Alphamab Oncology and Shanghai JMT-Bio Secure Breakthrough Therapy Designation for JSKN003 in HER2+ Advanced Colorectal Cancer
Reuters
Oct 20
Alphamab Oncology and Shanghai JMT-Bio Secure Breakthrough Therapy Designation for JSKN003 in HER2+ Advanced Colorectal Cancer
Alphamab Oncology has announced that JSKN003, a drug co-developed with Shanghai JMT-Bio Technology Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited, has been granted breakthrough therapy designation by the Center for Drug Evaluation $(CDE)$ of China's National Medical Products Administration. The designation is for the treatment of HER2-positive advanced colorectal cancer in patients who have failed prior treatments with oxaliplatin, fluorouracil, and irinotecan. This follows a previous breakthrough therapy designation in March 2025 for JSKN003 in the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
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