CSPC Pharmaceutical Group Limited (Stock Code: 1093) announced that JSKN003, a biparatopic HER2-targeting antibody-drug conjugate co-developed by its subsidiary Shanghai JMTBIO Technology Co., Ltd. and Jiangsu Alphamab Biopharmaceuticals Co., Ltd., has been granted another Breakthrough Therapy Designation by the National Medical Products Administration in China. The new designation covers its use as monotherapy for patients with HER2-positive advanced colorectal cancer who have previously failed treatment with oxaliplatin, fluorouracil, and irinotecan.

According to the announcement, colorectal cancer ranks among the most common malignant tumors both globally and in China. For patients with HER2-positive advanced colorectal cancer resistant to standard treatments, current therapeutic options offer limited clinical benefit. Preliminary clinical studies of JSKN003 for this patient population have shown promising efficacy and a favorable safety profile.

At the 2025 American Society of Clinical Oncology Annual Meeting, a pooled analysis included data from 50 patients with HER2-overexpressing advanced gastrointestinal tumors across two clinical trials (JSKN003-101 in Australia and JSKN003-102 in China). Among 23 patients with HER2-overexpressing advanced colorectal cancer, the objective response rate reached 61.9%, the disease control rate was 95.2%, and the median progression-free survival was 13.77 months. The median duration of response was 12.06 months, and no cases of treatment-related discontinuation or death were reported within the group receiving the recommended Phase II dose.

This is the second Breakthrough Therapy Designation received by JSKN003 in China. The first was awarded in March 2025 for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. JSKN003 is currently undergoing multiple Phase II and III clinical trials in China for various solid tumors, including breast, ovarian, and gastric cancers. The newly granted designation is expected to further accelerate its development and review process, aiming to benefit more patients with cancer in the near future.