{"id":42235,"date":"2025-09-25T13:08:06","date_gmt":"2025-09-25T05:08:06","guid":{"rendered":"https:\/\/flcube.com\/?p=42235"},"modified":"2025-09-25T13:08:07","modified_gmt":"2025-09-25T05:08:07","slug":"burning-rock-secures-japanese-approval-for-oncoguide-oncoscreen-plus-cdx-enabling-capivasertib-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=42235","title":{"rendered":"Burning Rock Secures Japanese Approval for OncoGuide OncoScreen Plus CDx, Enabling Capivasertib Therapy"},"content":{"rendered":"\n<p><strong>Burning Rock Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/BNR:NASDAQ\">NASDAQ: BNR<\/a>)<\/strong>, a China\u2011based medical\u2011technology company, announced that its <strong>OncoGuide OncoScreen\u202fPlus CDx System<\/strong> has received approval from Japan\u2019s Ministry of Health, Labour and Welfare (MHLW). The companion diagnostic, built on Burning Rock\u2019s proprietary OncoScreen\u202fPlus platform, is now cleared to guide clinical selection for <strong>AstraZeneca <\/strong>(<strong>AZ; <a href=\"https:\/\/www.google.com\/finance\/quote\/AZN:NASDAQ\">NASDAQ: AZN<\/a>)\u2019s<\/strong> AKT inhibitor <strong>capivasertib<\/strong> in hormone\u2011receptor\u2011positive, HER2\u2011negative breast\u2011cancer patients.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-approval-scope\">Approval Scope<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Target Population<\/strong> \u2013 Adults with HR\u207a\/HER2\u207b locally advanced or metastatic breast cancer who have progressed after \u2265\u202f1 endocrine therapy in the metastatic setting, or who have recurred within 12\u202fmonths of completing adjuvant therapy.<\/li>\n\n\n\n<li><strong>Genetic Markers<\/strong> \u2013 The kit simultaneously detects <strong>PIK3CA, AKT1, and PTEN<\/strong> alterations, the three biomarkers that predict eligibility for capivasertib plus fulvestrant.<\/li>\n\n\n\n<li><strong>Single\u2011Assay Advantage<\/strong> \u2013 By consolidating the three companion\u2011diagnostic targets into one test, OncoGuide OncoScreen\u202fPlus reduces turnaround time and workflow complexity for clinicians.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-clinical-context\">Clinical Context<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Capivasertib<\/strong> is a first\u2011in\u2011class, highly selective inhibitor of the AKT1\/2\/3 kinases, developed by AstraZeneca in partnership with Astex Therapeutics, the Institute of Cancer Research, and Cancer Research Technology Ltd.<\/li>\n\n\n\n<li>The drug targets the PI3K\u2011AKT\u2011mTOR signaling axis, a pathway frequently dysregulated in HR\u207a\/HER2\u207b breast cancer through PIK3CA, AKT1, or PTEN alterations.<\/li>\n\n\n\n<li>Capivasertib received U.S. FDA approval in November\u202f2023 and Chinese approval in April\u202f2025, positioning it as a critical therapeutic option in advanced breast cancer.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-market-amp-strategic-implications\">Market &amp; Strategic Implications<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Factor<\/th><th>Impact<\/th><\/tr><\/thead><tbody><tr><td><strong>Japanese Market<\/strong><\/td><td>MHLW approval opens a 30\u2011million\u2011patient market in Japan, where precision oncology is expanding rapidly.<\/td><\/tr><tr><td><strong>Diagnostic Ecosystem<\/strong><\/td><td>OncoGuide OncoScreen\u202fPlus complements existing companion\u2011diagnostic platforms, strengthening Burning Rock\u2019s portfolio and cross\u2011sell opportunities with AstraZeneca.<\/td><\/tr><tr><td><strong>Revenue Synergy<\/strong><\/td><td>The approval aligns diagnostic and therapeutic pathways, potentially accelerating reimbursement in Japan and other key markets.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-future-outlook\">Future Outlook<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pipeline Expansion<\/strong> \u2013 Burning Rock plans to extend OncoGuide OncoScreen\u202fPlus to additional indications, leveraging its multiplexing capability.<\/li>\n\n\n\n<li><strong>Regulatory Momentum<\/strong> \u2013 With approvals in the U.S., China, and now Japan, the company is positioned to pursue global regulatory clearance, including the EU market.<\/li>\n\n\n\n<li><strong>Commercial Partnerships<\/strong> \u2013 The alliance with Riken Genesis and AstraZeneca underscores a collaborative model for bringing precision therapies to patients worldwide.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Burning Rock Ltd. (NASDAQ: BNR), a China\u2011based medical\u2011technology company, announced that its OncoGuide OncoScreen\u202fPlus CDx&#8230;<\/p>\n","protected":false},"author":1,"featured_media":42237,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[22],"tags":[130,724,871,1108,15],"class_list":["post-42235","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","tag-astrazeneca","tag-burning-rock","tag-nasdaq-azn","tag-nasdaq-bnr","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Burning Rock Secures Japanese Approval for OncoGuide OncoScreen Plus CDx, Enabling Capivasertib Therapy - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Burning Rock Ltd. (NASDAQ: BNR), a China\u2011based medical\u2011technology company, announced that its OncoGuide OncoScreen\u202fPlus CDx System has received approval from Japan\u2019s Ministry of Health, Labour and Welfare (MHLW). The companion diagnostic, built on Burning Rock\u2019s proprietary OncoScreen\u202fPlus platform, is now cleared to guide clinical selection for AstraZeneca (AZ; NASDAQ: AZN)\u2019s AKT inhibitor capivasertib in hormone\u2011receptor\u2011positive, HER2\u2011negative breast\u2011cancer patients.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=42235\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Burning Rock Secures Japanese Approval for OncoGuide OncoScreen Plus CDx, Enabling Capivasertib Therapy\" \/>\n<meta property=\"og:description\" content=\"Burning Rock Ltd. (NASDAQ: BNR), a China\u2011based medical\u2011technology company, announced that its OncoGuide OncoScreen\u202fPlus CDx System has received approval from Japan\u2019s Ministry of Health, Labour and Welfare (MHLW). The companion diagnostic, built on Burning Rock\u2019s proprietary OncoScreen\u202fPlus platform, is now cleared to guide clinical selection for AstraZeneca (AZ; NASDAQ: AZN)\u2019s AKT inhibitor capivasertib in hormone\u2011receptor\u2011positive, HER2\u2011negative breast\u2011cancer patients.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=42235\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-25T05:08:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-25T05:08:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2505.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1088\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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(NASDAQ: BNR), a China\u2011based medical\u2011technology company, announced that its OncoGuide OncoScreen\u202fPlus CDx System has received approval from Japan\u2019s Ministry of Health, Labour and Welfare (MHLW). The companion diagnostic, built on Burning Rock\u2019s proprietary OncoScreen\u202fPlus platform, is now cleared to guide clinical selection for AstraZeneca (AZ; NASDAQ: AZN)\u2019s AKT inhibitor capivasertib in hormone\u2011receptor\u2011positive, HER2\u2011negative breast\u2011cancer patients.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=42235#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=42235"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=42235#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2505.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2505.webp","width":1088,"height":608,"caption":"Burning Rock Secures Japanese Approval for OncoGuide OncoScreen Plus CDx, Enabling Capivasertib Therapy"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=42235#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Burning Rock Secures Japanese Approval for OncoGuide OncoScreen Plus CDx, Enabling Capivasertib Therapy"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2505.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/42235","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=42235"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/42235\/revisions"}],"predecessor-version":[{"id":42238,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/42235\/revisions\/42238"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/42237"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=42235"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=42235"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=42235"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}