The title for Korea’s 31st homegrown novel drug goes to Yuhan’s lung cancer treatment, Leclaza.

On Monday, the Ministry of Food and Drug Safety announced its approval for the third-generation non-small cell lung cancer treatment, bringing relief to some 100,000 lung cancer patients in the country.

Leclaza is a swallowable tablet that can be taken at a fixed time every day, regardless of meals.

In clinical trials, the drug has shown an overall response rate of 58 percent and a progression-free survival of 11 months, meaning that a patient was able to live for that length of time without seeing a deterioration in health.

Leclaza is to be prescribed to non-small cell lung cancer patients who have advanced epidermal growth factor receptor mutations, as well as T90M mutations, even after receiving first and second-generation EGFR tyrosine kinase inhibitor therapies.

Leclaza has demonstrated a high blood-brain barrier penetration profile, and an excellent efficacy and tolerability in brain-metastasized lung cancer patients, according to Yuhan.

Lung cancer is the leading cause of cancer-related deaths in the country, having marked No. 1 mortality in Korea.

Divided into categories, there can be small cell lung cancer and non-small cell lung cancer, with the latter accounting for 85 percent of the total lung cancer cases.

EGFR mutations are commonly detected in the non-small cell cases, accounting for 30 to 40 percent of NSCLC patients in Korea.

Roughly 50 percent to 60 percent of NSCLC patients eventually form resistance to existing treatments. Lazertinib, as a third-generation novel drug, will be a highly needed alternative, and contribute to the progress of the overall Korean pharmaceutical industry, Yuhan said.

Global market researcher Global Data predicted in its recent report that the international NSCLC treatment market will grow from 21 trillion won ($19 billion) in 2019 to 36 trillion won in 2029.

This is the second novel drug Yuhan has obtained the MFDS authorization for, following gastritis treatment revaprazan in September 2005. It is also the first made-in-Korea novel drug in three years since HK inno.N’s heart burn drug tegoprazan in July 2018.

Yuhan licensed in lazertinib from Oscotec in 2015 and licensed it out to Janssen in 2018. Janssen has the rights to the drug in countries excluding Korea, and is currently undergoing a global phase 3 trial to use as an independent treatment and a combination therapy with existing drugs.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)