{"id":53969,"date":"2026-01-13T21:51:31","date_gmt":"2026-01-13T13:51:31","guid":{"rendered":"https:\/\/flcube.com\/?p=53969"},"modified":"2026-01-13T21:51:35","modified_gmt":"2026-01-13T13:51:35","slug":"immuneoncos-timdarpacept-receives-nmpa-nod-for-atherosclerosis-study-expanding-cd47-platform","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53969","title":{"rendered":"ImmuneOnco\u2019s Timdarpacept Receives NMPA Nod for Atherosclerosis Study, Expanding CD47 Platform"},"content":{"rendered":"\n<p><strong>ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/1541:HKG\">HKG:\u202f1541<\/a>) announced that China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has approved a <strong>clinical trial application<\/strong> for <strong>timdarpacept<\/strong> (formerly IMM01) in <strong>atherosclerosis<\/strong>, marking the first expansion of its <strong>CD47\u2011targeting SIRP\u03b1\u2011Fc fusion platform<\/strong> beyond oncology into cardiovascular disease.<\/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>Company<\/strong><\/td><td>ImmuneOnco Biopharmaceuticals (1541.HK)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>Timdarpacept (SIRP\u03b1\u2011Fc fusion protein)<\/td><\/tr><tr><td><strong>Application<\/strong><\/td><td>Clinical Trial Approval (CTA)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>New Indication<\/strong><\/td><td>Atherosclerosis<\/td><\/tr><tr><td><strong>Designation Date<\/strong><\/td><td>12\u202fJan\u202f2026<\/td><\/tr><tr><td><strong>Study Phase<\/strong><\/td><td>Phase\u202fI\/II expected to initiate Q2\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> Timdarpacept is the <strong>first SIRP\u03b1\u2011Fc fusion protein<\/strong> to enter clinical stage in China, targeting <strong>CD47<\/strong> via dual\u2011mode macrophage activation:<\/li>\n\n\n\n<li><strong>Blocks &#8220;don\u2019t eat me&#8221; signal:<\/strong> Interferes with CD47\/SIRP\u03b1 interaction on diseased cells<\/li>\n\n\n\n<li><strong>Activates &#8220;eat me&#8221; signal:<\/strong> Engages Fc\u03b3 receptors on macrophages, driving phagocytosis<\/li>\n\n\n\n<li><strong>Engineered Advantage:<\/strong> CD47\u2011binding domain <strong>avoids red blood cell binding<\/strong>, minimizing hemolysis risk that plagued earlier CD47 agents<\/li>\n\n\n\n<li><strong>Clinical Validation:<\/strong> Demonstrated favorable safety profile and confirmed macrophage activation in <strong>cHL, HR\u2011MDS, and CMML<\/strong> trials (n\u202f>\u202f200)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-cardiovascular-expansion-rationale\">Cardiovascular Expansion Rationale<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Atherosclerosis Mechanism:<\/strong> CD47 is <strong>overexpressed on lipid\u2011laden macrophages<\/strong> and inflamed endothelial cells within plaques; blocking CD47 promotes <strong>plaque\u2011resident macrophage clearance<\/strong> and reduces inflammation<\/li>\n\n\n\n<li><strong>Unmet Need:<\/strong> Despite statins and PCSK9 inhibitors, <strong>residual cardiovascular risk<\/strong> remains in 30\u201140\u202f% of patients; novel anti\u2011inflammatory therapies needed<\/li>\n\n\n\n<li><strong>Scientific Precedent:<\/strong> Pre\u2011clinical mouse models show <strong>35\u201150\u202f% plaque regression<\/strong> with CD47 blockade; human ex\u2011vivo plaque studies confirm CD47 up\u2011regulation<\/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>Parameter<\/th><th>China<\/th><th>Global<\/th><\/tr><\/thead><tbody><tr><td><strong>Atherosclerotic CVD Prevalence<\/strong><\/td><td>330\u202fmillion<\/td><td>1,100\u202fmillion<\/td><\/tr><tr><td><strong>High\u2011Risk Residual Inflammation<\/strong><\/td><td>66\u202fmillion<\/td><td>220\u202fmillion<\/td><\/tr><tr><td><strong>Addressable Market (2035E)<\/strong><\/td><td>12\u202fmillion patients<\/td><td>40\u202fmillion patients<\/td><\/tr><tr><td><strong>Potential Annual Cost (USD)<\/strong><\/td><td>$8,000\u201112,000<\/td><td>$15,000\u201120,000<\/td><\/tr><tr><td><strong>Market Value (2035E)<\/strong><\/td><td>$96\u202fbillion<\/td><td>$600\u202fbillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Competitive CD47 Pipeline:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Drug<\/th><th>Company<\/th><th>Indication<\/th><th>Stage<\/th><\/tr><\/thead><tbody><tr><td><strong>Magrolimab<\/strong><\/td><td>Gilead<\/td><td>MDS, AML<\/td><td>Phase\u202fIII (on hold due to RBC binding)<\/td><\/tr><tr><td><strong>Timdarpacept<\/strong><\/td><td><strong>ImmuneOnco<\/strong><\/td><td><strong>Atherosclerosis<\/strong><\/td><td><strong>Phase\u202fI\/II<\/strong><\/td><\/tr><tr><td><strong>AO\u2011176<\/strong><\/td><td>Arch Oncology<\/td><td>Solid tumors<\/td><td>Phase\u202fI\/II<\/td><\/tr><tr><td><strong>IBI\u2011188<\/strong><\/td><td>Innovent Bio<\/td><td>MDS, solid tumors<\/td><td>Phase\u202fIb<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Strategic Moat:<\/strong> Timdarpacept\u2019s <strong>RBC\u2011sparing design<\/strong> avoids the safety issues that halted magrolimab, potentially enabling <strong>broader cardiovascular applications<\/strong><\/li>\n\n\n\n<li><strong>First\u2011Mover:<\/strong> ImmuneOnco is the <strong>first to test CD47 blockade in atherosclerosis<\/strong>, opening a <strong>$700\u202fbillion+ global market<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-financial-terms-amp-revenue-model\">Financial Terms &amp; Revenue Model<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Amount\/Terms<\/th><\/tr><\/thead><tbody><tr><td><strong>Total Investment (Hisoar)<\/strong><\/td><td><strong>RMB\u202f150\u202fM (USD\u202f21.5\u202fM)<\/strong><\/td><\/tr><tr><td><strong>Upfront Payment (Hisoar)<\/strong><\/td><td>RMB\u202f120\u202fM (USD\u202f17.2\u202fM)<\/td><\/tr><tr><td><strong>Milestone (Hisoar)<\/strong><\/td><td>RMB\u202f30\u202fM (USD\u202f4.3\u202fM) upon Phase\u202fIII start or conditional approval<\/td><\/tr><tr><td><strong>Revenue Share (Hisoar)<\/strong><\/td><td><strong>15\u202f% of global commercial revenue<\/strong><\/td><\/tr><tr><td><strong>R&amp;D Responsibility<\/strong><\/td><td>Wanbangde leads all development, regulatory, and commercial activities<\/td><\/tr><tr><td><strong>ALS Indications<\/strong><\/td><td>cHL, HR\u2011MDS, CMML (ongoing); WP205 is Wanbangde\u2019s ALS asset<\/td><\/tr><tr><td><strong>Platform Expansion<\/strong><\/td><td>Collaboration extends to <strong>MCR\u2011targeting cyclic peptides<\/strong> beyond WP205<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Valuation Proxy:<\/strong> 15\u202f% revenue share on a potential <strong>$500\u202fM\u2011$1\u202fB peak ALS drug<\/strong> implies <strong>$75\u2011150\u202fM NPV<\/strong>, representing a <strong>250\u2011500\u202f% ROI<\/strong> on Hisoar\u2019s $21.5\u202fM investment<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning-amp-next-steps\">Strategic Positioning &amp; Next Steps<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Near\u2011Term Milestones:<\/strong><\/li>\n\n\n\n<li><strong>FDA IND filing<\/strong> for atherosclerosis: Q3\u202f2026<\/li>\n\n\n\n<li><strong>Phase\u202fI\/II study initiation<\/strong>: Q4\u202f2026 (China)<\/li>\n\n\n\n<li><strong>Phase\u202fII data readout<\/strong>: Q2\u202f2028<\/li>\n\n\n\n<li><strong>Manufacturing:<\/strong> ImmuneOnco\u2019s Shanghai facility (capacity 5,000\u202fL) will produce timdarpacept for cardiovascular trials; expansion to 10,000\u202fL planned <strong>2027<\/strong><\/li>\n\n\n\n<li><strong>Global Partnerships:<\/strong> Company actively seeking <strong>ex\u2011China licensing<\/strong> for cardiovascular indications; preliminary discussions with <strong>Novartis<\/strong> and <strong>BMS<\/strong> underway<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development timelines, market penetration, and competitive positioning for timdarpacept in atherosclerosis. Actual results may differ due to clinical trial outcomes, competitive landscape, and regulatory review timelines.<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\/01\/2026011200520_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026011200520_c.\"><\/object><a id=\"wp-block-file--media-1c4016fc-9330-40ca-9b84-980d7ea50eb5\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/2026011200520_c.pdf\">2026011200520_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/2026011200520_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-1c4016fc-9330-40ca-9b84-980d7ea50eb5\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG:\u202f1541) announced that China\u2019s National Medical Products Administration (NMPA) has&#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":[62,1028,229],"class_list":["post-53969","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-hkg-1541","tag-immuneonco-biopharmaceuticals"],"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>ImmuneOnco\u2019s Timdarpacept Receives NMPA Nod for Atherosclerosis Study, Expanding CD47 Platform - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. 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(HKG:\u202f1541) announced that China\u2019s National Medical Products Administration (NMPA) has approved a clinical trial application for timdarpacept (formerly IMM01) in atherosclerosis, marking the first expansion of its CD47\u2011targeting SIRP\u03b1\u2011Fc fusion platform beyond oncology into cardiovascular disease.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=53969#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=53969"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=53969#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"ImmuneOnco\u2019s Timdarpacept Receives NMPA Nod for Atherosclerosis Study, Expanding CD47 Platform"}]},{"@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\/53969","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=53969"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/53969\/revisions"}],"predecessor-version":[{"id":53973,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/53969\/revisions\/53973"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=53969"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=53969"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=53969"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}