Alphamab Oncology announces IND application for innovative EGFR/HER3 dual payload bispecific ADC JSKN021 was officially accepted by CDE

CAR-T Digest - August 2020

Weekly Digest - March 2026

13 March 2026: Alphamab Oncology announces IND application for innovative EGFR/HER3 dual payload bispecific ADC JSKN021 was officially accepted by CDE

Alphamab Oncology has achieved a key regulatory milestone, as its Investigational New Drug (IND) application for the novel bispecific ADC JSKN021 has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), paving the way for clinical development
Building on this milestone, the company now plans to initiate a Phase 1 clinical trial targeting patients with advanced malignant solid tumors, aiming to translate its cutting-edge science into potential therapeutic benefit
At the core of this development is JSKN021 itself a first-in-class “2-in-1” dual payload bispecific ADC designed to target both EGFR and HER3, leveraging advanced glycan-specific conjugation technology to precisely attach two distinct cytotoxic agents with high stability and efficiency
This innovative architecture is supported by encouraging preclinical findings, where JSKN021 demonstrated potent tumor growth inhibition across cancers expressing EGFR, HER3, or both, and showed superior efficacy compared to single-payload ADCs in multiple CDX models
With this strong foundation, the upcoming Phase 1 study will focus on evaluating safety, tolerability, pharmacokinetics, and early antitumor activity, marking the beginning of JSKN021’s clinical journey and potentially opening a new chapter in overcoming resistance and tumor heterogeneity in cancer treatment