{"id":59186,"date":"2026-03-10T16:32:40","date_gmt":"2026-03-10T08:32:40","guid":{"rendered":"https:\/\/flcube.com\/?p=59186"},"modified":"2026-03-10T16:32:41","modified_gmt":"2026-03-10T08:32:41","slug":"henlius-biotechs-hlx3901-wins-nmpa-approval-first-in-class-tetra-specific-antibody-targets-dll3-positive-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59186","title":{"rendered":"Henlius Biotech&#8217;s HLX3901 Wins NMPA Approval \u2013 First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors"},"content":{"rendered":"\n<p><strong>Shanghai Henlius Biotech, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced that <strong>HLX3901<\/strong>, a <strong>first-in-class tetra-specific antibody<\/strong> targeting <strong>DLL3 dual epitopes, CD3, and CD28<\/strong>, has received <strong>NMPA IND approval<\/strong> for a <strong>Phase I clinical trial<\/strong> in <strong>advanced\/metastatic solid tumors<\/strong>. The <strong>independently developed<\/strong> candidate represents a <strong>next-generation T-cell engager<\/strong> designed to <strong>overcome immune suppression<\/strong> and <strong>enhance therapeutic efficacy<\/strong> through <strong>simultaneous activation of primary and co-stimulatory T-cell signals<\/strong>, positioning Henlius at the forefront of <strong>multi-specific antibody innovation<\/strong>.<\/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>Investigational New Drug (IND) \u2013 Phase I<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>HLX3901 injection<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Tetra-specific antibody (DLL3\u00d7DLL3\u00d7CD3\u00d7CD28)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Advanced\/metastatic solid tumors<\/td><\/tr><tr><td><strong>Developer<\/strong><\/td><td>Shanghai Henlius Biotech, Inc. (HKG: 2696)<\/td><\/tr><tr><td><strong>Global Status<\/strong><\/td><td><strong>No approved tetra-specific antibody targeting this combination worldwide<\/strong><\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>10\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>HLX3901 Specification<\/th><\/tr><\/thead><tbody><tr><td><strong>Format<\/strong><\/td><td>Tetra-specific antibody (4 distinct binding domains)<\/td><\/tr><tr><td><strong>Targets<\/strong><\/td><td>\u2022 <strong>DLL3 dual epitopes<\/strong> (tumor antigen \u2013 delta-like ligand 3)<br>\u2022 <strong>CD3<\/strong> (T-cell receptor \u2013 primary activation signal)<br>\u2022 <strong>CD28<\/strong> (T-cell co-stimulatory receptor)<\/td><\/tr><tr><td><strong>Mechanism Class<\/strong><\/td><td>T-cell engager with dual-signal activation<\/td><\/tr><tr><td><strong>Action<\/strong><\/td><td>\u2022 Enhances targeted T-cell lysis of DLL3-positive tumor cells<br>\u2022 Activates CD3 (Signal 1) + CD28 (Signal 2) simultaneously<br>\u2022 Promotes T-cell activation, proliferation, and in vivo survival<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Scientific Innovation:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Dual DLL3 Epitope Binding:<\/strong> Enhanced tumor specificity and avidity vs. single-epitope targeting<\/li>\n\n\n\n<li><strong>Signal 1 + Signal 2 Co-activation:<\/strong> Mimics physiological T-cell activation; reduces exhaustion vs. CD3-only engagers<\/li>\n\n\n\n<li><strong>Immune Suppression Overcome:<\/strong> Co-stimulation counteracts tumor microenvironment inhibitory signals<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-preclinical-evidence-amp-differentiation\">Preclinical Evidence &amp; Differentiation<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>HLX3901 Performance<\/th><\/tr><\/thead><tbody><tr><td><strong>Anti-Tumor Efficacy<\/strong><\/td><td>Good activity demonstrated in disease models<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Favorable preclinical tolerability<\/td><\/tr><tr><td><strong>Therapeutic Window<\/strong><\/td><td>Improved vs. conventional T-cell engagers (reduced on-target\/off-tumor toxicity)<\/td><\/tr><tr><td><strong>T-Cell Persistence<\/strong><\/td><td>Enhanced activation, proliferation, and survival prolong anti-tumor immune response<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Competitive Positioning:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Competitor Approach<\/th><th>Mechanism<\/th><th>HLX3901 Advantage<\/th><\/tr><\/thead><tbody><tr><td><strong>Bispecific T-cell engagers (BiTEs)<\/strong><\/td><td>CD3 + tumor antigen (e.g., blinatumomab)<\/td><td>Adds CD28 co-stimulation + dual DLL3 targeting for enhanced efficacy and persistence<\/td><\/tr><tr><td><strong>CAR-T therapies<\/strong><\/td><td>Engineered T-cells<\/td><td>Off-the-shelf convenience; no lymphodepletion required; lower manufacturing complexity<\/td><\/tr><tr><td><strong>Other multi-specifics<\/strong><\/td><td>Tri-specific formats<\/td><td>Tetra-specific adds dual epitope avidity + co-stimulation; first-in-class globally<\/td><\/tr><\/tbody><\/table><\/figure>\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>DLL3 Expression<\/strong><\/td><td>High in small cell lung cancer (SCLC), neuroendocrine tumors, subset of solid tumors; validated by rovalpituzumab tesirine (failed ADC) and DLL3-CAR-T trials<\/td><\/tr><tr><td><strong>T-Cell Engager Market<\/strong><\/td><td>Global market projected $15+ billion by 2030; solid tumor applications expanding beyond hematologic malignancies<\/td><\/tr><tr><td><strong>Henlius Pipeline<\/strong><\/td><td>HLX3901 anchors next-generation immuno-oncology platform; complements approved PD-1 (serplulimab) and biosimilar portfolio<\/td><\/tr><tr><td><strong>Global Potential<\/strong><\/td><td>First-in-class status supports U.S.\/EU IND filing; Fast Track designation potential for SCLC indication<\/td><\/tr><tr><td><strong>Manufacturing<\/strong><\/td><td>Henlius&#8217; integrated biologics facility supports clinical and commercial tetra-specific production<\/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 I<\/strong><\/td><td>2026-2027<\/td><td>Safety, tolerability, MTD; DLL3-positive tumor enrichment (SCLC, neuroendocrine)<\/td><\/tr><tr><td><strong>Phase II<\/strong><\/td><td>2027-2029<\/td><td>Efficacy signals; combination with PD-1; biomarker development<\/td><\/tr><tr><td><strong>Regulatory Strategy<\/strong><\/td><td>2029-2030<\/td><td>Breakthrough Therapy designation pursuit; NDA preparation<\/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, first-in-class positioning, and competitive differentiation for HLX3901. Actual results may differ due to novelty of tetra-specific format, manufacturing complexity, and competitive dynamics in the T-cell engager market.<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\/2026030900283_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026030900283_c.\"><\/object><a id=\"wp-block-file--media-762ab800-0f54-4356-a70c-cee07e858ee1\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026030900283_c.pdf\">2026030900283_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026030900283_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-762ab800-0f54-4356-a70c-cee07e858ee1\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX3901, a first-in-class tetra-specific antibody targeting DLL3&#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":[62,270,862,28],"class_list":["post-59186","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-henlius-biotech","tag-hkg-2696","tag-multi-specific-antibodies"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Henlius Biotech&#039;s HLX3901 Wins NMPA Approval \u2013 First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX3901, a first-in-class tetra-specific antibody targeting DLL3 dual epitopes, CD3, and CD28, has received NMPA IND approval for a Phase I clinical trial in advanced\/metastatic solid tumors. 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(HKG: 2696) announced that HLX3901, a first-in-class tetra-specific antibody targeting DLL3 dual epitopes, CD3, and CD28, has received NMPA IND approval for a Phase I clinical trial in advanced\/metastatic solid tumors. The independently developed candidate represents a next-generation T-cell engager designed to overcome immune suppression and enhance therapeutic efficacy through simultaneous activation of primary and co-stimulatory T-cell signals, positioning Henlius at the forefront of multi-specific antibody innovation.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=59186#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=59186"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=59186#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Henlius Biotech&#8217;s HLX3901 Wins NMPA Approval \u2013 First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors"}]},{"@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\/59186","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=59186"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59186\/revisions"}],"predecessor-version":[{"id":59189,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59186\/revisions\/59189"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=59186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=59186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=59186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}