SK Biopharmaceuticals Launches Cenobamate in Japan

SK Biopharmaceuticals has officially launched its epilepsy treatment cenobamate in Japan, completing its market entry in all three Northeast Asian countries. The drug, developed and commercialized with local partner Ono Pharmaceutical Co., Ltd., is now available in Japan under the brand name Ekiscorpri, starting sales on November 13.

This marks SK Biopharmaceuticals' success in securing all three major Asian markets following its earlier launches in China in March and South Korea in November. Japan ranks as the world's second-largest epilepsy market after the United States, with an estimated 1 million local patients. The drug comes in four dosage strengths, ranging from 12.5 mg to 200 mg, and was tested in a Phase 3 clinical trial across South Korea, China, and Japan.

In adult patients with partial-onset seizures not controlled by existing treatments, cenobamate showed a significantly higher seizure freedom rate at 2.6% compared to placebo. Adverse reactions were mainly dizziness and somnolence. Prior to the Japan launch, SK Biopharmaceuticals signed a technology export agreement with Ono Pharmaceutical in October 2020.

With the market now established, SK Biopharmaceuticals aims to generate royalty revenue proportional to sales. Cenobamate has secured approval in approximately 50 countries and regions, including the U.S., where SK Life Science handles direct sales, while the company pursues a dual-track strategy in other regions through local partnerships.

SK Biopharmaceuticals' President, Lee Dong-hoon, stated that the company has established a commercialization base in major Northeast Asian markets and intends to expand its successful U.S. strategy into Asia, tailoring approaches to each region's unique characteristics.