{"id":48335,"date":"2025-11-15T22:52:05","date_gmt":"2025-11-15T14:52:05","guid":{"rendered":"https:\/\/flcube.com\/?p=48335"},"modified":"2025-11-15T22:52:06","modified_gmt":"2025-11-15T14:52:06","slug":"qyuns-therapeutics-receives-nmpa-trial-approvals-for-qx027n-long%e2%80%91acting-bispecific-antibody-targeting-asthma-and-atopic-dermatitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48335","title":{"rendered":"Qyuns Therapeutics Receives NMPA Trial Approvals for QX027N \u2013 Long\u2011Acting Bispecific Antibody Targeting Asthma and Atopic Dermatitis"},"content":{"rendered":"\n<p><strong>Qyuns Therapeutics Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2509:HKG\">HKG: 2509<\/a>) announced that China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has granted <strong>two clinical\u2011trial approvals<\/strong> (Acceptance Nos.: CXSL2500757 &amp; CXSL2500758) for its first\u2011in\u2011class, long\u2011acting bispecific antibody injection <strong>QX027N<\/strong>. The drug is slated for the treatment of <strong>asthma<\/strong> and <strong>atopic dermatitis<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-highlights\">Regulatory Highlights<\/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>Qyuns\u202fTherapeutics\u202fCo.,\u202fLtd. (HKG: 2509)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>National Medical Products Administration (NMPA)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Clinical\u2011trial authorization (Phase\u202fI\/II)<\/td><\/tr><tr><td><strong>Acceptance Nos.<\/strong><\/td><td>CXSL2500757, CXSL2500758<\/td><\/tr><tr><td><strong>Therapeutic Indications<\/strong><\/td><td>Asthma &amp; Atopic Dermatitis (autoimmune\u2011allergy)<\/td><\/tr><tr><td><strong>Date Granted<\/strong><\/td><td>14\u202fNov\u202f2025<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-qx027n-product-snapshot\">QX027N \u2013 Product Snapshot<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Format<\/strong>: Long\u2011acting bispecific antibody (humanized IgG1\u2011based).<\/li>\n\n\n\n<li><strong>Mechanism<\/strong>: Simultaneous engagement of <em>IL\u201113<\/em> and <em>IL\u20114R\u03b1<\/em> to block key Th2\u2011driven pathways in airway and skin inflammation.<\/li>\n\n\n\n<li><strong>Pre\u2011clinical Data<\/strong>: Superior suppression of eosinophilic inflammation in rodent asthma models and durable skin barrier healing in atopic dermatitis models.<\/li>\n\n\n\n<li><strong>Development Pathway<\/strong>: Expected to progress to Phase\u202fIIA in late 2026, contingent upon safety and PK data.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-company-profile-amp-recent-funding\">Company Profile &amp; Recent Funding<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Founded<\/strong>: 2015; focus on <strong>biological therapies<\/strong> for autoimmune and allergic disorders.<\/li>\n\n\n\n<li><strong>Capital Raise<\/strong>: August\u202f2025 \u2013 5\u202fmillion shares sold to <strong>TruMed Health Innovation Fund LP<\/strong>, raising <strong>HKD\u202f100\u202fmillion<\/strong> (\u2248\u202fUS$13\u202fmillion).<\/li>\n\n\n\n<li><strong>Use of Proceeds<\/strong>: R&amp;D for QX027N and expansion of the broader immunology pipeline, including a next\u2011generation IL\u201131 blocker.<\/li>\n\n\n\n<li><strong>Strategy<\/strong>: Leverage the bispecific platform to gain advantages in efficacy and dosing convenience, aiming for a <strong>first\u2011in\u2011class<\/strong> market entrance.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-implications\">Market Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Asthma &amp; Atopic Dermatitis Landscape<\/strong>: 35\u202fmillion asthmatics and 20\u202fmillion atopic dermatitis patients globally; short\u2011acting biologics dominate, leaving a gap for long\u2011acting, dual\u2011target agents.<\/li>\n\n\n\n<li><strong>Competitive Edge<\/strong>: QX027N\u2019s bispecific design may reduce frequent dosing and improve patient adherence compared with existing monoclonal antibodies.<\/li>\n\n\n\n<li><strong>Potential Revenue<\/strong>: If approved, QX027N could generate <strong>HK$5\u20138\u202fbillion<\/strong> (USD\u202f$650\u2013$1\u202fbillion) in 2028\u20112030, assuming a 1\u20132\u202f% market share in Hong\u00a0Kong and 0.5\u202f% in China.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief includes forward\u2011looking statements regarding regulatory approvals, clinical development, funding impact and commercial prospects. Results may differ due to market, regulatory, and operational risks.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Qyuns Therapeutics Co., Ltd. (HKG: 2509) announced that China\u2019s National Medical Products Administration (NMPA) has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48336,"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":[65,62,1239,495],"class_list":["post-48335","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-auto-immune","tag-clinical-trial-approval-initiation","tag-hkg-2509","tag-qyuns-therapeutics"],"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>Qyuns Therapeutics Receives NMPA Trial Approvals for QX027N \u2013 Long\u2011Acting Bispecific Antibody Targeting Asthma and Atopic Dermatitis - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Qyuns Therapeutics Co., Ltd. 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(HKG: 2509) announced that China\u2019s National Medical Products Administration (NMPA) has granted two clinical\u2011trial approvals (Acceptance Nos.: CXSL2500757 &amp; CXSL2500758) for its first\u2011in\u2011class, long\u2011acting bispecific antibody injection QX027N. 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(HKG: 2509) announced that China\u2019s National Medical Products Administration (NMPA) has granted two clinical\u2011trial approvals (Acceptance Nos.: CXSL2500757 & CXSL2500758) for its first\u2011in\u2011class, long\u2011acting bispecific antibody injection QX027N. The drug is slated for the treatment of asthma and atopic dermatitis.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=48335#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=48335"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=48335#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1502.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1502.webp","width":1080,"height":608,"caption":"Qyuns Therapeutics Receives NMPA Trial Approvals for QX027N \u2013 Long\u2011Acting Bispecific Antibody Targeting Asthma and Atopic Dermatitis"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=48335#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Qyuns Therapeutics Receives NMPA Trial Approvals for QX027N \u2013 Long\u2011Acting Bispecific Antibody Targeting Asthma and Atopic Dermatitis"}]},{"@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\/1502.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48335","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=48335"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48335\/revisions"}],"predecessor-version":[{"id":48337,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/48335\/revisions\/48337"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/48336"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=48335"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=48335"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=48335"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}