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Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Received Approval to Initiate a Phase III Clinical Study for Colorectal Cancer
Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003, independently developed by the Company, and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a Phase III clinical study (Study ID: JSKN003-005) for the treat
About this update from Alphamab Oncology
[{"type":"text","content":"SUZHOU, China, Oct. 27, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003, independently developed by the Company, and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a Phase III clinical study (Study ID: JSKN003-005) for the treatment of HER2-positive advanced colorectal cancer (CRC). This marks the fourth Phase III clinical study initiated for JSKN003, following the trials in HER2 low-expressing breast cancer, platinum-resistant ovarian cancer and HER2-positive breast cancer.","length":801,"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. China has a high incidence of CRC, with over 500,000 new cases diagnosed annually. Approximately 83% of patients are initially diagnosed at an advanced stage, and about 44% already have distant metastases to organs such as the liver or lungs. Despite advances in systemic therapies, the 5-year survival rate for patients with metastatic CRC remains below 20%, indicating a poor prognosis. 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":1168,"tagName":"p"},{"type":"text","content":"JSKN003 is a biparatopic HER2-targeting ADC independently developed based on Anbenitamab. It specifically binds to HER2 on the surface of tumor cells, internalizes, and releases a topoisomerase I inhibitor to exert its anti-tumor effects. JSKN003 demonstrates significant differentiated a...