South Korea’s Yuhan Corp. gained European Commission approval for its lung cancer drug Leclaza, marking the first Korean-developed treatment to receive EU authorization.
The drug, used in combination with Johnson & Johnson’s antibody treatment Rybrevant, targets non-small cell lung cancer. J&J holds global development and marketing rights through its Janssen Biotech unit.
The approval triggers a $30 million milestone payment to Yuhan, adding to the $210 million already received from licensing fees and US launch payments. The Korean drugmaker stands to earn royalties of 10-12% on European sales.
Yuhan’s deal with J&J could reach $950 million in total technology payments. The US healthcare giant has submitted marketing applications in China and Japan, with decisions expected in early 2025.
Leclaza, known generically as lazertinib, belongs to a class of targeted therapies called EGFR tyrosine kinase inhibitors. The drug works alongside Rybrevant, which received FDA accelerated approval in 2021, to block specific proteins involved in cancer growth.
