Panagene said on Monday it signed a contract with Yuhan Corp. to jointly develop the original companion diagnostic (CDx), called PANAMutyper R EGFR, for Yuhan’s lung cancer drug Leclaza (lazertinib).

According to the FDA, a CDx is a medical device which provides information that is essential for the safe and effective use of a corresponding drug or biological product. It can also assist health care professionals in determining whether a particular therapeutic product's benefits to patients will outweigh any potential serious side effects.

Yuhan’s Leclaza is an oral third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with high selectivity for EGFR T790M mutations. This drug shows efficacy in non-small cell lung cancer (NSCLC) patients with brain metastasis due to high permeability of the Blood-Brain-Barrier (BBB).

Therefore, it is necessary to test for mutations in T790M before the prescription of Leclaza to enhance the therapeutic effect of the drug and reduce side effects, said the company.

Furthermore, a CDx is an essential element for prescribing targeted anticancer drugs.

However, due to the high technical difficulty that requires accurate detection of a small amount of target gene mutation, only a few large global diagnostic companies are competing in this market.

"This collaboration with Yuhan is more meaningful because it is the first time that a domestic pharmaceutical firm and a diagnostic company jointly develop an original companion diagnostic," a Panagene official said. "We will continue to develop platform technologies and products to strengthen the status of the domestic CDx market and grow to lead the global market."

A Yuhan official said that pursuing clinical trials and licensing of PANAMutyper R EGFR as the original companion diagnosis of Leclaza together with Panagene, a leader in domestic companion diagnosis, will be a new milestone in the development of CDx in Korea.