SK Biopharm Submits Cenobamate NDA in Japan Through Ono Pharmaceutical

New Drug Applications Completed in Korea, China, and Japan
Following Commercialization in 25 Countries

SK Biopharm announced on September 30 that its partner, Ono Pharmaceutical, has submitted a New Drug Application (NDA) for the innovative epilepsy treatment cenobamate to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

SK Biopharm

There are approximately 1 million epilepsy patients in Japan, and it is known that 30% of them do not respond effectively to existing antiepileptic drugs. The submission of this NDA is expected to provide a new treatment option for patients in Japan and drive the expansion of cenobamate’s presence in the Northeast Asian market.

The NDA submission is based on the results of a Phase 3 clinical trial (YPK3089C035) conducted in Korea, China, and Japan, targeting adult patients with partial-onset epilepsy. The study demonstrated the efficacy of cenobamate in patients whose seizures were not controlled by existing antiepileptic therapies. Based on these results, SK Biopharm’s partners in China and Korea submitted NDAs at the end of last year and earlier this year, respectively. With Ono Pharmaceutical’s NDA submission in Japan, the commercialization process has now begun in all three Northeast Asian countries.

Ono Pharmaceutical is an R&D-focused pharmaceutical company headquartered in Osaka, Japan. The company is dedicated to developing innovative drugs for diseases with high unmet medical needs, including cancer, immune disorders, and neurological conditions. In October 2020, SK Biopharm signed a technology export agreement with Ono Pharmaceutical for the development and commercialization of cenobamate in Japan. As a result, SK Biopharm will receive milestone payments for regulatory submission and approval, as well as sales milestones and royalties at the commercialization stage.

SK Biopharm has successfully commercialized cenobamate in 25 major global markets, including Europe, through direct sales in the United States and technology export. The company is currently seeking to expand the market by broadening indications and age groups. Recently, SK Biopharm obtained positive topline results from a Phase 3 clinical trial targeting generalized seizures in adolescents and adults. Detailed results from this clinical study will be presented at the 2025 American Epilepsy Society (AES) meeting in December.

Lee Donghun, CEO of SK Biopharm, stated, "Japan is the world’s second-largest epilepsy market as a single country, following the United States. The NDA submission marks a significant milestone, as cenobamate has now entered the commercialization process in Korea, China, and Japan, further strengthening our position in the Asian market."

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