SK Biopharm said on the 30th that Ono Pharmaceutical, its partner in Japan, has submitted a new drug application (NDA) for cenobamate to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. With this, all three Northeast Asian countries have begun commercialization procedures.
SK Biopharm's partners in China and Korea each submitted an NDA at the end of last year and early this year, respectively, based on the results of a phase 3 clinical trial conducted in adult patients with focal-onset epilepsy in Korea, China, and Japan.
In October 2020, SK Biopharm signed a technology export agreement with Ono Pharmaceutical for the development and commercialization of cenobamate in Japan, under which it will receive filing and approval milestones, as well as milestones (stepwise technology fees) and royalties (a certain portion of sales revenue) according to the commercialization stage.
Meanwhile, SK Biopharm has commercialized cenobamate in 25 key global markets, including Europe, through direct sales in the United States and technology export. It recently secured positive results in a phase 3 clinical trial of generalized seizures in adolescents and adults conducted to expand the indication (treatment scope). Detailed clinical results are scheduled to be presented at the 2025 American Epilepsy Society meeting in December.
SK Biopharm President Lee Dong-hoon said, "Japan is a key market, ranking second in the global epilepsy market as a single country after the United States," adding, "With cenobamate entering commercialization procedures in the three countries of Korea, China, and Japan, we expect to broaden our foothold in the Asian market and offer new treatment opportunities to more patients."