· The first product from Korea to bypass Phase 1 and 2 clinical trials and proceed directly to Phase 3, with its domestic clinical results acknowledged by PMDA
· Trial conducted on patients with moderate to severe knee osteoarthritis, with one-year follow-up period to assess safety and efficacy
· Ongoing discussions with global pharmaceutical and biotech companies regarding potential partnerships and co-commercialization, while preparing to submit an IND application for Phase 3 clinical trials in the U.S.

On the 22nd, MEDIPOST (CEO Wonil Oh) announced the successful administration of treatment in the Phase 3 clinical trial of CARTISTEM^®, its stem cell therapy for knee osteoarthritis, in Japan.

CARTISTEM^®, which received Biologics License Application approval from the Korea Ministry of Food and Drug Safety in 2012, is an allogeneic umbilical cord blood-derived mesenchymal stem cell therapy for knee osteoarthritis. With its clinical results acknowledged by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), CARTISTEM^® became the first advanced biological product from Korea to bypass Phase 1 and 2 clinical trials and proceed directly to Phase 3 in Japan.

The first patient treatment of Phase 3 clinical trial in Japan began in 2023 and was conducted at 13 medical centers, enrolling 130 patients with moderate to severe knee osteoarthritis (Kellgren & Lawrence Grade 2–3). The trial utilized an open-label, randomized, active-controlled design, with hyaluronic acid (HA) injections serving as the control treatment. Patients are being monitored for a one-year (52-week) follow-up period to evaluate improvements in joint function, pain relief, and cartilage regeneration, with roughly 25% of participants having already completed their one-year follow-up.

MEDIPOST is also actively exploring global business opportunities for CARTISTEM^® to enhance its market presence worldwide. Last month, the company participated in a global conference in the U.S. and a bio-pharma event in Japan, engaging in business discussions with numerous multinational pharmaceutical and biotech companies for potential partnerships.

A MEDIPOST representative said, “Having the highest proportions of people aged 65 and older, Japan is one of the largest markets for degenerative arthritis treatments. We are currently collecting and analyzing Real World Evidence (RWE) from approximately 1,000 patients treated with CARTISTEM^® in Korea, which will play a critical role in supporting insurance reimbursement decisions and the Biologics License Application process in Japan.

Looking beyond Japan, MEDIPOST is preparing for its North American debut, aiming to submit an Investigational New Drug (IND) application for a Phase 3 clinical trial in the U.S. next year.