Lequembi\u00ae (lecanemab) subcutaneous injectable SC-AI is approved in China as an early therapy for mild Alzheimer’s disease. With a once-weekly 500 mg dose, home administration becomes possible, with a planned switch from IV administration. Launch is scheduled for fiscal year 2026. Minor impact expected on the earnings forecast for the fiscal year ending March 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":"4523","jir_company_name":"Astellas Pharma Inc.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-09-03","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/09\/4523-20260903-01.pdf","jir_short_summary":"Lequembi\u00ae (lecanemab) subcutaneous injectable SC-AI is approved in China as an early therapy for mild Alzheimer's disease. With a once-weekly 500 mg dose, home administration becomes possible, with a planned switch from IV administration. Launch is scheduled for fiscal year 2026. Minor impact expected on the earnings forecast for the fiscal year ending March 2027.","jir_summary":"### Section heading\nThis release announces the approval of the subcutaneous injectable SC-AI of lecanemab in China under the joint development and commercialization framework of Astellas and Biogen. SC-AI enables home administration with a weekly 500 mg dose, with the possibility of switching from IV administration. The approval is based on data from the Clarity AD trial and the long-term extension study LTE. Safety is generally comparable to IV administration, with local reactions but low frequency of systemic events.\n\n### Section 2 heading\nIn the Chinese market, the already launched Leqembi in June 2024 gains an additional at-home administration option through this approval, potentially improving treatment pathways and patient quality of life. Astellas leads global development and regulatory submissions, with co-promotion with Biogen. In China, Astellas handles sales and medical information through specialist MRs.","jir_financial_highlights":"Impact outlook: Unknown (Unknown)\nPlanned launch in China: Fiscal year 2026 (Plan)\nImpact on 2027 fiscal year earnings guidance: Minor; no change (No change)","jir_category":"","jir_hashtags":"#Astellas, #Leqembi, #Alzheimer'sDisease, #SCAdministration, #HomeAdministration, #ChinaApproval","jir_key_figures":"Approval: Leqembi SC-AI subcutaneous 500 mg weekly (IV exposure equivalent)\nPlanned launch: Fiscal year 2026\nImpact: Minor; no change to 2027 fiscal year earnings guidance","jir_meta_title":"\u3010Astellas\u3011Leqembi SC-AI, China for Early AD Approval\uff5cExpansion of Home Administration Options","jir_meta_description":"Astellas and Biogen have obtained approval for the subcutaneous injection of anti-amyloid beta lecanemab (SC-AI) for early Alzheimer's disease indications in China. Once-weekly dosing enables home administration, with launch planned for fiscal year 2026. Minor impact projected for FY2027.","jir_og_title":"\u3010Astellas\u3011Leqembi SC-AI China Approval Expands Home Administration \uff5c2026","jir_og_description":"Astellas and Biogen announce Leqembi SC-AI approval in China. Weekly dosing enables at-home treatment, with launch planned for fiscal year 2026. Impact lies in timing and treatment pathway convenience.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":7482,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-110395","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n