Sumitomo Pharma, a subsidiary of Sumitomo Chemical, obtained manufacturing and marketing approval on March 6, 2026, for the world’s first iPS cell-derived regenerative medicine “Amshepli\u00ae”. Sales exceeding 100 billion yen are expected in the 2030s.<\/p>\n","protected":false},"comment_status":"open","ping_status":"closed","template":"","meta":{"Ticker":"","DATE":"","longName":"","company_name_ja":"","fullTimeEmployees":0,"address":"","phone":"","website":"","industry":"","sector":"","regularMarketPrice":0,"financialCurrency":"","marketCap":0,"fiftyTwoWeekLow":0,"fiftyTwoWeekHigh":0,"epsTrailingTwelveMonths":0,"epsForward":0,"bookValue":0,"totalRevenue":0,"OperatingIncome":0,"operatingMargins":0,"NetIncome":0,"profitMargins":0,"ebitda":0,"trailingPE":0,"forwardPE":0,"priceToBook":0,"returnOnEquity":0,"recommendationMean":0,"recommendationKey":"","targetMeanPrice":0,"numberOfAnalystOpinions":0,"analyst_earnings_data":"","dividendRate":0,"dividendYield":0,"payoutRatio":0,"totalEsg":0,"environmentScore":0,"socialScore":0,"governanceScore":0,"title":"","providerPublishTime":"","link":"","longBusinessSummary":"","longBusinessSummary_ja":"","quarterly_revenue":0,"quarterly_net_income":0,"quarterly_operating_profit":0,"enterprise_value":0,"company_officer_1_name":"","company_officer_1_title":"","company_officer_2_name":"","company_officer_2_title":"","company_officer_3_name":"","company_officer_3_title":"","company_officer_4_name":"","company_officer_4_title":"","company_officer_5_name":"","company_officer_5_title":"","company_officers_update_time":"","get_dividend_history_year1":0,"get_dividend_history_year2":0,"get_dividend_history_year3":0,"get_dividend_history_year4":0,"get_dividend_history_year5":0,"get_dividend_history_year6":0,"get_dividend_history_year7":0,"get_dividend_history_year8":0,"get_dividend_history_year9":0,"get_dividend_history_year10":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"4005","jir_company_name":"Sumitomo Chemical Company, Limited","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-03-06","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/03\/4005-20260306-01.pdf","jir_short_summary":"Sumitomo Pharma, a subsidiary of Sumitomo Chemical, obtained manufacturing and marketing approval on March 6, 2026, for the world's first iPS cell-derived regenerative medicine \"Amshepli\u00ae\". Sales exceeding 100 billion yen are expected in the 2030s.","jir_summary":"### Overview of Approval for Manufacturing and Marketing\nSumitomo Pharma, a subsidiary of Sumitomo Chemical, together with RACTHERA, obtained conditional and time-limited manufacturing and marketing approval in Japan on March 6, 2026, for the non-autologous iPS cell-derived dopamine neural progenitor product \"Amshepli\u00ae.\" This product is the world's first approved regenerative and cellular medicine derived from iPS cells, based on physician-led clinical trial results at Kyoto University Hospital. Manufacturing is handled by S-RACMO Co., Ltd., a CDMO with proven commercial production experience in regenerative and cellular medicines.\n\n### Future Outlook and Social Significance\nThe Sumitomo Chemical Group positions regenerative and cellular medicine as a core area for medium- to long-term new growth. This product is expected to become a blockbuster with sales exceeding 100 billion yen in the 2030s. As this is a conditional and time-limited approval, post-marketing clinical trials and usage surveys will be conducted aiming for full approval. The product provides a novel treatment option for Parkinson's disease patients different from conventional drug therapies, contributing to solving social challenges.","jir_financial_highlights":"Approval Date for Manufacturing and Marketing: 2026\u5e743\u67086\u65e5 (Newly obtained)\nProjected Sales: Over 100 billion yen (2030s) (New forecast)\nEquity Ratio (Sumitomo Pharma): 51.76% (Unknown)","jir_category":"","jir_hashtags":"#SumitomoChemicalCompanyLimited, #product_announcement, #JapaneseStocks","jir_key_figures":"Approval Date for Manufacturing and Marketing: 2026\u5e743\u67086\u65e5\nProjected Sales: Over 100 billion yen (2030s)\nEquity Ratio: Sumitomo Pharma 51.76%, RACTHERA 66.6%","jir_meta_title":"Sumitomo Chemical Subsidiary Obtains Approval for iPS Cell-Derived Product \"Amshepli\u00ae\" with Sales Expected to Exceed 100 Billion Yen in 2030s","jir_meta_description":"A subsidiary of Sumitomo Chemical obtained the world's first manufacturing and marketing approval for the iPS cell-derived regenerative medicine \"Amshepli\u00ae\" on March 6, 2026. Sales exceeding 100 billion yen are projected in the 2030s, bringing innovation to Parkinson's disease treatment.","jir_og_title":"Sumitomo Chemical Subsidiary Obtains Approval for iPS Cell-Derived Product \"Amshepli\u00ae\"","jir_og_description":"A subsidiary of Sumitomo Chemical has obtained manufacturing and marketing approval for an iPS cell-derived product for Parkinson's disease treatment, with sales expected to exceed 100 billion yen in the 2030s.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":7702,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-33493","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n