Establishment of an R&D Division and Acceleration of Development of Allogeneic Cell Products

「✓ 1Q決算説明資料より変更なし。順調に開発進捗中。」

「With skin defects, including burns, as the indication, the product is progressing smoothly toward a marketing approval application, with a launch targeted for the fiscal year ending March 2028.」

「We completed a clinical trial in patients with deep partial-thickness second-degree burns, a representative disease involving skin defects. The epithelialization rate at the Allo-JaCE03 application site 7 days after the initial application, the primary endpoint, was shown to be statistically significantly higher than the estimated epithelialization rate with existing treatments, and no adverse events of concern were observed in terms of safety. With skin defects, including burns, as the indication, the product is progressing smoothly toward a marketing approval application, with a launch targeted for the fiscal year ending March 2027.」

「Allogeneic cultured epidermis, developed under the name Allo-JaCE03, completed a clinical trial in patients with deep partial-thickness second-degree burns, a representative disease causing skin defects. The epithelialization rate at the Allo-JaCE03 application site on day 7 after the initial application, the primary endpoint, was shown to be statistically significantly higher than the estimated epithelialization rate with existing treatment methods. No clinically concerning adverse events were observed in terms of safety. The company is currently preparing a marketing-authorization application with the aim of launching the product in the fiscal year ending March 2026. It will accelerate expansion into overseas markets as well as Japan by capitalizing on the product's characteristics as an allogeneic and dried product.」

「In the clinical trial, treatment of the final patient has been completed and follow-up of all patients has been completed. We will promptly compile the data and prepare the application.」

「In the clinical trial, treatment of the final patient has been completed and follow-up of all patients has been completed. We will promptly compile the data and prepare the application.」

「In addition, a project for establishing a stable supply system for human allogeneic cells used as raw materials for regenerative medicine products was selected as an AMED commissioned project in June 2021, and the Company is promoting the industrialization of regenerative medicine using allogeneic cells.」

「Allogeneic cultured epidermis using another person's skin tissue as the raw material, a ready-made product that is manufactured and stored in advance so that it can be used without delay when needed, is Japan's first such product and is being developed under the name Allo-JaCE03. In August 2021, a project for the development and commercialization of allogeneic cultured epidermis was selected as an AMED grant project, and in November 2021, the Company submitted a clinical trial notification. In addition, a project for establishing a stable supply system for human allogeneic cells used as raw materials for regenerative medicine products was selected as an AMED commissioned project in June 2021, and the Company is promoting the industrialization of regenerative medicine using allogeneic cells.」

「The company aims to realize Japan's first mass-produced ready-made product using allogeneic cells, manufactured and stored in advance for use without delay when needed. It advanced development of allogeneic cultured epidermis after being selected in October 2018 for a three-year AMED national project and conducted clinical research at Kyoto University to treat skin-defect wounds. It was subsequently selected in October 2021 for a three-year AMED national grant project and began a company-led clinical trial in November of the same year.」

「Regarding allogeneic cultured epidermis, a ready-made product using another person's skin tissue as the raw material and developed under the name Allo-JaCE03, a project concerning its development and commercialization was selected in August 2021 as an AMED grant project, and the clinical trial notification was submitted in November 2021.」

「Clinical research conducted by our joint research partner, Kyoto University, through the previous fiscal year using allogeneic cultured epidermis for skin-defect wounds suggested the product's safety and efficacy. We will therefore promptly begin a company-sponsored clinical trial as an AMED project.」

「In parallel, Kyoto University, our joint research partner, conducted clinical research on skin-defect wounds using allogeneic cultured epidermis, and evaluation data for company-sponsored clinical trials was accumulated.」

「For Japan's first ready-made product using another person's skin tissue as the raw material, we advanced 2 AMED commissioned national projects from October 2018: "Development of allogeneic cultured epidermis" and "Establishment of a stable supply system for allogeneic cells for industrial use." In parallel, Kyoto University, our joint research partner, conducted clinical research using the technology for skin-defect wounds, and evaluation data for conducting company-sponsored clinical trials has been accumulated.」

「Aiming to realize Japan's first ready-made product using allogeneic cells, we have been developing allogeneic cultured epidermis since October 2018 as an AMED commissioned national project.」

「The company aims to realize Japan's first ready-made product using another person's skin tissue as the raw material, manufactured and stored in advance for use without delay when needed. Since October 2018, it has been advancing two projects as AMED national projects: “Development of allogeneic cultured epidermis” and “Establishment of a stable supply system for allogeneic cells for industrial use.”」

「We aim to realize Japan's first ready-made product using another person's skin tissue as the raw material, meaning a product manufactured and stored in advance so that it can be used without delay when needed. Since October 2018, we have been advancing 2 AMED commissioned projects: "Development of allogeneic cultured epidermis" and "Establishment of a stable supply system for allogeneic cells for industrial use."」

「AMED and the Company will execute a commissioned research contract for the Medical Device Development Promotion Research Project (clinical research on innovative medical devices contributing to the optimization of medical costs). The commissioned research topic is as follows: "Development of dry allogeneic cultured epidermis for use in skin reconstruction." The project will develop dry allogeneic cultured epidermis as a new treatment to promote the early healing of wounds.」

「We aim to realize Japan's first ready-made product using another person's skin as the raw material, meaning a product manufactured and stored in advance so that it can be used without delay when needed. Since October 2018, we have advanced 2 commissioned national projects of AMED: development of allogeneic cultured epidermis and establishment of a stable supply system for allogeneic cells for industrial use. We will continue these developments as AMED commissioned projects in the fiscal year ending March 2020.」

「We aim to realize Japan's first ready-made product using another person's skin as the raw material, meaning a product manufactured and stored in advance so that it can be used without delay when needed. Since October 2018, we have been advancing development under 2 commissioned national projects of AMED: development of allogeneic cultured epidermis and establishment of a stable supply system for allogeneic cells for industrial use.」

「In September 2018, 2 projects were selected as commissioned projects, or national projects, by the Japan Agency for Medical Research and Development (AMED): development of products using allogeneic cells and the establishment of a stable supply system for allogeneic cells for industrial use. Aiming to commercialize Japan's first ready-made product using another person's skin as the raw material, meaning a product manufactured and stored in advance so that it can be used without delay when needed, we will accelerate the development of allogeneic cultured epidermis while using government subsidies and promote the industrialization of new regenerative medicine using allogeneic cells.」

「We will newly establish an R&D Division and accelerate the development of new products using allogeneic cells by making active investments, in addition to expanding the indications of existing products.」