South Korea’s Yuhan Corp. has achieved a significant breakthrough, securing approval from the U.S. Food and Drug Administration (FDA) for its lung cancer treatment, Lazertinib. The drug, marketed in South Korea as Leclaza, has been approved in combination with Johnson & Johnson’s Rybrevant for the first-line treatment of advanced non-small cell lung cancer (NSCLC). This marks a milestone as Lazertinib becomes the first antibiotic drug developed by a South Korean company to receive FDA approval.
The FDA’s decision is based on phase 3 clinical trial results that demonstrated the combination therapy’s effectiveness, reducing the risk of disease progression or death by 30% compared to AstraZeneca’s Osimertinib, the current market leader. The combination therapy also showed a nine-month longer progression-free survival period.
This approval could pave the way for Lazertinib to become South Korea’s first blockbuster drug, with potential annual sales exceeding 1 trillion won (approximately $750 million). Yuhan initially licensed Lazertinib to Janssen Biotech, a Johnson & Johnson subsidiary, in a deal worth up to $1.25 billion in 2018.
Yuhan’s success reflects South Korea’s growing presence in the global pharmaceutical industry, particularly in innovative drug development, although the sector is still emerging compared to its established biosimilar market.
