{"id":57723,"date":"2026-02-24T17:01:07","date_gmt":"2026-02-24T09:01:07","guid":{"rendered":"https:\/\/flcube.com\/?p=57723"},"modified":"2026-02-24T17:01:08","modified_gmt":"2026-02-24T09:01:08","slug":"sichuan-biokins-iza-bren-hits-pfs-and-os-endpoints-in-phase-iii-tnbc-study-first-bispecific-adc-to-show-dual-survival-benefit","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=57723","title":{"rendered":"Sichuan Biokin&#8217;s Iza\u2011Bren Hits PFS and OS Endpoints in Phase III TNBC Study \u2013 First Bispecific ADC to Show Dual Survival Benefit"},"content":{"rendered":"\n<p><strong>Sichuan Biokin Pharmaceutical Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/688506:SHA\">SHA:\u202f688506<\/a>)<\/strong> announced that its <strong>iza\u2011bren<\/strong>, a <strong>first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug conjugate (ADC)<\/strong>, has met <strong>both primary endpoints<\/strong> in a Phase III study for <strong>unresectable locally advanced or metastatic triple\u2011negative breast cancer (TNBC)<\/strong>. The trial (<strong>BL\u2011B01D1\u2011307<\/strong>) demonstrated <strong>statistically significant and clinically meaningful improvements in progression\u2011free survival (PFS) and overall survival (OS)<\/strong> in patients who had previously failed taxane\u2011based therapy. This marks the <strong>third Phase III success<\/strong> for iza\u2011bren and makes it the <strong>world&#8217;s first bispecific ADC<\/strong> to achieve positive PFS and OS results in TNBC.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-milestone-phase-iii-tnbc-study-bl-b01d1-307\">Clinical Milestone \u2013 Phase III TNBC Study (BL\u2011B01D1\u2011307)<\/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>Sponsor<\/strong><\/td><td>Sichuan Biokin Pharmaceutical Co., Ltd (SHA:\u202f688506)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Iza\u2011bren (EGFR\u00d7HER3 bispecific ADC)<\/td><\/tr><tr><td><strong>Study Protocol<\/strong><\/td><td>BL\u2011B01D1\u2011307<\/td><\/tr><tr><td><strong>Patient Population<\/strong><\/td><td>Unresectable locally advanced or metastatic TNBC, post\u2011taxane failure<\/td><\/tr><tr><td><strong>Primary Endpoints<\/strong><\/td><td>Progression\u2011free survival (PFS) + Overall survival (OS)<\/td><\/tr><tr><td><strong>Result<\/strong><\/td><td>Statistically significant and clinically meaningful improvement in both PFS and OS<\/td><\/tr><tr><td><strong>Significance<\/strong><\/td><td>World&#8217;s first bispecific ADC with positive PFS and OS in TNBC<\/td><\/tr><tr><td><strong>Phase III Success Count<\/strong><\/td><td>3rd Phase III study to meet primary endpoint<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-iza-bren\">Drug Profile \u2013 Iza\u2011Bren<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> <strong>First\u2011in\u2011class EGFR\u00d7HER3 bispecific ADC<\/strong><\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Dual\u2011targeting of EGFR and HER3 receptors for enhanced tumor selectivity and payload delivery<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> <strong>Only EGFR\u00d7HER3 bispecific ADC<\/strong> to advance to Phase III clinical trials globally<\/li>\n\n\n\n<li><strong>Clinical Footprint:<\/strong> <strong>40+ active clinical trials<\/strong> across China and the United States spanning multiple tumor types<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-status-amp-designations\">Regulatory Status &amp; Designations<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Regulatory Agency<\/th><th>Designation<\/th><th>Indications<\/th><\/tr><\/thead><tbody><tr><td><strong>CDE\/NMPA (China)<\/strong><\/td><td>Breakthrough Therapy Designation<\/td><td><strong>7 indications<\/strong> granted<\/td><\/tr><tr><td><strong>FDA (U.S.)<\/strong><\/td><td>Breakthrough Therapy Designation<\/td><td><strong>1 indication<\/strong> granted<\/td><\/tr><tr><td><strong>CDE\/NMPA<\/strong><\/td><td>Priority Review<\/td><td>NDA accepted for <strong>nasopharyngeal carcinoma<\/strong><\/td><\/tr><tr><td><strong>CDE\/NMPA<\/strong><\/td><td>Priority Review<\/td><td>NDA accepted for <strong>esophageal squamous cell carcinoma<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>TNBC Unmet Need:<\/strong> Triple\u2011negative breast cancer represents an aggressive subtype with limited targeted therapy options; iza\u2011bren&#8217;s <strong>dual survival benefit<\/strong> positions it as a potential new standard of care in the post\u2011taxane setting.<\/li>\n\n\n\n<li><strong>Bispecific ADC Leadership:<\/strong> As the <strong>first\u2011in\u2011class<\/strong> and only Phase III\u2011stage EGFR\u00d7HER3 bispecific ADC, Biokin has established <strong>first\u2011mover advantage<\/strong> in a novel therapeutic class.<\/li>\n\n\n\n<li><strong>Regulatory Momentum:<\/strong> With <strong>7 Chinese and 1 U.S. Breakthrough Therapy designations<\/strong>, plus <strong>2 NDAs under priority review<\/strong>, iza\u2011bren is on an accelerated path to market in multiple indications.<\/li>\n\n\n\n<li><strong>Global Expansion:<\/strong> The extensive <strong>40+ trial portfolio<\/strong> across China and the U.S. supports potential <strong>worldwide commercialization<\/strong> and label expansion beyond TNBC into nasopharyngeal and esophageal cancers.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-outlook\">Market Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Revenue Potential:<\/strong> TNBC, nasopharyngeal carcinoma, and esophageal squamous cell carcinoma represent <strong>multi\u2011billion\u2011dollar addressable markets<\/strong> in China and globally, with significant unmet medical need.<\/li>\n\n\n\n<li><strong>Competitive Positioning:<\/strong> Iza\u2011bren&#8217;s <strong>bispecific mechanism<\/strong> may offer superior efficacy and safety compared to single\u2011target ADCs, potentially capturing market share from existing standards of care.<\/li>\n\n\n\n<li><strong>Valuation Catalyst:<\/strong> The <strong>dual PFS\/OS positive readout<\/strong> and third Phase III success strengthen Biokin&#8217;s investment case and partnership attractiveness ahead of anticipated NMPA approvals.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory approvals, commercial expectations, and clinical outcomes for iza\u2011bren. Actual results may differ due to risks including regulatory review timelines, competitive dynamics, and manufacturing scalability.<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\/2026\/02\/688506_20260224_0CJQ.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688506_20260224_0CJQ.\"><\/object><a id=\"wp-block-file--media-1591ccd7-26e4-4ead-b7de-024e0086b766\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/688506_20260224_0CJQ.pdf\">688506_20260224_0CJQ<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/688506_20260224_0CJQ.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-1591ccd7-26e4-4ead-b7de-024e0086b766\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sichuan Biokin Pharmaceutical Co., Ltd (SHA:\u202f688506) announced that its iza\u2011bren, a first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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-57723","post","type-post","status-publish","format-standard","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 v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sichuan Biokin&#039;s Iza\u2011Bren Hits PFS and OS Endpoints in Phase III TNBC Study \u2013 First Bispecific ADC to Show Dual Survival Benefit - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sichuan Biokin Pharmaceutical Co., Ltd (SHA:\u202f688506) announced that its iza\u2011bren, a first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug conjugate (ADC), has met both primary endpoints in a Phase III study for unresectable locally advanced or metastatic triple\u2011negative breast cancer (TNBC). The trial (BL\u2011B01D1\u2011307) demonstrated statistically significant and clinically meaningful improvements in progression\u2011free survival (PFS) and overall survival (OS) in patients who had previously failed taxane\u2011based therapy. This marks the third Phase III success for iza\u2011bren and makes it the world&#039;s first bispecific ADC to achieve positive PFS and OS results in TNBC.\" \/>\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=57723\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sichuan Biokin&#039;s Iza\u2011Bren Hits PFS and OS Endpoints in Phase III TNBC Study \u2013 First Bispecific ADC to Show Dual Survival Benefit\" \/>\n<meta property=\"og:description\" content=\"Sichuan Biokin Pharmaceutical Co., Ltd (SHA:\u202f688506) announced that its iza\u2011bren, a first\u2011in\u2011class EGFR\u00d7HER3 bispecific antibody\u2011drug conjugate (ADC), has met both primary endpoints in a Phase III study for unresectable locally advanced or metastatic triple\u2011negative breast cancer (TNBC). The trial (BL\u2011B01D1\u2011307) demonstrated statistically significant and clinically meaningful improvements in progression\u2011free survival (PFS) and overall survival (OS) in patients who had previously failed taxane\u2011based therapy. 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The trial (BL\u2011B01D1\u2011307) demonstrated statistically significant and clinically meaningful improvements in progression\u2011free survival (PFS) and overall survival (OS) in patients who had previously failed taxane\u2011based therapy. This marks the third Phase III success for iza\u2011bren and makes it the world's first bispecific ADC to achieve positive PFS and OS results in TNBC.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=57723#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=57723"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=57723#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Sichuan Biokin&#8217;s Iza\u2011Bren Hits PFS and OS Endpoints in Phase III TNBC Study \u2013 First Bispecific ADC to Show Dual Survival Benefit"}]},{"@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":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/57723","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=57723"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/57723\/revisions"}],"predecessor-version":[{"id":57726,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/57723\/revisions\/57726"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=57723"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=57723"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=57723"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}