{"id":62907,"date":"2026-04-12T11:43:47","date_gmt":"2026-04-12T03:43:47","guid":{"rendered":"https:\/\/flcube.com\/?p=62907"},"modified":"2026-04-12T11:43:48","modified_gmt":"2026-04-12T03:43:48","slug":"henlius-biotech-secures-two-new-nmpa-approvals-for-hanlikang-expands-rituximab-biosimilar-into-dlbcl-combination-therapies","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=62907","title":{"rendered":"Henlius Biotech Secures Two New NMPA Approvals for Hanlikang \u2013 Expands Rituximab Biosimilar into DLBCL Combination Therapies"},"content":{"rendered":"\n<p><strong>Shanghai Henlius Biotech, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG:\u202f2696<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has granted <strong>two additional indication approvals<\/strong> for <strong>Hanlikang<\/strong>, its <strong>biosimilar version of rituximab<\/strong> (reference: Roche&#8217;s MabThera\/Rituxan). The approvals authorize Hanlikang for use in <strong>diffuse large B\u2011cell lymphoma (DLBCL)<\/strong> combination regimens, expanding its addressable patient population in China&#8217;s oncology market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-new-indication-approvals\">New Indication Approvals<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Indication<\/th><th>Regimen<\/th><th>Patient Population<\/th><th>Setting<\/th><\/tr><\/thead><tbody><tr><td><strong>1L DLBCL<\/strong><\/td><td>Hanlikang + polatuzumab vedotin + cyclophosphamide + doxorubicin + prednisone (pola\u2011R\u2011CHP)<\/td><td>Adult patients with <strong>previously untreated DLBCL<\/strong><\/td><td>First\u2011line<\/td><\/tr><tr><td><strong>R\/R DLBCL<\/strong><\/td><td>Hanlikang + bendamustine + polatuzumab vedotin (pola\u2011BR)<\/td><td>Adult patients with <strong>relapsed\/refractory DLBCL<\/strong> ineligible for stem cell transplant<\/td><td>Second\u2011line<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-approved-indication-portfolio-china\">Approved Indication Portfolio (China)<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Indication<\/th><th>Approval Date<\/th><th>Therapeutic Area<\/th><\/tr><\/thead><tbody><tr><td>Non\u2011Hodgkin&#8217;s lymphoma<\/td><td>Feb\u202f2019<\/td><td>Oncology<\/td><\/tr><tr><td>Chronic lymphocytic leukemia (CLL)<\/td><td>Post\u2011Feb\u202f2019<\/td><td>Oncology<\/td><\/tr><tr><td>Rheumatoid arthritis (RA)<\/td><td>Post\u2011Feb\u202f2019<\/td><td>Immunology<\/td><\/tr><tr><td><strong>1L DLBCL<\/strong> (new)<\/td><td><strong>Apr\u202f2026<\/strong><\/td><td><strong>Oncology<\/strong><\/td><\/tr><tr><td><strong>R\/R DLBCL<\/strong> (new)<\/td><td><strong>Apr\u202f2026<\/strong><\/td><td><strong>Oncology<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-significance\">Strategic Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Biosimilar Leadership:<\/strong> Hanlikang is <strong>China&#8217;s first approved rituximab biosimilar<\/strong> (since 2019), establishing Henlius as pioneer in CD20 biosimilar space<\/li>\n\n\n\n<li><strong>Combination Strategy:<\/strong> New approvals position Hanlikang as <strong>backbone therapy<\/strong> for <strong>polatuzumab vedotin\u2011based regimens<\/strong>, aligning with global standard\u2011of\u2011care evolution (POLARIX and POLAR trials)<\/li>\n\n\n\n<li><strong>Market Expansion:<\/strong> DLBCL represents <strong>30\u201135% of all non\u2011Hodgkin&#8217;s lymphomas<\/strong> in China; ~<strong>20,000\u201125,000 new cases annually<\/strong> eligible for these combination therapies<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-outlook\">Market Context &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China Rituximab Market:<\/strong> <strong>US$400\u2011500\u202fmillion<\/strong> annually; biosimilars capturing <strong>>60% volume share<\/strong> through national reimbursement and tendering advantages<\/li>\n\n\n\n<li><strong>Polatuzumab Vedotin Access:<\/strong> Roche&#8217;s ADC recently gained NMPA approval; Hanlikang combination approvals enable <strong>local biosimilar + innovator ADC<\/strong> cost\u2011effective pairing<\/li>\n\n\n\n<li><strong>Revenue Impact:<\/strong> New DLBCL indications expected to contribute <strong>RMB 150\u2011200\u202fmillion<\/strong> incremental annual sales by 2028, assuming 20\u201125% penetration in eligible pola\u2011R\u2011CHP\/pola\u2011BR regimens<\/li>\n\n\n\n<li><strong>Pipeline Synergy:<\/strong> Henlius leveraging Hanlikang platform for <strong>next\u2011gen CD20\u2011targeted therapies<\/strong> and <strong>subcutaneous formulation<\/strong> development<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding market penetration, revenue projections, and competitive positioning for Hanlikang. Actual results may differ due to risks including pricing pressure, competitive biosimilar entry, combination therapy adoption rates, and reimbursement negotiations.<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\/04\/2026040901522_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026040901522_c.\"><\/object><a id=\"wp-block-file--media-f3b464fe-f332-4e32-a4ad-d793b18946e6\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2026040901522_c.pdf\">2026040901522_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2026040901522_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-f3b464fe-f332-4e32-a4ad-d793b18946e6\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech, Inc. (HKG:\u202f2696) announced that China&#8217;s National Medical Products Administration (NMPA) has granted&#8230;<\/p>\n","protected":false},"author":1,"featured_media":62909,"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":[43,16,270,862,15,163],"class_list":["post-62907","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-biosimilars","tag-cancer","tag-henlius-biotech","tag-hkg-2696","tag-product-approvals","tag-roche"],"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>Henlius Biotech Secures Two New NMPA Approvals for Hanlikang \u2013 Expands Rituximab Biosimilar into DLBCL Combination Therapies - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech, Inc. (HKG:\u202f2696) announced that China&#039;s National Medical Products Administration (NMPA) has granted two additional indication approvals for Hanlikang, its biosimilar version of rituximab (reference: Roche&#039;s MabThera\/Rituxan). The approvals authorize Hanlikang for use in diffuse large B\u2011cell lymphoma (DLBCL) combination regimens, expanding its addressable patient population in China&#039;s oncology market.\" \/>\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=62907\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Henlius Biotech Secures Two New NMPA Approvals for Hanlikang \u2013 Expands Rituximab Biosimilar into DLBCL Combination Therapies\" \/>\n<meta property=\"og:description\" content=\"Shanghai Henlius Biotech, Inc. (HKG:\u202f2696) announced that China&#039;s National Medical Products Administration (NMPA) has granted two additional indication approvals for Hanlikang, its biosimilar version of rituximab (reference: Roche&#039;s MabThera\/Rituxan). 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(HKG:\u202f2696) announced that China's National Medical Products Administration (NMPA) has granted two additional indication approvals for Hanlikang, its biosimilar version of rituximab (reference: Roche's MabThera\/Rituxan). The approvals authorize Hanlikang for use in diffuse large B\u2011cell lymphoma (DLBCL) combination regimens, expanding its addressable patient population in China's oncology market.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=62907#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=62907"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=62907#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/1202.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/1202.webp","width":1080,"height":608,"caption":"Henlius Biotech Secures Two New NMPA Approvals for Hanlikang \u2013 Expands Rituximab Biosimilar into DLBCL Combination Therapies"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=62907#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Henlius Biotech Secures Two New NMPA Approvals for Hanlikang \u2013 Expands Rituximab Biosimilar into DLBCL Combination Therapies"}]},{"@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\/2026\/04\/1202.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/62907","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=62907"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/62907\/revisions"}],"predecessor-version":[{"id":62910,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/62907\/revisions\/62910"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/62909"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=62907"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=62907"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=62907"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}