{"id":25029,"date":"2022-10-19T23:32:00","date_gmt":"2022-10-19T15:32:00","guid":{"rendered":"https:\/\/flcube.com\/?p=25029"},"modified":"2025-02-02T23:37:41","modified_gmt":"2025-02-02T15:37:41","slug":"henlius-biotechs-hanbeitai-gains-nmpa-approval-for-recurrent-glioblastoma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=25029","title":{"rendered":"Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma"},"content":{"rendered":"\n

Shanghai Henlius Biotech Inc. (HKG: 2696<\/a>) has announced that a supplementary Biologic License Application (sBLA) for its bevacizumab biosimilar, Hanbeitai, has been approved by the National Medical Products Administration (NMPA). The drug can now be used to treat recurrent glioblastoma (GBM), expanding its therapeutic applications in China.<\/p>\n\n\n\n

Previous Approvals and Market Position<\/strong>
Hanbeitai was first approved in China in November of last year for the treatment of advanced, metastatic, or recurrent non-small cell lung cancer and metastatic colorectal cancer. It is the eighth bevacizumab biosimilar in China. This year, its sBLAs for hepatocellular carcinoma (HCC) and for cervical cancer, epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer were accepted for review in August and October, respectively.<\/p>\n\n\n\n

Pipeline and Global Trials<\/strong>
Henlius is also developing HLX04-O, an anti-VEGF monoclonal antibody (mAb) based on Hanbeitai, targeting wet age-related macular degeneration (wAMD). The drug completed first patient dosing in a Phase III clinical study in China in November last year and initiated a global multi-center Phase III clinical trial in Latvia and Australia in April this year. HLX04-O has secured Phase III clinical trial approvals in several countries, including Australia, the United States, Singapore, Latvia, Spain, the Czech Republic, and Poland.<\/p>\n\n\n\n

Market Landscape<\/strong>
In addition to Henlius Pharma, a total of eight other companies, including Roche, Qilu Pharma, Innovent Bio, Hengrui Medicine, Bio-Thera Solutions, Betta Pharma, and Tot Bio, have biosimilar versions of bevacizumab on the local market. Hanbeitai generated significant sales in China, reaching RMB 6.315 billion (USD 874 million) in 2021 and RMB 3.196 billion (USD 442 million) in the first half of 2022.<\/p>\n\n\n\n

Future Outlook<\/strong>
The approval of the sBLA for recurrent glioblastoma underscores Henlius Biotech’s commitment to expanding the therapeutic indications of Hanbeitai. With ongoing global trials and a robust pipeline, Henlius aims to enhance its market position and address significant unmet medical needs in oncology and ophthalmology.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA)…<\/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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[43,30,16,270,15],"class_list":["post-25029","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biosimilars","tag-biotech","tag-cancer","tag-henlius-biotech","tag-product-approvals"],"yoast_head":"\nHenlius Biotech's Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its bevacizumab biosimilar, Hanbeitai, has been approved by the National Medical Products Administration (NMPA). The drug can now be used to treat recurrent glioblastoma (GBM), expanding its therapeutic applications in China.\" \/>\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=25029\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Henlius Biotech's Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma\" \/>\n<meta property=\"og: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 property=\"og:url\" content=\"https:\/\/flcube.com\/?p=25029\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2022-10-19T15:32:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-02T15:37:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\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=25029#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25029\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma\",\"datePublished\":\"2022-10-19T15:32:00+00:00\",\"dateModified\":\"2025-02-02T15:37:41+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25029\"},\"wordCount\":321,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Biosimilars\",\"Biotech\",\"Cancer\",\"Henlius Biotech\",\"Product approvals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=25029#respond\"]}],\"copyrightYear\":\"2022\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25029\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=25029\",\"name\":\"Henlius Biotech's Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2022-10-19T15:32:00+00:00\",\"dateModified\":\"2025-02-02T15:37:41+00:00\",\"description\":\"Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its bevacizumab biosimilar, Hanbeitai, has been approved by the National Medical Products Administration (NMPA). The drug can now be used to treat recurrent glioblastoma (GBM), expanding its therapeutic applications in China.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25029#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=25029\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25029#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma\"}]},{\"@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":"Henlius Biotech's Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma - Insight, China's Pharmaceutical Industry","description":"Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its bevacizumab biosimilar, Hanbeitai, has been approved by the National Medical Products Administration (NMPA). The drug can now be used to treat recurrent glioblastoma (GBM), expanding its therapeutic applications in China.","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=25029","og_locale":"en_US","og_type":"article","og_title":"Henlius Biotech's Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma","og_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","og_url":"https:\/\/flcube.com\/?p=25029","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2022-10-19T15:32:00+00:00","article_modified_time":"2025-02-02T15:37:41+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=25029#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=25029"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma","datePublished":"2022-10-19T15:32:00+00:00","dateModified":"2025-02-02T15:37:41+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=25029"},"wordCount":321,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Biosimilars","Biotech","Cancer","Henlius Biotech","Product approvals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=25029#respond"]}],"copyrightYear":"2022","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=25029","url":"https:\/\/flcube.com\/?p=25029","name":"Henlius Biotech's Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2022-10-19T15:32:00+00:00","dateModified":"2025-02-02T15:37:41+00:00","description":"Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its bevacizumab biosimilar, Hanbeitai, has been approved by the National Medical Products Administration (NMPA). The drug can now be used to treat recurrent glioblastoma (GBM), expanding its therapeutic applications in China.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=25029#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=25029"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=25029#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma"}]},{"@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\/25029","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=25029"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/25029\/revisions"}],"predecessor-version":[{"id":25030,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/25029\/revisions\/25030"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=25029"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=25029"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=25029"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}