The path has opened for SK Biopharmaceuticals' innovative epilepsy drug "cenobamate" and sleep disorder treatment "solriamfetol" to launch in China.
Cenobamate and solriamfetol are innovative new drugs independently developed by SK Biopharmaceuticals. They were first approved and launched in the United States and Europe, and have now succeeded in entering the Chinese market.
SK Biopharmaceuticals said on the 9th that "cenobamate (Chinese name 翼弗瑞®)" and the sleep disorder treatment "solriamfetol (Chinese name 翼朗清®)" received new drug application (NDA) approval from China's National Medical Products Administration (NMPA).
The approval came about a year after Ignis Therapeutics (hereinafter Ignis), a joint venture established by SK Biopharmaceuticals and global investment firm 6 Dimensions Capital, submitted its application in Dec. last year.
Considering that various forms of supplements are often required in China's new drug approval process, some say this review moved quickly.
The company said, "It proves the completeness of the submitted data and our globally competitive clinical and quality control capabilities," adding, "SK Biopharmaceuticals and Ignis closely cooperated throughout the approval process and communicated frequently with the Center for Drug Evaluation (CDE), an agency under the NMPA."
Ignis, the joint venture, will handle development and commercialization of cenobamate and solriamfetol in China. In 2021, SK Biopharmaceuticals signed a partnership with Ignis covering the rights in China and the overall approval procedures for key pipelines including cenobamate and solriamfetol.
Ignis has prepared marketing and sales strategies in anticipation of approval. The companies said the approval is expected to drive a full-fledged rise in Ignis' corporate value. SK Biopharmaceuticals holds about 41% equity and is using this as a foundation to further expand its business in China.
China is estimated to have more than about 11 million epilepsy patients. As of last year, the pharmaceutical market size was $1.1 billion (about 1.61 trillion won). The number of patients with obstructive sleep apnea is also estimated at more than 170 million. The company said it expects solriamfetol to become a treatment option for patients with excessive daytime sleepiness caused by obstructive sleep apnea.
Eileen Long, CEO of Ignis Therapeutics, said, "Cenobamate and solriamfetol are innovative therapies that will bring meaningful change to patients with central nervous system disorders in China," adding, "Based on our partnership with SK Biopharmaceuticals, we will move quickly to prepare for product launches so patients can receive treatment benefits as soon as possible."
Lee Dong-hoon, president of SK Biopharmaceuticals, said, "This approval in China is the result of long-term collaboration between SK Biopharmaceuticals and Ignis Therapeutics," adding, "It has become an important milestone for the global expansion of cenobamate and solriamfetol." Lee said, "The two companies will work closely together so patients in China can experience new treatment opportunities more quickly."