Sino Biopharmaceutical (HKG:1177) said the phase III trial of TQB3454 developed by unit Chia Tai Tianqing Pharmaceutical Group reached the pre-specified primary endpoints of both progression-free and overall survival, according to a Thursday Hong Kong bourse filing.
The drug is being tested for the treatment of advanced biliary tract cancer with IDH1 mutations.
The pharmaceutical firm has communicated with China's National Medical Products Administration in relation to the marketing application for this indication and obtained written approval. The marketing application will be submitted soon.