Jo Jung-woo "In New Drug Development, Securing Reliable Step-by-Step Data Is Crucial"

SK Biopharm Shares Development Experience of Epilepsy New Drug 'Xcopri'

Jung Woo Cho, CEO of SK Biopharm, is delivering the keynote speech at the '2022 KoNECT International Conference' on the 12th.
Photo by Youngwon Kim

[Asia Economy Reporter Kim Young-won] Cho Jung-woo, CEO of SK Biopharm, explained the know-how based on the company's experience in new drug development, including 'definitive step-by-step data.'

Attending as a keynote speaker at the '2022 KoNECT International Conference (KIC·KoNECT International Conference)' held at the Conrad Hotel in Yeongdeungpo-gu, Seoul on the 12th, CEO Cho spoke about SK Biopharm's epilepsy treatment Xcopri, saying, "We paid a lot of tuition because there were many things we did not know," and added, "The most important thing in new drug development is definitive stepwise data."

CEO Cho stated, "How well solid scientific data and toxicity data are supported plays a very important role in step-by-step decision-making," and added, "Also, since those who provide funding are not scientists, it is important to explain and persuade them well about the science."

SK Biopharm's Xcopri (cenobamate) is the fifth domestic new drug to receive approval from the U.S. Food and Drug Administration (FDA). It is an adult partial seizure treatment, and the entire process from candidate substance discovery, clinical trials, to FDA approval was independently conducted. The U.S. local subsidiary, SK Life Science, is responsible for sales.

CEO Cho also summarized five success strategies for the development of Xcopri. First, from the perspective of drug research and development (R&D), he emphasized that drug efficacy must be present but stressed 'safety.' He said, "So far, the FDA's questions have been about safety, not efficacy," and added, "It is not about the gap between efficacy and safety, but continuous questions arise on how to respond when an issue occurs."

Regarding the New Drug Application (NDA), he pointed out the importance of 'strategic and proactive preparation.' CEO Cho explained, "How to present the drug is important," and said, "We considered the points that allow simultaneous operation in the world's largest markets, the U.S. and the European Union (EU), and incorporated them into the clinical protocol."

He also revealed that efforts were made from the pre-launching stage through marketing during the development phase. He said, "Before receiving the NDA, we could not talk about the drug's name and identity, so during pre-launching, we focused on promoting the SK brand and the company name SK Life Science," adding, "For three years, we had the largest booths at related events and conferences, and when people asked 'What kind of company is this?' we continuously exposed the market to the level of 'We are conducting clinical development.'"

CEO Cho explained that marketing activities should be conducted as quickly and actively as possible even after development. He introduced that Xcopri utilizes social networking services (SNS) and shares stories of patients who have shown remarkable effects after taking the drug.

He also emphasized the need to conduct clinical research to expand indications and support marketing after the NDA, as well as to enter the global market. CEO Cho said, "(Xcopri) will enter the markets in Korea, Japan, and China after bridging clinical trials around 2024-2025," and added, "Contracts have been completed in South America, and the Middle East is expected to be the last entry location."

Finally, CEO Cho stated that phase 4 clinical studies to confirm long-term efficacy and side effects must continue even after new drug approval and market launch, saying, "We are still conducting such research."

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