MediPost Completes Phase 3 Trial of Cartistem in Japan... Results to Be Announced in Q2

All Patient Data Secured Following Last Patient Out (LPO) in November Last Year

MediPost has completed the phase 3 clinical trial in Japan for Cartistem, its allogeneic umbilical cord blood-derived mesenchymal stem cell therapy. In November of last year, the company completed the final patient visit, securing all patient data, and has now entered the stage of preparing the clinical trial results report. MediPost plans to release the results in the second quarter of this year.

Medipost Pangyo Headquarters Exterior. Medipost

According to MediPost on March 3, this phase 3 clinical trial in Japan was conducted at 13 institutions across the country, targeting 130 patients with moderate to severe knee osteoarthritis. The trial was designed as a randomized, observer-blinded study with hyaluronic acid injection as the control group. Safety and efficacy were evaluated through a 52-week follow-up observation.

This phase 3 trial simultaneously set two primary efficacy endpoints. Along with patient-reported outcomes that assess pain and functional improvement, structural indicators were included to directly confirm cartilage regeneration through secondary verification with arthroscopy. This is a differentiated structure compared to typical osteoarthritis phase 3 trials, which are generally designed around subjective indicators such as pain improvement.

The company aims to receive the results report within the first half of the year and is targeting to submit an application for product approval in Japan in the second half. The target for obtaining approval is by the end of 2027.

Previously, in December of last year, MediPost signed an exclusive sales license agreement in Japan with Teikoku Pharma. Under the agreement, MediPost is expected to receive a signing payment of KRW 11.8 billion and regulatory milestone payments totaling KRW 14.8 billion. The company also anticipates future revenue from sales milestones and the supply of raw materials and finished products.

In the United States, MediPost recently obtained approval for the clinical trial plan for phase 3. The company plans to accelerate development with the goal of enrolling the first patient in the first quarter of this year. The target for obtaining approval in the United States is 2031.

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