CSPC Pharmaceutical Group Limited has announced that their drug JMT101 has been granted Breakthrough Therapy Designation in China for the treatment of colorectal cancer. The designation was awarded by the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China. JMT101, developed by CSPC Pharmaceutical Group, is intended for use in combination with irinotecan for treating RAS, RAF, EGFR ECD, and PIK3CA exon 20 wild-type advanced colorectal cancer after the failure of standard treatment in second-line or beyond. Clinical studies have demonstrated JMT101's breakthrough efficacy and favorable safety profile, indicating potential as a new standard treatment for later-line colorectal cancer. The company is currently conducting a pivotal phase III clinical trial of JMT101 in combination with irinotecan for this indication and is also exploring its use in multiple phase II and III trials for other solid tumors. The Breakthrough Therapy Designation is expected to expedite the drug's research and development process.
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