{"id":114431,"date":"2026-09-16T15:04:54","date_gmt":"2026-09-16T06:04:54","guid":{"rendered":"https:\/\/japanir.jp\/en\/ir\/4507-20260916-01_wp_general_ir\/"},"modified":"2026-09-16T15:04:54","modified_gmt":"2026-09-16T06:04:54","slug":"4507-20260916-01_wp_general_ir","status":"publish","type":"ir_release","link":"https:\/\/japanir.jp\/en\/company\/company-4507\/ir\/4507-20260916-01_wp_general_ir\/","title":{"rendered":"Approval of partial amendment to manufacturing and marketing consent for the Omicron lineage JN.1-based recombinant protein vaccine &#8216;Cobgoes\u2122 Injection&#8217; for domestic use"},"content":{"rendered":"<p>Obtained partial approval to add the dosing and administration as a supplementary indication for the COVID-19 booster vaccine &#8216;Cobgoes\u2122 Injection&#8217; in domestic markets. Aims to establish a platform for rapid development and production of a vaccine aligned with the recommended strain for the 2026\/2027 season. No impact expected on the fiscal year ending March 2027 as it has already been baked into guidance.<\/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\u2606\u2606","jir_publication_date":"2026-09-16","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/09\/4507-20260916-01.pdf","jir_short_summary":"Obtained partial approval to add the dosing and administration as a supplementary indication for the COVID-19 booster vaccine 'Cobgoes\u2122 Injection' in domestic markets. Aims to establish a platform for rapid development and production of a vaccine aligned with the recommended strain for the 2026\/2027 season. No impact expected on the fiscal year ending March 2027 as it has already been baked into guidance.","jir_summary":"### Overview of the news\nShionogi & Co., Ltd. has obtained partial approval to amend the manufacturing and marketing approval to add the indication of dosing as a supplementary immunization for the Omicron lineage JN.1-based recombinant protein vaccine 'Cobgoes\u2122 Injection.' The approval intends to enable the rapid development and production of a recommended-strain vaccine by constructing a platform by fiscal year 2026. Domestic supply is not planned for the 2026\/2027 season as it differs from the recommended-strain vaccine.\n\n### Outlook\/Impact\nThe company is pursuing its materiality of 'liberation from infectious disease threats' by continuing to provide solutions from prevention to diagnosis and treatment. The approval aims to solidify the platform and reinforce the supply framework for vaccines aligned with the latest recommended strains. The impact on the fiscal year ending March 2027 is already baked in, and there is no additional disclosure of short-term financial effects.","jir_financial_highlights":"Impact on consolidated results for the fiscal year ending March 2027: Unknown (Already reflected in earnings forecast)","jir_category":"","jir_hashtags":"#Shionogi, #NewC19Vaccine, #GeneralIRInfo","jir_key_figures":"Period of impact: Fiscal year ending March 2027\nApproval details: Partial amendment to add dosing as supplementary immunization in manufacturing and marketing approval\nSupply plan: No planned supply since it differs from the recommended-strain vaccine for the 2026\/2027 season","jir_meta_title":"Shionogi: COVID-19 Vaccine Approval Change | September 2026","jir_meta_description":"Shionogi obtained partial approval to amend the domestic indication for the Omicron lineage JN.1-based vaccine 'Cobgoes\u2122 Injection.' Pushing platform establishment for the recommended-strain vaccine. Impact for FY2027 already baked in.","jir_og_title":"Shionogi: COVID-19 Vaccine Approval Change | September 2026","jir_og_description":"Shionogi has obtained approval change for Cobgoes\u2122 Injection. Aiming to build the platform for the recommended-strain vaccine. Impact for FY2027 already baked in.","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":"general_ir","footnotes":""},"sector":[],"importance":[],"class_list":["post-114431","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Approval of partial amendment to manufacturing and marketing consent for the Omicron lineage JN.1-based recombinant protein vaccine &#039;Cobgoes\u2122 Injection&#039; for domestic use - Japan IR<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/japanir.jp\/en\/company\/company-4507\/ir\/4507-20260916-01_wp_general_ir\/\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/japanir.jp\/en\/company\/company-4507\/ir\/4507-20260916-01_wp_general_ir\/\",\"url\":\"https:\/\/japanir.jp\/en\/company\/company-4507\/ir\/4507-20260916-01_wp_general_ir\/\",\"name\":\"Approval of partial amendment to manufacturing and marketing consent for the Omicron lineage JN.1-based recombinant protein vaccine 'Cobgoes\u2122 Injection' for domestic use - Japan IR\",\"isPartOf\":{\"@id\":\"https:\/\/japanir.jp\/en\/#website\"},\"datePublished\":\"2026-09-16T06:04:54+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/japanir.jp\/en\/company\/company-4507\/ir\/4507-20260916-01_wp_general_ir\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/japanir.jp\/en\/company\/company-4507\/ir\/4507-20260916-01_wp_general_ir\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/japanir.jp\/en\/company\/company-4507\/ir\/4507-20260916-01_wp_general_ir\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/japanir.jp\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Approval of partial amendment to manufacturing and marketing consent for the Omicron lineage JN.1-based recombinant protein vaccine &#8216;Cobgoes\u2122 Injection&#8217; 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