SK Biopharmaceuticals' Cenobamate Receives New Drug Approval in Japan... Entry into Three Northeast Asian Countries

[Financial News] SK Biopharmaceuticals' epilepsy treatment drug 'cenobamate' has received new drug approval in Japan. By securing approval in Japan, following Korea and China, the company has laid the foundation for expanding its global business in the three major Northeast Asian countries.
SK Biopharmaceuticals announced on the 16th that its partner, Ono Pharmaceutical Co., Ltd., has obtained new drug approval for cenobamate from the Ministry of Health, Labour and Welfare of Japan. The Japanese product name is 'Ekiscopuri'.
Cenobamate is a drug used for adult patients with partial seizure epilepsy whose seizures are not adequately controlled with conventional anticonvulsant treatment. It is estimated that there are approximately 1 million epilepsy patients in Japan.
This approval was based on the results of a multinational Phase 3 clinical trial (YKP3089C035) conducted on adult patients with partial seizure epilepsy in Korea, China, and Japan. In the trial, cenobamate add-on therapy met the primary endpoint by significantly reducing seizure frequency compared to placebo, and safety was also confirmed to be manageable.
With this approval in Japan, cenobamate has secured new drug approval in Korea, China, and Japan. It received approval in Korea in November 2025 and in China in December of the same year, and prescriptions began in China in March of this year.
The Japanese business is proceeding based on a technology export agreement with Ono Pharmaceutical Co., Ltd. In 2020, SK Biopharmaceuticals signed a development and commercialization agreement for cenobamate in Japan. Following this approval, the company will receive contractual milestones, although the specific amount has not been disclosed. It will also receive royalties based on future sales in Japan.
Cenobamate is currently approved in more than 45 countries and regions, including the United States and Europe. In the United States, SK Biopharmaceuticals' local subsidiary, SK Life Science, sells it directly, while in other regions, it is expanding its business through partner companies.
In Japan, clinical trials to expand the patient population are also underway. Ono Pharmaceutical Co., Ltd. is conducting Phase 3 clinical trials for adolescent and adult patients with generalized tonic-clonic seizures, and is also conducting Phase 3 clinical trials for pediatric patients with partial seizures.
SK Biopharmaceuticals CEO Donghoon Lee said, "Now that the foundation for entering major Northeast Asian markets connecting Korea, China, and Japan has been completed, we will focus on producing commercialization results that lead to actual prescriptions in each market."

[email protected] Jeong Sang-hee Reporter