[Edaily Reporter NA EUN-KYUNG ] MEDIPOST CO., LTD.(078160)announced on the 8th that it has officially begun its global commercialization efforts after completing the enrollment of the first patient and administering the first treatment (First Patient Treatment, FPT) in the U.S. Phase 3 clinical trial for “CARTISTEM®,” an allogeneic mesenchymal stem cell therapy derived from umbilical cord blood.

This Phase 3 clinical trial will be conducted at approximately 70 clinical trial sites in the U.S. and Canada, enrolling 300 patients with moderate to severe knee osteoarthritis. After recruiting patients and administering the treatment over approximately two years, the company plans to evaluate improvements in cartilage structure and clinical symptoms through a two-year follow-up period. Following this, the company plans to sequentially prepare the Clinical Study Report (CSR) and submit a Biologics License Application (BLA).

Through this trial, MEDIPOST CO., LTD. aims to demonstrate that Cartistem is a disease-modifying osteoarthritis drug (DMOAD) based on cartilage regeneration.

Another notable feature of this trial is that it is being conducted under approval from the U.S. Food and Drug Administration (FDA) as a single pivotal study. While U.S. drug approval typically requires two or more pivotal trials, MEDIPOST CO., LTD. secured approval for a single trial based on clinical data obtained in South Korea and Japan, post-marketing real-world evidence (RWE) from South Korea, and a clinical design aligned with FDA standards.

The company expects that this approval for a single pivotal study will allow it to secure the evidence necessary for approval while reducing the clinical trial scale, development timeline, and costs compared to its original plan.

CATIS INC. is a stem cell therapy for knee osteoarthritis that is currently approved and on the market in South Korea; it recently completed a Phase 3 clinical trial in Japan and is currently undergoing the marketing authorization process. MEDIPOST CO., LTD. is conducting U.S. clinical trials alongside local business development (BD) efforts and plans to expand its market into Europe and China, following its entry into the U.S. and Japan.

Lee Seung-jin, Head of MEDIPOST CO., LTD.’s Global Business Division, stated, “The first patient dosing in the U.S. Phase 3 clinical trial is a significant milestone for our entry into the global market.” He added, “As U.S. orthopedic specialists are also showing great interest in Cartistem’s cartilage regeneration effects, we will proceed with the clinical trial without a hitch to demonstrate its therapeutic value in the world’s largest pharmaceutical market.”

Meanwhile, MEDIPOST CO., LTD. has completed its Phase 3 clinical trial in Japan and obtained the final Clinical Study Report (CSR); the company is currently proceeding with the necessary procedures with the goal of submitting a marketing authorization application in Japan by the end of this year. Last year, MEDIPOST CO., LTD. signed an agreement with Japan’s Teikoku Pharmaceutical for the exclusive sales rights to Cartistem in Japan, securing an upfront payment of 11.8 billion won and regulatory milestone payments totaling 14.8 billion won; the company also anticipates additional milestone payments upon future marketing authorization and product supply.