{"id":50369,"date":"2025-12-10T23:12:03","date_gmt":"2025-12-10T15:12:03","guid":{"rendered":"https:\/\/flcube.com\/?p=50369"},"modified":"2025-12-10T23:12:03","modified_gmt":"2025-12-10T15:12:03","slug":"innovent-doses-first-patient-in-phase-1-trial-of-ibi3011-chinas-first-anti-il-1rap-antibody-for-gout-flares","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50369","title":{"rendered":"Innovent Doses First Patient in Phase 1 Trial of IBI3011, China\u2019s First Anti\u2011IL\u20111RAP Antibody for Gout Flares"},"content":{"rendered":"\n<p><strong>Innovent Biologics, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/1801:HKG\">HKG: 1801<\/a>) announced that the first participant has been dosed in a <strong>Phase\u202f1 single\u2011ascending\u2011dose (SAD)<\/strong> trial of <strong>IBI3011<\/strong>, an <strong>anti\u2011IL\u20111RAP monoclonal antibody<\/strong> targeting inflammatory and autoimmune diseases. The study will enroll <strong>40 healthy volunteers and 24 acute gout patients<\/strong> to evaluate safety, tolerability, and pharmacokinetics.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-study-design-amp-regulatory-path\">Study Design &amp; Regulatory Path<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Trial Identifier<\/strong><\/td><td>NCT06754321 (China)<\/td><\/tr><tr><td><strong>Phase<\/strong><\/td><td>Phase\u202f1 SAD \/ MAD expansion planned<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>IBI3011 (anti\u2011IL\u20111RAP mAb)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Blocks IL\u20111 signaling via IL\u20111RAP accessory protein<\/td><\/tr><tr><td><strong>Enrollment<\/strong><\/td><td>64 total: 40 healthy volunteers; 24 gout flare patients<\/td><\/tr><tr><td><strong>Primary Endpoints<\/strong><\/td><td>Safety, tolerability, PK profile, PD biomarkers (IL\u20116, CRP)<\/td><\/tr><tr><td><strong>First Dose Date<\/strong><\/td><td>09\u202fDec\u202f2025<\/td><\/tr><tr><td><strong>Expected Completion<\/strong><\/td><td>Q4\u202f2026 (SAD); Q2\u202f2027 (MAD)<\/td><\/tr><tr><td><strong>Next Milestone<\/strong><\/td><td>IND filing for rheumatoid arthritis \/ CAPS indications H2\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-preclinical-evidence\">Drug Profile &amp; Preclinical Evidence<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Novel Target:<\/strong> IL\u20111RAP (Interleukin\u20111 receptor accessory protein) \u2013 a key co\u2011receptor for IL\u20111\u03b1\/\u03b2 signaling, implicated in <strong>gout, rheumatoid arthritis, CAPS, and other autoinflammatory diseases<\/strong>.<\/li>\n\n\n\n<li><strong>First\u2011in\u2011China:<\/strong> IBI3011 is the <strong>first anti\u2011IL\u20111RAP mAb<\/strong> developed in China for inflammatory disease; global competitors include SOBI\u2019s LUTIKIZUMAB (Phase\u202f2) and Novartis\u2019 early\u2011stage candidates.<\/li>\n\n\n\n<li><strong>Preclinical Data:<\/strong> In <strong>acute gouty arthritis models<\/strong>, IBI3011 demonstrated <strong>dose\u2011dependent suppression of joint swelling<\/strong> and <strong>reduced neutrophil infiltration<\/strong>, with <strong>ED50 of 0.3\u202fmg\/kg<\/strong> \u2013 comparable to IL\u20111\u03b2 blockers but with <strong>extended PK half\u2011life<\/strong> (projected 18\u201122\u202fdays in humans).<\/li>\n\n\n\n<li><strong>Broader Pipeline Potential:<\/strong> IL\u20111RAP inhibition may address <strong>gout flare prevention<\/strong> and <strong>tumor\u2011associated inflammation<\/strong>, offering a <strong>dual immunology\u2011oncology<\/strong> platform opportunity.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-competitive-landscape\">Market Opportunity &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Metric<\/th><th>Value<\/th><th>Source<\/th><\/tr><\/thead><tbody><tr><td><strong>China Gout Prevalence<\/strong><\/td><td>15.9\u202fmillion patients (2024)<\/td><td>China CDC<\/td><\/tr><tr><td><strong>China Gout Treatment Market<\/strong><\/td><td>\u00a53.2\u202fbillion (\u2248\u202fUS$450\u202fM)<\/td><td>IQVIA<\/td><\/tr><tr><td><strong>Unmet Need<\/strong><\/td><td>~40% of patients experience \u22652 flares\/year despite urate\u2011lowering therapy<\/td><td><\/td><\/tr><tr><td><strong>Competing Agents<\/strong><\/td><td>Canakinumab (Ilaris\u00ae) \u2013 IL\u20111\u03b2 mAb; Anakinra \u2013 IL\u20111R antagonist; both require frequent dosing and are not IL\u20111RAP\u2011targeted<\/td><td><\/td><\/tr><tr><td><strong>IBI3011 Value Proposition<\/strong><\/td><td><strong>Monthly dosing<\/strong>, <strong>potentially superior flare prevention<\/strong>, <strong>first local biosimilar\u2011like cost structure<\/strong><\/td><td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Innovent projects <strong>\u00a5800\u202fmillion (\u2248\u202fUS$110\u202fM) peak China sales<\/strong> by 2033 if approved, assuming <strong>12% market share<\/strong> of the refractory gout segment. Global rights could add <strong>US$250\u2011300\u202fM<\/strong> opportunity in EU\/U.S. markets currently lacking an IL\u20111RAP\u2011specific therapy.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief includes forward\u2011looking statements regarding IBI3011 clinical progression, market size estimates, and competitive positioning. Actual results may differ due to regulatory delays, unforeseen safety signals, or slower market adoption.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Innovent Biologics, Inc. (HKG: 1801) announced that the first participant has been dosed in a&#8230;<\/p>\n","protected":false},"author":1,"featured_media":50370,"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":[62,910,198],"class_list":["post-50369","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-hkg-1801","tag-innovent-biologics"],"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>Innovent Doses First Patient in Phase 1 Trial of IBI3011, China\u2019s First Anti\u2011IL\u20111RAP Antibody for Gout Flares - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Innovent Biologics, Inc. 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The study will enroll 40 healthy volunteers and 24 acute gout patients to evaluate safety, tolerability, and pharmacokinetics.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=50369#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=50369"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=50369#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/1007.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/1007.webp","width":1080,"height":608,"caption":"Innovent Doses First Patient in Phase 1 Trial of IBI3011, China\u2019s First Anti\u2011IL\u20111RAP Antibody for Gout Flares"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=50369#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Innovent Doses First Patient in Phase 1 Trial of IBI3011, China\u2019s First Anti\u2011IL\u20111RAP Antibody for Gout Flares"}]},{"@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\/12\/1007.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/50369","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=50369"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/50369\/revisions"}],"predecessor-version":[{"id":50371,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/50369\/revisions\/50371"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/50370"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=50369"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=50369"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=50369"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}