SK Biopharm Epilepsy Treatment, Clinical Trials in Korea, China, and Japan... "Full-Scale Development in Asia"

SK Biopharm Epilepsy New Drug 'Cenobamate'

[Asia Economy Reporter Choi Dae-yeol] SK Biopharm announced on the 10th that its domestic Phase 3 clinical trial plan for the epilepsy treatment Cenobamate has been approved by the Ministry of Food and Drug Safety. This new drug was previously approved and launched first in the United States.

According to the company, in China, they applied for Phase 1 and Phase 3 clinical trial plans for this treatment in June and are currently awaiting approval results. In China, clinical trial results involving local citizens are required, so they decided to conduct both clinical trials simultaneously. Next month, they plan to submit the Phase 3 clinical trial plan to the Pharmaceuticals and Medical Devices Agency under the Ministry of Health, Labour and Welfare in Japan.

The company stated that once clinical trial plan approvals are obtained in each country, they will conduct an Asian Phase 3 clinical trial involving about 500 Japanese, Chinese, and Korean participants. Park Jeong-shin, head of SK Biopharm’s New Drug Development Division, said, "This is to expand accessibility of Cenobamate in Asia, addressing the unmet needs of patients with refractory epilepsy in the region while providing a new treatment option."

Cenobamate, independently developed by SK Biopharm, is an adult partial seizure treatment approved by the U.S. Food and Drug Administration (FDA) and was launched in the U.S. in May. It is the first domestic new drug for which the subsidiary directly handled local sales.

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