Sino Biopharmaceutical has announced positive interim results from a Phase III trial of its IDH1 inhibitor, TQB3454, for the treatment of advanced biliary tract cancer (BTC) harbouring an IDH1 mutation. The trial met its primary endpoints, demonstrating a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS) compared to the control group. The company has consulted with China's Centre for Drug Evaluation (CDE) and received agreement to submit a new drug application (NDA) for this indication in the near future.

This marks the first domestic IDH1 inhibitor to complete a successful Phase III study in China and the second globally for BTC. BTC is an aggressive malignancy with poor prognosis, and there are currently no approved IDH1-targeted therapies for this cancer in China.

The safety profile of TQB3454 was consistent with known risks, with no new safety signals identified. Detailed data from the study are planned for presentation at an international scientific conference later this year.

PharmCube's NextBiopharm® database lists TQB3454 in the fourth position among IDH1 inhibitors globally in terms of development progress. Click here to request a free trial for NextBiopharm®.