MEDIPOST will unveil the phase 3 clinical trial results in Japan for Cartistem, a stem cell therapy for knee osteoarthritis, 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 completed the phase 3 clinical trial of Cartistem in Japan in Nov. last year and is awaiting the phase 3 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.
The company is also aiming to enter the United States, the largest market. In Feb., the company obtained investigational new drug (IND) approval for a U.S. phase 3 trial of Cartistem. The company said it is ramping up clinical development with the goal of first patient in (FPI) within the first half of this year. The goal is to secure U.S. marketing approval and launch in 2031.
◇ Pioneer of a barren field, first-generation bio…world's first approval for a "cord blood therapy"
MEDIPOST is a first-generation Korean bio company founded in 2000 by former obstetrician-gynecologist Yang Yoon-sun. In 2000, Yang left Samsung Medical Center and started a business to store cord blood (臍帶血) and, if a person later became ill, extract stem cells from it and transplant them into the body like bone marrow. At the time, there was no recognition of cord blood stem cells among physicians. During delivery, umbilical cords were discarded as medical waste.
The company pioneered the market through its cord blood bank brand Celltree and has remained the industry leader. The company's business structure consists largely of the following: cord blood banking, stem cell therapies, and health functional foods. Looking at last year's results, revenue from the cord blood business was about 41.5 billion won, accounting for about 56% of total revenue (73.656 billion won).
The cord blood banking business served as a cash cow supporting R&D that requires medium- to long-term investment. On this basis, the company developed Cartistem, the world's first allogeneic cord blood–derived stem cell therapy, and succeeded in commercializing it in 2012 after receiving marketing approval from the Ministery of Food and Drug Safety.
There were controversies during the growth process. Right after Cartistem's approval in 2012, executives sold equity, sparking controversy. In 2015, some civic groups raised questions about the utility of cord blood, prompting a prosecution investigation, including a search and seizure of the company's headquarters, but it concluded with no charges, and the therapeutic's medical value 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. At the time, private equity funds (PEF) Skylake Equity Partners and Crescendo Equity Partners executed an investment of about 140 billion won and secured management control.
The largest shareholder is SkyMedi LLC, an investment purpose company (SPC) affiliated with Skylake, with 22.28%, and Marvel 2022 Holdings affiliated with Crescendo holds 20.91% as the second-largest shareholder. Including related parties on both sides, the equity is about 47.2%, forming a joint control structure. In essence, domestic PE and global PE have formed an alliance to exercise management control of MEDIPOST.
In recent years, MEDIPOST has seen both top-line growth and a slowdown in profitability. On a consolidation basis, revenue increased 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 widening deficit include increased overseas clinical expenses, upfront investment related to U.S. contract manufacturing (CMO), and higher research and development (R&D) expenses. Analysts say these are investments aimed at global expansion under the PE regime.
◇ Cartistem's domestic sales stagnate…global performance is key
The core task is Cartistem's performance in global markets. Osteoarthritis is a degenerative disease in which knee cartilage wears down and is damaged, causing repeated inflammation and pain. Until now, most treatments have focused on pain relief.
By contrast, Cartistem 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 key growth business, decreased from 21.5 billion won in 2023 to 19.4 billion won in 2025, showing a stagnant trend. This indicates that growth is limited in the domestic market alone.
The company's valuation could change depending on global clinical and commercialization results in Japan, the United States, and elsewhere. In Dec. last year, MEDIPOST signed an exclusive license and sales agreement in Japan for Cartistem with Teikoku Seiyaku. The upfront payment MEDIPOST received under this contract was $8 million (about 11.7 billion won). Upon marketing approval, MEDIPOST will receive an additional $10 million (about 14.7 billion won). The terms also include separate royalty revenue based on future sales.
The company has also begun a U.S. phase 3 trial of Cartistem. This trial compares Cartistem with surgical cartilage debridement and evaluates efficacy and safety over two years of postoperative follow-up. It will be conducted at more than 60 institutions in the United States and Canada with patients of moderate severity or worse.
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 its manufacturing and quality control standards by global regulators," adding, "We will proceed with the U.S. trial without a hitch and lead a paradigm shift in osteoarthritis treatment."
The follow-up pipeline SMUP-IA-01 is also a key pillar. It works by alleviating inflammation and suppressing cartilage damage through therapeutic factors secreted by stem cells. While leveraging the same cord blood–derived stem cell–based technology as Cartistem, it can be administered intra-articularly by injection without surgery. If the treatment paradigm shifts from surgery to injection, the market size could grow further.
The company aims to submit 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, recognizing the domestic phase 1 data, it can skip phase 1 in the United States and proceed directly to phase 2.
Lee Ji-soo, a pharmaceuticals and biotech analyst at Daol Investment & Securities, said, "If Cartistem's global clinical trials succeed, license revenue will be added on top of existing sales, and if SMUP-IA-01 enters a domestic phase 3 trial, it is meaningful in that the company can build a lineup that covers the full spectrum of osteoarthritis stages together with Cartistem."
Some observers expect Skylake Equity Partners and Crescendo Equity Partners to seek an exit by boosting corporate value based on the phase 3 U.S. trial of Cartistem and its overseas commercialization results.
An industry official said, "MEDIPOST appears focused less on short-term expense cuts and more on proving growth potential through investments in global clinical programs and manufacturing infrastructure ahead of a sale," adding, "Whether Cartistem gains a foothold overseas will likely determine future corporate value and the timing of an exit."