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Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Was Granted Fast Track Designation by FDA for the Treatment of PROC
Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC), not restricted by HER2 expression. This marks another accelerated review recognition for JSKN003 from an internationally au
About this update from Alphamab Oncology
[{"type":"text","content":"SUZHOU, China, Oct. 28, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC), not restricted by HER2 expression. This marks another accelerated review recognition for JSKN003 from an internationally authoritative regulatory agency, following two previous Breakthrough Therapy Designations from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC) and an Orphan Drug Designation from the FDA for gastric cancer/gastroesophageal junction cancer (GC/GEJ) this year. As a significant milestone in its global development progress, this achievement fully validates the drug's substantial clinical potential and market prospects.","length":1011,"tagName":"p"},{"type":"text","content":"Ovarian cancer (OC) is one of the most common malignant tumors of the female reproductive system. Most patients are diagnosed at an advanced stage, and the disease is characterized by a high recurrence rate and significant treatment challenges. The standard treatment regimens recommended by authoritative guidelines both domestically and internationally include surgery combined with platinum-based chemotherapy and targeted therapy maintenance. However, about 80% of OC cases recur, and eventually progress to PROC, leaving patients with limited effective treatment options and poor prognosis. The U.S. National Comprehensive Cancer Network (NCCN) recommended single-agent non-platinum chemotherapy with or without bevacizumab as preferred regimens for PROC. However, these non-platinum chemotherapies demonstrate limited efficacy, with the objective response rate (ORR) of only 10% to 15%, a median progression-free survival (mPFS) of only 3 to 4 months, and a median overall survival (OS) of approximately 12 months, highlighting an urgent need for new treatment options.","length":1075,"tagName":"p"},{"type":"text","content":"The grant of FTD is based on the promising clinical data of JSKN003. The Company has presented a pooled analysis of the phase I clinical study in Australia (JSKN003-101, ...