Yuhan Corporation‘s Lung Cancer Drug ’LECLAZA®' in combination with ‘RYBREVANT®' Receives First U.S. Food and Drug Administration Approval for a Korea-Born Anticancer Drug

The U.S. Food and Drug Administration (FDA) has approved Yuhan Corporation (CEO: WookJe Cho)’s LECLAZA® (approved by FDA as LAZCLUZE™)plus Johnson & Johnson’s RYBREVANT®(amivantamab-vmjw) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Designated as a priority review by the FDA in February, the approval is based on positive results from the Phase 3 MARIPOSA study, which showed RYBREVANT® plus LECLAZA® reduced the risk of disease progression or death by 30 percent compared to osimertinib (median progression-free survival [PFS]: 23.7 months vs. 16.6 months) in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The median duration of response (DOR) was nine months longer with RYBREVANT® plus LECLAZA® vs. osimertinib (25.8 months vs. 16.8 months), a secondary endpoint of the study.

With this approval, the combination of LECLAZA® and RYBREVANT® is the first and only multi-targeted, chemotherapy-free combination regimen with demonstrated superior progression-free survival over osimertinib as a first-line treatment for patients with EGFR-mutant NSCLC. LECLAZA®, a highly selective, brain-penetrant, third-generation oral EGFR tyrosine kinase inhibitor (TKI), combined with RYBREVANT®, an EGFR and MET receptor-directed bispecific antibody with immune cell-directing activity, delivers the only multi-targeted combination with mechanisms of action in both the extra-and intracellular domains of EGFR.

With this FDA approval, Yuhan Corporation has achieved the first success of open innovation in its R&D investments. LECLAZA®, a non-small cell lung cancer treatment approved as the 31st domestically developed new drug in January 2021, received approval as a first-line treatment in Korea in June 2023 and obtained health insurance coverage within six months.

Starting from January 2024, LECLAZA®, which became eligible for domestic health insurance coverage, achieved approximately 20 billion KRW in prescriptions in the first quarter, and is expected to reach the goal of 100 billion KRW within the year.

"The FDA's approval of LECLAZA®is particularly significant as it marks the first major success of R&D investment through open innovation. We hope this approval serves not as an endpoint but as a milestone, laying the foundation for Yuhan to achieve its goal of becoming a Global Top 50 company," said Wook-Je Cho, CEO of Yuhan Corporation.

About Yuhan Corporation

Since its foundation by Dr. Il-Han Yoo in 1926, Yuhan Corporation has been dedicated to contributing to the health and happiness of humanity. The company upholds a corporate culture of trust and integrity, adhering to its core principles of producing superior pharmaceuticals, fulfilling its tax obligations faithfully, and reinvesting corporate profits back into society.

Yuhan Corporation has grown to become South Korea's leading pharmaceutical company by supplying a wide range of high-quality pharmaceuticals, consumer products, and veterinary medicines both domestically and internationally. The company is now accelerating its efforts to expand into overseas markets to become a global pharmaceutical company with a strong focus on R&D.

Yuhan Corporation serves as a model company in the Korean corporate landscape with a governance structure that separates ownership from management. It diligently fulfills its social responsibilities, striving to create greater social value. Rooted in its founding spirit, Yuhan Corporation is strengthening its ESG (Environmental, Social, and Governance) management, prioritizing patient-centered research and development, and is committed to delivering sustainable products and services.