Yuhan’s lung cancer drug clears FDA hurdle for global debut

A new lung cancer treatment developed by South Korea’s Yuhan Corp. has secured approval from the US Food and Drug Administration (FDA) as a combination therapy with Johnson & Johnson’s (J&J) antibiotic drug, the US pharmaceutical company said on Tuesday.

Lazertinib, sold by Yuhan under the brand name Leclaza in South Korea, and J&J’s Rybrevant got the nod from the FDA as a first-line combination treatment of adult patients with advanced non-small cell lung cancer (NSCLC), based on their phase 3 clinical test results, according to J&J.

With the approval, Lazertinib became the first antibiotic drug developed by a South Korean company and is poised to become the country's first blockbuster drug with annual sales of over 1 trillion won ($750 million).

In 2018, Yuhan signed a licensing-out agreement of up to $1.25 billion for Lazertinib with Janssen Biotech Inc. of J&J for clinical trials and global approval. It is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).

In 2015, Yuhan purchased the Lazertinib substance license from Genosco, a Boston-based R&D arm of Oscotec Inc. in the phase of the substance development.

Lazertinib is also called Lazcluze.

“With this milestone, Rybrevant plus Lazcluze becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC,” J&J said in a statement.

Osimertinib, developed by AstraZeneca, is sold under the brand name Tagrisso. It dominates the EGFR-mutated NSCLC medication market.

NSCLC accounts for 80 to 85 percent of lung cancers, according to the American Cancer Society.

In clinical trials, the combination therapy of Rybrevant and Lazertinib reduced the risk of disease progression or death by 30 percent versus osimertinib with a nine-month-longer progression-free survival period, J&J added.

Yuhan had invested in some 50 non-listed biopharmaceutical companies with new drug candidates.

But it has changed its strategy late last year to directly purchase innovative drug candidates and lead their development. Out of its 33 new drug candidates in the pipeline, it has obtained 16 from outside companies.

South Korea’s innovative drug development is in its infancy. But it has built its strong presence in the biosimilar market, developing an average of 1.5 new biosimilars annually, led by Celltrion Inc.

Among the 56 biosimilars approved by the FDA in the first half of this year, South Korea claimed 12 to rank second in the market after the US with 24.

Write to Yu-Rim Kim and Young-Ae Lee at youforest@hankyung.com
 

Yeonhee Kim edited this article