Alphamab Oncology announces biparatopic HER2-targeting ADC JSKN003 was granted fast track designation by FDA for the treatment of PROC

CAR-T Digest - August 2020

Weekly Digest - October 2025

28 October 2025: Alphamab Oncology announces biparatopic HER2-targeting ADC JSKN003 was granted fast track designation by FDA for the treatment of PROC

Alphamab Oncology’s biparatopic HER2-targeting ADC, JSKN003, has received Fast Track Designation (FTD) from the U.S. FDA for advanced or metastatic platinum-resistant ovarian, peritoneal, or fallopian tube cancer (PROC), regardless of HER2 expression
This follows multiple prior recognitions, including two BTD from China’s NMPA (for PROC and CRC) and an ODD from the FDA (for gastric/GEJ cancer), strengthening JSKN003’s global regulatory momentum
The FTD decision is supported by strong clinical data, with pooled analysis showing a 63% ORR and 7.7 month median PFS, and notably 72.2% ORR and 9.4 month PFS in HER2
JSKN003 addresses a major unmet need in PROC, where existing non-platinum regimens offer only 10-15% ORR and 3-4 months median PFS, emphasizing its potential to shift the treatment paradigm
JSKN003 with a Phase 3 trial ongoing in China and a Phase 2 trial cleared in the U.S., the FDA’s FTD is expected to accelerate global development and review, advancing JSKN003 as a potential new option for patients with limited therapies