Yuhan Corp., a Korean pharma giant that developed the lung cancer drug Leclaza (lazertinib), is expected to begin phase 1 and 2 trials in Korea for another lung cancer drug in oral form.

According to a Thursday update from the Ministry of Food and Drug Safety on domestic clinical trials, the regulator approved “an open-label, multicenter, first-in-human phase 1 and 2 study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of YH42946 in patients with locally advanced or metastatic solid tumors with human epidermal growth factor receptor 2 (HER2) abnormalities and epidermal growth factor receptor (EGFR) exon 20 insertions.”

The trial in Korea will take place at Severance Hospital in central Seoul. 

YH42946, which Yuhan acquired from J Ints Bio in 2023, is an oral tyrosine kinase inhibitor (TKI) that targets HER2 abnormalities in non-small cell lung cancer (NSCLC). This candidate drug specifically targets the HER2 exon 20 insertion mutation.

In the U.S. in May 2024, YH42946 received approval from the FDA for a phase 1/2 clinical trial.

"YH42946 was introduced at the preclinical stage through an open innovation approach, and we were able to quickly enter the clinical stage as a result of our collaboration with the original developer as well as our own additional research," said Yuhan Corp. R&D President Kim Yeol-hong. 

"YH42946 is one of the next targeted anti-cancer drugs in our pipeline following Leclaza, and we plan to start recruiting patients in Korea and the U.S. in the second half of the year."