[Edaily Reporter Yoo Jin-hee] Stem cell therapy specialist #Medipost is stepping up efforts to strengthen its global competitiveness by actively pursuing the localization of its core material—culture medium—ahead of the launch of its flagship product, the knee osteoarthritis treatment 'CARTISTEM,' in the Japanese market.

Medipost announced on the 11th that it will use chemically defined media from #Excel Therapeutics, a domestic specialist in cell and gene therapy (CGT) media, for the commercialization project of CARTISTEM, a cord blood-derived allogeneic mesenchymal stem cell therapy, in Japan.

This transition is scheduled to be fully implemented during the marketing phase following the acquisition of a Biologics License Application (BLA) in Japan. The strategy aims to improve the safety and homogeneity of the therapy, while also achieving import substitution for key materials and reducing production costs.

Culture media, which provide essential nutrients for cell growth, are a key material that determines the proliferation and characteristics of stem cells. However, the domestic biotech industry has been criticized for its vulnerability to supply chain instability and price volatility risks, as it currently relies on imports for the majority of its culture media needs.

The chemically defined medium (CellCor™ MSC CD AOF) for mesenchymal stem cells introduced by Medipost, developed by Excel Therapeutics, has overcome the safety limitations of existing media by strictly excluding animal- and human-derived materials. Globally, only a handful of companies possess the technology to develop chemically defined media specifically for cell and gene therapy (CGT).

The two companies have been collaborating closely since 2020, conducting preliminary tests for the application of the chemical-based medium. In particular, the project to adopt domestically produced media gained significant momentum in 2023 when Medipost became the first company in the biotech industry to be selected as a "Top Company" in the "Materials, Parts, and Equipment" (MPE) sector by the Ministry of Trade, Industry and Energy.

This government-funded project, with a total budget of 13 billion won, aims to "develop advanced clinical sample manufacturing technology for stem cell therapies based on culture media that replaces animal-derived components" and will run until December 2026. Medipost is overseeing the project and leading Sub-task 1, while Excel Therapeutics is participating in Sub-task 2.

This localization of the culture medium is expected to contribute to the successful establishment of Cartistem in the Japanese market and maximize profitability. This is because the culture medium is a key material accounting for approximately 10–15% of the production cost of cell therapies.

Lee Eui-il, CEO of Excel Therapeutics, emphasized, “We will complete the registration of the Drug Master File (DMF) with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and demonstrate equivalence by early next year to prove the excellence of the domestically produced culture medium,” adding, “Once the commercialization of Cartistem in Japan gains full momentum, we will be able to secure long-term and stable sales.”

Lee Seung-jin, Head of Medipost’s Global Business Division (and CEO of its U.S. and Japan subsidiaries), who serves as the overall project leader for this government-funded initiative, said, “We have expanded our collaboration to proactively respond to tightening global regulations.” He added, “By fully demonstrating equivalence resulting from the culture medium switch during the Japanese marketing authorization process and implementing it post-launch, we will simultaneously achieve reduced production costs and secure a stable supply chain for this key material.”

Meanwhile, Medipost’s Cartistem is a proven treatment for knee osteoarthritis that has recorded over 36,000 cumulative procedures since receiving domestic approval in 2012. Having demonstrated excellent efficacy and safety in a recent Phase 3 clinical trial in Japan, the company plans to begin the full-scale product approval process. Previously, Medipost signed an exclusive sales agreement in Japan with Teikoku Pharmaceutical worth a total of 26.4 billion won, including an upfront payment and short-term regulatory milestone payments.