15 May 2023 - Innovent Biologics announced that the Center for Drug Evaluation of China’s National Medical Products Administration has granted breakthrough therapy designation for IBI351 (GFH925) for the treatment of previously treated advanced colorectal carcinoma patients with KRASG12C mutation.
This breakthrough therapy designation for IBI351 was based on the pooled analysis of two ongoing clinical trials (NCT05005234, NCT05497336), which include 54 colorectal cancer patients that received IBI351 monotherapy.