{"id":54097,"date":"2026-01-14T21:27:06","date_gmt":"2026-01-14T13:27:06","guid":{"rendered":"https:\/\/flcube.com\/?p=54097"},"modified":"2026-01-14T21:27:07","modified_gmt":"2026-01-14T13:27:07","slug":"henliuss-hanbeitai-bevacizumab-biosimilar-bla-accepted-by-fda-for-multiple-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=54097","title":{"rendered":"Henlius\u2019s HANBEITAI Bevacizumab Biosimilar BLA Accepted by FDA for Multiple Solid Tumors"},"content":{"rendered":"\n<p><strong>Shanghai Henlius Biotech, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced that the <strong>U.S. Food and Drug Administration (FDA)<\/strong> has formally accepted its <strong>Biologics License Application (BLA)<\/strong> for <strong>HANBEITAI<\/strong>, a <strong>recombinant anti\u2011VEGF humanized monoclonal antibody (bevacizumab biosimilar)<\/strong>, for the treatment of <strong>multiple solid tumors<\/strong> including metastatic colorectal cancer, non\u2011squamous NSCLC, glioblastoma, renal cell carcinoma, cervical cancer, and ovarian 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>Shanghai Henlius Biotech, Inc. (2696.HK)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>HANBEITAI (bevacizumab biosimilar)<\/td><\/tr><tr><td><strong>Application<\/strong><\/td><td>BLA (Biologics License Application)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>US FDA<\/td><\/tr><tr><td><strong>Indications<\/strong><\/td><td>mCRC, nsNSCLC, glioblastoma, RCC, cervical cancer, ovarian cancer<\/td><\/tr><tr><td><strong>Filing Date<\/strong><\/td><td>13\u202fJan\u202f2026<\/td><\/tr><tr><td><strong>PDUFA Target<\/strong><\/td><td>Q3\u202f2026 (eligible for biosimilar pathway)<\/td><\/tr><tr><td><strong>China Approval<\/strong><\/td><td>2021<\/td><\/tr><tr><td><strong>Latin America<\/strong><\/td><td>Approved in Bolivia, Dominican Republic, Mexico (2021\u20112023)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> <strong>Anti\u2011VEGF monoclonal antibody<\/strong> that inhibits tumor angiogenesis, starving tumors of blood supply and enhancing chemotherapy efficacy<\/li>\n\n\n\n<li><strong>Biosimilarity:<\/strong> Demonstrates <strong>analytical, functional, and clinical similarity<\/strong> to reference product Avastin (bevacizumab)<\/li>\n\n\n\n<li><strong>Clinical Experience:<\/strong> >5,000 patients treated across China and Latin America with <strong>comparable safety and efficacy<\/strong> to originator<\/li>\n\n\n\n<li><strong>Pipeline Expansion:<\/strong> Henlius is actively advancing a <strong>Phase\u202fII\/III study<\/strong> of HANBEITAI in combination with its core immunotherapy product <strong>Hetronifly (serplulimab, anti\u2011PD\u20111 mAb)<\/strong> for <strong>first\u2011line metastatic colorectal cancer<\/strong>, aiming for <strong>chemo\u2011free regimen<\/strong> differentiation<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-competitive-landscape\">Market Impact &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2026E<\/th><th>2027E<\/th><th>2028E<\/th><\/tr><\/thead><tbody><tr><td><strong>US Bevacizumab Market Size<\/strong><\/td><td>$2.8\u202fbillion<\/td><td>$2.6\u202fbillion<\/td><td>$2.4\u202fbillion<\/td><\/tr><tr><td><strong>Biosimilar Penetration<\/strong><\/td><td>78\u202f%<\/td><td>85\u202f%<\/td><td>90\u202f%<\/td><\/tr><tr><td><strong>HANBEITAI Market Share (if approved)<\/strong><\/td><td>0\u202f%<\/td><td>8\u202f%<\/td><td>15\u202f%<\/td><\/tr><tr><td><strong>Annual Price (70\u202f% discount to brand)<\/strong><\/td><td>$18,000<\/td><td>$17,500<\/td><td>$17,000<\/td><\/tr><tr><td><strong>Henlius US Revenue<\/strong><\/td><td>\u2013<\/td><td>$326\u202fmillion<\/td><td>$614\u202fmillion<\/td><\/tr><tr><td><strong>Henlius LatAm Revenue<\/strong><\/td><td>$45\u202fmillion<\/td><td>$52\u202fmillion<\/td><td>$58\u202fmillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitors:<\/strong> <strong>Amgen\u2019s Mvasi<\/strong> (first US bevacizumab biosimilar, 2019), <strong>Roche\u2019s bevacizumab biosimilar portfolio<\/strong> (market leader with 60\u202f% share)<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> Henlius\u2019s <strong>cost advantage<\/strong> (manufacturing in China) enables <strong>aggressive pricing<\/strong>; combination with <strong>Hetronifly<\/strong> offers <strong>first\u2011line IO\u2011VEGF option<\/strong> at <strong>30\u201140\u202f% discount<\/strong> to Keytruda + Avastin<\/li>\n\n\n\n<li><strong>Market Access:<\/strong> FDA biosimilar pathway acceptance demonstrates <strong>robust similarity package<\/strong>; potential for <strong>interchangeability designation<\/strong> in 2027<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-timeline-amp-strategic-value\">Development Timeline &amp; Strategic Value<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Expected Date<\/th><\/tr><\/thead><tbody><tr><td><strong>FDA Advisory Committee<\/strong><\/td><td>Q2\u202f2026 (if required)<\/td><\/tr><tr><td><strong>Potential US Approval<\/strong><\/td><td>Q4\u202f2026<\/td><\/tr><tr><td><strong>US Commercial Launch<\/strong><\/td><td>Q1\u202f2027<\/td><\/tr><tr><td><strong>Hetronifly + HANBEITAI Phase\u202fII\/III topline<\/strong><\/td><td>Q3\u202f2027<\/td><\/tr><tr><td><strong>China + LatAm Combination Filing<\/strong><\/td><td>Q4\u202f2027<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Strategic Moat:<\/strong> Henlius becomes <strong>first Chinese biotech<\/strong> with <strong>FDA\u2011approved oncology biosimilar<\/strong> and <strong>simultaneous IO combo in development<\/strong>, enabling <strong>global branded oncology franchise<\/strong><\/li>\n\n\n\n<li><strong>Reinvestment:<\/strong> US biosimilar revenue will fund <strong>Hetronifly global expansion<\/strong> and <strong>next\u2011gen ADC pipeline<\/strong> (e.g., HLX42, HLX43)<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding FDA review timelines, commercial launch, and market penetration for HANBEITAI. Actual results may differ due to regulatory decisions, competitive pricing dynamics, and market access negotiations.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)&#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":[43,270,862,38],"class_list":["post-54097","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biosimilars","tag-henlius-biotech","tag-hkg-2696","tag-market-approval-filings"],"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>Henlius\u2019s HANBEITAI Bevacizumab Biosimilar BLA Accepted by FDA for Multiple Solid Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech, Inc. 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(HKG: 2696) announced that the U.S. Food and Drug Administration (FDA) has formally accepted its Biologics License Application (BLA) for HANBEITAI, a recombinant anti\u2011VEGF humanized monoclonal antibody (bevacizumab biosimilar), for the treatment of multiple solid tumors including metastatic colorectal cancer, non\u2011squamous NSCLC, glioblastoma, renal cell carcinoma, cervical cancer, and ovarian cancer.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=54097#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=54097"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=54097#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Henlius\u2019s HANBEITAI Bevacizumab Biosimilar BLA Accepted by FDA for Multiple Solid Tumors"}]},{"@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\/54097","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=54097"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/54097\/revisions"}],"predecessor-version":[{"id":54098,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/54097\/revisions\/54098"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=54097"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=54097"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=54097"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}