Sumitomo Dainippon Pharma Annual Report 2017

SB623Secretion of various factorsPromotion of central nerve regenerationNeuro-protectionAngiogenesisAnti-inflammationImprovement of disability related toMotor Function, Cognitive Function, etc.SB623 administered throughbrain surgeryRPE cells (iPS cell-derived)Chronic Stroke (SB623) In-licensed from SanBioSB623 is an allogeneic cell product, derived from mesenchymal stem cells isolated from bone marrow of healthy donors. Unlike autologous cell therapy, which requires individualized cell preparation at a medical institution, SB623 production can be scaled up from a single donor’s cells, enabling delivery of uniform-quality products to a large number of stroke patients.In 2014, Sumitomo Dainippon Pharma concluded a license agreement for joint development and exclusive commercialization rights in North America. Currently, a Phase 2b study is being conducted in the U.S. with SanBio, Inc. to evaluate the effects of SB623 on chronic stroke.AMD (Age-related macular degeneration) Retinal Pigment Epithelial (RPE) cells (iPS cell-derived)Sumitomo Dainippon Pharma concluded a joint development agreement with Healios K.K. in December 2013, and established a joint venture company Sighregen K.K. through joint investment Parkinson’s disease Dopaminergic neural progenitor cells (iPS cell-derived)In February 2017, allogeneic iPS cell-derived dopaminergic neural progenitor cells, which we are working to use in practice in collaboration with the Center for iPS Cell Research and Application (CiRA) at Kyoto University, were designated as a “SAKIGAKE Designation System” product for regenerative medicine & cell therapy by the Ministry of Health, Labour and Welfare.Kyoto University is planning an investigator-initiated clinical study in regenerative medicine for Parkinson’s disease using dopaminergic neural progenitor cells derived from iPS cells of healthy (allogeneic) donors. Based on the results of the investigator-initiated clinical study, we are aiming to acquire manufacturing and marketing approval for the cells as a regenerative medicine product.Retinitis pigmentosa Photoreceptor cells (iPS cell-derived)In the eye disease field, Sumitomo Dainippon Pharma is conducting research into regenerative medicine for retinitis pigmentosa as well as age-related macular degeneration. As for basic research, Sumitomo Chemical Co., Ltd. in partnership with RIKEN has already become the first in the world to succeed in generating a three-dimensional retina from human embryonic stem cells. Carrying this research forward, we are applying the results to human iPS cells and are working with RIKEN on R&D to bring about regenerative medicine addressing retinitis pigmentosa.Spinal Cord Injury Neural precursor cells (iPS cell-derived)Under the Research Center Network for Realization of Regenerative Medicine, a joint initiative between government, industry and academia, Sumitomo Dainippon Pharma, together with the National Hospital Organization Osaka National Hospital, is taking part as a contributing organization in the Keio University project on “Regenerative medicine for spinal cord injury and stroke using iPS cell-derived neural precursor cells.” The goal of the project is to develop a treatment for the transplantation of iPS cell-derived neural precursor cells for spinal cord injury.Expected Mode of Actionwith Healios K.K. in February 2014. Aiming to commercialize the world’s first products using iPS cells, we are pursuing joint development with Healios K.K. and promoting examinations for manufacturing to take place at Sighregen K.K.26Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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