{"id":46296,"date":"2025-11-11T11:30:49","date_gmt":"2025-11-11T03:30:49","guid":{"rendered":"https:\/\/flcube.com\/?p=46296"},"modified":"2025-11-11T11:30:49","modified_gmt":"2025-11-11T03:30:49","slug":"innovent-biologics-sanegene-bio-usa-report-first%e2%80%91in%e2%80%91human-success-for-ibi3016-sirna-hypertension-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=46296","title":{"rendered":"Innovent Biologics &amp; Sanegene Bio USA Report First\u2011in\u2011Human Success for IBI3016 siRNA Hypertension Therapy"},"content":{"rendered":"\n<p><strong>Innovent Biologics, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/1801:HKG\">HKG: 1801<\/a>) and <strong>Sanegene Bio USA Inc.<\/strong> announced today the <strong>first\u2011in\u2011human (FIH) Phase\u202fI data<\/strong> for <strong>IBI3016<\/strong> (Sanegene R&amp;D code:\u202fSGB\u20113908), a <strong>small\u2011interfering RNA (siRNA) drug that targets angiotensinogen (AGT)<\/strong>. The results were presented at the <strong>digital poster session of the 2025 American Heart Association (AHA) Scientific Sessions<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-study-design-amp-key-endpoints\">Study Design &amp; Key Endpoints<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Study Type<\/strong><\/td><td>Single\u2011ascending\u2011dose, open\u2011label Phase\u202fI<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>Healthy volunteers (n\u202f=\u202f48)<\/td><\/tr><tr><td><strong>Dose Levels<\/strong><\/td><td>0.5\u202fmg, 1\u202fmg, 2\u202fmg, 4\u202fmg sub\u2011cutaneous (GalNAc\u2011mediated)<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Safety &amp; tolerability (6\u2011month follow\u2011up)<\/td><\/tr><tr><td><strong>Secondary Endpoints<\/strong><\/td><td>Serum AGT reduction, systolic\/diastolic BP change<\/td><\/tr><tr><td><strong>Presentation<\/strong><\/td><td>AHA 2025 Digital Poster Session (Nov\u202f10)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-efficacy-highlights\">Efficacy Highlights<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Serum AGT:<\/strong> Single dose produced <strong>>\u202f95\u202f% maximal reduction<\/strong> in circulating AGT, sustained <strong>up to 6\u202fmonths<\/strong> post\u2011dose.<\/li>\n\n\n\n<li><strong>Blood Pressure:<\/strong> All dose cohorts showed <strong>significant systolic\/diastolic reductions<\/strong> at the 3\u2011month mark, with the greatest effect observed in the 4\u202fmg group (average SBP \u2193\u202f\u201112\u202fmmHg, DBP \u2193\u202f\u20117\u202fmmHg).<\/li>\n\n\n\n<li><strong>Durability:<\/strong> The AGT knock\u2011down plateau persisted without additional dosing, indicating a <strong>potential once\u2011yearly regimen<\/strong>.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-safety-profile\">Safety Profile<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Observation<\/th><th>Outcome<\/th><\/tr><\/thead><tbody><tr><td><strong>Severe AEs \/ SAEs<\/strong><\/td><td>None reported over 6\u202fmonths<\/td><\/tr><tr><td><strong>Hypotensive Events<\/strong><\/td><td>Zero incidents<\/td><\/tr><tr><td><strong>Overall AE Severity<\/strong><\/td><td>Mild\u2011to\u2011moderate, reversible (e.g., injection\u2011site erythema, transient headache)<\/td><\/tr><tr><td><strong>Discontinuations<\/strong><\/td><td>None<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-amp-strategic-implications\">Technology &amp; Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Delivery Platform:<\/strong> Utilises <strong>Sanegene Bio\u2019s proprietary GalNAc liver\u2011targeting conjugate<\/strong>, enabling high\u2011efficiency hepatocyte uptake and potent RNAi activity.<\/li>\n\n\n\n<li><strong>Mechanistic Rationale:<\/strong> By silencing hepatic <strong>AGT<\/strong>, IBI3016 reduces the substrate for <strong>angiotensin\u2011II (Ang\u202fII)<\/strong> generation, delivering <strong>vasodilation and sustained BP lowering<\/strong> without the need for chronic daily dosing.<\/li>\n\n\n\n<li><strong>Market Opportunity:<\/strong> Hypertension affects <strong>\u2248\u202f1.13\u202fbillion<\/strong> adults worldwide. A <strong>once\u2011yearly siRNA therapy<\/strong> could capture a sizable share of the <strong>$200\u202fbillion<\/strong> antihypertensive market, especially among patients non\u2011responsive to ACE inhibitors or ARBs.<\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> A <strong>Phase\u202fIIb dose\u2011ranging study<\/strong> is slated for Q2\u202f2026 in patients with stage\u202f2 hypertension, followed by a <strong>global Phase\u202fIII program<\/strong> targeting both monotherapy and combination\u2011therapy indications.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the development timeline, regulatory expectations, and commercial potential of IBI3016. Actual results may differ due to risks including clinical trial outcomes, regulatory approvals, and market acceptance.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Innovent Biologics, Inc. (HKG: 1801) and Sanegene Bio USA Inc. announced today the first\u2011in\u2011human (FIH)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":46298,"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":[106,17,108,910,198,64,546],"class_list":["post-46296","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-academic-conference","tag-clinical-trial-results","tag-high-blood-pressure","tag-hkg-1801","tag-innovent-biologics","tag-rnai-aso","tag-sanegene-bio"],"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>Innovent Biologics &amp; Sanegene Bio USA Report First\u2011in\u2011Human Success for IBI3016 siRNA Hypertension Therapy - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Innovent Biologics, Inc. 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(HKG: 1801) and Sanegene Bio USA Inc. announced today the first\u2011in\u2011human (FIH) Phase\u202fI data for IBI3016 (Sanegene R&amp;D code:\u202fSGB\u20113908), a small\u2011interfering RNA (siRNA) drug that targets angiotensinogen (AGT). 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