{"id":64969,"date":"2026-05-11T12:34:09","date_gmt":"2026-05-11T04:34:09","guid":{"rendered":"https:\/\/flcube.com\/?p=64969"},"modified":"2026-05-11T12:34:10","modified_gmt":"2026-05-11T04:34:10","slug":"henlius-biotech-expands-european-footprint-with-two-additional-ec-approvals-for-hansizhuang-pd-1-inhibitor","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64969","title":{"rendered":"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor"},"content":{"rendered":"\n<p><strong>Shanghai Henlius Biotech Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced it has secured <strong>two additional indication approvals<\/strong> from the <strong>European Commission (EC)<\/strong> for its <strong>anti-PD-1 monoclonal antibody HanSiZhuang (serplulimab, HLX10)<\/strong>, significantly broadening its commercial scope in Europe&#8217;s $45 billion immuno-oncology market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-newly-approved-european-indications\">Newly Approved European Indications<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Indication<\/th><th>Patient Population<\/th><th>Combination Regimen<\/th><th>Biomarker Requirement<\/th><\/tr><\/thead><tbody><tr><td><strong>Esophageal Squamous Cell Carcinoma (ESCC)<\/strong><\/td><td>Unresectable locally advanced, recurrent, or metastatic<\/td><td>Fluoropyrimidine + platinum-based chemotherapy<\/td><td>PD-L1 CPS \u2265 5<\/td><\/tr><tr><td><strong>Non-Squamous NSCLC (nsNSCLC)<\/strong><\/td><td>Unresectable locally advanced or metastatic<\/td><td>Carboplatin + pemetrexed<\/td><td>EGFR wild-type, ALK\/ROS1 negative<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>These approvals complement HanSiZhuang&#8217;s existing <strong>European authorization for first-line extensive-stage small cell lung cancer (ES-SCLC)<\/strong> in combination with carboplatin and etoposide, granted previously.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-global-regulatory-portfolio-amp-commercial-strategy\">Global Regulatory Portfolio &amp; Commercial Strategy<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-comprehensive-approval-landscape\">Comprehensive Approval Landscape<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China<\/strong>: MSI-H solid tumors, sqNSCLC, ES-SCLC, ESCC, nsNSCLC<\/li>\n\n\n\n<li><strong>European Union<\/strong>: ES-SCLC, ESCC, nsNSCLC (3 indications)<\/li>\n\n\n\n<li><strong>Additional Markets<\/strong>: UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, India<\/li>\n\n\n\n<li><strong>Orphan Drug Designations<\/strong>: United States, Switzerland, South Korea<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-strategic-partnership-framework\">Strategic Partnership Framework<\/h3>\n\n\n\n<p>The October 2023 <strong>licensing agreement with Intas Pharmaceuticals Ltd.<\/strong> grants the Indian firm exclusive <strong>commercialization rights in Europe and India<\/strong>, enabling Henlius to leverage Intas&#8217; established European oncology distribution infrastructure while maintaining manufacturing control and receiving tiered royalties.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-differentiation-amp-market-position\">Clinical Differentiation &amp; Market Position<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-therapeutic-advantages\">Therapeutic Advantages<\/h3>\n\n\n\n<p>HanSiZhuang represents <strong>Henlius&#8217; first innovative monoclonal antibody<\/strong> and demonstrates:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Broad tumor agnostic activity<\/strong> in MSI-H solid tumors<\/li>\n\n\n\n<li><strong>Superior progression-free survival<\/strong> in head-to-head trials against reference PD-1 inhibitors<\/li>\n\n\n\n<li><strong>Favorable safety profile<\/strong> with reduced immune-related adverse events compared to competitors<\/li>\n\n\n\n<li><strong>Cost-effectiveness<\/strong> positioning in price-sensitive European markets<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-competitive-landscape-analysis\">Competitive Landscape Analysis<\/h3>\n\n\n\n<p>With these new approvals, HanSiZhuang becomes one of only <strong>four PD-1 inhibitors<\/strong> with European marketing authorization for both ESCC and nsNSCLC, competing directly with established players including Merck&#8217;s Keytruda, Bristol Myers Squibb&#8217;s Opdivo, and Roche&#8217;s Tecentriq.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-revenue-outlook-amp-strategic-impact\">Revenue Outlook &amp; Strategic Impact<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>European Market Potential<\/strong>: Combined ESCC and nsNSCLC addressable market estimated at \u20ac800 million annually<\/li>\n\n\n\n<li><strong>Royalty Structure<\/strong>: Intas partnership provides upfront payments plus 15-25% royalty rates on net sales<\/li>\n\n\n\n<li><strong>Manufacturing Leverage<\/strong>: Existing GMP facilities in Shanghai support global supply requirements<\/li>\n\n\n\n<li><strong>Pipeline Synergies<\/strong>: HanSiZhuang serves as backbone for combination trials with Henlius&#8217; other oncology assets<\/li>\n<\/ul>\n\n\n\n<p>The expanded European indications validate Henlius&#8217; international regulatory strategy and position the company as a leading Chinese biotech with genuine global commercial capabilities in the competitive immuno-oncology space.<\/p>\n\n\n\n<p><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding commercial performance, market adoption, and revenue projections for HanSiZhuang in Europe. Actual results may differ due to competitive dynamics, pricing negotiations, and evolving treatment guidelines.<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\/05\/2026051000010_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026051000010_c.\"><\/object><a id=\"wp-block-file--media-53a070c5-ca68-49c6-be35-27edd74f1294\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/2026051000010_c.pdf\">2026051000010_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/2026051000010_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-53a070c5-ca68-49c6-be35-27edd74f1294\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from&#8230;<\/p>\n","protected":false},"author":1,"featured_media":64972,"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":[16,270,862,1259,18,15],"class_list":["post-64969","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-henlius-biotech","tag-hkg-2696","tag-intas-pharmaceuticals","tag-pd-1-l1","tag-product-approvals"],"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 Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from the European Commission (EC) for its anti-PD-1 monoclonal antibody HanSiZhuang (serplulimab, HLX10), significantly broadening its commercial scope in Europe&#039;s $45 billion immuno-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=64969\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor\" \/>\n<meta property=\"og:description\" content=\"Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from the European Commission (EC) for its anti-PD-1 monoclonal antibody HanSiZhuang (serplulimab, HLX10), significantly broadening its commercial scope in Europe&#039;s $45 billion immuno-oncology market.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=64969\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-05-11T04:34:09+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-11T04:34:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/1103.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter: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 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=64969#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=64969\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor\",\"datePublished\":\"2026-05-11T04:34:09+00:00\",\"dateModified\":\"2026-05-11T04:34:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=64969\"},\"wordCount\":414,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=64969#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/1103.webp\",\"keywords\":[\"Cancer\",\"Henlius Biotech\",\"HKG: 2696\",\"Intas Pharmaceuticals\",\"PD-1\\\/L1\",\"Product approvals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=64969#respond\"]}],\"copyrightYear\":\"2026\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=64969\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=64969\",\"name\":\"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=64969#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=64969#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/1103.webp\",\"datePublished\":\"2026-05-11T04:34:09+00:00\",\"dateModified\":\"2026-05-11T04:34:10+00:00\",\"description\":\"Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from the European Commission (EC) for its anti-PD-1 monoclonal antibody HanSiZhuang (serplulimab, HLX10), significantly broadening its commercial scope in Europe's $45 billion immuno-oncology market.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=64969#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=64969\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=64969#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/1103.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/1103.webp\",\"width\":1080,\"height\":608,\"caption\":\"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=64969#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor\"}]},{\"@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 Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor - Insight, China&#039;s Pharmaceutical Industry","description":"Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from the European Commission (EC) for its anti-PD-1 monoclonal antibody HanSiZhuang (serplulimab, HLX10), significantly broadening its commercial scope in Europe's $45 billion immuno-oncology market.","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=64969","og_locale":"en_US","og_type":"article","og_title":"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor","og_description":"Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from the European Commission (EC) for its anti-PD-1 monoclonal antibody HanSiZhuang (serplulimab, HLX10), significantly broadening its commercial scope in Europe's $45 billion immuno-oncology market.","og_url":"https:\/\/flcube.com\/?p=64969","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2026-05-11T04:34:09+00:00","article_modified_time":"2026-05-11T04:34:10+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/1103.webp","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_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","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=64969#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=64969"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor","datePublished":"2026-05-11T04:34:09+00:00","dateModified":"2026-05-11T04:34:10+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=64969"},"wordCount":414,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=64969#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/1103.webp","keywords":["Cancer","Henlius Biotech","HKG: 2696","Intas Pharmaceuticals","PD-1\/L1","Product approvals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=64969#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=64969","url":"https:\/\/flcube.com\/?p=64969","name":"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=64969#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=64969#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/1103.webp","datePublished":"2026-05-11T04:34:09+00:00","dateModified":"2026-05-11T04:34:10+00:00","description":"Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from the European Commission (EC) for its anti-PD-1 monoclonal antibody HanSiZhuang (serplulimab, HLX10), significantly broadening its commercial scope in Europe's $45 billion immuno-oncology market.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=64969#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=64969"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=64969#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/1103.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/05\/1103.webp","width":1080,"height":608,"caption":"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=64969#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor"}]},{"@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\/05\/1103.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/64969","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=64969"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/64969\/revisions"}],"predecessor-version":[{"id":64973,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/64969\/revisions\/64973"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/64972"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=64969"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=64969"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=64969"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}