20/12/2025 Alphamab & CSPC's JSKN003 ADC received the FDA Breakthrough Therapy Designation for the Treatment of PROC Alphamab & CSPC's JSKN003 ADC received the FDA Breakthrough Therapy Designation for the Treatment of PROC (Ref) The US FDA granted the breakthrough therapy designation to Alphamab Oncology and CSPC Pharma's JSKN003 (biparatopic HER2-targeting ADC) for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian ca

28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC (Ref) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab entered a licensing agreement with JMT-Bio Technology (a wholly-ow

March 3rd Week, 2025 Regulatory Events 🎯 The US FDA granted traditional approval to Merck & Co./MSD’s pembrolizumab (anti-PD-1) + trastuzumab (anti-HER2) + fluoropyrimidine- and platinum-containing chemo for the first-line treatment of adults with locally advanced, unresectable/metastatic HER2+ve gastric/gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1 (Ref 1). The regimen was previously granted accelerated approval for this indication in May’21. ❓ Which other re