
The success of Cenobamate is a symbolic event demonstrating the innovative capabilities of the Korean bio-industry. Since receiving U.S. FDA approval in 2019, its annual sales have surged, surpassing 500 billion Korean Won in 2024, with projections for sales exceeding 700 billion Korean Won this year. Even more astonishing is the sharp rise in operating profit margins, making it possible for this domestically developed new drug to achieve the world's number one market share. In terms of safety, Cenobamate also demonstrated excellent tolerability, with adverse event rates of 60% in the Cenobamate group and 53% in the placebo group, mostly mild to moderate in severity. Based on these results, SK Biopharmaceuticals plans to pursue a supplemental New Drug Application (sNDA) to the FDA for an additional indication for PGTC seizures. Detailed results are expected to be unveiled at the American Epilepsy Society (AES) meeting in December, which is anticipated to draw even greater attention from the global medical community. Currently, 30% of the 50 million epilepsy patients worldwide are refractory to existing treatments, and the expanded indication for Cenobamate is expected to offer new hope to millions of patients. Cenobamate's success not only proves the global competitiveness of K-Bio but also signifies a new turning point for the domestic pharmaceutical industry. In particular, the fact that this clinical trial was conducted simultaneously in 12 countries, including Korea, demonstrates K-Bio's capability to lead global clinical trials. Industry experts evaluate that Cenobamate has a high probability of achieving blockbuster sales of over 1 billion USD annually. However, challenges remain, such as competition from global pharmaceutical companies and the formulation of strategies to prepare for patent expiration. Nevertheless, Cenobamate's latest achievement holds symbolic significance, announcing to the world that Korea is transitioning from a mere producer of generic drugs to a powerhouse of innovative new drugs. Once FDA approval is completed in the second half of 2025, it will be recorded as the most successful global new drug in Korean bio-history.

