SK Biopharmaceuticals has shared its experience in developing and commercializing the epilepsy drug “cenobamate” in the United States and has moved to expand collaboration with global pharmaceutical and biotechnology experts.

SK Biopharmaceuticals announced on the 12th that on the 10th (local time) it jointly hosted the “From Unmet Need to Patient Access” conference in New Jersey, USA, with the New Jersey–New York chapter of the Korean American Society in Biotech and Pharmaceuticals (KASBP).

Approximately 170 participants attended the event, including representatives from SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, KASBP, and stakeholders from the pharmaceutical, biotech, and academic sectors. Participants discussed key challenges and cooperation strategies spanning new drug research and development, clinical trials, regulatory approvals, and commercialization.

The conference highlighted as a primary case study the U.S. Food and Drug Administration (FDA) approval of cenobamate—independently developed by SK Biopharmaceuticals and marketed in the U.S. under the brand name Xcopri—and its direct sales experience in the U.S. market.

The program was organized into three sessions: Discovery & R&D, Clinical & Regulatory, and Commercial & Beyond.

In the Discovery & R&D session, faculty members from New York Medical College and Rutgers New Jersey Medical School outlined unmet medical needs and challenges in new drug development in the field of epilepsy treatment. SK Biopharmaceuticals shared key decision-making processes, trial and error, and its research and development experience gained during the development of cenobamate.

The Clinical & Regulatory session examined considerations in the approval process, focusing on the FDA’s new drug review procedures and the clinical development case of cenobamate. The Commercial & Beyond session discussed drug pricing and market access strategies as well as approaches to expanding sales and business operations in the United States.

Leveraging this event, SK Biopharmaceuticals plans to expand exchanges with academic and industry experts in the U.S. and to pursue opportunities for joint research and business collaboration in the future.

Kang Min-seok, head of the New Jersey–New York chapter of KASBP, said, “The journey of a Korean company independently carrying a new drug from the initial discovery stage all the way through FDA approval and local launch in the United States is a source of great pride and a learning example for all Korean American scientists.”

Lee Dong-hoon, President of SK Biopharmaceuticals, said, “This event was organized not so much to showcase the achievements of cenobamate themselves as to share the concerns we faced and the key decisions we made along the way,” adding, “Because countless judgments and trials and errors are required for a single new drug to reach patients, we hope that the experience we have accumulated will help reduce trial and error in other development efforts.”

Popular News