SK Biopharmaceuticals shares the full drug development process in the U.S., seeks to expand local partnerships

\ \ [Financial News] SK Biopharmaceuticals shared its experience in new drug development and commercialization in the U.S. and explored opportunities to collaborate with local pharmaceutical and biotech industries. The aim is to build closer ties with the global drug development ecosystem, drawing on its experience securing U.S. Food and Drug Administration (FDA) approval for its self-developed epilepsy treatment cenobamate and selling it directly.
\ \ SK Biopharmaceuticals said on the 12th that it had held a conference on the 10th (local time) in New Jersey, U.S., in partnership with the New Jersey and New York chapters of the Korean-American Society of Biopharmaceutical Scientists (KASBP). About 170 people attended the event, themed “From Unmet Medical Needs to Patient Access,” including representatives of SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, as well as people from the pharmaceutical and biotech industries and academia.
The event featured three sessions on research and development, clinical development and regulation, and commercialization and business expansion. Attendees discussed challenges across the drug development process, from identifying drug candidates to clinical trials and regulatory approval, drug pricing and market access strategies, and plans for growth after a U.S. launch.
The development and U.S. commercialization of SK Biopharmaceuticals’ epilepsy treatment cenobamate (marketed in the U.S. as Xcopri) featured as a key case study. Participants shared key decisions made during R&D, considerations in the FDA approval process and local sales strategies, along with lessons learned from the actual commercialization process.
Building on the event, SK Biopharmaceuticals plans to expand its engagement with experts in academia and industry and explore opportunities for joint research and business collaboration.
Lee Dong-hoon, president of SK Biopharmaceuticals, said, “Rather than focusing on cenobamate’s results themselves, we focused on sharing the challenges we faced during development and our experience with key decisions,” adding, “I hope the experience we have accumulated will help reduce trial and error in the development of other new drugs.”

[email protected] Jeong Sang-hee Reporter