Ignis Therapeutics, a joint venture established by SK Biopharm and global investment firm 6D Capital, has submitted a New Drug Application (NDA) for the epilepsy drug Cenobamate to China’s National Medical Products Administration (NMPA), SK Biopharm announced on December 4. As a result, SK Biopharm is set to receive a $15 million milestone payment.

According to SK Biopharm, the milestone payment amounts to 21.05 billion KRW, equivalent to 5.9% of the company’s consolidated revenue of 354.89 billion KRW in 2023. A company representative stated, “The milestone payment will be received within 15 business days of the NDA submission.”

Ignis Therapeutics holds the commercial rights in the Greater China region for Cenobamate, Solriamfetol, and other CNS therapeutic candidates developed by SK Biopharm. Alongside Cenobamate, the innovative drug Solriamfetol, which was developed and approved by the FDA in the U.S., has also been submitted for NDA review in China.

Cenobamate has already been successfully commercialized in major global markets, including the U.S. and Europe. The NDA submission in China is expected to further bolster SK Biopharm's global expansion strategy. To mark the occasion, a joint ceremony was held in China, with Ignis Therapeutics CEO Aileen Long attending in person and SK Biopharm President Donghoon Lee participating via video conference.

Aileen Long stated, “We expect significant anticipation for Cenobamate in the Chinese market and will do our utmost to provide patients with a better quality of life.”

Donghoon Lee added, “China is one of the fastest-growing healthcare markets in the world. This NDA submission represents a critical milestone that could maximize the growth potential of Cenobamate.”