[2024 JPMHC] Yuhan Corporation "Second Reclarza Rises to Global 50"

"By 2026, we will launch two or more innovative new drugs including 'Reclaza'. We aim to achieve annual sales of 4 trillion KRW and leap into the global top 50 pharmaceutical companies." (Kim Yeolhong, President of R&D at Yuhan Corporation)

Following the recent FDA approval application for the domestic new drug Reclaza (active ingredient: Lazertinib), Yuhan Corporation has set a goal to develop additional blockbuster new drugs. Kim Yeolhong, President of Yuhan Corporation, announced this on the 9th (local time) during a presentation and press conference at the JP Morgan Healthcare Conference (JPMHC) held in San Francisco, California, USA.

Reclaza, developed by Yuhan Corporation as a treatment for non-small cell lung cancer, is considered a candidate for the "first domestic global blockbuster new drug." In South Korea, health insurance coverage for both first- and second-line treatments with Reclaza as a monotherapy began this year. Overseas, Johnson & Johnson (J&J) Innovative Medicine, which licensed the technology, applied for FDA and European Medicines Agency (EMA) approval at the end of last year for a combination therapy of Reclaza and J&J's targeted anticancer drug 'Rybrevant (Amivantamab)'. Approval is expected to be decided within this year.

At the JPMHC presentation on the 8th, J&J CEO Joaquin Duato mentioned, "If the Reclaza-Rybrevant combination therapy is launched, it will be the first EGFR-mutated non-small cell lung cancer first-line treatment without chemotherapy," and expressed high expectations, forecasting annual sales of 5 billion USD (approximately 6.6 trillion KRW). President Kim also stated, "We have confirmed clinical evidence superior to existing treatments," and "It will establish itself as the global first-line standard treatment." Regarding the overseas expansion potential of the monotherapy, he explained, "We will cooperate with J&J to provide reference when commercializing in countries where combination therapy is economically burdensome."

President Kim referred to the Reclaza monotherapy Phase 3 trial (LAZER 301) and the combination therapy Phase 3 trial (MARIPOSA) conducted by J&J, saying, "Based on the experience of conducting global Phase 3 clinical trials, we will prepare the next new drug." He added, "We will focus on three areas where Yuhan Corporation excels: oncology, metabolic diseases, and immune diseases, and utilize open innovation if necessary."

Yuhan Corporation's highlighted pipeline includes the allergy treatment 'YH35324' and the immuno-oncology drug 'YH32367'. These are substances secured through open innovation from GI Innovation (GI-301) and ABL Bio (ABL105), respectively, and are currently in Phase 1 clinical trials. Im Hyo-young, Head of Clinical Medicine, explained, "We are striving to accelerate the clinical progress of various new drug substances," and added, "For YH32367, interim clinical results confirmed a reduction in immunoglobulin E (IgE) in the blood, which causes allergies, compared to Novartis's competing drug 'Xolair'."

Interest was also expressed in emerging new therapeutic platforms. Lee Young-mi, Head of R&D, said, "We are actively reviewing future-oriented modalities such as antibody-drug conjugates (ADC) and targeted protein degradation (TPD)," and added, "In the case of TPD, we have started basic research that could enable in-house development." The plan includes reviewing various pipelines in the future and pursuing mergers and acquisitions (M&A) if necessary.

This content was produced with the assistance of AI translation services.