Sumitomo Pharma obtained manufacturing and marketing approval with conditions and time limits for the allogeneic iPS cell-derived dopaminergic neural progenitor cell ‘Amsepre\u00ae’ in Japan, effective March 6, 2026. 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The impact on financial results for the fiscal year ending March 2026 is minor.","jir_summary":"### Overview of Manufacturing and Marketing Approval\nSumitomo Pharma Co., Ltd., in collaboration with RACTHERA, Inc., obtained manufacturing and marketing approval with conditions and time limits in Japan for the allogeneic iPS cell-derived dopaminergic neural progenitor cell product 'Amsepre\u00ae' effective March 6, 2026. This product is indicated for the improvement of motor symptoms in Parkinson\u2019s disease patients who have an insufficient response to existing drug therapies including levodopa-containing formulations. It is the world\u2019s first regenerative and cellular medicine derived from iPS cells. The application was based on physician-initiated clinical trial results conducted at Kyoto University Hospital.\n\n### Future Outlook and Manufacturing System\nFollowing drug price listing, Sumitomo Pharma will handle sales while manufacturing will be undertaken by S-RACMO Co., Ltd. The approval is conditional and time-limited, with plans to conduct post-marketing clinical trials and usage surveys within the stipulated timeframe to achieve full approval. Sumitomo Pharma and RACTHERA aim to provide a new treatment option for Parkinson\u2019s disease patients and contribute to therapeutic advancements.","jir_financial_highlights":"Date of Manufacturing and Marketing Approval: 2026\u5e743\u67086\u65e5 (Unknown)\nImpact on Financial Results: Minor (Unknown)\nProduct Name: Amsepre\u00ae (Generic Name: Lagneprocel) (Unknown)","jir_category":"","jir_hashtags":"#SumitomoPharma, #product_announcement, #JapaneseStocks","jir_key_figures":"Date of Manufacturing and Marketing Approval: 2026\u5e743\u67086\u65e5\nProduct Name: Amsepre\u00ae (Generic Name: Lagneprocel)\nImpact on Financial Results: Minor for fiscal year ending March 2026","jir_meta_title":"Sumitomo Pharma Obtains Manufacturing and Marketing Approval for Allogeneic iPS Cell-Derived 'Amsepre\u00ae' (March 6, 2026)","jir_meta_description":"On March 6, 2026, Sumitomo Pharma obtained manufacturing and marketing approval in Japan for 'Amsepre\u00ae', an allogeneic iPS cell-derived dopaminergic neural progenitor cell for Parkinson\u2019s disease treatment. The financial impact is minor.","jir_og_title":"Sumitomo Pharma Announces Approval of Allogeneic iPS Cell-Derived 'Amsepre\u00ae'","jir_og_description":"Sumitomo Pharma secured manufacturing and marketing approval for 'Amsepre\u00ae', a Parkinson\u2019s disease therapeutic, on March 6, 2026, introducing a new treatment option.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":7612,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-33494","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n