Date: 08/01/25
Yuhan Corporation’s novel EGFR-targeting non-small cell lung cancer (NSCLC) therapy Leclaza (lazertinib) has received official marketing approval in China, further solidifying its global footprint. The Chinese National Medical Products Administration (NMPA) approved the combination therapy of Leclaza and Rybrevant (amivantamab), expanding the drug’s availability to the world’s three largest pharmaceutical markets: the U.S., Europe, and now China.
The application was submitted by Janssen, which holds global rights to Leclaza, for use in patients with EGFR-mutant progressive or recurrent NSCLC.
China represents the largest lung cancer market globally, accounting for over one-third of all lung cancer patients worldwide, with approximately 1 million diagnoses annually. Around 85% of these are NSCLC cases, and an estimated 40% of those patients carry EGFR mutations. As of 2020, the Chinese NSCLC treatment market had already surpassed 2 trillion KRW (~$1.5 billion USD).
With this regulatory milestone, Yuhan will receive a $45 million milestone payment from Janssen. Under the licensing agreement, milestone payments are triggered by approvals in the U.S., Europe, Japan, and China. In other regions, Yuhan receives royalties based on sales performance.
Previously, Yuhan received $60 million and $15 million in milestone payments for U.S. and Japan approvals, respectively. The payments for Europe and China are expected within this year, with additional royalties tied to future sales.
The Leclaza + Rybrevant combination is now approved in seven countries: the U.S. (since August 2024), Europe, South Korea, the U.K., Canada, Japan, and China. Regulatory processes are underway in other countries including Australia and Brazil. Notably, Germany has recognized the clinical value of the combination, with health insurance coverage anticipated in early 2026.
In the first half of 2025, global sales of the Leclaza + Rybrevant combination reached $320 million, nearly tripling from $116 million in the same period last year. Approximately 80% of this revenue—$252 million—was generated in the U.S. market.
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