Yuhan Corporation announced it will receive a $15 million milestone payment from Janssen Biotech, a Johnson & Johnson subsidiary, following the successful commercialization of its Lazertinib in combination with Janssen's Amivantamab in Japan. The milestone payment, equivalent to approximately 20.7 billion Korean won, is expected to be received within 60 days.
The payment was triggered by Japan's inclusion of Lazertinib (marketed as Leclaza in Korea and Ruziluclast in the U.S.) on the insurance benefit list for new drugs, marking the official market entry of the combination therapy. Japan's Ministry of Health, Labour and Welfare approved the Lazertinib-Amivantamab combination in March 2024 as a first-line treatment for EGFR-mutated non-small cell lung cancer (NSCLC).
Superior Clinical Outcomes Drive Approval
The Japanese approval was based on results from the Phase 3 MARIPOSA clinical trial conducted by Janssen Biotech, which enrolled 1,074 patients. The study compared the efficacy and safety of the Lazertinib-Amivantamab combination against the current standard of care, Osimertinib (Tagrisso), and Lazertinib monotherapy.
The combination therapy demonstrated significant clinical advantages, reducing the risk of disease progression or death by 30% compared to Osimertinib monotherapy. Patients receiving the combination achieved a median progression-free survival of 23.7 months, substantially longer than the 16.6 months observed with Osimertinib alone.
Duration of response also favored the combination therapy, with patients maintaining responses for a median of 25.8 months compared to 16.7 months for Osimertinib monotherapy—a difference of more than nine months. The median overall survival for the Lazertinib-Amivantamab combination is projected to extend by more than one year compared to Osimertinib monotherapy.
Market Projections and Financial Impact
Japan's Ministry of Health, Labor and Welfare projects that approximately 6,400 lung cancer patients will receive Lazertinib treatment over the next decade, representing a market opportunity of up to 13 billion yen. Beyond the current milestone payment, Yuhan Corporation will receive ongoing royalties based on local sales performance in Japan.
The Japanese market entry represents the third major regulatory milestone for the combination therapy under Yuhan's licensing agreement with Janssen. The companies signed the original license-out agreement in November 2018, valued at $1.255 billion total. Previous approvals generated substantial milestone payments: $60 million for U.S. FDA approval in August 2023 and $30 million for European Commission approval in January 2024.
Global Expansion Pipeline
The combination therapy's regulatory success continues to expand globally. Marketing approval in China is anticipated within 2024, which would trigger an additional $45 million milestone payment to Yuhan Corporation. The European launch, expected in the third quarter of 2024, represents a $30 million milestone opportunity.
The Lazertinib-Amivantamab combination addresses a significant unmet need in EGFR-mutated NSCLC, a patient population that represents a substantial portion of lung cancer cases in Asia. The therapy's demonstrated superiority over current standard-of-care treatments positions it as a potential new benchmark for first-line EGFR-mutated NSCLC treatment globally.
