Yuhan’s lung cancer drug gets OK in Europe

Leclaza (ingredient: lazertinib), a new lung cancer treatment developed by South Korea’s Yuhan Corp. secured approval from the European Commission (EC)  as a combination therapy with a Johnson & Johnson’s (J&J) antibiotic, the company said on Monday.

With the approval, Lazertinib became the first antibiotic drug developed by a South Korean company.

With the approval, Yuhan is expected to receive a $30 million milestone from Johnson & Johnson. Depending on Leclaza's European sales, the company will receive more than 10~12% royalties.

Lazertinib, sold by Yuhan under the brand name Leclaza in South Korea, is an oral, third-generation, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Yuhan and Janssen Biotech for the treatment of NSCLC. 

Rybrevant, a fully human bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) with immune cell-directing activity, received accelerated approval from the FDA in May 2021.

Yuhan received an upfront payment of $50 million for the export of the Leclaza technology, and an additional $100 million for clinical progress. 

In September, the company earned $60 million in the US launch fees. Yuhan has up to $950 million in technology payments from Lectaza. 

Johnson & Johnson, which holds global development and marketing rights to Leclaza, has filed for marketing authorization in China and Japan, with approval expected in the first half of next year.

Write to Dae-Kyu Ahn and Ji-Hyun Lee at powerzanic@hankyung.com