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Biparatopic HER2-targeting ADC JSKN003 Was Granted Another Breakthrough Therapy Designation for HER2-Positive Advanced Colorectal Cancer
October 20, 2025- Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) jointly announced that biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted another breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the indication of monotherapy for the treatment of HER2-positive advanced colorectal cancer (CRC) in patients who have failed
About this update from Cspc Pharmaceutical Group Limited
[{"type":"text","content":"SUZHOU, China, Oct. 20, 2025 /PRNewswire/ -- October 20, 2025- Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) jointly announced that biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted another breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the indication of monotherapy for the treatment of HER2-positive advanced colorectal cancer (CRC) in patients who have failed prior treatments with oxaliplatin, fluorouracil and irinotecan. Previously, JSKN003 had received breakthrough therapy designation from the CDE for platinum-resistant ovarian cancer (PROC) (not restricted by HER2 expression), as well as clinical trial approval from the U.S. Food and Drug Administration (FDA). It has also been granted Orphan Drug Designation by the U.S. FDA for gastric and gastroesophageal junction cancer. This latest designation in colorectal cancer further underscores its clinical value and global development potential across multiple refractory tumor types.","length":1141,"tagName":"p"},{"type":"text","content":"Colorectal cancer is among the most common malignancies worldwide. According to data from the International Agency for Research on Cancer (IARC), there were approximately 1.93 million newly diagnosed cases and about 903,900 deaths attributed to CRC globally in 2022, ranking third in incidence and second in mortality among all cancers. In China, CRC has the second-highest incidence after lung cancer, with over 500,000 new cases annually and a continuing upward trend. There are currently no HER2-targeted therapies approved in China for CRC. For patients with HER2-positive advanced CRC who have failed prior treatments with oxaliplatin, fluorouracil and irinotecan, the median progression-free survival (mPFS) of approved therapies is only 2.0 to 3.7 months, and the median overall survival (mOS) is approximately 7 to 10 months. There remains a significant unmet clinical need within this patient population.","length":913,"tagName":"p"},{"type":"text","content":"Clinical studies demonstrated that JSKN003 monotherapy exhibited notable efficacy and a favorable safety profile in patients with HER2-positive advanced CRC, showing meaningful clinical advantages over e...