Yuhan Corporation has recently showcased its growing competitiveness in the global pharmaceutical market with significant research and development successes. The company’s flagship product, Lazertinib (marketed domestically as Leclaza), has demonstrated encouraging data in clinical trials, paving the way for a potential launch in the U.S. market.
Ha Hyunsoo, an analyst at Yuanta Securities, reiterated a buy recommendation for Yuhan Corporation on May 5, citing the strong clinical results of Lazertinib. “Following the positive results of Lazertinib, Yuhan Corporation’s sales are expected to rise,” Ha stated, reflecting the bullish outlook on the company’s financial performance.
Yuhan Corporation is currently advancing clinical research on a combination therapy of Lazertinib and Janssen’s Amivantamab (Rybrevant). This therapy, named MARIPOSA, is being compared to AstraZeneca’s Osimertinib (Tagrisso), the current gold standard for first-line treatment of non-small cell lung cancer (NSCLC) with EGFR mutations.
In October 2023, at the European Society for Medical Oncology (ESMO), the MARIPOSA combination therapy demonstrated superior efficacy compared to Osimertinib monotherapy. It was shown to reduce the risk of cancer progression or death by approximately 30%. Importantly, MARIPOSA maintained consistent efficacy regardless of brain metastasis, offering a significant advantage over existing treatments.
Additional results presented at the American Society of Clinical Oncology (ASCO) 2024 further reinforced MARIPOSA’s efficacy. The progression-free survival period for patients with circulating tumor DNA 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 to 18.2 months with MARIPOSA.
MARIPOSA is currently under review for approval by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA’s decision is anticipated around August 22. Given the combination therapy’s demonstrated superiority over the standard Osimertinib monotherapy, particularly for high-risk groups, approval prospects are promising.
Non-small cell lung cancer (NSCLC) is a common form of lung cancer, with EGFR mutations significantly contributing to its development and progression. Standard treatments for NSCLC typically involve tyrosine kinase inhibitors (TKIs) like Osimertinib, which target these mutations. However, the limitations and side effects of current treatments underscore the need for more effective therapies like MARIPOSA.
Yuhan Corporation’s collaboration with Janssen Pharmaceuticals aims to provide a more potent treatment option for NSCLC patients, especially those with high-risk factors. The successful outcomes from clinical trials not only bolster Yuhan Corporation’s market position but also have profound economic and healthcare implications. New, effective treatments can substantially improve patient outcomes and reduce the disease burden, making the approval of MARIPOSA a highly anticipated event in the pharmaceutical industry.
As Yuhan Corporation continues to push the boundaries of cancer treatment, its innovative approach and strong partnership with Janssen highlight its commitment to improving patient care and expanding its global footprint in the pharmaceutical market.
