{"id":56542,"date":"2026-02-06T22:14:19","date_gmt":"2026-02-06T14:14:19","guid":{"rendered":"https:\/\/flcube.com\/?p=56542"},"modified":"2026-02-06T22:14:21","modified_gmt":"2026-02-06T14:14:21","slug":"akesos-ivonescimab-secures-fifth-breakthrough-therapy-designation-for-biliary-tract-cancer-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56542","title":{"rendered":"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China"},"content":{"rendered":"\n<p><strong>Akeso, Inc.<\/strong> (<strong><a href=\"https:\/\/www.google.com\/finance\/quote\/9926:HKG\">HKG: 9926<\/a><\/strong>) announced that <strong>Yidafang (ivonescimab)<\/strong> has been awarded <strong>Breakthrough Therapy Designation (BTD)<\/strong> by the <strong>Center for Drug Evaluation (CDE)<\/strong> of China\u2019s <strong>NMPA<\/strong> for <strong>first\u2011line combination therapy of advanced biliary tract malignancies (BTC)<\/strong>. This marks the <strong>fifth BTD<\/strong> for the <strong>world\u2019s first PD\u20111\/VEGF bispecific antibody<\/strong>, expanding its oncology footprint beyond lung and breast cancer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Akeso, Inc. (9926.HK)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>CDE\/NMPA (China)<\/td><\/tr><tr><td><strong>Asset<\/strong><\/td><td>Ivonescimab (Yidafang) \u2013 PD\u20111\/VEGF bispecific antibody<\/td><\/tr><tr><td><strong>Designation<\/strong><\/td><td>Breakthrough Therapy Designation (BTD)<\/td><\/tr><tr><td><strong>New Indication<\/strong><\/td><td>First\u2011line combination therapy for advanced biliary tract malignancies (BTC)<\/td><\/tr><tr><td><strong>BTD Tally<\/strong><\/td><td>Fifth overall (3 lung cancer + 1 TNBC + 1 BTC)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-approved-indications-amp-reimbursement-status\">Approved Indications &amp; Reimbursement Status<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Indication<\/th><th>Approval Date<\/th><th>Status<\/th><\/tr><\/thead><tbody><tr><td><strong>EGFR\u2011mutated non\u2011squamous NSCLC<\/strong> (post\u2011EGFR\u2011TKI progression)<\/td><td>May\u202f2024<\/td><td>Approved; NRDL listed<\/td><\/tr><tr><td><strong>PD\u2011L1\u2011positive advanced NSCLC<\/strong> (first\u2011line)<\/td><td>April\u202f2025<\/td><td>Approved; NRDL listed<\/td><\/tr><tr><td><strong>Biliary tract malignancies<\/strong> (first\u2011line combo)<\/td><td>Feb\u202f2026<\/td><td>BTD granted; pivotal trial stage<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-profile-amp-mechanism-of-action\">Technology Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Novelty:<\/strong> <strong>World\u2019s first bispecific antibody<\/strong> simultaneously targeting <strong>PD\u20111 (cancer immunotherapy)<\/strong> and <strong>VEGF (anti\u2011angiogenesis)<\/strong> in a single molecule<\/li>\n\n\n\n<li><strong>Mechanistic Synergy:<\/strong><\/li>\n\n\n\n<li><strong>PD\u20111 blockade<\/strong> \u2013 Reactivates T\u2011cell anti\u2011tumor immunity<\/li>\n\n\n\n<li><strong>VEGF inhibition<\/strong> \u2013 Normalizes tumor vasculature, enhances immune cell infiltration, and suppresses metastasis<\/li>\n\n\n\n<li><strong>Competitive Edge:<\/strong> Dual\u2011targeting reduces need for combination chemotherapy while potentially improving efficacy over PD\u20111 monotherapy or PD\u20111 + VEGF tyrosine kinase inhibitor combinations<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-amp-commercial-implications\">Clinical &amp; Commercial Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Biliary Tract Opportunity:<\/strong> BTC represents a <strong>high\u2011unmet\u2011need malignancy<\/strong> with limited effective first\u2011line options; BTD positions ivonescimab for <strong>priority review and accelerated approval pathway<\/strong> in China.<\/li>\n\n\n\n<li><strong>BTD Portfolio Validation:<\/strong> Five Breakthrough designations establish ivonescimab as a <strong>platform asset<\/strong> with broad mechanistic applicability across solid tumors, supporting Akeso\u2019s <strong>global licensing strategy<\/strong>.<\/li>\n\n\n\n<li><strong>NRDL Inclusion Momentum:<\/strong> Existing NSCLC indications already on <strong>National Reimbursement Drug List<\/strong> demonstrate pricing negotiation success and market access foundation for future BTC approval.<\/li>\n\n\n\n<li><strong>Global Expansion Potential:<\/strong> BTD status strengthens data package for <strong>ex\u2011China regulatory submissions<\/strong>, particularly in hepatobiliary\u2011prevalent Asian markets and Western territories seeking novel BTC therapies.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-outlook\">Strategic Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Priority<\/th><th>Execution Plan<\/th><\/tr><\/thead><tbody><tr><td><strong>BTC Pivotal Trial<\/strong><\/td><td>Initiate\/registrational study leveraging BTD fast\u2011track<\/td><\/tr><tr><td><strong>Combination Strategy<\/strong><\/td><td>Explore ivonescimab + chemotherapy \u00b1 other IO agents in first\u2011line BTC<\/td><\/tr><tr><td><strong>Geographic Expansion<\/strong><\/td><td>Use BTD\u2011backed China data to support US\/EU IND filings<\/td><\/tr><tr><td><strong>Pipeline Synergies<\/strong><\/td><td>Leverage bispecific platform for next\u2011gen PD\u20111\/VEGF iterations and novel targets<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding ivonescimab\u2019s clinical development in biliary tract cancer, regulatory timelines for BTC approval, and Akeso\u2019s global commercialization strategy. Actual results may differ due to trial outcomes, competitive dynamics in the IO space, and reimbursement negotiation results.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Akeso, Inc. (HKG: 9926) announced that Yidafang (ivonescimab) has been awarded Breakthrough Therapy Designation (BTD)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":56543,"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":[360,34,850,28,18],"class_list":["post-56542","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-akeso-biopharma","tag-breakthrough-therapy","tag-hkg-9926","tag-multi-specific-antibodies","tag-pd-1-l1"],"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 Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Akeso, Inc. (HKG: 9926) announced that Yidafang (ivonescimab) has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China\u2019s NMPA for first\u2011line combination therapy of advanced biliary tract malignancies (BTC). This marks the fifth BTD for the world\u2019s first PD\u20111\/VEGF bispecific antibody, expanding its oncology footprint beyond lung and breast cancer.\" \/>\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=56542\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China\" \/>\n<meta property=\"og:description\" content=\"Akeso, Inc. (HKG: 9926) announced that Yidafang (ivonescimab) has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China\u2019s NMPA for first\u2011line combination therapy of advanced biliary tract malignancies (BTC). This marks the fifth BTD for the world\u2019s first PD\u20111\/VEGF bispecific antibody, expanding its oncology footprint beyond lung and breast cancer.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=56542\" \/>\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=\"2026-02-06T14:14:19+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-06T14:14:21+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0608.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\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. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China\",\"datePublished\":\"2026-02-06T14:14:19+00:00\",\"dateModified\":\"2026-02-06T14:14:21+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542\"},\"wordCount\":444,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/0608.webp\",\"keywords\":[\"Akeso Biopharma\",\"Breakthrough therapy\",\"HKG: 9926\",\"Multi-specific antibodies\",\"PD-1\\\/L1\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=56542#respond\"]}],\"copyrightYear\":\"2026\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=56542\",\"name\":\"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/0608.webp\",\"datePublished\":\"2026-02-06T14:14:19+00:00\",\"dateModified\":\"2026-02-06T14:14:21+00:00\",\"description\":\"Akeso, Inc. (HKG: 9926) announced that Yidafang (ivonescimab) has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China\u2019s NMPA for first\u2011line combination therapy of advanced biliary tract malignancies (BTC). This marks the fifth BTD for the world\u2019s first PD\u20111\\\/VEGF bispecific antibody, expanding its oncology footprint beyond lung and breast cancer.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=56542\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/0608.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/02\\\/0608.webp\",\"width\":1080,\"height\":608,\"caption\":\"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=56542#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer 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\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China - Insight, China&#039;s Pharmaceutical Industry","description":"Akeso, Inc. (HKG: 9926) announced that Yidafang (ivonescimab) has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China\u2019s NMPA for first\u2011line combination therapy of advanced biliary tract malignancies (BTC). This marks the fifth BTD for the world\u2019s first PD\u20111\/VEGF bispecific antibody, expanding its oncology footprint beyond lung and breast cancer.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=56542","og_locale":"en_US","og_type":"article","og_title":"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China","og_description":"Akeso, Inc. (HKG: 9926) announced that Yidafang (ivonescimab) has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China\u2019s NMPA for first\u2011line combination therapy of advanced biliary tract malignancies (BTC). This marks the fifth BTD for the world\u2019s first PD\u20111\/VEGF bispecific antibody, expanding its oncology footprint beyond lung and breast cancer.","og_url":"https:\/\/flcube.com\/?p=56542","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2026-02-06T14:14:19+00:00","article_modified_time":"2026-02-06T14:14:21+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0608.webp","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=56542#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=56542"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China","datePublished":"2026-02-06T14:14:19+00:00","dateModified":"2026-02-06T14:14:21+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=56542"},"wordCount":444,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=56542#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0608.webp","keywords":["Akeso Biopharma","Breakthrough therapy","HKG: 9926","Multi-specific antibodies","PD-1\/L1"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=56542#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=56542","url":"https:\/\/flcube.com\/?p=56542","name":"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=56542#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=56542#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0608.webp","datePublished":"2026-02-06T14:14:19+00:00","dateModified":"2026-02-06T14:14:21+00:00","description":"Akeso, Inc. (HKG: 9926) announced that Yidafang (ivonescimab) has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China\u2019s NMPA for first\u2011line combination therapy of advanced biliary tract malignancies (BTC). This marks the fifth BTD for the world\u2019s first PD\u20111\/VEGF bispecific antibody, expanding its oncology footprint beyond lung and breast cancer.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=56542#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=56542"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=56542#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0608.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0608.webp","width":1080,"height":608,"caption":"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=56542#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Akeso\u2019s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer 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\/2026\/02\/0608.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/56542","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=56542"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/56542\/revisions"}],"predecessor-version":[{"id":56544,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/56542\/revisions\/56544"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/56543"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=56542"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=56542"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=56542"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}