Phase III clinical trial of TDI01 “ROCK2 inhibitor” independently developed by China Biopharmaceutical (01177) to treat idiopathic pulmonary fibrosis completed the first patient enrollment

Zhitong Finance App News, China Biopharmaceutical (01177) announced that the TDI01 “ROCK2 inhibitor” independently developed by the group for the treatment of idiopathic pulmonary fibrosis (IPF) has completed the first patient enrollment. It is the first ROCK2 highly selective inhibitor in the world to enter IPF phase III clinical trials.

TDI01 is a highly selective ROCK2 kinase inhibitor through structural innovation. It can accurately act on the vascular secretion system, a core hub for regulating vascular leakage, fibrosis, inflammation, and immune disorders, and intervene in the complex pathogenesis of IPF in multiple dimensions. TDI01's highly selective inhibition of ROCK2 can effectively optimize the drug safety window and is expected to achieve clinical benefits superior to existing standard therapies.

Phase II clinical trial data showed that after 24 weeks of treatment, the vigorous lung capacity (FVC) of patients in the TDI01 400mg group improved by 89mL compared to the placebo group, which can significantly reduce the risk of all-cause death in patients, while effectively reducing the risk of acute exacerbation and progression of IPF. In terms of safety, the incidence of serious adverse events and discontinuation rates due to adverse events in the TDI01 treatment group were lower than those of similar standard treatments, showing that TDI01 had good safety and tolerability.