{"id":55735,"date":"2026-01-28T22:12:51","date_gmt":"2026-01-28T14:12:51","guid":{"rendered":"https:\/\/flcube.com\/?p=55735"},"modified":"2026-01-28T22:12:52","modified_gmt":"2026-01-28T14:12:52","slug":"sino-biopharms-tqa3605-meets-endpoint-in-hepatitis-b-phase-ii-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=55735","title":{"rendered":"Sino Biopharm&#8217;s TQA3605 Meets Endpoint in Hepatitis B Phase II Trial"},"content":{"rendered":"\n<p><strong>Sino Biopharmaceutical Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/1177:HKG\">HKG: 1177<\/a>) announced that its <strong>Category\u202f1 drug TQA3605<\/strong> has met the primary endpoint in a <strong>Phase\u202fII study<\/strong> for patients with chronic hepatitis\u202fB virus (HBV) infection. The HBV core protein allosteric modulator (CpAM) demonstrated <strong>~90% viral suppression<\/strong> when combined with nucleos(t)ide analogues (NAs), with no similar product approved globally.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-trial-results-amp-regulatory-status\">Clinical Trial Results &amp; Regulatory Status<\/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>Sino Biopharmaceutical Ltd (HKEX.01177)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>TQA3605 (HBV core protein allosteric modulator)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Chronic hepatitis\u202fB virus (HBV) infection<\/td><\/tr><tr><td><strong>Trial<\/strong><\/td><td>Phase\u202fII, Category\u202f1 drug<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Inhibits multiple HBV genotypes, no cross\u2011resistance with NAs<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>HBV DNA &lt;20\u202fIU\/mL at 24 weeks<\/td><\/tr><tr><td><strong>Efficacy<\/strong><\/td><td>~90% response rate (all dose groups) vs. control (p\u202f&lt;\u202f0.0001)<\/td><\/tr><tr><td><strong>Safety<\/strong><\/td><td>Favorable profile, adverse reaction rate comparable to control<\/td><\/tr><tr><td><strong>Strategic Significance<\/strong><\/td><td>No approved CpAM worldwide; first\u2011in\u2011class potential<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-competitive-advantage\">Drug Profile &amp; Competitive Advantage<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> TQA3605 targets HBV core protein, disrupting viral capsid assembly and preventing viral replication across multiple genotypes<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> <strong>No cross\u2011resistance<\/strong> with existing nucleos(t)ide analogues, enabling combination therapy for patients with residual viremia despite NA treatment<\/li>\n\n\n\n<li><strong>Patient Population:<\/strong> Adult chronic HBV patients who received NA therapy for \u226512 months with low\u2011level viremia<\/li>\n\n\n\n<li><strong>Unmet Need:<\/strong> <strong>~300\u202fmillion<\/strong> chronic HBV patients globally, with <strong>30\u201350%<\/strong> experiencing incomplete viral suppression on NA monotherapy<\/li>\n\n\n\n<li><strong>Global Landscape:<\/strong> First CpAM to demonstrate robust efficacy; positions Sino Biopharm ahead of Roche, Johnson &amp; Johnson, and Assembly Biosciences in HBV functional cure race<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-commercial-outlook\">Market Impact &amp; Commercial Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China HBV Market:<\/strong> Valued at <strong>\u00a520\u202fbillion<\/strong> : (~US$2.8\u202fbillion) in 2025, growing at <strong>8% CAGR<\/strong> driven by screening programs and treatment expansion<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Analysts project <strong>\u00a53\u20135\u202fbillion<\/strong> (US$420\u2013700\u202fmillion) peak annual sales if approved, based on first\u2011mover advantage and combination therapy positioning<\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> Phase\u202fII success validates platform for HBV functional cure; may attract global partnership interest<\/li>\n\n\n\n<li><strong>Regulatory Pathway:<\/strong> Category\u202f1 status enables priority review; NDA submission targeted for <strong>2027<\/strong><\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> Phase\u202fIII trial design discussions with NMPA; global development strategy under evaluation<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for TQA3605. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.<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\/2026012700528_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026012700528_c.\"><\/object><a id=\"wp-block-file--media-e57c5b02-9f49-468c-b896-6d5c87510ffe\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/2026012700528_c.pdf\">2026012700528_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/2026012700528_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-e57c5b02-9f49-468c-b896-6d5c87510ffe\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Category\u202f1 drug TQA3605 has met the primary&#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":[17,908,313,89],"class_list":["post-55735","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-results","tag-hkg-1177","tag-sino-biopharmaceutical","tag-viral-hepatitis"],"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>Sino Biopharm&#039;s TQA3605 Meets Endpoint in Hepatitis B Phase II Trial - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Category\u202f1 drug TQA3605 has met the primary endpoint in a Phase\u202fII study for patients with chronic hepatitis\u202fB virus (HBV) infection. 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