{"id":25152,"date":"2022-10-12T14:55:00","date_gmt":"2022-10-12T06:55:00","guid":{"rendered":"https:\/\/flcube.com\/?p=25152"},"modified":"2025-02-03T14:58:49","modified_gmt":"2025-02-03T06:58:49","slug":"henlius-biotechs-hanbeitai-biosimilar-accepted-for-review-by-cde","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=25152","title":{"rendered":"Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE"},"content":{"rendered":"\n

Shanghai Henlius Biotech Inc. (HKG: 2696<\/a>) has announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of bevacizumab, has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indications for this application include cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The drug is also awaiting regulatory decisions regarding the treatment of glioblastoma (GBM) and hepatocellular carcinoma (HCC).<\/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, with its sBLAs for GBM and HCC accepted for review in July and August of this year, respectively.<\/p>\n\n\n\n

Market Landscape<\/strong>
Roche’s originator drug Avastin was first approved in the United States in February 2004 and entered the Chinese market in February 2010, gaining inclusion on the National Reimbursement Drug List (NRDL) in 2017. In addition to Henlius Pharma, a total of eight other companies, including Qilu Pharma, Innovent Bio, Hengrui Medicine, Bio-Thera Solutions, Betta Pharma, and Tot Bio, have biosimilar versions of bevacizumab on the local market.<\/p>\n\n\n\n

Future Outlook<\/strong>
The acceptance of the sBLA for HanBeiTai by the CDE underscores Henlius Biotech’s commitment to expanding its biosimilar portfolio. By targeting multiple indications, HanBeiTai aims to address significant unmet medical needs and improve patient outcomes in oncology.-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":[43,16,270,862,38],"class_list":["post-25152","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biosimilars","tag-cancer","tag-henlius-biotech","tag-hkg-2696","tag-market-approval-filings"],"yoast_head":"\nHenlius Biotech's HanBeiTai Biosimilar Accepted for Review by CDE - 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 HanBeiTai, a biosimilar of bevacizumab, has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indications for this application include cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The drug is also awaiting regulatory decisions regarding the treatment of glioblastoma (GBM) and hepatocellular carcinoma (HCC).\" \/>\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=25152\" \/>\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 Biosimilar Accepted for Review by CDE\" \/>\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=25152\" \/>\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=\"2022-10-12T06:55:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-03T06:58:49+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=25152#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25152\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE\",\"datePublished\":\"2022-10-12T06:55:00+00:00\",\"dateModified\":\"2025-02-03T06:58:49+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25152\"},\"wordCount\":248,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Biosimilars\",\"Cancer\",\"Henlius Biotech\",\"HKG: 2696\",\"Market approval filings\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=25152#respond\"]}],\"copyrightYear\":\"2022\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25152\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=25152\",\"name\":\"Henlius Biotech's HanBeiTai Biosimilar Accepted for Review by CDE - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2022-10-12T06:55:00+00:00\",\"dateModified\":\"2025-02-03T06:58:49+00:00\",\"description\":\"Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of bevacizumab, has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indications for this application include cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The drug is also awaiting regulatory decisions regarding the treatment of glioblastoma (GBM) and hepatocellular carcinoma (HCC).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25152#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=25152\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=25152#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE\"}]},{\"@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 Biosimilar Accepted for Review by CDE - Insight, China's Pharmaceutical Industry","description":"Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of bevacizumab, has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indications for this application include cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The drug is also awaiting regulatory decisions regarding the treatment of glioblastoma (GBM) and hepatocellular carcinoma (HCC).","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=25152","og_locale":"en_US","og_type":"article","og_title":"Henlius Biotech's HanBeiTai Biosimilar Accepted for Review by CDE","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=25152","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2022-10-12T06:55:00+00:00","article_modified_time":"2025-02-03T06:58:49+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=25152#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=25152"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE","datePublished":"2022-10-12T06:55:00+00:00","dateModified":"2025-02-03T06:58:49+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=25152"},"wordCount":248,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Biosimilars","Cancer","Henlius Biotech","HKG: 2696","Market approval filings"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=25152#respond"]}],"copyrightYear":"2022","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=25152","url":"https:\/\/flcube.com\/?p=25152","name":"Henlius Biotech's HanBeiTai Biosimilar Accepted for Review by CDE - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2022-10-12T06:55:00+00:00","dateModified":"2025-02-03T06:58:49+00:00","description":"Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of bevacizumab, has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indications for this application include cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The drug is also awaiting regulatory decisions regarding the treatment of glioblastoma (GBM) and hepatocellular carcinoma (HCC).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=25152#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=25152"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=25152#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE"}]},{"@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\/25152","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=25152"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/25152\/revisions"}],"predecessor-version":[{"id":25153,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/25152\/revisions\/25153"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=25152"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=25152"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=25152"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}