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.
By Dae-Kyu Ahn and Ji-Hyun Lee
powerzanic@hankyung.com
