To rebuild a stable supply framework for the BNCT therapeutic Stavaronin\u00ae, PMDA submission and receipt of a partial approval change to add a new contract manufacturing site as a manufacturing facility. Approval is expected around January 2027.<\/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":"4888","jir_company_name":"StellaPharma Corporation","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-08-07","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/08\/4888-20260807-01.pdf","jir_short_summary":"To rebuild a stable supply framework for the BNCT therapeutic Stavaronin\u00ae, PMDA submission and receipt of a partial approval change to add a new contract manufacturing site as a manufacturing facility. Approval is expected around January 2027.","jir_summary":"### Background and purpose\nStellaPharma is strengthening its stable supply framework for the BNCT therapeutic Stavaronin\u00ae, expanding its long-term manufacturing and supply base. This release announces receipt of a partial approval change to add a new domestic contract manufacturing site as a manufacturing facility. As part of a plan to transfer from a major contract manufacturer undergoing quasi-bankruptcy, the company is proceeding with pilot-plant prototype manufacturing, quality assessments, and manufacturing trials and process validation at a commercial plant to rebuild a stable supply framework.\n\n### Outlook and business impact\nAfter approval, commercial manufacturing can be conducted at the new site, improving supply stability and capacity to meet future demand growth. Reviews will be conducted by PMDA and GMP conformity inspections, with an anticipated approval timing around January 2027. The BNCT business growth strategy includes expanding indications and overseas expansion, and this filing is positioned as an important initiative contributing to expanded treatment opportunities and enhanced corporate value.","jir_financial_highlights":"Unknown: Unknown (Unknown)","jir_category":"","jir_hashtags":"#StellaPharma, #BNCT, #StableSupply, #ManufacturingSystem, #ApprovalApplication","jir_key_figures":"Partial approval change for adding a new contract manufacturing site as a manufacturing facility: Receipt\nExpected timing of approval: around January 2027\nTarget product: Stavaronin\u00ae (Boropharan (10B))","jir_meta_title":"\u3010StellaPharma\u3011 Receipt of approval application for adding a manufacturing site to strengthen BNCT therapy supply\u2014Expected January 2027","jir_meta_description":"StellaPharma submitted and received a partial approval change to add a new manufacturing site for stable BNCT drug Stavaronin. Approval is expected around January 2027. Explains impact on supply framework strengthening and mid-term growth plan.","jir_og_title":"StellaPharma Receives Approval Application for BNCT Drug Supply Strengthening","jir_og_description":" As part of rebuilding a stable supply framework for the BNCT drug Stavaronin\u00ae, the company submitted and received a partial approval change to add a new manufacturing site. Expected approval around January 2027.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":59263,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"corporate_restructuring","footnotes":""},"sector":[],"importance":[],"class_list":["post-98266","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n