Core Insights - Corning Jereh Pharmaceutical-B (09966.HK) announced that JSKN003 has received Fast Track Designation (FTD) from the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, marking a significant milestone in its global development process [1] - JSKN003 has also been approved by the FDA to conduct a Phase II clinical trial for the same indication and has received Breakthrough Therapy Designation from the National Medical Products Administration for both PROC and colorectal cancer, as well as Orphan Drug Designation for gastric/gastroesophageal junction cancer [1] - The FTD designation underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 as a new treatment candidate [1] Clinical Data Summary - The FTD for JSKN003 is based on promising clinical data, with a summary analysis presented at the 2025 American Society of Clinical Oncology Annual Meeting, which included 46 PROC patients [2] - Among these patients, 21 had HER2 IHC 0 (45.7%) and 18 had HER2 IHC 1+, 2+, and 3+ (39.1%), with an overall objective response rate (ORR) of 63.0% and a median progression-free survival (mPFS) of 7.7 months [2] - In patients with HER2 IHC 1+, 2+, and 3+, the ORR was 72.2% and mPFS was 9.4 months, indicating robust PFS benefits across different HER2 expression levels [2] Market Need - Ovarian cancer is one of the most common malignant tumors of the female reproductive system, with most patients diagnosed at an advanced stage, leading to high recurrence rates and poor prognosis [3] - Treatment options for PROC patients are limited, with existing non-platinum single-agent chemotherapy regimens showing an ORR of only 10% to 15%, mPFS of approximately 3 to 4 months, and a median overall survival of about 12 months, highlighting a significant unmet clinical need [3] - The FTD is expected to accelerate the clinical development and regulatory review process for JSKN003, providing new treatment options for PROC patients globally [3]
康宁杰瑞制药-B(09966.HK)JSKN003获美国FDA授予用于治疗PROC的FTD