{"id":48761,"date":"2025-11-21T21:53:31","date_gmt":"2025-11-21T13:53:31","guid":{"rendered":"https:\/\/flcube.com\/?p=48761"},"modified":"2025-11-21T21:53:32","modified_gmt":"2025-11-21T13:53:32","slug":"henlius-serplulimab-wins-btd-for-gastric-cancer-perioperative-treatment-a-china-first","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48761","title":{"rendered":"Henlius Serplulimab Wins BTD for Gastric Cancer Perioperative Treatment, a China First"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Shanghai Henlius Biotech, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced that its anti\u2011PD\u20111 monoclonal antibody <strong>serplulimab<\/strong> (HANSIZHUANG, Hetronifly in Europe) received <strong>Breakthrough Therapy Designation (BTD)<\/strong> from the <strong>Center for Drug Evaluation (CDE)<\/strong> of NMPA for neo\u2011\/adjuvant gastric cancer treatment, marking the <strong>first perioperative gastric cancer drug<\/strong> to earn this designation.<\/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>Product<\/strong><\/td><td>Serplulimab (HANSIZHUANG)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Shanghai Henlius Biotech, Inc. (2696.HK)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>CDE\/NMPA (China)<\/td><\/tr><tr><td><strong>Designation<\/strong><\/td><td>Breakthrough Therapy Designation (BTD)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Perioperative (neo\u2011\/adjuvant) gastric cancer<\/td><\/tr><tr><td><strong>Trial Basis<\/strong><\/td><td><strong>ASTRUM\u2011006<\/strong> Phase\u202f3 study<\/td><\/tr><tr><td><strong>Significance<\/strong><\/td><td><strong>First gastric cancer perioperative drug<\/strong> to receive BTD<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile\">Drug Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> Anti\u2011PD\u20111 monoclonal antibody<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Restores T\u2011cell mediated anti\u2011tumor immunity by blocking PD\u20111\/PD\u2011L1 pathway<\/li>\n\n\n\n<li><strong>Global Status:<\/strong> Approved in EU as <strong>Hetronifly<\/strong> for MSI\u2011H solid tumors; China BTD accelerates gastric cancer development<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> Pioneers <strong>chemotherapy\u2011free adjuvant<\/strong> model post\u2011neoadjuvant chemo\u2011immunotherapy<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-astrum-006-trial\">Clinical Evidence \u2013 ASTRUM\u2011006 Trial<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Serplulimab + Chemo (vs. Control)<\/th><\/tr><\/thead><tbody><tr><td><strong>Event\u2011Free Survival (EFS)<\/strong><\/td><td>Significantly extended (HR\u202f&lt;\u202f0.60; p\u202f&lt;\u202f0.001)<\/td><\/tr><tr><td><strong>Pathological Complete Response (pCR)<\/strong><\/td><td><strong>&gt;3\u00d7 higher<\/strong> than control group<\/td><\/tr><tr><td><strong>Recurrence Risk<\/strong><\/td><td>Statistically significant reduction<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Overall manageable; consistent with PD\u20111 class<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The interim analysis supports a novel <strong>perioperative chemo\u2011immunotherapy<\/strong> approach, with serplulimab monotherapy continuing as adjuvant therapy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-outlook\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Metric<\/th><th>Value<\/th><\/tr><\/thead><tbody><tr><td><strong>China Gastric Cancer Incidence<\/strong><\/td><td>~680,000 new cases (2024)<\/td><\/tr><tr><td><strong>Perioperative\u2011Eligible Patients<\/strong><\/td><td>~200,000 operable cases (30% of total)<\/td><\/tr><tr><td><strong>Current Standard<\/strong><\/td><td>Chemotherapy alone; no approved perioperative immunotherapy<\/td><\/tr><tr><td><strong>Peak Market Potential<\/strong><\/td><td><strong>\u00a55\u20117\u202fbillion<\/strong> (US$680\u2011950\u202fmillion) by 2030<\/td><\/tr><tr><td><strong>Market Share Target<\/strong><\/td><td>25\u201130% of eligible patients<\/td><\/tr><tr><td><strong>Competition<\/strong><\/td><td><strong>Merck\u2019s Keytruda<\/strong>, <strong>BMS\u2019s Opdivo<\/strong> still in Phase\u202f3; serplulimab BTD creates <strong>first\u2011mover advantage<\/strong><\/td><\/tr><tr><td><strong>Reimbursement Path<\/strong><\/td><td>BTD status likely accelerates <strong>NRDL inclusion<\/strong> within 12\u201118 months post\u2011approval<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Next Catalyst:<\/strong> Full Phase\u202f3 data readout <strong>Q2\u202f2026<\/strong>; NDA submission expected <strong>H2\u202f2026<\/strong><\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> BTD reinforces Henlius\u2019s leadership in <strong>GI oncology<\/strong>, building on serplulimab\u2019s approved indications in NSCLC and MSI\u2011H cancers<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding serplulimab\u2019s clinical development, regulatory timeline, and commercial potential. Actual results may differ due to risks including final trial data, NMPA review outcomes, and competitive dynamics.<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 its anti\u2011PD\u20111 monoclonal antibody serplulimab (HANSIZHUANG, Hetronifly&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48762,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[34,270,862,18],"class_list":["post-48761","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-breakthrough-therapy","tag-henlius-biotech","tag-hkg-2696","tag-pd-1-l1"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Henlius Serplulimab Wins BTD for Gastric Cancer Perioperative Treatment, a China First - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech, Inc. 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(HKG: 2696) announced that its anti\u2011PD\u20111 monoclonal antibody serplulimab (HANSIZHUANG, Hetronifly in Europe) received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of NMPA for neo\u2011\/adjuvant gastric cancer treatment, marking the first perioperative gastric cancer drug to earn this designation.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=48761#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=48761"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=48761#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2104.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2104.webp","width":1080,"height":608,"caption":"Henlius Serplulimab Wins BTD for Gastric Cancer Perioperative Treatment, a China First"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=48761#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Henlius Serplulimab Wins BTD for Gastric Cancer Perioperative Treatment, a China First"}]},{"@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\/2025\/11\/2104.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48761","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=48761"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48761\/revisions"}],"predecessor-version":[{"id":48763,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48761\/revisions\/48763"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/48762"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=48761"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=48761"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=48761"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}