Core Viewpoint - The company has received breakthrough therapy designation from the National Medical Products Administration of China for JSKN 003, a targeted HER2 bispecific antibody-drug conjugate, aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in all patient populations [1][4] Industry Summary - Ovarian cancer ranks as the third most common gynecological malignancy among women in China, with the highest mortality rate among female reproductive tract cancers, as approximately 70% of patients are diagnosed at an advanced stage [2] - Current treatment primarily involves tumor reduction surgery combined with postoperative platinum-based chemotherapy, but nearly all patients eventually develop resistance to platinum [2] - For platinum-resistant patients, non-platinum single-agent chemotherapy is the recommended treatment, but it has limited efficacy, with low objective response rates (ORR) and short median progression-free survival (PFS) and overall survival, indicating a significant unmet clinical need [2] Clinical Research Findings - A summary analysis of two clinical studies presented at the 2024 European Society for Medical Oncology (ESMO) annual meeting included 50 platinum-resistant participants treated with JSKN 003, showing an ORR of 56.8% and a disease control rate (DCR) of 95.5% [3] - Among 44 evaluable participants, 39 experienced tumor shrinkage, and the 6-month PFS rate was 44.7%, with HER2 expression levels influencing response rates [3] - The safety profile was favorable, with only 10% of participants experiencing grade 3 or higher treatment-related adverse events (TRAEs), and no treatment-related deaths reported [3] Ongoing Development - The Phase III clinical trial for this indication is currently in the enrollment stage and progressing smoothly [4] - JSKN 003 is also undergoing multiple Phase II and III clinical studies in China for the treatment of breast cancer, gastric cancer, colorectal cancer, and biliary tract cancer [4] - The breakthrough therapy designation is expected to expedite the development and review process, positioning JSKN 003 as a potential first-line anti-HER2 treatment for all platinum-resistant ovarian cancer patients [4]
石药集团(01093)：JSKN 003于中国获突破性治疗认定