· Following the selection as a leading company in materials, parts, and equipment by the Ministry of Trade, Industry and Energy in March, the first for a biotech company, this national project selection is worth a total project budget of KRW 13 billion.
· This project is expected to enhance the market competitiveness of the stem cell therapy CARTISTEM^®, including its Phase 3 clinical trials in the U.S., as it enters the global market.

MEDIPOST (078160, CEO Oh Won-il) announced on the 4th that it has been selected for the material parts technology development (package-type) project sponsored by the Ministry of Trade, Industry, and Energy.

The specified national project aims development of advanced clinical-grade stem cell therapeutics manufacturing platform based on animal origin-free (AoF) culture media for global markets based on animal-origin free (AOF) culture media, in an effort to secure global competitiveness in the field.” The project period runs from September 2023 to December 2026, approximately 3 years and 4 months (40 months), with a total project cost of KRW 13 billion, of which KRW 7.7 billion is government support funds.

In this national project, MEDIPOST is to lead sub-project 1 and manage the overall project, while Beyond Cell and Xcell Therapeutics are to participate in sub-project 2 to conduct research. MEDIPOST plans to develop customized animal-origin free culture media for stem cell therapies that can address the needs of global pharmaceutical regulatory agencies such as the U.S. FDA through this national project. They anticipate application of this noble AOF will enable simplification of the manufacturing process and quality improvement of stem cell products.

The Korea Evaluation Institute of Industrial Technology (KEIT), which oversaw the R&D evaluation, made its final selection and stated, “The development of stem cell therapies for global clinical trial use and the removal of potential risks of animal-derived contamination to address the uncertainties of international regulatory standards could lead to significant market entry and import substitution effects.”

Culture media is a primary nutrient source necessary for culturing of cells, which are the primary active pharmaceutical ingredients (API) in pharmaceutical production and advanced biopharmaceuticals. Despite the heavy cost burden of such culture media, accounting for 30-60% of the total production cost of cell-based biopharmaceuticals, South Korea currently relies entirely on imports .

MEDIPOST, holding proprietary cell culturing manufacturing process as its core strategic technology for the mass production of the stem cell therapy CARTISTEM^®, plans through this national project to develop a serum-free chemical composition media without animal-origin components (AOF) as an alternative to the current fetal bovine serum (FBS) media. They plan to apply this noble AOF media to CARTISTEM^® production to reduce costs and enhance competitiveness in the stem cell therapy market.

A representative from MEDIPOST voiced the company’s optimistic outlook on the selection for the national project, following their March recognition as the first biotech company to be chosen as a leading company in materials, parts, and equipment. They stated, “We find it very encouraging to be selected for this national project and plan to use the technological achievements developed through this project for CARTISTEM^®’s preparation for its Phase 3 clinical trial in the U.S. and the ongoing Phase 3 clinical trial in Japan, as well as for global clinical and market expansion.”

Furthermore, MEDIPOST is preparing for a Phase 3 clinical trial in the U.S. for CARTISTEM^®, which was commercialized in Korea in 2012 as world‘s first commercially successful allogeneic stem cell therapy. They announced the completion of their first Type C meeting with the FDA to establish a clinical protocol in June of 2023. Plans are in place to submit an Investigational New Drug Application (IND) next year.

[Glossary]
Culture medium: Substance designed to support culturing of microorganisms, or animal or plant tissues/cells, by providing the essential nutrients required for the cell proliferation process.

Fetal Bovine Serum (FBS): The serum taken from fetal bovine blood. Fetal bovine serum is the most widely used serum supplement for cell culture.

Animal-Origin Free (AoF) serum free chemical composition medium: A culture medium composed only of chemically defined components that excludes any animal-derived substances.

Type C Meeting: A non-routine meeting conducted at the request of the clinical trial sponsor (developer) during the new drug development process. This meeting allows the developer to inquire and receive responses from the FDA regarding the development and review of new drugs.