Yuhan Corporation Reveals Phase 1 & 2 Clinical Trials for HER2-Targeted Therapy YH42946

[Financial News] Yuhan Corporation has unveiled the design for Phase 1 and 2 clinical trials of 'YH42946,' an oral anticancer drug targeting HER2, a protein involved in the growth of cancer cells.
Yuhan Corporation announced on the 14th that it presented the design of the first-in-human clinical study of YH42946 as a poster at the '2026 World Conference on Lung Cancer (WCLC)' held at the COEX Convention & Exhibition Center in Seoul.
YH42946 is an oral small-molecule tyrosine kinase inhibitor (TKI) targeting HER2. Yuhan Corporation has been developing it since receiving a technology transfer from J INTS BIO in 2023. It is being developed for patients with solid tumors, such as non-small cell lung cancer, who have HER2 abnormalities or EGFR exon 20 insertion mutations.
In nonclinical studies, YH42946 demonstrated antitumor effects in tumor models with HER2 mutations, amplification and overexpression, and EGFR exon 20 insertion mutations. Notably, efficacy was also confirmed in an intracranial tumor model used to evaluate the potential for brain metastasis.
The ongoing Phase 1 and 2 clinical trials evaluate safety, tolerability, pharmacokinetics (PK), and antitumor effects in patients with locally advanced or metastatic solid tumors with the relevant gene mutations.
In the Phase 1 clinical trial, the appropriate dose is being explored by gradually increasing the dose from 5 mg to a maximum of 240 mg. The trial began with once-daily (QD) administration as the standard and added a twice-daily (BID) administration group based on pharmacokinetic modeling results.
In the Phase 2 clinical trial, the recommended dose will be determined by comparing the two doses selected in Phase 1. Subsequently, the scope of evaluation will be expanded to include various solid tumors with HER2 abnormalities.
The primary evaluation criteria are safety and tolerability based on treatment-related adverse events. Pharmacokinetics and antitumor effects, including objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and progression-free survival (PFS), will also be evaluated.
Yuhan Corporation plans to obtain initial results from the dose-escalation phase of the Phase 1 clinical trial by the end of this year. Based on these results, the company plans to select the recommended dose and begin the Phase 2 clinical trial in early 2027.
"YH42946 could be a new oral treatment option for patients with solid tumors harboring HER2 abnormalities and EGFR exon 20 insertion mutations," said Yuhan Corporation's President overseeing R&D, Kim Yeol-hong. "We will continue to evaluate its safety and antitumor effects through clinical trials, establish the recommended dose, and pursue subsequent development."

[email protected] Jeong Sang-hee Reporter