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Photo = Yonhap news |
[Alpha Biz= Kim Jisun] Yuhan Corporation's lung cancer treatment 'Leclaza' (ingredient: lazertinib, marketed as 'Rylaze' in the U.S.) has secured market approval in Europe following its U.S. approval. This marks the first time a domestically developed Korean anticancer drug has been approved in both the U.S. and Europe.
On Sunday (local time), Johnson & Johnson (J&J) announced that its subsidiary, Janssen Pharmaceutical's Innovative Medicines Division, received European Commission (EC) approval for the combination therapy of 'Rybrevant' (ingredient: amivantamab) and Yuhan's Leclaza. The approval applies as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R substitution mutations). The combination therapy had previously received a positive opinion for approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in August.
With this approval, Yuhan Corporation is expected to receive a milestone payment of $30 million (approximately KRW 44 billion) from Innovative Medicines. Following FDA approval in August and the subsequent U.S. launch in September, Yuhan received a $60 million (approximately KRW 88.5 billion) milestone payment.
Leclaza was initially developed by South Korean biotech company Oscotec and licensed to Yuhan in 2015. In 2018, Yuhan licensed the drug to Janssen for $1.255 billion (approximately KRW 1.7 trillion) to develop it as an EGFR-mutant NSCLC treatment. With its European expansion, the total revenue Yuhan could generate from the Leclaza licensing deal is expected to increase to approximately $240 million (approximately KRW 354 billion).
Yuhan has also applied for marketing approval in China and Japan. Depending on the review outcomes, additional milestone payments may be forthcoming.
AlphaBIZ Kim Jisun(stockmk2020@alphabiz.co.kr)
