Yuhan Corporation presents clinical progress for HER2-targeted cancer drug YH42946

Yuhan Corporation has presented the research design and progress of its oral HER2-targeted therapy candidate, YH42946, at the 2026 World Conference on Lung Cancer (WCLC). The drug is being developed following a technology transfer from J-Ints Bio in 2023.

YH42946 is a small-molecule tyrosine kinase inhibitor (TKI) designed to target HER2 mutations, HER2 amplification/overexpression, and EGFR exon 20 insertion mutations. These factors are significant drivers in various solid tumors, including non-small cell lung cancer. Preclinical studies conducted in collaboration with Yonsei University demonstrated anti-tumor efficacy in both standard and intracranial tumor models, addressing a high unmet need for oral treatments capable of crossing the blood-brain barrier to treat brain metastases.

The ongoing Phase 1/2 clinical trial is evaluating the safety, tolerability, pharmacokinetics, and anti-tumor effects in adult patients with locally advanced or metastatic solid tumors. The study is currently in the dose-escalation phase (Part 1), with initial results regarding safety and preliminary efficacy expected by the end of 2026. Following this, a dose-optimization and expansion phase (Part 2) is scheduled to begin in early 2027.