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中国生物制药(01177.HK):TDI01「ROCK2抑制剂」特发性肺纤维化Ⅲ期临床试验完成首例患者入组
Ge Long Hui· 2025-12-31 06:22
Core Viewpoint - China Biologic Products (01177.HK) has announced that its self-developed TDI01, a 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 for IPF [1] Group 1: Product Development - 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 [1] - The high selectivity of TDI01 for ROCK2 is expected to optimize the drug's safety profile and potentially provide clinical benefits superior to existing standard therapies [1] Group 2: Clinical Trial Results - Phase II clinical trial data showed 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 [1] - TDI01 also effectively reduced the risk of acute exacerbation and progression of IPF, with a lower incidence of serious adverse events and drug discontinuation due to adverse events compared to standard treatment options, demonstrating good safety and tolerability [1]
中国生物制药自主研发的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
Zhi Tong Cai Jing· 2025-12-31 04:45
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 ROCK2 high-selectivity inhibitor to enter Phase III clinical trials for IPF [1] Group 1: Product Development - 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 [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: Clinical Trial Results - Phase II clinical trial data indicates 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 [1] - TDI01 also effectively reduces the risk of acute exacerbation and progression of IPF, with the incidence of serious adverse events and discontinuation rates due to adverse events in the TDI01 treatment group being lower than those of standard treatment drugs, demonstrating good safety and tolerability [1]