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ROCK2抑制剂
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中国生物制药(01177)自主研发的TDI01“ROCK2抑制剂”用于治疗特发性肺纤维化的Ⅲ期临床试验完成首例患者入组
智通财经网· 2025-12-31 04:48
Core Viewpoint - China Biopharmaceutical (01177) has announced that its self-developed TDI01 "ROCK2 inhibitor" for the treatment of idiopathic pulmonary fibrosis (IPF) has completed the enrollment of its first patient in a Phase III clinical trial, marking it as the world's first high-selectivity ROCK2 inhibitor to enter Phase III clinical trials for IPF [1] Group 1 - TDI01 is a highly selective ROCK2 kinase inhibitor achieved through structural innovation, targeting the vascular secretion system, which is crucial for regulating vascular leakage, fibrosis, inflammation, and immune disorders, thereby intervening in the complex pathogenesis of IPF from multiple dimensions [1] - The high selectivity of TDI01 for ROCK2 is expected to optimize the drug's safety window and potentially provide clinical benefits superior to existing standard therapies [1] Group 2 - Phase II clinical trial data shows that after 24 weeks of treatment, patients in the TDI01 400mg group experienced an improvement of 89mL in forced vital capacity (FVC) compared to the placebo group, significantly reducing the risk of all-cause mortality and effectively lowering the risk of acute exacerbation and progression of IPF [1] - In terms of safety, the incidence of serious adverse events and the rate of discontinuation due to adverse events in the TDI01 treatment group were lower than those of similar standard treatment drugs, demonstrating TDI01's good safety and tolerability profile [1]