South Korean health authorities announced on Monday it has granted marketing authorization of Yuhan Corp.’s Leclaza (lazertinib mesylate monohydrate) for the treatment of patients with non-small cell lung cancer (NSCLC).

The approval marks the country’s 31st home-made novel therapy that was achieved in three years after marketing approval of HK inno.N’s gastroesophageal reflux disease drug K-cab (Tegoprazan).

Lung cancer is a leading cause of death in Korea, and NSCLC is the most common lung cancer, with 30 to 40 percent of NSCLC patients with positive epithelial growth factor receptor (EGFR) mutation. For these patients, first- and second-generation targeted cancer therapies are standard of care but more than half of them experience treatment resistance at some point due to mutations, representing a highly unmet medical need.

Yuhan`s Leclaza is a solution to address this resistance problem. It is known to have excellent efficacy even in the treatment of lung cancer that metastasizes to the brain as it can pass through the blood-brain barrier, according to the company.

Yuhan shares were trading up 1.11 percent at 72,900 won ($66.18) in morning trade on Tuesday.

By Park Yoon-gyun and Minu Kim

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