[Edaily Reporter YU JIN-HEE ] “Antipuramin,” the first drug developed in-house by Yuhan(000100), was born in 1933 from Dr. Yoo Il-han’s resolve to provide affordable, high-quality over-the-counter medicines to fellow Koreans suffering from disease and poverty. Developed with the professional medical guidance of his wife, Dr. Ho Mi-ri—a pediatrician—and successfully localized despite challenging conditions, Antipuramin marked the great beginning of pharmaceutical research and development (R&D) in South Korea. Now, some 90 years later, Yuhan Corporation’s spirit of technological self-reliance has blossomed into a global blockbuster drug that is transforming the paradigm for cancer patients worldwide.

Celebrating its 100th anniversary this year, Yuhan has broken free from the mold of a traditional pharmaceutical company and has successfully transformed itself into a sophisticated, R&D-driven global biotech firm. Its persistent long-term investment—boldly allocating 10% to 20% of annual revenue to R&D—is finally bearing fruit in the global market.

Lecraza Secures U.S. FDA Approval... Becoming the Global Standard for Lung Cancer Treatment

The key player that ended Yuhan Corporation’s history of setbacks in innovative drug development and elevated South Korea to the status of a powerhouse in new drug development is “Lecraza” (active ingredient: lazertinib), a treatment for non-small cell lung cancer. As South Korea’s 31st domestically developed new drug, Lecraza set a historic milestone by becoming the first Korean anticancer drug to receive approval from the U.S. Food and Drug Administration (FDA) for use in combination therapy with “Libravant” (active ingredient: amivantamab), an anticancer drug developed by global pharmaceutical giant J&J. This was a major event signifying that South Korea’s new drug development capabilities—which had previously been considered peripheral—were recognized by the world’s most authoritative regulatory agency.

As a third-generation EGFR-targeted anticancer drug, Lecraza demonstrated exceptional clinical efficacy and safety in patients with EGFR mutations resistant to existing treatments and in those with brain metastases. A large-scale global clinical trial (MARIPOSA) confirmed remarkable improvements in progression-free survival (PFS) and overall survival (OS) compared to standard therapy. Furthermore, it has established itself as the new standard of care for lung cancer treatment globally by demonstrating an overwhelming response rate even in patients with brain metastases—a particularly challenging group to treat. Following approval in the U.S., the drug is steadily securing approvals in major global markets such as Europe, Japan, and China, expanding Yuhan Corporation’s global footprint.

This year, in particular, as the company marks its 100th anniversary, is expected to be a turning point that further accelerates the global commercial expansion of Lecraza. This is because efforts to improve administration convenience—currently underway in collaboration with J&J—are driving market expansion. The existing intravenous (IV) formulation required several hours just for administration, placing a significant burden on both patients and healthcare providers. However, the subcutaneous (SC) formulation developed by J&J and approved by the FDA has dramatically reduced administration time to just 5 minutes.

Innovations have been achieved not only in terms of convenience but also in safety. The incidence of injection-related adverse reactions (IRR) has plummeted from 66% to 13%—a reduction to just one-fifth of the previous rate. Coupled with this year’s approval of the “once-monthly dosing regimen,” the adoption rate of combination therapy at major global hospitals is on an explosive upward trajectory. Yuhan Corporation has secured a contract entitling it to receive royalties of over 10% of Lecraza’s global sales; the licensing revenue and milestone payments expected in the future are anticipated to propel Yuhan Corporation’s financial structure to the next level.

Just as great as Lecraza’s industrial achievements is the “humanism” demonstrated by Yuhan. Yuhan launched an “Early Access Program” (EAP) to supply the drug free of charge until Lecraza was covered by national health insurance. It was a bold decision to forgo hundreds of billions of won in sales for the sake of lung cancer patients who would otherwise have to forgo treatment due to the high cost of the medication. Ultimately, 895 patients benefited from this program, and their lives were saved. This is regarded as an example of how the spirit of the company’s founder, Dr. Yoo Il-han—who once said, “Let’s make the best medicine to help our fellow citizens”—is being put into practice 100 years later in the modern era.

Launching the “Post-Lecraza” Era... Next-Generation Growth Led by Resigercept and YH35995

However, Yuhan is not resting on its laurels following the success of Lecraza. Led by CEO Cho Wook-je, Yuhan’s management defines Lecraza’s success not as an endpoint, but as the starting point of a “virtuous cycle of R&D.” The substantial royalty revenue generated from Lecraza is being reinvested in full into the next-generation pipeline to discover “the second and third Lecrazas.” The pace is also accelerating for the follow-up candidates that will drive Yuhan Corporation’s publicly declared goal of becoming a “Global Top 50” pharmaceutical company.

The leading candidate is “lesigercept” (YH35324), an innovative new drug candidate for the treatment of allergic diseases. Lesigercept, a next-generation anti-IgE biologic, garnered significant attention from the academic community during its Phase 1 clinical trial by demonstrating a markedly superior and sustained IgE-inhibiting effect compared to the existing global blockbuster treatment, omalizumab (brand name Xolair).

After successfully obtaining approval for its Phase 2 clinical trial application (IND) in South Korea in 2025, Yuhan Corporation has now fully launched a large-scale, multinational Phase 2 clinical trial involving 150 participants across Japan, China, and Europe. The key commercial differentiator that sets Resigercept apart is that its clinical design includes the “omalizumab-refractory patient group”—patients who do not respond to existing Xolair treatment—to directly verify its therapeutic efficacy in this population. Market experts generally agree that if efficacy in this refractory patient group is demonstrated in the Phase 2 trial, the scale of a global technology export (L/O) deal could surpass that of Lecraza.

Another key pillar is “YH35995,” a treatment for Gaucher disease, a rare inherited disorder. Gaucher disease is a fatal lysosomal storage disorder (LSD) caused by a deficiency of a specific enzyme in the body, which prevents the metabolism of a lipid substance called glucoserebroside (GL1), leading to its accumulation in the liver, spleen, skeletal system, and brain tissue and resulting in systemic dysfunction. Yuhan Corporation’s in-house development candidate, YH35995, is an oral glucosylceramide synthase (GCS) inhibitor.

YH35995’s competitive edge lies in its molecular design, which enables the drug to effectively cross the “blood-brain barrier” (BBB). Existing Gaucher disease treatments cannot cross the BBB, limiting their therapeutic utility for patients with Type 2 and Type 3 Gaucher disease, who experience neurological symptoms. Yuhan Corporation has secured excellent preclinical data demonstrating overwhelming BBB permeability and long-term suppression of GL1 accumulation in brain tissue. Following IND approval for a Phase 1 clinical trial in 2024, a dosing study in healthy volunteers is proceeding smoothly. Given the nature of the global rare disease market, where unmet needs are extremely high, the likelihood of a large-scale global technology export and Fast Track designation is considered very high.

Yuhan Corporation’s pipeline diversification strategy is built on a robust “virtuous cycle of the R&D ecosystem,” in which the commercial success of Lecraza serves as a catalyst for the development of next-generation new drugs, which in turn secure future growth engines. The clinical pipeline, which has expanded across the fields of oncology, immunology, and metabolic diseases—including Resigersept, YH35995, and treatments for metabolic-associated steatohepatitis (MASH)—demonstrates why Yuhan is a sustainable enterprise.

A century ago, the founder’s humble yet profound belief—“Let us help our fellow Koreans with the best products”—has now evolved into innovative new drugs that save the lives of patients worldwide, powered by cutting-edge biotechnology. Building on the success of Lecraza and meticulously constructing a next-generation pipeline to lead the coming century, Yuhan Corporation now stands at the center of a great inflection point that will reshape the global biotech market. Through continuous investment in R&D and global expansion, Yuhan Corporation’s vision for the next 100 years—“Great & Global”—is already becoming a reality.