MEDIPOST will release phase 3 clinical trial results in Japan for its knee osteoarthritis stem cell therapy "Cartistem" on the 13th of next month. As a key indicator for gauging the potential to expand overseas markets for Cartistem, which has been commercialized in Korea for more than 10 years, the industry is paying close attention.
According to the industry on the 29th, MEDIPOST finished phase 3 in Japan for Cartistem in Nov. last year and is awaiting the analysis results. Based on this, the company plans to apply for marketing approval with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan by the end of this year.
It is also eyeing entry into the United States, the largest market. The company obtained investigational new drug (IND) approval in Feb. for a U.S. phase 3 trial of Cartistem. The company said it is ramping up clinical development with a goal of first patient in (FPI) in the first half of this year. The goal is to win U.S. marketing approval and launch in 2031.
◇ A first-generation bio that pioneered a barren field…world's first approval for a "cord blood therapy"
MEDIPOST is a first-generation Korean biotech founded in 2000 by former obstetrician-gynecologist Yang Yun-sun. In 2000, Yang left Samsung Medical Center and started a business storing cord blood and later, if a person became ill, extracting stem cells from it and implanting them in the body like bone marrow. At the time, physicians had little awareness of cord blood stem cells. During delivery, umbilical cords were discarded as medical waste.
The company opened the market through its cord blood bank brand "Celltree" and remains the industry leader. Its business structure largely consists of △ cord blood banking △ stem cell therapies △ health functional foods. In last year's results, the cord blood business revenue was about 41.5 billion won, accounting for about 56% of total revenue (73.656 billion won).
The cord blood bank business served as a cash cow supporting R&D that requires mid- to long-term investment. On this foundation, the company developed the world's first allogeneic cord blood–derived stem cell therapy, Cartistem, won marketing approval from the Ministery of Food and Drug Safety in 2012, and succeeded in commercializing it.
There were controversies during growth. Right after Cartistem's approval in 2012, management sold equity, sparking criticism. In 2015, some civic groups questioned the usefulness of cord blood, leading to a prosecution investigation that included a search and seizure of the company's headquarters, but it concluded with no charges, and the medical value of the therapy was demonstrated through clinical trials and commercialization.
◇ Shift to a PE regime in 2022…joint control by Skylake and Crescendo
MEDIPOST's governance changed starting in 2022. Private equity funds Skylake Equity Partners and Crescendo Equity Partners secured management control by making an investment of about 140 billion won.
The largest shareholder is SkyMedi LLC, a special purpose company (SPC) of Skylake, with 22.28%, and Marble 2022 Holdings of Crescendo holds 20.91% as the second-largest shareholder. Including related parties on both sides, equity is about 47.2%, forming a joint control structure. In effect, a domestic PE and a global PE are allied in exercising management control over MEDIPOST.
In recent years, MEDIPOST has seen top-line growth and profitability slow at the same time. On a consolidation basis, revenue rose from about 68.6 billion won in 2023 to about 73.6 billion won in 2025, but operating losses widened from about 25.1 billion won to about 67.9 billion won over the same period.
The main reasons for the deeper losses are rising overseas clinical expenses, upfront investment related to U.S. contract manufacturing (CMO), and higher research and development costs. Analysts say these are investment-heavy moves aimed at global expansion under the PE regime.
◇ Cartistem's domestic sales are stagnant…global performance is key
The key task is Cartistem's performance in global markets. Osteoarthritis is a degenerative disease in which knee cartilage wears down and is damaged, causing recurrent inflammation and pain. Until now, most treatments have focused on pain relief.
Cartistem, by contrast, suppresses inflammatory signals within the joint to reduce pain while stem cells differentiate into chondrocytes to induce regeneration of damaged cartilage. It is a fundamental therapeutic approach that restores the cartilage structure itself, not just pain relief.
Revenue from the stem cell therapy (Cartistem) business, the company's core growth line, fell from 21.5 billion won in 2023 to 19.4 billion won in 2025, showing a stagnant trend. It suggests the domestic market alone has growth limits.
MEDIPOST's valuation could change depending on results in global clinical trials and commercialization in countries such as Japan and the United States. In Dec. last year, MEDIPOST signed an exclusive license and sales agreement in Japan for Cartistem with Teikoku Seiyaku. MEDIPOST received an $8 million (about 11.7 billion won) upfront payment under the deal. Upon marketing approval, MEDIPOST will receive an additional $10 million (about 14.7 billion won). It will also receive separate royalty revenue based on future sales.
The company has also begun a U.S. phase 3 trial of Cartistem. The study compares Cartistem with surgical debridement and follows patients for two years after surgery to evaluate efficacy and safety. It will enroll patients with moderate or worse disease at more than 60 sites across the United States and Canada.
Lee Seung-jin, head of global business at MEDIPOST and co-CEO of the U.S. subsidiary, said, "This U.S. phase 3 IND approval recognizes not only Cartistem's clinical value but also our manufacturing and quality control standards by global regulators," adding, "We will conduct the U.S. trial without a hitch and lead a paradigm shift in osteoarthritis treatment."
The follow-on pipeline SMUP-IA-01 is another key pillar. It works by easing inflammation and suppressing cartilage damage through therapeutic factors secreted by stem cells. It uses the same cord blood–derived stem cell platform as Cartistem but is administered as an intra-articular injection without surgery. If the treatment paradigm shifts from surgery to injections, the market could grow larger.
The company aims to file an IND for a domestic phase 3 trial of SMUP-IA-01 in the third quarter of this year. The U.S. Food and Drug Administration (FDA) informed the company that it would recognize Korean phase 1 data, allowing it to skip U.S. phase 1 and move straight into phase 2.
Lee Ji-su, a pharmaceuticals and biotech analyst at Daol Investment & Securities, said, "If Cartistem succeeds in global clinical trials, license revenue will be added to existing revenue, and if SMUP-IA-01 enters domestic phase 3, it is meaningful in that the company can build a lineup covering the full spectrum of osteoarthritis stages together with Cartistem."
Some in the market expect Skylake Equity Partners and Crescendo Equity Partners to pursue an exit by boosting corporate value based on Cartistem's U.S. phase 3 results and overseas commercialization.
An industry official said, "Rather than short-term expense cuts, MEDIPOST is leaning toward a strategy of proving growth by investing in global trials and manufacturing infrastructure and then pursuing a sale," adding, "Whether Cartistem gains a foothold in overseas markets will likely determine future corporate value and the timing of an exit."