{"id":59191,"date":"2026-03-10T16:37:28","date_gmt":"2026-03-10T08:37:28","guid":{"rendered":"https:\/\/flcube.com\/?p=59191"},"modified":"2026-03-10T16:37:28","modified_gmt":"2026-03-10T08:37:28","slug":"kelun-biotechs-skb575-hbm7575-wins-nmpa-approval-long-acting-tslp-bispecific-targets-atopic-dermatitis-with-q3-dosing-potential","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59191","title":{"rendered":"Kelun-Biotech&#8217;s SKB575\/HBM7575 Wins NMPA Approval \u2013 Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential"},"content":{"rendered":"\n<p><strong>Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/6990:HKG\">HKG: 6990<\/a>) announced that <strong>SKB575\/HBM7575<\/strong>, a <strong>long-acting bispecific antibody (bsAb) targeting TSLP and an undisclosed second target<\/strong>, has received <strong>NMPA IND approval<\/strong> for the treatment of <strong>atopic dermatitis (AD)<\/strong>. Co-developed with <strong>Harbour BioMed (HBM Holdings)<\/strong>, the candidate features <strong>extended half-life engineering<\/strong> supporting <strong>dosing intervals exceeding three months<\/strong>, positioning it as a <strong>potential best-in-class therapy<\/strong> that overcomes <strong>resistance limitations of single-target TSLP antibodies<\/strong> through <strong>synergistic dual-target blockade<\/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-ready<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>SKB575\/HBM7575<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Long-acting bispecific antibody (bsAb)<\/td><\/tr><tr><td><strong>Targets<\/strong><\/td><td>TSLP (thymic stromal lymphopoietin) + undisclosed second target<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Atopic dermatitis<\/td><\/tr><tr><td><strong>Co-Developers<\/strong><\/td><td>Kelun-Biotech (6990.HK) + Harbour BioMed (HBM Holdings)<\/td><\/tr><tr><td><strong>Lead Partner<\/strong><\/td><td>Kelun-Biotech (global development and commercialization)<\/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>SKB575\/HBM7575 Specification<\/th><\/tr><\/thead><tbody><tr><td><strong>Primary Target<\/strong><\/td><td>TSLP (upstream cytokine in Th2 inflammation cascade)<\/td><\/tr><tr><td><strong>Secondary Target<\/strong><\/td><td>Undisclosed (synergistic immune modulation)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>\u2022 Blocks TSLP-receptor interaction \u2192 inhibits Th2 cell activation<br>\u2022 Dual-target blockade generates synergistic effect<br>\u2022 Overcomes resistance to TSLP monotherapy<\/td><\/tr><tr><td><strong>Half-Life Engineering<\/strong><\/td><td>Extended via Fc modifications or fusion technologies<\/td><\/tr><tr><td><strong>Anticipated Human Half-Life<\/strong><\/td><td>Supports dosing intervals <strong>&gt;3 months<\/strong><\/td><\/tr><tr><td><strong>Route<\/strong><\/td><td>Subcutaneous administration<\/td><\/tr><tr><td><strong>Developability<\/strong><\/td><td>Favorable manufacturing and stability properties<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Scientific Rationale:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>TSLP Driver Role:<\/strong> Master switch for Th2 inflammation in AD; Tezepelumab (Amgen\/AstraZeneca) validated target with $1.5B+ annual sales<\/li>\n\n\n\n<li><strong>Resistance Challenge:<\/strong> ~30-40% of AD patients inadequate responders to TSLP monotherapy; dual-target approach addresses heterogeneity<\/li>\n\n\n\n<li><strong>Convenience Advantage:<\/strong> Q3+ dosing vs. monthly\/quarterly injections for existing biologics (dupilumab Q2W, lebrikizumab Q2W\/Q4W)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-partnership-structure\">Partnership Structure<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Element<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Lead Development<\/strong><\/td><td>Kelun-Biotech (design, global development, commercialization)<\/td><\/tr><tr><td><strong>Investment Partner<\/strong><\/td><td>Harbour BioMed (HBM Holdings)<\/td><\/tr><tr><td><strong>Benefit Sharing<\/strong><\/td><td>Per collaboration agreement terms<\/td><\/tr><tr><td><strong>Strategic Value<\/strong><\/td><td>Kelun-Biotech leverages Harbour BioMed&#8217;s antibody engineering platform; Harbour gains China market access via Kelun infrastructure<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-competitive-landscape\">Market Context &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Factor<\/th><th>Market Implication<\/th><\/tr><\/thead><tbody><tr><td><strong>China AD Market<\/strong><\/td><td>70+ million patients; biologic penetration &lt;5% vs. 15-20% in U.S.\/EU; rapid growth anticipated<\/td><\/tr><tr><td><strong>TSLP Class Validation<\/strong><\/td><td>Tezepelumab (Amgen\/AZ) approved 2021; annual sales approaching $2 billion globally<\/td><\/tr><tr><td><strong>Competitive Threats<\/strong><\/td><td>Dupilumab (IL-4R\u03b1, Sanofi\/Regeneron) dominates; lebrikizumab (IL-13, Lilly), nemolizumab (IL-31, Galderma) fragmenting market<\/td><\/tr><tr><td><strong>Differentiation<\/strong><\/td><td>Dual-target mechanism + ultra-long half-life addresses unmet need in refractory AD and treatment burden<\/td><\/tr><tr><td><strong>Pricing Power<\/strong><\/td><td>Q3+ dosing supports premium positioning; cost-effectiveness vs. frequent injections<\/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>Competitor<\/th><th>Product<\/th><th>Mechanism<\/th><th>Dosing<\/th><th>SKB575\/HBM7575 Advantage<\/th><\/tr><\/thead><tbody><tr><td><strong>Amgen\/AZ<\/strong><\/td><td>Tezspire (tezepelumab)<\/td><td>TSLP mAb<\/td><td>Q4W (monthly)<\/td><td>Dual-target synergy; &gt;3-month interval<\/td><\/tr><tr><td><strong>Sanofi\/Regeneron<\/strong><\/td><td>Dupixent (dupilumab)<\/td><td>IL-4R\u03b1 blockade<\/td><td>Q2W<\/td><td>Mechanistic differentiation for non-responders<\/td><\/tr><tr><td><strong>Eli Lilly<\/strong><\/td><td>Ebglyss (lebrikizumab)<\/td><td>IL-13 mAb<\/td><td>Q2W\/Q4W<\/td><td>Longer dosing interval; dual-pathway inhibition<\/td><\/tr><tr><td><strong>Kelun\/Harbour<\/strong><\/td><td><strong>SKB575\/HBM7575<\/strong><\/td><td><strong>TSLP + undisclosed bsAb<\/strong><\/td><td><strong>Q3+ anticipated<\/strong><\/td><td><strong>Best-in-class convenience; resistance overcoming<\/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 I<\/strong><\/td><td>2026-2027<\/td><td>Safety, tolerability, PK\/PD; dose-ranging; half-life confirmation<\/td><\/tr><tr><td><strong>Phase II<\/strong><\/td><td>2027-2029<\/td><td>Efficacy in moderate-severe AD; biomarker stratification; combination potential<\/td><\/tr><tr><td><strong>Phase III<\/strong><\/td><td>2029-2031<\/td><td>Non-inferiority\/superiority vs. tezepelumab; China NDA; global expansion<\/td><\/tr><tr><td><strong>Global Strategy<\/strong><\/td><td>2028+<\/td><td>U.S.\/EU IND filing; Fast Track designation pursuit<\/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, half-life validation, and competitive positioning for SKB575\/HBM7575. Actual results may differ due to target disclosure timing, manufacturing scale-up, and competitive dynamics in the atopic dermatitis biologics 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\/2026030900305_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026030900305_c.\"><\/object><a id=\"wp-block-file--media-ad38ac3b-9d97-48bf-ab8f-ce5cd50a2776\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026030900305_c.pdf\">2026030900305_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026030900305_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-ad38ac3b-9d97-48bf-ab8f-ce5cd50a2776\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that SKB575\/HBM7575, a long-acting bispecific antibody (bsAb)&#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":[62,971,1832,28],"class_list":["post-59191","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-hkg-6990","tag-kelun-biotech-biopharmaceutical","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>Kelun-Biotech&#039;s SKB575\/HBM7575 Wins NMPA Approval \u2013 Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that SKB575\/HBM7575, a long-acting bispecific antibody (bsAb) targeting TSLP and an undisclosed second target, has received NMPA IND approval for the treatment of atopic dermatitis (AD). Co-developed with Harbour BioMed (HBM Holdings), the candidate features extended half-life engineering supporting dosing intervals exceeding three months, positioning it as a potential best-in-class therapy that overcomes resistance limitations of single-target TSLP antibodies through synergistic dual-target blockade.\" \/>\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=59191\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kelun-Biotech&#039;s SKB575\/HBM7575 Wins NMPA Approval \u2013 Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential\" \/>\n<meta property=\"og:description\" content=\"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that SKB575\/HBM7575, a long-acting bispecific antibody (bsAb) targeting TSLP and an undisclosed second target, has received NMPA IND approval for the treatment of atopic dermatitis (AD). 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Co-developed with Harbour BioMed (HBM Holdings), the candidate features extended half-life engineering supporting dosing intervals exceeding three months, positioning it as a potential best-in-class therapy that overcomes resistance limitations of single-target TSLP antibodies through synergistic dual-target blockade.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=59191#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=59191"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=59191#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Kelun-Biotech&#8217;s SKB575\/HBM7575 Wins NMPA Approval \u2013 Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential"}]},{"@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\/59191","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=59191"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59191\/revisions"}],"predecessor-version":[{"id":59193,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59191\/revisions\/59193"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=59191"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=59191"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=59191"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}