Medipost announced on Thursday that it will begin implementing domestically produced media for the commercialization of CARTISTEM, its umbilical cord-derived allogeneic mesenchymal stem cell treatment, in Japan.
Media is a crucial component that provides nutrients for cell growth, determining cell proliferation and characteristics. Currently, South Korea relies almost entirely on imported media, highlighting the ongoing need for localization to ensure supply chain stability and boost industrial competitiveness.
The core material localization project will utilize CellCor MSC CD AOF, a specialized chemical composition media for mesenchymal stem cells developed and produced by Xcell Therapeutics, a company specializing in cell and gene therapy (CGT) media.
Xcell Therapeutics’ chemical composition media excludes animal and human-derived substances, addressing limitations of existing media while ensuring safety, homogeneity, and stable supply. Companies with the technology to develop chemical composition media specifically for CGT are reportedly rare in the global market.
The two companies have been conducting tests for the application of chemical composition media since establishing their partnership in 2020. Medipost’s selection for the Top Enterprises in Materials, Parts, and Equipment project by the Ministry of Trade, Industry and Energy in 2023, with a total investment of 13 billion KRW (about 8.54 million USD), has further accelerated the push for domestic media application. This national project aims to develop advanced clinical sample manufacturing technology for stem cell therapies based on culture media that replace animal-derived components to secure global competitiveness.
Lee Seung-jin, project leader and co-representative of Medipost’s U.S. and Japan subsidiaries, stated that they’ve expanded our collaboration with Xcell Therapeutics to proactively address global regulatory changes. By demonstrating equivalence during the media replacement process in Japan’s licensing procedure and applying it post-marketing, we aim to reduce production costs and secure a stable supply chain for core materials.
Xcell Therapeutics’ Chief Executive Officer (CEO), Lee Ui-il, said that it’ll complete the registration of the raw material drug with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and prove the excellence of domestic media by early next year. With core materials accounting for 10-15% of treatment costs, CARTISTEM’s full-scale commercialization in Japan will enable long-term, stable revenue generation.
CARTISTEM, Medipost’s treatment for severe knee osteoarthritis, has been a leading option since its approval in South Korea in 2012, with over 36,000 procedures performed. Following impressive efficacy and safety results in a Japanese Phase 3 clinical trial, the company is set to initiate the Biologics License Application process.
Earlier this month, the U.S. Food and Drug Administration (FDA) approved Medipost to conduct a single Phase 3 clinical trial for product licensing, a departure from the typical requirement of two or more independent trials. This could significantly reduce development time and costs for the company.
