By Fineline Cube 
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its JMT101 has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). This designation highlights the drug’s potential as a treatment for wild-type advanced colorectal cancer (CRC) patients with RAS, RAF, EGFR ECD, and PIK3CA 20 exons who have failed second-line or above standard treatment, in combination with irinotecan.
JMT101 Clinical Performance
JMT101, an anti-EGFR monoclonal antibody (mAb) with ADCC and CDC effects, demonstrated superior outcomes when combined with irinotecan in a Phase II trial. It achieved a median progression-free survival (mPFS) of 7.4 months, compared to 2.9 months in the control group. The drug also showed improvements in objective response rate (ORR) and disease control rate (DCR).
Colorectal Cancer in China
Colorectal cancer is the second most common malignant tumor in China, with 517,000 new cases and 240,000 deaths reported in 2022. The limited efficacy of standard treatment regimens for advanced patients underscores the significant unmet clinical need. JMT101’s breakthrough therapy designation reflects its potential to address this critical demand.-Fineline Info & Tech