SK Biopharmaceuticals' Cenobamate and Solriamfetol Receive NDA Approval in China

Swift Approval Completed in About One Year After Application

On December 9, SK Biopharmaceuticals announced that its innovative epilepsy drug "Cenobamate" and sleep disorder treatment "Solriamfetol" have received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) of China.

This approval was granted for the application submitted in December last year by Ignis Therapeutics (Ignis), a joint venture established by SK Biopharmaceuticals and global investment firm 6 Dimensions Capital. The review process was completed in about one year. Considering that the new drug approval process in the Chinese pharmaceutical sector typically requires various forms of supplementation, the review of Cenobamate and Solriamfetol is being evaluated as having proceeded swiftly.

The NMPA is an institution that integrates and reviews various evaluation items, including clinical evidence, quality control, and manufacturing facility verification. Throughout the approval process, SK Biopharmaceuticals and Ignis have worked closely together, applying a submission strategy that simultaneously considers compliance with local Chinese guidelines through communication with the Center for Drug Evaluation (CDE) under the NMPA, as well as global clinical design strategies.

Cenobamate and Solriamfetol are innovative drugs independently developed by SK Biopharmaceuticals. Their development and commercialization in China will be carried out by Ignis. In 2021, SK Biopharmaceuticals entered into a partnership with Ignis covering rights and approval procedures for major pipelines, including Cenobamate and Solriamfetol, in China. With the approval of these two new drugs, the corporate value of Ignis is expected to rise significantly. SK Biopharmaceuticals holds approximately a 41% stake in Ignis, which is anticipated to provide a foundation for further expansion of its business in China.

The number of epilepsy patients in China is estimated to exceed 11 million, making it one of the world's largest markets, valued at 1.1 billion dollars (approximately 1.6173 trillion KRW) as of 2024. The number of patients with obstructive sleep apnea (OSA) is also estimated to be over 170 million, and Solriamfetol is expected to become a treatment alternative for patients suffering from excessive daytime sleepiness due to OSA. With the approval of these two new drugs, Ignis plans to enhance access to central nervous system disorder treatments in Greater China and continue its efforts to provide new treatment options for local patients.

Aileen Long, CEO of Ignis, stated, "Cenobamate and Solriamfetol are innovative therapies that will bring meaningful change to patients suffering from central nervous system disorders in China. Based on our partnership with SK Biopharmaceuticals, we will expedite preparations for product launch to ensure that patients can benefit from these treatments as soon as possible."

Lee Donghoon, CEO of SK Biopharmaceuticals, commented, "This approval in China is the result of long-term collaboration between SK Biopharmaceuticals and Ignis Therapeutics, and it marks an important milestone for the global expansion of Cenobamate and Solriamfetol. Both companies will continue to work closely together to ensure that Chinese patients can experience new treatment opportunities more quickly."

This content was produced with the assistance of AI translation services.