Yuhan Corporation's Reclaza Marks One Year Since FDA Approval... Accelerating Additional Clinical Trials and Next-Generation Drug Development

Received $60 Million in Milestones from the US Over One Year
Conducting Clinical Trials Showing Over One-Year OS Improvement Compared to Standard Therapies
Expanding Open Innovation Model to Basic Science Fields

It has been exactly one year since Yuhan Corporation's lung cancer treatment, Reklaza (ingredient name: lazertinib), became the first domestic anticancer drug to receive approval from the US Food and Drug Administration (FDA). To date, Reklaza remains the only innovative new drug among domestic anticancer drugs to have received FDA approval. Yuhan Corporation plans to leverage Reklaza's successful entry into the US market as a springboard to further strengthen its competitiveness through additional clinical trials and to accelerate the development of next-generation pipelines.

Reclaza, the first domestic anticancer drug approved by the US FDA. Yuhan Corporation

According to industry sources on August 19, Reklaza, the 31st domestically developed new drug, received FDA approval on August 20 last year for combination therapy with Johnson & Johnson's Rybrevant (ingredient name: amivantamab). Over the past year, Yuhan Corporation has received milestone payments totaling $60 million (approximately KRW 8.3 billion) from the US. More than 10% of its sales are separately received as royalties from overseas sales. During the same period, the company also received $15 million (approximately KRW 2.08 billion) in milestone payments from Japan and has since obtained approvals in Europe, China, Canada, and the UK, furthering its global expansion efforts.

Efforts to strengthen Reklaza’s global competitiveness, such as additional global clinical trials, are ongoing. Notably, clinical trials are underway that are expected to improve overall survival (OS) by more than one year compared to standard therapies, and approval for the subcutaneous (SC) formulation of Rybrevant, which is prescribed in combination therapy, is being pursued. The SC formulation is currently approved in Europe, and global approvals, including in the US, are pending.

Building on Reklaza's success, Yuhan Corporation is also actively developing its next-generation pipeline. The allergy treatment Resigercet (YH35324) recently presented results from a Phase 1b clinical trial at the European Academy of Allergy and Clinical Immunology (EAACI), demonstrating strong immunoglobulin E (IgE) inhibition and symptom improvement in patients with chronic spontaneous urticaria.

In the field of immuno-oncology, YH32367 and YH35995 are gaining attention. YH32367 confirmed safety and antitumor activity in a Phase 1 clinical trial for patients with HER2-expressing solid tumors, and dose expansion studies are currently underway in Korea, Australia, and the United States. YH35995, which is being developed for the treatment of Gaucher disease, received Phase 1 clinical trial approval in July last year.

To drive innovative new drug development, Yuhan Corporation expanded its open innovation model this year to include the basic science sector, extending it to the exploration and candidate optimization stages, which precede preclinical trials. The open innovation approach involves selecting promising candidate substances from various biotech companies that possess technology but lack the capacity to conduct clinical trials independently, acquiring the technology through licensing-in, and then exploring the potential of these candidates through in-house clinical development. The company then pursues global clinical trials and commercialization by licensing-out to major global pharmaceutical companies.

In pursuit of its vision to become a global top 50 pharmaceutical company, Yuhan Corporation is also increasing its investment in research and development (R&D). The company invests more than 10% of its annual sales in R&D and plans to raise this ratio to over 20% in the future. Over the past five years, as sales have increased, Yuhan Corporation's total R&D investment has exceeded KRW 1 trillion.

A Yuhan Corporation representative stated, "The combination therapy of Reklaza and Rybrevant received approval from the US FDA in August last year, followed by approvals in Europe, Japan, and China within a year, and global expansion is still ongoing." The representative added, "As a company dedicated to developing innovative new drugs, we will continue to generate R&D results to become a global company."