Alphamab oncology announces IND application for innovative EGFR/HER3 dual payload bispecific ADC JSKN021 was approved by the FDA

CAR-T Digest - August 2020

Weekly Digest - November 2026

02 November 2026: Alphamab oncology announces IND application for innovative EGFR/HER3 dual payload bispecific ADC JSKN021 was approved by the FDA

Alphamab Oncology announced that the FDA has approved the IND application for JSKN021, its independently developed EGFR/HER3-targeted dual-payload bispecific ADC, enabling the initiation of clinical development in the US

The approval supports the open-label, multicenter Phase 1 JSKN021-101 study in the US, which will enroll patients with locally advanced or metastatic solid tumors that have relapsed or are refractory to standard treatment, or have no approved treatment options
JSKN021’s Phase 1 study was previously approved in China, with the first patient dosed in June 2026; preliminary efficacy was observed during dose escalation, while clinical development in China is ongoing
JSKN021 is a first-in-class EGFR/HER3 bispecific ADC carrying two payloads: Topo-I; DAR 4 and MMAE; DAR 2, conjugated using glycosite-specific technology at defined sites on the antibody’s Fc region
Preclinical studies demonstrated greater tumor inhibition than single-payload ADCs, supporting its potential to address tumor heterogeneity and resistance