Shionogi & Co., Ltd.’s anti-SARS-CoV-2 drug Xocova\u00ae obtained additional approval in Japan for post-exposure prevention of COVID-19. Impact on FY ending March 2026 earnings is minimal.<\/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":"4507","jir_company_name":"Shionogi & Co., Ltd.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-03-23","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/03\/4507-20260323-01.pdf","jir_short_summary":"Shionogi & Co., Ltd.'s anti-SARS-CoV-2 drug Xocova\u00ae obtained additional approval in Japan for post-exposure prevention of COVID-19. Impact on FY ending March 2026 earnings is minimal.","jir_summary":"### Regarding Additional Approval of Product Indications\nShionogi & Co., Ltd.'s anti-SARS-CoV-2 drug Xocova\u00ae (Ensitrelvir Fumarate) has received additional approval in Japan for the indication of post-exposure prevention of COVID-19 based on favorable results from the global Phase 3 post-exposure prophylaxis trial (SCORPIO-PEP). Xocova is the world's first and only oral antiviral drug that can be used to prevent infection development after exposure. The dosage is 375mg orally once on Day 1, followed by 125mg once daily orally from Day 2 to Day 5 for children aged 12 and over and adults.\n\n### Future Outlook and Global Expansion\nShionogi positions liberation from the threat of infectious diseases as a key issue and is advancing research and development toward comprehensive infectious disease care. Internationally, a new drug application was submitted to the U.S. FDA in 2025 and is under review (PDUFA date: June 16, 2026), with reviews ongoing in Europe and Taiwan as well. Additionally, a licensing agreement with Medicines Patent Pool has been concluded to expand global access in low- and middle-income countries. The impact on consolidated earnings for the fiscal year ending March 2026 is expected to be minimal.","jir_financial_highlights":"Drug Price: Xocova\u00ae tablet 125mg, 1 tablet 7,090 yen (Unknown)\nImpact on Consolidated Earnings for FY Ending March 2026: Minimal (Unknown)\nDosage and Administration: For patients aged 12 and older, 375mg on Day 1, then 125mg once daily from Day 2 to Day 5 orally (Unknown)","jir_category":"","jir_hashtags":"#Shionogi, #NewDrugApproval, #COVID19, #Xocova, #product_announcement, #JapaneseStocks","jir_key_figures":"Drug Price: Xocova\u00ae tablet 125mg, 1 tablet 7,090 yen\nDosage and Administration: For patients aged 12 and older, 375mg on Day 1, then 125mg once daily orally from Day 2 to Day 5\nImpact on Consolidated Earnings for FY Ending March 2026: Minimal","jir_meta_title":"Shionogi Obtains Additional Approval for Post-Exposure Prevention Indication of COVID-19 Drug Xocova\u00ae","jir_meta_description":"Shionogi & Co., Ltd. gains additional approval in Japan for the post-exposure prevention indication of the anti-SARS-CoV-2 drug Xocova\u00ae. Global expansion underway with minimal earnings impact.","jir_og_title":"Shionogi Announces Additional Approval of Xocova\u00ae for COVID-19 Prevention","jir_og_description":"Xocova\u00ae obtains additional approval in Japan for post-exposure prevention of COVID-19. Promoting global expansion and strengthening infectious disease measures.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6919,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-35688","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n