CSPC Pharmaceutical Group announced that JSKN003 (an antibody-drug conjugate targeting HER2 dual epitopes) developed by its subsidiary Shanghai Jinman Biotechnology Co., Ltd. and Jiangsu Alphamab Biopharmaceuticals Co., Ltd. has been granted Breakthrough Therapy Designation by the China National Medical Products Administration. The proposed indication is monotherapy for the treatment of all patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer ("the indication").

The annual incidence of ovarian cancer ranks third among female reproductive system tumors in China, and the mortality rate ranks first among female reproductive tract malignancies. About 70% of patients are in the advanced stage when they seek medical treatment. Tumor cell reduction surgery combined with postoperative platinum-containing chemotherapy is the current main treatment method, but almost all patients eventually develop platinum resistance. For patients with platinum resistance, non-platinum single-agent chemotherapy is the main treatment option recommended by domestic and international guidelines, but the efficacy is very limited, the objective response rate (ORR) is low, the median progression-free survival (PFS) and overall survival are short, and there is a huge unmet clinical need. The clinical study of JSKN003 in this indication has initially shown a breakthrough in efficacy, and its safety is good, with obvious clinical advantages compared with existing treatments.

The Phase III clinical trial of this indication is currently in the enrollment stage and is progressing smoothly. JSKN003 is also conducting multiple Phase II and Phase III clinical studies in China for the treatment of solid tumors such as breast cancer, gastric cancer, colorectal cancer, and biliary cancer. The granting of breakthrough therapy designation to JSKN003 will help further accelerate its research and development and review, making it likely to become the first anti-HER2 treatment for the entire population of patients with platinum-resistant ovarian cancer.

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