凋亡，实现免疫稳态并逆转纤维化的双重机制。
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(EBMT 2025)以口头报告的形式公布。
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