We sincerely appreciate your continued support.
While the development of therapeutic drugs and the spread of vaccines for COVID-19 have brought a sign of economic recovery, the soar of crude oil prices and transportation costs that are pressuring economic activities have kept the future unpredictable. CellSeed is actively introducing remote work and keeping efforts in the regenerative medicine support business and the cell sheet regenerative medicine business.
In our cultureware business, we have started supplying cultureware products to new markets, which play a part in developing new methods for preventing and treating COVID-19 and other infectious diseases. To address the increasing demand for cultureware products, “Aomi Cell Cultureware Innovation Center,” a facility for development and manufacturing, was newly built and is now up and running.
In our regenerative medicine contract services, we manufactured autologous chondrocyte sheets for the Advanced Medicine B program contracted by Tokai University at the Cell Processing Facility (CPC), in continuation from the previous year. (CPC obtained approval to manufacture specified cell processing products acquired pursuant to the Act on the Safety of Regenerative Medicine.)
Since an application for clinical trials on epithelial cell sheets for esophageal regeneration was submitted in October 2020 under the Act on Pharmaceuticals and Medical Devices (the “PMD Act”), additional clinical has been started.
For the allogeneic chondrocyte sheets, we are currently promoting our research to obtain marketing approval under the PMD Act. In December 2020, we received a permission for commercial use of chondrocytes that were collected from patients with polydactyly at the National Center for Child Health and Development. Also, in July 2021, the allogeneic chondrocyte sheet project was awarded a grant project in a public invitation issued by the Japan Agency for Medical Research and Development (AMED). This intends to accelerate the commercialization of knee osteoarthritis products and speed up our R&D activities to initiate corporate-sponsered clinical trials as early as possible. Additionally, we plan to submit the clinical trial application at the end of 2022 and ultimately achieve marketing approval as regenerative medicine products under the PMD Act.
To deliver treatments worldwide based on Japan-originated cell sheet engineering, we will make persistent efforts to commercialize products of cell sheet regenerative medicine. As one of our recent efforts, the 21st Congress of the Japanese Society for Regenerative Medicine was held online from March 17 to 19, 2022. CellSeed participated as a sponsor by displaying our cultureware products and contract services as well as giving co-organized academic seminars and short presentations. The seminar featured development of allogeneic chondrocyte sheets.
We sincerely ask our shareholders for your continued support.