{"id":59622,"date":"2026-03-16T16:36:30","date_gmt":"2026-03-16T08:36:30","guid":{"rendered":"https:\/\/flcube.com\/?p=59622"},"modified":"2026-03-16T16:36:31","modified_gmt":"2026-03-16T08:36:31","slug":"hengruis-irinotecan-liposome-ii-wins-nmpa-phase-ii-approval-adjuvant-pancreatic-cancer-study-vs-gemcitabine-capecitabine","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59622","title":{"rendered":"Hengrui&#8217;s Irinotecan Liposome (II) Wins NMPA Phase II Approval \u2013 Adjuvant Pancreatic Cancer Study vs. Gemcitabine\/Capecitabine"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA: 600276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG: 1276<\/a>) announced <strong>NMPA clearance<\/strong> to initiate a <strong>clinical study<\/strong> evaluating <strong>irinotecan liposome (II)<\/strong> in <strong>combination with oxaliplatin, 5-fluorouracil, and leucovorin<\/strong> versus <strong>gemcitabine plus capecitabine<\/strong> as <strong>adjuvant therapy following pancreatic cancer surgery<\/strong>. The <strong>liposomal irinotecan formulation<\/strong>, which received <strong>initial NMPA approval in 2023 for metastatic pancreatic cancer post-gemcitabine progression<\/strong>, now expands into the <strong>curative-intent adjuvant setting<\/strong>, targeting the <strong>high-risk population<\/strong> where <strong>~80% of patients relapse within 2 years<\/strong> despite surgery.<\/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>Agency<\/strong><\/td><td>National Medical Products Administration (NMPA)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Clinical trial authorization (IND)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Irinotecan liposome (II)<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Liposomal irinotecan hydrochloride injection<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Topoisomerase I inhibitor; induces reversible single-strand DNA breaks<\/td><\/tr><tr><td><strong>Study Design<\/strong><\/td><td>Irinotecan liposome + oxaliplatin\/5-FU\/leucovorin vs. gemcitabine\/capecitabine<\/td><\/tr><tr><td><strong>Setting<\/strong><\/td><td>Adjuvant therapy post-pancreatic cancer surgery<\/td><\/tr><tr><td><strong>Developer<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals (SHA: 600276, HKG: 1276)<\/td><\/tr><tr><td><strong>Prior Approval<\/strong><\/td><td>NMPA approved 2023 \u2013 metastatic pancreatic cancer (post-gemcitabine)<\/td><\/tr><tr><td><strong>Originator Reference<\/strong><\/td><td>Onivyde (Merrimack\/Ipsen) \u2013 approved U.S.\/EU 2015; China 2022<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>16\u202fMar\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism\">Drug Profile &amp; Mechanism<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>Irinotecan Liposome (II) Specification<\/th><\/tr><\/thead><tbody><tr><td><strong>Active Moiety<\/strong><\/td><td>Irinotecan hydrochloride (camptothecin derivative)<\/td><\/tr><tr><td><strong>Formulation<\/strong><\/td><td>Liposomal encapsulation (II generation)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>\u2022 Binds topoisomerase I \u2192 induces reversible single-strand DNA breaks<br>\u2022 Active metabolite SN-38 binds topoisomerase I-DNA complex \u2192 prevents religation \u2192 DNA damage \u2192 apoptosis<\/td><\/tr><tr><td><strong>Liposomal Advantage<\/strong><\/td><td>Extended circulation; enhanced tumor penetration; reduced systemic toxicity<\/td><\/tr><tr><td><strong>Approved Indication (Current)<\/strong><\/td><td>Metastatic pancreatic cancer \u2013 combination with 5-FU\/leucovorin post-gemcitabine progression<\/td><\/tr><tr><td><strong>New Development<\/strong><\/td><td>Adjuvant setting \u2013 curative-intent post-surgery<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Adjuvant Rationale:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pancreatic Cancer Surgery:<\/strong> Whipple procedure or distal pancreatectomy; microscopic residual disease common<\/li>\n\n\n\n<li><strong>High Relapse Rate:<\/strong> 80% recurrence within 2 years without adjuvant therapy<\/li>\n\n\n\n<li><strong>Current Standard:<\/strong> Gemcitabine\/capecitabine (ESPAC-4 regimen) or modified FOLFIRINOX<\/li>\n\n\n\n<li><strong>Liposomal Irinotecan Potential:<\/strong> Improved tolerability vs. free irinotecan; enhanced efficacy in adjuvant micro-metastatic setting<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-context-amp-market-opportunity\">Strategic Context &amp; Market Opportunity<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Factor<\/th><th>Implication<\/th><\/tr><\/thead><tbody><tr><td><strong>Pancreatic Cancer Burden<\/strong><\/td><td>China: 120,000+ annual cases; 5-year survival &lt;10%; surgical candidates ~20%<\/td><\/tr><tr><td><strong>Adjuvant Market<\/strong><\/td><td>~25,000 patients\/year eligible for adjuvant therapy; high unmet need for improved regimens<\/td><\/tr><tr><td><strong>Competitive Landscape<\/strong><\/td><td>Gemcitabine\/capecitabine standard; modified FOLFIRINOX (high toxicity) for fit patients; liposomal irinotecan offers middle ground<\/td><\/tr><tr><td><strong>Hengrui Positioning<\/strong><\/td><td>Extends irinotecan liposome franchise from palliative to curative setting; lifecycle management<\/td><\/tr><tr><td><strong>Global Ambitions<\/strong><\/td><td>Adjuvant data could support U.S.\/EU label expansion; differentiate from Onivyde metastatic-only indication<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-study-design-amp-comparator\">Study Design &amp; Comparator<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Arm<\/th><th>Regimen<\/th><th>Rationale<\/th><\/tr><\/thead><tbody><tr><td><strong>Experimental<\/strong><\/td><td>Irinotecan liposome (II) + oxaliplatin + 5-FU + leucovorin<\/td><td>Liposomal irinotecan replaces standard irinotecan; enhanced tolerability and efficacy<\/td><\/tr><tr><td><strong>Control<\/strong><\/td><td>Gemcitabine + capecitabine<\/td><td>Current China standard of care (ESPAC-4 based)<\/td><\/tr><tr><td><strong>Setting<\/strong><\/td><td>Post-surgical adjuvant<\/td><td>Micro-metastatic disease eradication<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Disease-free survival (anticipated)<\/td><td>Standard adjuvant oncology endpoint<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-dynamics\">Competitive Dynamics<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Regimen<\/th><th>Components<\/th><th>Status<\/th><th>Hengrui Liposomal Irinotecan Advantage<\/th><\/tr><\/thead><tbody><tr><td><strong>Gemcitabine\/capecitabine<\/strong><\/td><td>Nucleoside analogs<\/td><td>Standard adjuvant<\/td><td>Liposomal delivery; topoisomerase I mechanism<\/td><\/tr><tr><td><strong>Modified FOLFIRINOX<\/strong><\/td><td>Oxaliplatin\/irinotecan\/5-FU\/leucovorin<\/td><td>High-efficacy, high-toxicity option<\/td><td>Improved irinotecan tolerability via liposomal formulation<\/td><\/tr><tr><td><strong>Onivyde (originator)<\/strong><\/td><td>Liposomal irinotecan<\/td><td>Metastatic only (China)<\/td><td>Hengrui adjuvant development first-in-class for liposomal irinotecan<\/td><\/tr><tr><td><strong>Hengrui<\/strong><\/td><td><strong>Irinotecan liposome (II) + FOLFOX<\/strong><\/td><td><strong>Phase II adjuvant<\/strong><\/td><td><strong>Potential for superior DFS with manageable toxicity<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-outlook\">Development Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Phase<\/th><th>Timeline<\/th><th>Objectives<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase II<\/strong><\/td><td>2026-2028<\/td><td>Safety\/tolerability of liposomal irinotecan in adjuvant setting; disease-free survival signal<\/td><\/tr><tr><td><strong>Phase III<\/strong><\/td><td>2028-2032<\/td><td>Registrational study vs. gemcitabine\/capecitabine; overall survival secondary endpoint<\/td><\/tr><tr><td><strong>Regulatory Strategy<\/strong><\/td><td>2032-2033<\/td><td>China NDA adjuvant indication; U.S.\/EU sNDA potential<\/td><\/tr><tr><td><strong>Global Positioning<\/strong><\/td><td>2028+<\/td><td>First liposomal irinotecan adjuvant data; potential best-in-class pancreatic adjuvant therapy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development timelines, adjuvant efficacy signals, and competitive positioning for irinotecan liposome (II) in pancreatic cancer. Actual results may differ due to surgical patient selection variability, adjuvant therapy tolerability challenges, and competitive dynamics with FOLFIRINOX.<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\/03\/600276_20260314_AT1T.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20260314_AT1T.\"><\/object><a id=\"wp-block-file--media-501607ca-417d-46d4-9b0c-638915d23ddf\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/600276_20260314_AT1T.pdf\">600276_20260314_AT1T<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/600276_20260314_AT1T.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-501607ca-417d-46d4-9b0c-638915d23ddf\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a&#8230;<\/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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,62,2586,4228,852],"class_list":["post-59622","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-sha-600276"],"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>Hengrui&#039;s Irinotecan Liposome (II) Wins NMPA Phase II Approval \u2013 Adjuvant Pancreatic Cancer Study vs. Gemcitabine\/Capecitabine - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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The liposomal irinotecan formulation, which received initial NMPA approval in 2023 for metastatic pancreatic cancer post-gemcitabine progression, now expands into the curative-intent adjuvant setting, targeting the high-risk population where ~80% of patients relapse within 2 years despite surgery.\" \/>\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=59622\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui&#039;s Irinotecan Liposome (II) Wins NMPA Phase II Approval \u2013 Adjuvant Pancreatic Cancer Study vs. Gemcitabine\/Capecitabine\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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Stay informed, stay ahead with FLCUBE.COM","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=59622#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=59622"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Hengrui&#8217;s Irinotecan Liposome (II) Wins NMPA Phase II Approval \u2013 Adjuvant Pancreatic Cancer Study vs. Gemcitabine\/Capecitabine","datePublished":"2026-03-16T08:36:30+00:00","dateModified":"2026-03-16T08:36:31+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=59622"},"wordCount":579,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Cancer","Clinical trial approval \/ initiation","Hengrui Pharmaceuticals","HKG: 1276","SHA: 600276"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=59622#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=59622","url":"https:\/\/flcube.com\/?p=59622","name":"Hengrui's Irinotecan Liposome (II) Wins NMPA Phase II Approval \u2013 Adjuvant Pancreatic Cancer Study vs. Gemcitabine\/Capecitabine - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2026-03-16T08:36:30+00:00","dateModified":"2026-03-16T08:36:31+00:00","description":"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a clinical study evaluating irinotecan liposome (II) in combination with oxaliplatin, 5-fluorouracil, and leucovorin versus gemcitabine plus capecitabine as adjuvant therapy following pancreatic cancer surgery. The liposomal irinotecan formulation, which received initial NMPA approval in 2023 for metastatic pancreatic cancer post-gemcitabine progression, now expands into the curative-intent adjuvant setting, targeting the high-risk population where ~80% of patients relapse within 2 years despite surgery.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=59622#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=59622"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=59622#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Hengrui&#8217;s Irinotecan Liposome (II) Wins NMPA Phase II Approval \u2013 Adjuvant Pancreatic Cancer Study vs. Gemcitabine\/Capecitabine"}]},{"@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\/59622","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=59622"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59622\/revisions"}],"predecessor-version":[{"id":59626,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59622\/revisions\/59626"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=59622"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=59622"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=59622"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}