SK Biopharm wins China approval for cenobamate, solriamfetol

SK Biopharmaceuticals CI

SK Biopharmaceuticals said Tuesday that its epilepsy drug cenobamate and sleep disorder treatment solriamfetol have received new drug application (NDA) approval from China’s National Medical Products Administration (NMPA), completing the review process roughly one year after submission.

The application was filed last December by Ignis Therapeutics, a joint venture established by SK Biopharmaceuticals and global investment firm 6 Dimensions Capital. SK Biopharmaceuticals holds about 41 percent of the entity.

Both cenobamate and solriamfetol were independently developed by the South Korean company, while Ignis leads their clinical development and commercialization in China. In 2021, the two companies signed a partnership covering Chinese rights and regulatory procedures for key pipeline assets including cenobamate and solriamfetol, and they have collaborated across all stages of clinical development and approval.

China is one of the world’s largest markets for central nervous system disorders, with more than 11 million people estimated to have epilepsy. The market for epilepsy treatments was valued at roughly $1.1 billion last year. The number of patients with obstructive sleep apnea (OSA) is estimated to exceed 170 million.

“This approval marks a significant step forward for patients in China living with central nervous system disorders,” said Dr. Eileen Long, CEO of Ignis Therapeutics. “We will work closely with SK Biopharmaceuticals to accelerate launch preparations so patients can benefit from these treatments as soon as possible.”

Lee Dong-hoon, CEO of SK Biopharmaceuticals, said, “This milestone reflects the long-standing collaboration between SK Biopharmaceuticals and Ignis Therapeutics. It also represents a key inflection point for the global expansion of cenobamate and solriamfetol. We will continue to work together to ensure Chinese patients gain timely access to these new therapeutic options.”