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Photo = Yonhap news |
[Alpha Biz= Paul Lee] Yuhan Corporation is preparing for a major leap in the global oncology market, following the approval of Leclaza as a first-line treatment for EGFR-mutant non-small cell lung cancer (NSCLC) by the U.S. Food and Drug Administration (FDA) in August 2023. This milestone marked the first-ever FDA approval for a Korean-developed anti-cancer drug. As prescriptions expand beyond the U.S., Yuhan’s global market presence is strengthening.
In a report published on the 14th, NH Investment & Securities stated, "Leclaza is Yuhan’s first blockbuster drug to reach commercialization, serving as a key indicator of the company’s competitiveness in the global pharmaceutical industry." The report projects Leclaza’s global sales to reach $4.7 billion by 2032, with Yuhan expected to generate approximately $700 million in royalty revenue.
Yuhan has already launched Leclaza in the U.S. and is set to expand prescriptions to Europe and Japan this year. Notably, after receiving FDA approval for its use in combination therapy under the MARIPOSA trial, the drug is gaining strong preference among local physicians, driving expectations for increased market share. NH Investment & Securities forecasts Leclaza’s U.S. market share to reach up to 55% by 2030.
A key driver of Leclaza’s long-term growth is its overall survival (OS) improvement demonstrated in the MARIPOSA regimen. Clinical data revealed an OS extension of over 12 months compared to existing treatments, boosting confidence in the drug. Additionally, the anticipated approval of Rybrevant SC (subcutaneous formulation) between 2025 and 2026 is expected to enhance convenience and reduce side effects, accelerating prescription growth.
NH Investment & Securities further estimated that Yuhan’s operating profit will reach KRW 474 billion ($355 million) by 2027, driven by milestone payments and increased royalty revenue.
Beyond oncology, Yuhan is also focusing on YH35324, a next-generation allergy treatment for chronic spontaneous urticaria (CSU). The drug candidate has demonstrated superior UAS7 score improvement compared to Xolair, with a targeted market launch in 2031.
Alphabiz Reporter Paul Lee(hoondork1977@alphabiz.co.kr)
