Yuhan Corporation has disclosed the current status of phase 1/2 clinical development and future plans for its investigational oral targeted therapy for lung cancer. The company plans to confirm initial clinical results by the end of this year and to initiate the next-stage clinical trial with an expanded patient population in early 2027.

Yuhan Corporation announced on the 14th that it presented, in poster form at the 2026 World Conference on Lung Cancer (WCLC) held at COEX in Seoul, the progress and future plans of the first-in-human phase 1/2 clinical study of its novel lung cancer treatment candidate ‘YH42946’.

YH42946 is an oral therapy that targets human epidermal growth factor receptor 2 (HER2), a protein involved in the growth and proliferation of cancer cells. HER2 is one of the proteins located on the cell surface, and in certain cancers, mutations in the related gene or overproduction of the protein can promote cancer cell growth.

Yuhan Corporation is developing YH42946 primarily for cancer patients with HER2 alterations and for patients with EGFR exon 20 insertion mutations. EGFR is also a protein involved in cancer cell growth, and when an exon 20 insertion mutation occurs, some lung cancers may respond poorly to existing therapies.

In particular, these patient groups are known to frequently develop brain metastases. Among existing treatments, some require intravenous administration or have usage restrictions due to adverse effects. As a result, there is demand for an orally administered targeted therapy that is convenient to take and can be effective against brain lesions as well.

YH42946 has been under development at Yuhan Corporation since it was in-licensed from J INTS BIO in 2023. According to Yuhan, in non-clinical studies the candidate showed antitumor activity in tumor models with HER2 mutations, HER2 gene amplification, HER2 protein overexpression, and EGFR exon 20 insertion mutations.

In simple terms, the candidate has been designed to broadly target cancers in which various forms of HER2-related abnormalities appear. In animal studies, efficacy was also confirmed in models with intracranial tumors. The related research was conducted jointly with Yonsei University and was published in February this year in the international journal ‘npj Precision Oncology’.

The ongoing phase 1/2 clinical trial targets patients with advanced or metastatic solid tumors harboring HER2 or EGFR exon 20 insertion mutations. The study is designed to assess the safety of the drug, determine an appropriate dosage, and evaluate whether it actually reduces tumor size.

In part 1 of the trial, doses are being escalated stepwise from 5 mg up to a maximum of 240 mg to assess adverse events and therapeutic effect. The study initially started with once-daily dosing, and based on analyses of how the drug is absorbed and maintained in the body, a twice-daily dosing cohort was subsequently added.

At certain dose levels, additional patients are being enrolled to further accumulate data on safety, drug concentration, and antitumor activity.

In part 2, two doses selected from those evaluated in part 1 will be compared to determine the recommended dose for future clinical trials. The company then plans to broaden the trial population to include other solid tumor patients with HER2 abnormalities.

Yuhan Corporation expects to derive results from part 1, including safety, tolerability, pharmacokinetics, and initial antitumor activity, by the end of this year. It then plans to select two dose levels and commence part 2 in early 2027.

Kim Yeol Hong, President and Head of R&D at Yuhan Corporation, said, “YH42946 is a candidate that can be orally administered to patients with solid tumors harboring HER2 abnormalities or EGFR exon 20 insertion mutations, and is expected to show efficacy even in brain metastases,” adding, “Through the ongoing clinical trial, we will evaluate its safety and antitumor activity, establish the recommended dose, and advance subsequent development.”

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