TEMCELL

TEMCELL® HS Inj. is a regenerative medical product using human mesenchymal stem cells (MSCs) for the treatment of acute graft-versus-host disease (acute GVHD)*, a severe complication arising from hematopoietic stem cell transplantation, which was launched in February 2016. TEMCELL® HS Inj. is an innovative product manufactured by isolating and expanding mesenchymal stem cells derived from the bone marrow aspirate of a healthy adult donor. It utilizes the function of mesenchymal stem cells for the treatment of acute GVHD. Ultra-low temperature must be kept during the transportation of TEMCELL® HS Inj. in order to maintain its quality. We operate an ultra-low cold chain system jointly developed with MEDIPAL HOLDINGS CORPORATION to ensure the timely delivery of high-quality products to clinical sites across Japan. There is a large expectation for the new therapeutic product for steroid-refractory acute GVHD, and the sales of TEMCELL® HS Inj. in FY2016 reached 688 million yen, exceeding our forecast. We will expand the sales coverage of medical institutions to deliver TEMCELL® HS Inj. and continue to provide information for proper use in an effort for further market penetration. [1] Mesenchymal stem cells (MSCs), the main components of TEMCELL® HS Inj., are activated by substances secreted from sites of inflammation within blood vessels. Human somatic stem cell-processed products TEMCELL Human (allogenic) bone marrow-derived mesenchymal stem cells ® HS Inj. World’s first Migration ability, one of the properties of TEMCELL® Close-up HS Inj. [2] Activated MSCs migrate to and accumulate in the inflammatory tissue. [3] Activated MSCs exert therapeutic effects for the treatment of acute GVHD by secreting various anti-inflammatory substances within the inflammatory tissues. * It is a life-threatening complication associated with the transplant which arises following hematopoietic stem cell transplant and a disease which immunocompetent cells (e.g. lymphocytes) present in the transplanted hematopoietic stem cells regard the recipient’s body as foreign and attack the recipient’s cells. “Ultra-low temperature storage and transport cart SDDU (Specialty Drug Distribution Unit)” using liquid nitrogen Sales in FY2016 688 million yen

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