Core Viewpoint - The collaboration between Shanghai Jinmant Biotech Co., Ltd. and Jiangsu Kangning Jereh Biopharmaceutical Co., Ltd. has led to the development of JSKN003, a targeted HER2 bispecific antibody-drug conjugate, which has received breakthrough therapy designation from the National Medical Products Administration of China for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in the entire patient population [1][2]. Group 1 - Ovarian cancer ranks third in incidence among female reproductive system tumors in China and has the highest mortality rate among malignant tumors of the female reproductive tract, with approximately 70% of patients diagnosed at an advanced stage [1]. - Current treatment methods primarily involve tumor reduction surgery combined with postoperative platinum-based chemotherapy, but nearly all patients eventually develop platinum resistance [1]. - For platinum-resistant patients, non-platinum single-agent chemotherapy is the main treatment recommended by domestic and international guidelines, but its efficacy is limited, with low objective response rates (ORR) and short median progression-free survival (PFS) and overall survival [1]. Group 2 - Clinical studies of JSKN003 have shown preliminary efficacy breakthroughs in the specified indication, with good safety profiles and significant clinical advantages compared to existing treatment methods [1]. - The Phase III clinical trial for this indication is currently in the enrollment stage and is progressing smoothly [2]. - JSKN003 is also undergoing multiple Phase II and III clinical studies in China for the treatment of other solid tumors, including breast cancer, gastric cancer, colorectal cancer, and biliary tract cancer [2].
石药集团：JSKN003于中国获突破性治疗认定