CSPC's JMT101 gets breakthrough therapy designation in China

CSPC Pharmaceutical Group Limited (HKEX: 1093) announced that its JMT101, a recombinant humanised anti-epidermal growth factor receptor (EGFR) IgG1 subtype monoclonal antibody injection, has been granted Breakthrough Therapy Designation by China's National Medical Products Administration. This designation is for the treatment of RAS, RAF, EGFR ECD and PIK3CA exon 20 wild-type advanced colorectal cancer in patients who have failed standard second-line treatment or beyond when used in combination with irinotecan. Clinical trial data showed that JMT101 combined with irinotecan achieved significantly better objective response rates (ORR), disease control rate (DCR) and median progression-free survival (mPFS) compared to the control group, warranting its accelerated development. The Group has advanced JMT101 to a pivotal phase III clinical trial, with additional trials underway for other solid tumors including lung cancer and nasopharyngeal carcinoma. In 2022, new cases of and deaths from colorectal cancer in China reached 517,000 and 240,000, respectively.