FUJIFILM Toyama Chemical Applies for Manufacturing and Marketing Approval in Japan for FF-31501, an Autologous Synovial Mesenchymal Stem Cell-based Therapy

TOKYO, May 13, 2025 – FUJIFILM TOYAMA CHEMICAL Co., Ltd. (President Mitsuhiro Sato) today announced that it has submitted an application with the Ministry of Health, Labor and Welfare for manufacturing and marketing approval in Japan for a stem cell therapy product (development code: FF-31501) based on autologous synovial mesenchymal stem cells (MSCs)^*1 for the treatment of meniscus injury where meniscectomy is indicated.

FF-31501 consists of autologous synovial MSCs expanded from processed synovial tissue obtained from the patient's own knee. Arthroscopic administration of FF-31501 to the injured area after reshaping by suture repair is expected to improve healing of the meniscus lesion and the symptoms associated with the injury. The treatment efficacy and safety in patients were first observed in a feasibility clinical trial^*2 conducted by the Institute of Science Tokyo and led by Professor Ichiro Sekiya, who developed this cell transplantation technology. Subsequently, FUJIFILM Corporation conducted a domestic Phase 3 clinical trial (“JP301 study”) that started in January 2023 and met the primary endpoint of demonstrating improvement in symptom and healing of the injured area by FF-31501 administration.

The JP301 study was a single-arm, multicenter clinical trial of 19 patients with meniscus injuries for which meniscectomy was indicated. The primary endpoint was the change in the Lysholm knee scoring scale^*3 from screening to 52 weeks post-administration; secondary endpoints included arthroscopic evaluation of meniscus healing, providing an objective assessment of the injured area before and after treatment with FF-31501.

The meniscus is a critical tissue in the knee joint that acts as a cushion to absorb shock and distribute weight. Excessive load on the meniscus can cause a meniscus injury (meniscal tear), resulting in pain and catching during knee flexion, which may sometimes make walking difficult. Arthroscopic meniscectomy, a surgical procedure to resect the injured area, has often been performed for severe meniscus injuries where suture repair is not suitable. However, meniscectomy has been associated with a higher risk of developing knee osteoarthritis^*4 , presenting a significant need for novel treatments for meniscus healing and preservation. FUJIFILM Toyama Chemical is dedicated to advancing medical progress by developing innovative therapies.

• *1 Autologous synovial mesenchymal stem cells (MSCs) are derived from a patient's own synovium. MSCs are multipotent progenitor cells that exist in vivo and have the potential to differentiate into various tissues, including bone, cartilage, and fat.
• *2 “Investigator-Initiated clinical trial of autologous synovial stem cells for meniscus injury” (UMIN000026383) - This trial was supported by the Japan Agency for Medical Research and Development (AMED) as part of the Research and Development Project for Practical Application of Regenerative Medicine: “Physician-Initiated Clinical Trial of Autologous Synovial Stem Cells for Meniscus Injury”.
• *3 The Lysholm knee scoring scale is a widely used tool for evaluating knee function and symptoms such as pain, instability, and locking, and is suitable for the evaluation of meniscus function and symptoms in the context of meniscus treatment.
• *4 Knee osteoarthritis, a common degenerative joint disease, is characterized by progressive cartilage loss. Radiographic knee osteoarthritis is estimated to affect approximately 25 million people in Japan.

• * Please note that the contents including the product availability, specification, prices and contacts in this website are current as of the date of the press announcement and may be subject to change without prior notice.