{"id":70108,"date":"2026-07-16T16:40:10","date_gmt":"2026-07-16T08:40:10","guid":{"rendered":"https:\/\/flcube.com\/?p=70108"},"modified":"2026-07-16T16:40:11","modified_gmt":"2026-07-16T08:40:11","slug":"harbour-biomed-and-kelun-biotech-secure-nmpa-ind-approval-for-hbm7575-skb575-long-acting-bispecific-antibody-for-asthma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=70108","title":{"rendered":"Harbour BioMed and Kelun-Biotech Secure NMPA IND Approval for HBM7575\/SKB575, Long-Acting Bispecific Antibody for Asthma"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Harbour BioMed<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2142:HKG\">HKG: 2142<\/a>) and <strong>Kelun-Biotech<\/strong> (<a href=\"HKG: 6990\">HKG: 6990<\/a>) announced today that the <strong>Investigational New Drug (IND)<\/strong> application for <strong>HBM7575\/SKB575<\/strong>\u2014a co-developed <strong>long-acting bispecific antibody<\/strong> targeting <strong>thymic stromal lymphopoietin (TSLP)<\/strong> and an undisclosed target\u2014has been approved by China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for the treatment of <strong>asthma<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone-key-details\" class=\"wp-block-heading\">Regulatory Milestone | Key Details<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Component<\/th><th>Specification<\/th><\/tr><\/thead><tbody><tr><td><strong>Companies<\/strong><\/td><td>Harbour BioMed (HKG: 2142) and Kelun-Biotech (HKG: 6990)<\/td><\/tr><tr><td><strong>Drug Candidate<\/strong><\/td><td>HBM7575\/SKB575<\/td><\/tr><tr><td><strong>Regulatory Authority<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>IND approval<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Asthma<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>July 15, 2026<\/td><\/tr><tr><td><strong>Development Stage<\/strong><\/td><td>Phase I (asthma indication)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<h3 id=\"h-molecular-characteristics\" class=\"wp-block-heading\">Molecular Characteristics<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> Long-acting bispecific antibody<\/li>\n\n\n\n<li><strong>Primary Target:<\/strong> Thymic stromal lymphopoietin (TSLP)<\/li>\n\n\n\n<li><strong>Secondary Target:<\/strong> Undisclosed (confidential competitive advantage)<\/li>\n\n\n\n<li><strong>Administration:<\/strong> Subcutaneous injection<\/li>\n\n\n\n<li><strong>Dosing Interval:<\/strong> Expected to exceed three months based on preclinical half-life data<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-therapeutic-innovation\" class=\"wp-block-heading\">Therapeutic Innovation<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">HBM7575\/SKB575 represents a next-generation approach to asthma management:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Dual Targeting:<\/strong> Simultaneous inhibition of TSLP and secondary pathway<\/li>\n\n\n\n<li><strong>Extended Duration:<\/strong> Potential for quarterly or less frequent dosing<\/li>\n\n\n\n<li><strong>Convenience:<\/strong> Subcutaneous administration suitable for outpatient settings<\/li>\n\n\n\n<li><strong>Best-in-Class Potential:<\/strong> Superior half-life profile compared to existing biologics<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-clinical-development-status\" class=\"wp-block-heading\">Clinical Development Status<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Atopic Dermatitis:<\/strong> Phase I trial successfully completed first subject dosing<\/li>\n\n\n\n<li><strong>Asthma:<\/strong> IND approval enables Phase I initiation in China<\/li>\n\n\n\n<li><strong>Half-Life Data:<\/strong> Preclinical studies support >3-month dosing intervals in humans<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-strategic-collaboration-framework\" class=\"wp-block-heading\">Strategic Collaboration Framework<\/h2>\n\n\n\n<h3 id=\"h-partnership-structure\" class=\"wp-block-heading\">Partnership Structure<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The collaboration between Harbour BioMed and Kelun-Biotech leverages complementary strengths:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Company<\/th><th>Role<\/th><\/tr><\/thead><tbody><tr><td><strong>Kelun-Biotech<\/strong><\/td><td>Leading design, global development, and commercialization<\/td><\/tr><tr><td><strong>Harbour BioMed<\/strong><\/td><td>Co-investing and co-developing the project<\/td><\/tr><tr><td><strong>Both Parties<\/strong><\/td><td>Sharing profits as agreed in collaboration agreement<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 id=\"h-strategic-rationale\" class=\"wp-block-heading\">Strategic Rationale<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Kelun-Biotech:<\/strong> Expands biologics pipeline beyond oncology into respiratory diseases<\/li>\n\n\n\n<li><strong>Harbour BioMed:<\/strong> Leverages proprietary bispecific antibody platforms for new indications<\/li>\n\n\n\n<li><strong>Synergy:<\/strong> Combines Harbour&#8217;s discovery expertise with Kelun&#8217;s development and commercial capabilities<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-opportunity-amp-competitive-landscape\" class=\"wp-block-heading\">Market Opportunity &amp; Competitive Landscape<\/h2>\n\n\n\n<h3 id=\"h-asthma-therapeutics-market\" class=\"wp-block-heading\">Asthma Therapeutics Market<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Prevalence:<\/strong> Affects over <strong>300 million people globally<\/strong><\/li>\n\n\n\n<li><strong>Severe Asthma:<\/strong> Represents 5-10% of total asthma cases but drives significant healthcare costs<\/li>\n\n\n\n<li><strong>Biologics Market:<\/strong> Current anti-TSLP (tezepelumab), anti-IL5\/5R, anti-IgE, and anti-IL4R therapies<\/li>\n\n\n\n<li><strong>Market Size:<\/strong> Global severe asthma biologics market projected to reach <strong>$15+ billion by 2030<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-competitive-differentiation\" class=\"wp-block-heading\">Competitive Differentiation<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">HBM7575\/SKB575&#8217;s unique positioning includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Bispecific Advantage:<\/strong> Dual targeting may provide superior efficacy vs. single-target biologics<\/li>\n\n\n\n<li><strong>Dosing Convenience:<\/strong> >3-month intervals vs. monthly or bi-weekly dosing of current biologics<\/li>\n\n\n\n<li><strong>Patient Compliance:<\/strong> Reduced injection frequency improves long-term adherence<\/li>\n\n\n\n<li><strong>Cost-Effectiveness:<\/strong> Less frequent administration reduces healthcare resource utilization<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-tslp-target-validation\" class=\"wp-block-heading\">TSLP Target Validation<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Thymic stromal lymphopoietin represents a <strong>validated upstream target<\/strong> in asthma pathogenesis:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Upstream Cytokine:<\/strong> TSLP initiates inflammatory cascade affecting multiple downstream pathways<\/li>\n\n\n\n<li><strong>Broad Applicability:<\/strong> Effective across different asthma phenotypes regardless of eosinophil levels<\/li>\n\n\n\n<li><strong>Clinical Proof:<\/strong> Tezepelumab (anti-TSLP) demonstrated efficacy in broad asthma population<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The undisclosed second target provides potential for <strong>enhanced efficacy or safety<\/strong> beyond TSLP inhibition alone.<\/p>\n\n\n\n<h2 id=\"h-development-outlook-amp-commercial-potential\" class=\"wp-block-heading\">Development Outlook &amp; Commercial Potential<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The successful completion of first subject dosing in atopic dermatitis provides <strong>early clinical validation<\/strong> of the molecule&#8217;s safety profile, de-risking the asthma development program. The extended half-life profile positions HBM7575\/SKB575 to potentially become a <strong>best-in-class therapy<\/strong> with significant commercial advantages:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Premium Pricing:<\/strong> Extended dosing intervals support higher per-dose pricing<\/li>\n\n\n\n<li><strong>Market Share Capture:<\/strong> Convenience factor attracts patients from more frequently dosed competitors<\/li>\n\n\n\n<li><strong>Global Expansion:<\/strong> Strong intellectual property position supports international development<\/li>\n\n\n\n<li><strong>Indication Expansion:<\/strong> Potential for other TSLP-mediated diseases (chronic rhinosinusitis, COPD)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The partnership structure enables both companies to share development risks while maintaining significant commercial upside in one of the most valuable specialty pharmaceutical markets.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development, regulatory approvals, and market opportunities. Actual results may differ due to risks including clinical trial outcomes, regulatory decisions, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Harbour BioMed (HKG: 2142) and Kelun-Biotech (HKG: 6990) announced today that the Investigational New Drug&#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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[62,190,916,971,1832],"class_list":["post-70108","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-harbour-biomed","tag-hkg-2142","tag-hkg-6990","tag-kelun-biotech-biopharmaceutical"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Harbour BioMed and Kelun-Biotech Secure NMPA IND Approval for HBM7575\/SKB575, Long-Acting Bispecific Antibody for Asthma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Harbour BioMed (HKG: 2142) and Kelun-Biotech (HKG: 6990) announced today that the Investigational New Drug (IND) application for HBM7575\/SKB575\u2014a co-developed long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed target\u2014has been approved by China&#039;s National Medical Products Administration (NMPA) for the treatment of asthma.\" \/>\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=70108\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Harbour BioMed and Kelun-Biotech Secure NMPA IND Approval for HBM7575\/SKB575, Long-Acting Bispecific Antibody for Asthma\" \/>\n<meta property=\"og:description\" content=\"Harbour BioMed (HKG: 2142) and Kelun-Biotech (HKG: 6990) announced today that the Investigational New Drug (IND) application for HBM7575\/SKB575\u2014a co-developed long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed target\u2014has been approved by China&#039;s National Medical Products Administration (NMPA) for the treatment of asthma.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=70108\" \/>\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=\"2026-07-16T08:40:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-16T08:40:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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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