{"id":48547,"date":"2025-11-18T15:17:00","date_gmt":"2025-11-18T07:17:00","guid":{"rendered":"https:\/\/flcube.com\/?p=48547"},"modified":"2025-11-18T15:17:01","modified_gmt":"2025-11-18T07:17:01","slug":"biokins-iza-bren-adc-achieves-dual-pfs-os-endpoints-in-phase-3-esophageal-cancer-a-global-first","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48547","title":{"rendered":"Biokin&#8217;s iza-bren ADC Achieves Dual PFS &amp; OS Endpoints in Phase 3 Esophageal Cancer, a Global First"},"content":{"rendered":"\n<p><strong>Sichuan Biokin Pharmaceutical Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/688506:SHA\">SHA: 688506<\/a>) announced its antibody-drug conjugate <strong>iza-bren<\/strong> (izalontamab brengitecan, BL\u2011B01D1) met both primary endpoints of progression-free survival (PFS) and overall survival (OS) in a prespecified interim analysis of a Phase 3 trial for recurrent\/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed after PD\u20111\/PD\u2011L1 inhibitors plus platinum chemotherapy, marking the first global Phase 3 trial where an ADC has demonstrated positive results for both endpoints in esophageal cancer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-trial-milestone\">Trial 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>Product<\/strong><\/td><td>iza-bren (BL\u2011B01D1)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>EGFR\u00d7HER3 bispecific ADC<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Recurrent\/metastatic ESCC post PD\u20111\/PD\u2011L1 + platinum chemo<\/td><\/tr><tr><td><strong>Trial Phase<\/strong><\/td><td>Phase\u202f3 (prespecified interim)<\/td><\/tr><tr><td><strong>Primary Endpoints<\/strong><\/td><td>PFS and OS (both met)<\/td><\/tr><tr><td><strong>Significance<\/strong><\/td><td><strong>Global first<\/strong> ADC to demonstrate dual survival benefit in esophageal cancer<\/td><\/tr><tr><td><strong>Next Step<\/strong><\/td><td>NDA submission to NMPA in H1\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile\">Drug Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> First\u2011in\u2011class, new\u2011concept EGFR\u00d7HER3 bispecific ADC; only candidate of its kind in Phase\u202f3 development<\/li>\n\n\n\n<li><strong>Pipeline:<\/strong> Under evaluation in <strong>>40 clinical trials<\/strong> across China and the U.S. for various tumor types<\/li>\n\n\n\n<li><strong>Global Rights:<\/strong> Exclusive license to <strong>Bristol\u2011Myers Squibb (BMS)<\/strong> outside mainland China since December\u202f2023; BMS funds global program<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-designations\">Regulatory Designations<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Agency<\/th><th>Breakthrough Therapy Designations<\/th><\/tr><\/thead><tbody><tr><td><strong>CDE (NMPA)<\/strong><\/td><td><strong>7 indications<\/strong> (including ESCC, NSCLC, breast cancer)<\/td><\/tr><tr><td><strong>FDA<\/strong><\/td><td><strong>1 indication<\/strong> (breast cancer)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-summary\">Clinical Evidence Summary<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient Population:<\/strong> Recurrent\/metastatic ESCC after prior checkpoint inhibitor + chemotherapy (high unmet need)<\/li>\n\n\n\n<li><strong>Efficacy:<\/strong> Both PFS and OS primary endpoints met at interim analysis (statistical significance not yet disclosed)<\/li>\n\n\n\n<li><strong>Safety:<\/strong> Profile consistent with prior studies; no new safety signals identified<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-outlook\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China Market:<\/strong> ~320,000 new esophageal cancer cases annually; ~40% ESCC eligible for second\u2011line therapy<\/li>\n\n\n\n<li><strong>Revenue Forecast:<\/strong> Analysts project peak China sales of <strong>\u00a53.5\u20114.0\u202fbillion<\/strong> (~US$480\u2011550\u202fmillion) by 2030<\/li>\n\n\n\n<li><strong>BMS Partnership:<\/strong> Upfront payment of <strong>US$800\u202fmillion<\/strong> plus milestones and double\u2011digit royalties; BMS driving global Phase\u202f3 program<\/li>\n\n\n\n<li><strong>Competitive Edge:<\/strong> Only ADC with OS data in esophageal cancer; positions ahead of Merck\u2019s MK\u20112870 and Daiichi\u2019s T\u2011DXd in this setting<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding iza\u2011bren\u2019s regulatory path, commercial potential, and partnership outcomes. Actual results may differ due to risks including final trial data, NMPA\/FDA review, and market adoption.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/688506_20251118_8UH0.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688506_20251118_8UH0.\"><\/object><a id=\"wp-block-file--media-6c436bc2-6bdb-466f-9b59-b04e631393c5\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/688506_20251118_8UH0.pdf\">688506_20251118_8UH0<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/688506_20251118_8UH0.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-6c436bc2-6bdb-466f-9b59-b04e631393c5\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced its antibody-drug conjugate iza-bren (izalontamab brengitecan, BL\u2011B01D1)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48550,"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":[35,151,16,17,857],"class_list":["post-48547","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-biokin-pharmaceutical","tag-cancer","tag-clinical-trial-results","tag-sha-688506"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Biokin&#039;s iza-bren ADC Achieves Dual PFS &amp; OS Endpoints in Phase 3 Esophageal Cancer, a Global First - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced its antibody-drug conjugate iza-bren (izalontamab brengitecan, BL\u2011B01D1) met both primary endpoints of progression-free survival (PFS) and overall survival (OS) in a prespecified interim analysis of a Phase 3 trial for recurrent\/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed after PD\u20111\/PD\u2011L1 inhibitors plus platinum chemotherapy, marking the first global Phase 3 trial where an ADC has demonstrated positive results for both endpoints in esophageal 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=48547\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biokin&#039;s iza-bren ADC Achieves Dual PFS &amp; OS Endpoints in Phase 3 Esophageal Cancer, a Global First\" \/>\n<meta property=\"og:description\" content=\"Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced its antibody-drug conjugate iza-bren (izalontamab brengitecan, BL\u2011B01D1) met both primary endpoints of progression-free survival (PFS) and overall survival (OS) in a prespecified interim analysis of a Phase 3 trial for recurrent\/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed after PD\u20111\/PD\u2011L1 inhibitors plus platinum chemotherapy, marking the first global Phase 3 trial where an ADC has demonstrated positive results for both endpoints in esophageal cancer.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48547\" \/>\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=\"2025-11-18T07:17:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-18T07:17:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1805.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. 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(SHA: 688506) announced its antibody-drug conjugate iza-bren (izalontamab brengitecan, BL\u2011B01D1) met both primary endpoints of progression-free survival (PFS) and overall survival (OS) in a prespecified interim analysis of a Phase 3 trial for recurrent\/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed after PD\u20111\/PD\u2011L1 inhibitors plus platinum chemotherapy, marking the first global Phase 3 trial where an ADC has demonstrated positive results for both endpoints in esophageal cancer.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=48547#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=48547"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=48547#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1805.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1805.webp","width":1080,"height":608,"caption":"Biokin's iza-bren ADC Achieves Dual PFS & OS Endpoints in Phase 3 Esophageal Cancer, a Global First"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=48547#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Biokin&#8217;s iza-bren ADC Achieves Dual PFS &amp; OS Endpoints in Phase 3 Esophageal Cancer, a Global First"}]},{"@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\/1805.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48547","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=48547"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48547\/revisions"}],"predecessor-version":[{"id":48551,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48547\/revisions\/48551"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/48550"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=48547"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=48547"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=48547"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}