Yuhan Corp.'s Lazertinib has reached the second anniversary of its Aug. 19, 2024, U.S. Food and Drug Administration approval as a first-line combination treatment with Johnson & Johnson's Rybrevant for EGFR-mutated non-small cell lung cancer. The approval made Lazertinib the first South Korean-developed cancer drug to win FDA clearance. Since then, it has gained approvals in Europe, the United Kingdom, Japan, Canada and China, while reimbursement listings and prescription access have expanded in major markets. Yuhan's cumulative milestone receipts, including an upfront payment, have exceeded $300 million, with up to $650 million more available against global sales targets. Royalties, which are known to exceed 10% of net sales, rose to 7 billion won in the second quarter from 5.4 billion won in the first. Analysts expect the U.S. J-code for the subcutaneous Rybrevant Faspro, effective July 1, to improve hospital reimbursement and make the sales impact more visible from the third quarter. The Lazertinib-Rybrevant combination generated $546 million in global sales in the first half of the year, up about 70% from a year earlier, while Johnson & Johnson has set a sales target of about $5 billion for next year.