{"id":48989,"date":"2025-11-25T20:13:32","date_gmt":"2025-11-25T12:13:32","guid":{"rendered":"https:\/\/flcube.com\/?p=48989"},"modified":"2025-11-25T20:13:32","modified_gmt":"2025-11-25T12:13:32","slug":"hengruis-ivarmacitinib-nda-accepted-for-non%e2%80%91radiographic-axial-spondyloarthritis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48989","title":{"rendered":"Hengrui&#8217;s Ivarmacitinib NDA Accepted for Non\u2011Radiographic Axial Spondyloarthritis"},"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 that the <strong>China National Medical Products Administration (NMPA)<\/strong> has accepted its new drug application (NDA) for <strong>ivarmacitinib (Aisuda)<\/strong> to treat <strong>active non\u2011radiographic axial spondyloarthritis (nr\u2011axSpA)<\/strong> in adults with inadequate response to NSAIDs, based on positive <strong>Phase\u202f3 SHR0302\u2011305<\/strong> data showing statistically significant <strong>ASAS40<\/strong> improvement at Week\u202f12.<\/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>Ivarmacitinib (Aisuda)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Application Type<\/strong><\/td><td>New indication NDA<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Active nr\u2011axSpA with elevated CRP and\/or abnormal MRI<\/td><\/tr><tr><td><strong>Study Basis<\/strong><\/td><td>Phase\u202f3 SHR0302\u2011305 (multi\u2011center, randomized, double\u2011blind, placebo\u2011controlled)<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>ASAS40 at Week\u202f12<\/td><\/tr><tr><td><strong>Key Result<\/strong><\/td><td>Statistically significant and clinically meaningful improvement vs. placebo<\/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>Mechanism:<\/strong> <strong>Highly selective JAK1 inhibitor<\/strong> blocking inflammatory cytokine signaling<\/li>\n\n\n\n<li><strong>Current Indications:<\/strong> Approved March\u202f2025 for <strong>ankylosing spondylitis, rheumatoid arthritis, atopic dermatitis, severe alopecia areata<\/strong> (4 total)<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> <strong>Fifth potential indication<\/strong> would make ivarmacitinib the most versatile JAK1 inhibitor in China<\/li>\n\n\n\n<li><strong>Patient Population:<\/strong> Targets <strong>~180,000 nr\u2011axSpA patients<\/strong> in China who are NSAID\u2011refractory<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-shr0302-305-trial\">Clinical Evidence \u2013 SHR0302-305 Trial<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Result (Ivarmacitinib vs. Placebo)<\/th><\/tr><\/thead><tbody><tr><td><strong>Primary (ASAS40 at Week\u202f12)<\/strong><\/td><td><strong>Statistically significant<\/strong> improvement (p\u202f&lt;\u202f0.001)<\/td><\/tr><tr><td><strong>Secondary (ASAS20, BASDAI, CRP)<\/strong><\/td><td>Clinically meaningful improvements across all measures<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Consistent with prior JAK1 inhibitor data; no new safety signals<\/td><\/tr><tr><td><strong>Patient Population<\/strong><\/td><td>304 adults with active nr\u2011axSpA and objective inflammation<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-outlook\">Market Context &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 nr\u2011axSpA Patients<\/strong><\/td><td>~<strong>180,000<\/strong> eligible for advanced therapy<\/td><\/tr><tr><td><strong>Progression Risk<\/strong><\/td><td>~10% convert to ankylosing spondylitis within 2\u202fyears<\/td><\/tr><tr><td><strong>Current Standard<\/strong><\/td><td>NSAIDs (first\u2011line); TNF\/IL\u201117 inhibitors (second\u2011line)<\/td><\/tr><tr><td><strong>JAK Inhibitor Market<\/strong><\/td><td><strong>AbbVie\u2019s upadacitinib<\/strong> (Rinvoq) approved for nr\u2011axSpA in China in 2024<\/td><\/tr><tr><td><strong>Peak Sales Forecast<\/strong><\/td><td><strong>\u00a52.8\u20113.5\u202fbillion<\/strong> (~US$380\u2011480\u202fmillion) by 2032<\/td><\/tr><tr><td><strong>Market Share Target<\/strong><\/td><td>25\u201130% of nr\u2011axSpA patients (competing with upadacitinib)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Reimbursement Path:<\/strong> NMPA acceptance triggers <strong>Priority Review<\/strong>; NRDL inclusion likely within 12\u202fmonths of approval<\/li>\n\n\n\n<li><strong>Competitive Moat:<\/strong> Strong Phase\u202f3 data, established safety profile, and Hengrui\u2019s commercial scale provide first\u2011mover advantage vs. newer entrants<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding ivarmacitinib\u2019s regulatory review, market penetration, and commercial performance. Actual results may differ materially due to risks including NMPA approval timelines, competitive dynamics, and market adoption rates.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the China National Medical&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48990,"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":[2586,4228,38,852],"class_list":["post-48989","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-market-approval-filings","tag-sha-600276"],"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>Hengrui&#039;s Ivarmacitinib NDA Accepted for Non\u2011Radiographic Axial Spondyloarthritis - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the China National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for ivarmacitinib (Aisuda) to treat active non\u2011radiographic axial spondyloarthritis (nr\u2011axSpA) in adults with inadequate response to NSAIDs, based on positive Phase\u202f3 SHR0302\u2011305 data showing statistically significant ASAS40 improvement at Week\u202f12.\" \/>\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=48989\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui&#039;s Ivarmacitinib NDA Accepted for Non\u2011Radiographic Axial Spondyloarthritis\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the China National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for ivarmacitinib (Aisuda) to treat active non\u2011radiographic axial spondyloarthritis (nr\u2011axSpA) in adults with inadequate response to NSAIDs, based on positive Phase\u202f3 SHR0302\u2011305 data showing statistically significant ASAS40 improvement at Week\u202f12.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48989\" \/>\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=\"2025-11-25T12:13:32+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2503-1.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. 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(SHA: 600276, HKG: 1276) announced that the China National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for ivarmacitinib (Aisuda) to treat active non\u2011radiographic axial spondyloarthritis (nr\u2011axSpA) in adults with inadequate response to NSAIDs, based on positive Phase\u202f3 SHR0302\u2011305 data showing statistically significant ASAS40 improvement at Week\u202f12.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=48989#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=48989"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=48989#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2503-1.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2503-1.webp","width":1080,"height":608,"caption":"Hengrui's Ivarmacitinib NDA Accepted for Non\u2011Radiographic Axial Spondyloarthritis"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=48989#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Hengrui&#8217;s Ivarmacitinib NDA Accepted for Non\u2011Radiographic Axial Spondyloarthritis"}]},{"@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\/2503-1.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48989","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=48989"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48989\/revisions"}],"predecessor-version":[{"id":48991,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48989\/revisions\/48991"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/48990"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=48989"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=48989"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=48989"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}