Alphamab Oncology announces anti-HER2 biparatopic ADC JSKN003 obtained orphan drug designation from the U.S. FDA for the treatment of GC/GEJ

CAR-T Digest - August 2020

Weekly Digest - August 2025

29 July 2025: Alphamab Oncology announces anti-HER2 biparatopic ADC JSKN003 obtained orphan drug designation from the U.S. FDA for the treatment of GC/GEJ

Alphamab Oncology’s anti-HER2 biparatopic ADC, JSKN003, received ODD from the U.S. FDA, strategically positioning the company for accelerated development and market exclusivity in gastric and gastroesophageal junction (GC/GEJ) cancer treatment
JSKN003 is developed using Alphamab’s glycan-specific conjugation platform, enabling a DAR of 4, and delivers a topoisomerase 1 inhibitor via HER2-targeted biparatopic binding and endocytosis
Clinical studies in Australia and China have shown promising safety and efficacy in heavily pretreated patients with high HER2-expressing solid tumors; results were presented at ASCO 2025
ODD will enable Alphamab to access regulatory and financial incentives such as tax credits, waived fees, fast-track approval, and up to seven years of U.S. market exclusivity if JSKN003 is approved