Yuhan Corporation (000100.KS) is accelerating its leap into a global pharmaceutical company on the strength of its lung cancer drug Leclaza. The company is solidifying a virtuous earnings structure that extends beyond technology licensing into global commercialization and expanding royalty income. The market expects Yuhan to surpass 100 billion won in operating profit this year, following a similar feat last year.
According to financial information provider FnGuide on Wednesday, the consensus estimate for Yuhan's full-year revenue this year stands at 2.35 trillion won, with operating profit reaching 135.6 billion won. The figures represent year-on-year increases of 7.5% and 29.9%, respectively. Expanding milestone and royalty income from Leclaza is expected to drive earnings growth.
Yuhan has built a stable revenue structure that extends from technology licensing through global commercialization and sales royalties. The company recently received a $30 million (approximately 45 billion won) commercialization milestone from Janssen for Leclaza's European launch. Earlier, Yuhan secured commercialization milestones in the U.S. ($60 million), Japan ($15 million), and China ($45 million), bringing cumulative commercialization milestones to approximately $150 million.
Yuhan licensed Leclaza to Janssen, a Johnson & Johnson subsidiary, in 2018. The total deal value is approximately $950 million. To date, the company has received about $300 million (approximately 448 billion won), including upfront payments and development and commercialization milestones. This represents roughly one-third of the total deal value. Additional milestones tied to global sales expansion and sales royalties of more than 10% are also expected. A particular strength is that Yuhan can secure revenue without bearing marketing, logistics, or sales costs by leveraging its global pharmaceutical partner's sales network.
Yuhan is also moving quickly to secure next-generation growth engines beyond Leclaza. The company is strengthening its research and development (R&D) capabilities centered on oncology, immune diseases, and metabolic diseases, while improving development efficiency by focusing on pipelines with high commercialization potential.
The candidate drawing attention as the "post-Leclaza" asset is YH25724, a treatment for metabolic dysfunction-associated steatohepatitis (MASH). Based on a dual mechanism of action targeting both GLP-1 and FGF21, the candidate is seen as having high potential in the MASH market, where treatment options remain limited. The global MASH treatment market is forecast to grow to approximately $30 billion by 2030.
Notably, while existing treatments have shown efficacy mainly in early-stage patient populations, FGF21-based therapies are drawing market interest by demonstrating potential even in severely ill patients. Yuhan is refining its clinical and commercialization strategy based on the technology licensing experience accumulated through Leclaza.
In the immune disease field, allergy treatment Resigersept (YH35324) is undergoing global Phase 2 clinical trials. YH35995, a treatment for Gaucher disease, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). This establishes a foundation for market exclusivity and tax benefits, and safety has been confirmed in Phase 1 trials.
Yuhan is also reviewing the introduction of a "NewCo" model to enhance R&D efficiency and accelerate monetization. The strategy involves establishing independent legal entities centered on specific pipelines to attract external investment and speed up clinical development. The plan aims to disperse the cost burden that surges in late-stage clinical trials while concentrating investment on assets with high probability of success to maximize return on investment (ROI).
Leclaza's global competitiveness is also strengthening. Last year, Leclaza was listed as a preferred regimen in the U.S. National Comprehensive Cancer Network (NCCN) guidelines, laying the groundwork for expanded global prescriptions. The approval of a subcutaneous (SC) formulation of Janssen's EGFR-MET bispecific antibody Rybrevant, which is co-prescribed with Leclaza, is also a positive factor. While the existing intravenous (IV) formulation required administration times of up to five hours, the SC formulation has been reduced to about five minutes, significantly improving convenience for both patients and medical staff.
If overall median overall survival (mOS) data is secured going forward, survival benefits over competing drugs will be highlighted, accelerating global prescription expansion further. "With the NCCN preferred regimen listing, all conditions for prescription expansion have been secured," said Jung Hee-ryung, an analyst at Kyobo Securities. "The pace of prescription expansion is expected to accelerate further following the release of mOS data."
