{"id":45563,"date":"2025-11-03T11:24:18","date_gmt":"2025-11-03T03:24:18","guid":{"rendered":"https:\/\/flcube.com\/?p=45563"},"modified":"2025-11-03T11:24:19","modified_gmt":"2025-11-03T03:24:19","slug":"akesos-ivonescimab-ak112-receives-fourth-breakthrough-therapy-designation-in-china-for-triple%e2%80%91negative-breast-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=45563","title":{"rendered":"Akeso\u2019s ivonescimab (AK112) Receives Fourth Breakthrough Therapy Designation in China for Triple\u2011Negative Breast Cancer"},"content":{"rendered":"\n<p><strong>Akeso Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/9926:HKG\">HKG: 9926<\/a>) announced that its proprietary bispecific antibody <strong>ivonescimab (AK112)<\/strong> has been granted a <strong>Breakthrough Therapy Designation (BTD)<\/strong> by the <strong>Center for Drug Evaluation (CDE)<\/strong> of China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong>. The designation applies to the use of ivonescimab <strong>in combination with chemotherapy as a first\u2011line treatment for locally advanced, unresectable or metastatic triple\u2011negative breast cancer (TN\u2011BC).<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-key-highlights\">Key Highlights<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug<\/strong><\/td><td>ivonescimab (AK112) \u2013 first\u2011in\u2011class PD\u20111\/VEGF bispecific immune\u2011checkpoint inhibitor<\/td><\/tr><tr><td><strong>Designation<\/strong><\/td><td>Fourth CDE Breakthrough Therapy Designation (BTD)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>First\u2011line chemo\u2011plus\u2011ivonescimab for locally advanced\/unresectable or metastatic <strong>TN\u2011BC<\/strong><\/td><\/tr><tr><td><strong>Previous BTDs<\/strong><\/td><td>1\ufe0f\u20e3 NSCLC (EGFR\u2011TKI\u2011resistant) \u2013 approved &amp; on NRDL<br>2\ufe0f\u20e3 NSCLC (PD\u2011L1\u2011positive) \u2013 approved<br>3\ufe0f\u20e3 NSCLC (post\u2011PD\u20111\/L1 + platinum) \u2013 Phase\u202fIII enrollment accelerating<\/td><\/tr><tr><td><strong>Regulatory Impact<\/strong><\/td><td>Faster clinical\u2011development pathways, priority review, and potential accelerated market entry in China<\/td><\/tr><tr><td><strong>Commercial Outlook<\/strong><\/td><td>Adds a high\u2011value oncology asset to Akeso\u2019s pipeline; strengthens positioning in the rapidly growing Chinese immuno\u2011oncology market (projected &gt;\u202f$3\u202fB by 2028)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-scientific-rationale\">Scientific Rationale<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Bispecific Mechanism<\/strong> \u2013 Simultaneous blockade of PD\u20111 (restoring T\u2011cell activity) and VEGF (normalising tumour vasculature) creates a synergistic anti\u2011tumour micro\u2011environment.<\/li>\n\n\n\n<li><strong>TN\u2011BC Unmet Need<\/strong> \u2013 Triple\u2011negative disease lacks hormone\u2011receptor targets; current options are limited to chemotherapy and, more recently, antibody\u2011drug conjugates. Early data suggest ivonescimab plus chemotherapy improves objective response rates and progression\u2011free survival.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-timeline\">Development Timeline<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>May\u202f2025<\/strong> \u2013 CDE accepts NDA for ivonescimab in TN\u2011BC (first\u2011line combo).<\/li>\n\n\n\n<li><strong>Nov\u202f2025<\/strong> \u2013 Fourth BTD granted, enabling priority review and accelerated clinical milestones.<\/li>\n\n\n\n<li><strong>2026\u20112027<\/strong> \u2013 Planned Phase\u202fIII registration trial (\u2248\u202f600 patients) to support Chinese market filing and potential global expansion.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Regulatory Momentum<\/strong> \u2013 Four BTDs within a single product line underscore the CDE\u2019s confidence in ivonescimab\u2019s clinical benefit.<\/li>\n\n\n\n<li><strong>Pipeline Leverage<\/strong> \u2013 Success in TN\u2011BC could accelerate development of additional bispecific indications (e.g., colorectal, gastric cancers).<\/li>\n\n\n\n<li><strong>Investor Impact<\/strong> \u2013 The designation is expected to reinforce Akeso\u2019s valuation narrative, with analysts projecting a <strong>+15\u202f%<\/strong> uplift in the company\u2019s market\u2011cap upon eventual approval.<\/li>\n<\/ol>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This release contains forward\u2011looking statements that involve risks and uncertainties, including regulatory approvals, clinical trial results, and commercial performance. Actual results may differ materially from those expressed herein.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Akeso Inc. (HKG: 9926) announced that its proprietary bispecific antibody ivonescimab (AK112) has been granted&#8230;<\/p>\n","protected":false},"author":1,"featured_media":45565,"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":[360,34,16,850,28],"class_list":["post-45563","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-akeso-biopharma","tag-breakthrough-therapy","tag-cancer","tag-hkg-9926","tag-multi-specific-antibodies"],"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>Akeso\u2019s ivonescimab (AK112) Receives Fourth Breakthrough Therapy Designation in China for Triple\u2011Negative Breast Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Akeso Inc. (HKG: 9926) announced that its proprietary bispecific antibody ivonescimab (AK112) has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). The designation applies to the use of ivonescimab in combination with chemotherapy as a first\u2011line treatment for locally advanced, unresectable or metastatic triple\u2011negative breast cancer (TN\u2011BC).\" \/>\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=45563\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Akeso\u2019s ivonescimab (AK112) Receives Fourth Breakthrough Therapy Designation in China for Triple\u2011Negative Breast Cancer\" \/>\n<meta property=\"og:description\" content=\"Akeso Inc. (HKG: 9926) announced that its proprietary bispecific antibody ivonescimab (AK112) has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). 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(HKG: 9926) announced that its proprietary bispecific antibody ivonescimab (AK112) has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA). The designation applies to the use of ivonescimab in combination with chemotherapy as a first\u2011line treatment for locally advanced, unresectable or metastatic triple\u2011negative breast cancer (TN\u2011BC).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=45563#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=45563"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=45563#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/0304.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/0304.webp","width":1080,"height":608,"caption":"Akeso\u2019s ivonescimab (AK112) Receives Fourth Breakthrough Therapy Designation in China for Triple\u2011Negative Breast Cancer"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=45563#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Akeso\u2019s ivonescimab (AK112) Receives Fourth Breakthrough Therapy Designation in China for Triple\u2011Negative Breast Cancer"}]},{"@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\/0304.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/45563","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=45563"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/45563\/revisions"}],"predecessor-version":[{"id":45566,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/45563\/revisions\/45566"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/45565"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=45563"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=45563"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=45563"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}