The Secret Behind the Trillion-Won Blockbuster Drug: SK Biopharm and Dong-A ST's Collaboration

Xcopri, a new epilepsy drug developed by SK Biopharm and commercialized domestically by Dong-A ST, has received approval from the Ministry of Food and Drug Safety (MFDS) as the 41st domestically developed new drug. Approved on November 3, Xcopri is an innovative anticonvulsant containing cenobamate, used as an adjunctive therapy for partial-onset seizures in adult epilepsy patients. This approval marks the fourth instance of a new drug emerging from collaboration between domestic pharmaceutical companies, following Besivo (Ildong Pharmaceutical-LG Chem), Lazertinib (Yuhan Corporation-Oscotec), and Enblo (Daewoong Pharmaceutical-GC Biopharma). It demonstrates the successful establishment of an R&D collaboration and division-of-labor model in the Korean pharmaceutical industry. Xcopri is particularly lauded as an exemplary case where SK Biopharm independently carried out the entire process from initial development to US FDA approval, after which Dong-A ST swiftly brought it to the commercialization stage based on its expertise in domestic regulatory affairs.

The Secret Behind the Trillion-Won Blockbuster Drug: SK Biopharm and Dong-A ST's Collaboration photo 1

Xcopri's global market success is a prime example of the potential of Korean new drugs. After receiving US FDA approval for Xcopri in November 2019, SK Biopharm began direct sales through its US subsidiary, SK Life Science, in May 2020. Starting with initial sales of 2.1 billion won, Xcopri has shown continuous quarterly growth, recording US sales of 438.7 billion won in 2024 (a 62.1% increase year-on-year). With sales of 287.4 billion won in the first half of 2025 alone, cumulative US sales have reached 1.2563 trillion won. This represents the highest sales performance in the US market among domestically developed new drugs, proving that Korean pharmaceutical technology has reached a global standard. Dong-A ST signed a licensing agreement with SK Biopharm in January 2024, securing rights for approval, production, and sales in 30 countries. After paying an upfront fee of 5 billion won, it received domestic sales approval in just 1 year and 9 months. The Xcopri case presents a new ecosystem model for the Korean pharmaceutical industry. In the past, Korean pharmaceutical companies attempted to carry out the entire new drug development process individually, facing difficulties due to immense costs, time, and lack of expertise. However, with the recent activation of collaborations between highly skilled bio-ventures and mid-sized pharmaceutical companies possessing regulatory and commercialization know-how, efficient new drug development has become possible. The collaboration between Yuhan Corporation and Oscotec for Lazertinib demonstrates a successful model for technology fee distribution, with Oscotec securing cumulative technology fee revenue of 107.8 billion won. This collaborative model provides a win-win structure for both pharmaceutical companies and bio-ventures, fostering sustainable growth in the Korean bio-ecosystem. It is expected that as such collaborative cases increase, K-Bio will exert even stronger competitiveness in the global market.