Japan Tissue Engineering Co., Ltd. obtained marketing approval for Autologous Cultured Epidermis Maintaining Melanocytes "JACEMIN", a regenerative medical product for the treatment of vitiligo, on March 17. JACEMIN is the fifth regenerative medical product launched by company in Japan. Through JACEMIN, J-TEC will contribute to the improvement of quality of life (QOL) in a greater number of patients while providing them with a new treatment method.

Autologous Cultured Epidermis Maintaining Melanocytes JACEMIN is autologous cultured epidermis in which the patient's own cutaneous tissue is harvested, and isolated cells cultured to maintain melanocytes are produced in sheet form for use in the patient. Curing vitiligo with pigment regeneration JACEMIN is transplanted into areas affected by vitiligo where nonsurgical therapy is ineffective or not indicated, after the epidermal layer has been shaved thin. Melanocytes are supplied through transplantation of this product, and its purpose is to regenerate pigment.

Low invasiveness and improvement of quality of life (QOL) Because JACEMIN grafts are manufactured using a smaller area of cutaneous tissue than in existing surgical therapies, the procedure is low in invasiveness for the patient, and it makes it possible to treat a large area at one time. Moreover, regenerating pigment with this treatment method can be expected to reduce the patient's psychological burden regarding aesthetics and improve patient quality of life (QOL). Vitiligo is a disease in which the skin loses color and turns white because of the loss or decrease of pigment cells called melanocytes that are normally present in the skin.

This product is for the treatment of vitiligo for which nonsurgical therapies such as topical preparations, oral medications, or phototherapy are ineffective or not indicated, such as acquired vitiligo vulgaris in which there has been destruction of melanocytes and symptoms have been stable for about 12 months, or piebaldism caused by a congenital genetic abnormality. The number of patients with vitiligo vulgaris is estimated at about 150,000 in Japan. Moreover, the incidence of piebaldism is thought to be one in 20,000 to 100,000 people.

J-TEC made its business plan for JACEMIN public in "Medium-Term Management Plan (Matters Related to Business Plans and Growth Potential) " dated March 10, 2022. Because things have been proceeding according to plan, this product approval will not have any effect on full-year earnings forecast for the term ending in March 2023.