Yuhan Corp. said on the 31st that Leclaza (ingredient name lazertinib), a new drug for non-small cell lung cancer licensed to Johnson & Johnson (J&J) in the United States, is entering full-scale commercialization in China, and the company will receive about 64 billion won in stepwise milestone payments.
The company transferred the global commercialization rights for Leclaza to J&J's pharmaceutical subsidiary Janssen in 2018, in a deal worth up to 1.4 trillion won. Since then, Janssen developed Leclaza as a combination therapy with its anticancer drug Rybrevant (amivantamab) and won approval from the U.S. Food and Drug Administration (FDA) in Aug. last year.
It subsequently received marketing approval in China from the National Medical Products Administration (NMPA) in July, following Europe, the United Kingdom, and Japan. Yuhan Corp. said, "Under the contract, Janssen Biotech is scheduled to make the milestone payment within 60 days from the date the invoice is received." The amount to be received this time is about 3.1% of Yuhan Corp.'s sales last year (2.0678 trillion won).
China is a country with a particularly high rate of mutations in the epidermal growth factor receptor (EGFR) targeted by Leclaza. Among Asian non-small cell lung cancer patients, the EGFR expression rate is about 50%, higher than that of Westerners (10–15%). Accordingly, some analysts say additional milestone revenue from the Chinese market is also expected.