Yuhan Corporation’s Lazertinib’s Promising Clinical Trial Results Boost U.S. Market Prospects

Yuhan Corporation’s key product Lazertinib (domestic brand name Leclaza) has shown promising data in clinical trials.

Yuhan Corporation has recently demonstrated its competitiveness in the global pharmaceutical market through successful research and development outcomes. The company’s key product, Lazertinib (domestic brand name Leclaza), has shown promising data in clinical trials, significantly increasing the likelihood of its official launch in the U.S. market.

On May 5, Ha Hyunsoo, an analyst at Yuanta Securities, maintained a buy recommendation for Yuhan Corporation, citing the positive results of Lazertinib. “Following the positive results of Lazertinib, Yuhan Corporation’s sales are expected to rise,” Ha stated, reflecting the optimistic outlook for the company’s financial performance.

Yuhan Corporation is currently conducting clinical research on the combination therapy of Lazertinib and Janssen’s Amivantamab (brand name Rybrevant). This combination therapy, named MARIPOSA, is being compared to AstraZeneca’s Osimertinib (brand name Tagrisso), the current standard first-line treatment for patients with non-small cell lung cancer (NSCLC) with EGFR mutations.

In October of the previous year, at the European Society for Medical Oncology (ESMO 2023), MARIPOSA was shown to be more effective than Osimertinib monotherapy, reducing the risk of cancer progression or death by about 30%. Notably, MARIPOSA demonstrated consistent efficacy regardless of brain metastasis, a significant advantage over existing treatments.

Recently, at the American Society of Clinical Oncology (ASCO 2024) annual meeting, additional results were presented, further solidifying MARIPOSA’s efficacy. The progression-free survival period for patients with circulating tumor DNA was extended from 14.8 months with Osimertinib monotherapy to 18.2 months with MARIPOSA therapy. For patients with liver metastasis, the survival period increased from 11 months with Osimertinib to 18.2 months with MARIPOSA.

MARIPOSA is currently applying for approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA’s decision on approval is expected around August 22. Given the combination therapy’s demonstrated advantages over the standard Osimertinib monotherapy, particularly for high-risk groups, the approval and subsequent sales prospects appear promising.

Non-small cell lung cancer (NSCLC) is a prevalent form of lung cancer, with EGFR mutations playing a critical role in its development and progression. Current standard treatments for NSCLC include tyrosine kinase inhibitors (TKIs) like Osimertinib, which target these mutations. However, the limitations and side effects of existing treatments highlight the potential benefits of new therapies like MARIPOSA.

Yuhan Corporation, with its history of research and development achievements, has partnered with Janssen Pharmaceuticals to combine Lazertinib with Amivantamab in the MARIPOSA study. This collaboration aims to provide a more effective treatment option for NSCLC patients, particularly those with high-risk factors.

The positive clinical trial results not only enhance Yuhan Corporation’s market position but also have significant economic and healthcare implications. Successful new treatments can improve patient outcomes and reduce the burden of disease, making the approval of MARIPOSA a highly anticipated development in the pharmaceutical industry.

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