{"id":45856,"date":"2025-11-05T14:50:05","date_gmt":"2025-11-05T06:50:05","guid":{"rendered":"https:\/\/flcube.com\/?p=45856"},"modified":"2025-11-05T14:50:06","modified_gmt":"2025-11-05T06:50:06","slug":"daiichi-sankyos-enhertu-wins-cde-acceptance-for-first%e2%80%91line-her2%e2%80%91positive-breast%e2%80%91cancer-indication-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=45856","title":{"rendered":"Daiichi Sankyo\u2019s Enhertu Wins CDE Acceptance for First\u2011Line HER2\u2011Positive Breast\u2011Cancer Indication in China"},"content":{"rendered":"\n<p><strong>Daiichi Sankyo Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/4568:TYO\">TYO: 4568<\/a>) announced that China\u2019s <strong>Center for Drug Evaluation (CDE)<\/strong> of the <strong>National Medical Products Administration (NMPA)<\/strong> has <strong>accepted<\/strong> the company\u2019s application to add a <strong>new first\u2011line indication<\/strong> for <strong>Enhertu<\/strong> (trastuzumab deruxtecan, T\u2011DXd) in combination with <strong>pertuzumab<\/strong>. The indication targets <strong>unresectable or metastatic HER2\u2011positive adult breast\u2011cancer patients<\/strong>.<\/p>\n\n\n\n<p>This marks <strong>Enhertu\u2019s eighth Chinese indication<\/strong> and the <strong>fifth breast\u2011cancer indication<\/strong> approved for submission in the People\u2019s Republic.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-destiny-breast09-phase-3\">Clinical Evidence \u2013 DESTINY\u2011Breast09 (Phase\u202f3)<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Enhertu\u202f+\u202fPertuzumab vs. Standard of Care (THP)<\/th><th>Hazard Ratio \/ Reduction<\/th><\/tr><\/thead><tbody><tr><td><strong>Investigator\u2011assessed PFS<\/strong><\/td><td>Median <strong>40.7\u202fmonths<\/strong> vs. <strong>20.7\u202fmonths<\/strong><\/td><td><strong>44\u202f%<\/strong> risk reduction for progression or death<\/td><\/tr><tr><td><strong>OS (interim)<\/strong><\/td><td>Early trend favoring Enhertu\u202f+\u202fPertuzumab<\/td><td>Data not yet mature<\/td><\/tr><tr><td><strong>Safety<\/strong><\/td><td>Profile consistent with known safety of each agent; <strong>no new signals<\/strong><\/td><td>\u2014<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><em>THP = taxane\u202f+\u202ftrastuzumab\u202f+\u202fpertuzumab (current first\u2011line standard of care).<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-amp-commercial-implications\">Regulatory &amp; Commercial Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>CDE Acceptance<\/strong> \u2013 The filing moves to the formal review stage; if approved, Enhertu\u202f+\u202fpertuzumab could be launched in Q2\u202f2026.<\/li>\n\n\n\n<li><strong>Market Position<\/strong> \u2013 Enhertu, a <strong>HER2\u2011directed antibody\u2011drug conjugate (ADC)<\/strong> co\u2011developed with <strong>AstraZeneca<\/strong>, will join an increasingly competitive Chinese HER2\u2011positive breast\u2011cancer space, currently dominated by <strong>trastuzumab\u2011based regimens<\/strong> and emerging <strong>T\u2011DXd monotherapy<\/strong> data.<\/li>\n\n\n\n<li><strong>Revenue Outlook<\/strong> \u2013 Daiichi\u202fSankyo projects an incremental <strong>\u00a5120\u202fbillion<\/strong> (\u2248\u202fUS$1.7\u202fbillion) in 2027\u20112029 sales from the new indication, assuming a 15\u202f% market\u2011share capture of first\u2011line HER2\u2011positive patients.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-context\">Strategic Context<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Accelerating ADC Portfolio<\/strong> \u2013 Enhertu is Daiichi\u202fSankyo\u2019s flagship ADC, already approved for multiple indications worldwide, including lung and gastric cancers.<\/li>\n\n\n\n<li><strong>China\u2011Centric Growth<\/strong> \u2013 China now accounts for <strong>\u2248\u202f30\u202f%<\/strong> of global HER2\u2011positive breast\u2011cancer patients; expanding first\u2011line options strengthens Daiichi\u2019s foothold.<\/li>\n\n\n\n<li><strong>Co\u2011development Synergy<\/strong> \u2013 The partnership with <strong>AstraZeneca<\/strong> provides shared commercialization resources, enabling rapid market entry and joint pharmacovigilance.<\/li>\n<\/ol>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the regulatory timeline, commercial potential, and financial impact of the Enhertu indication. Actual results may differ materially due to risks including regulatory approval, competitive dynamics, and market acceptance.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Daiichi Sankyo Co., Ltd. (TYO: 4568) announced that China\u2019s Center for Drug Evaluation (CDE) of&#8230;<\/p>\n","protected":false},"author":1,"featured_media":45863,"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":[7,11],"tags":[35,194,38,978],"class_list":["post-45856","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-daiichi-sankyo","tag-market-approval-filings","tag-tyo-4568"],"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>Daiichi Sankyo\u2019s Enhertu Wins CDE Acceptance for First\u2011Line HER2\u2011Positive Breast\u2011Cancer Indication in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Daiichi Sankyo Co., Ltd. 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The indication targets unresectable or metastatic HER2\u2011positive adult breast\u2011cancer patients.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=45856#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=45856"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=45856#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/0502.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/0502.webp","width":1080,"height":608,"caption":"Daiichi\u202fSankyo\u2019s Enhertu Wins CDE Acceptance for First\u2011Line HER2\u2011Positive Breast\u2011Cancer Indication in China"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=45856#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Daiichi Sankyo\u2019s Enhertu Wins CDE Acceptance for First\u2011Line HER2\u2011Positive Breast\u2011Cancer Indication in China"}]},{"@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\/11\/0502.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/45856","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=45856"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/45856\/revisions"}],"predecessor-version":[{"id":45864,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/45856\/revisions\/45864"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/45863"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=45856"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=45856"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=45856"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}