{"id":52164,"date":"2025-12-29T14:00:54","date_gmt":"2025-12-29T06:00:54","guid":{"rendered":"https:\/\/flcube.com\/?p=52164"},"modified":"2025-12-29T14:00:54","modified_gmt":"2025-12-29T06:00:54","slug":"sino-biopharmaceuticals-tqh3906-achieves-90-pasi-75-response-in-phase-2-psoriasis-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52164","title":{"rendered":"Sino Biopharmaceutical&#8217;s TQH3906 Achieves 90% PASI 75 Response in Phase 2 Psoriasis Trial"},"content":{"rendered":"\n<p><strong>Sino Biopharmaceutical Limited<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/1177:HKG\">HKG: 1177<\/a>) announced that <strong>TQH3906<\/strong>, a <strong>Category\u202f1 innovative oral TYK2\/JAK1 inhibitor<\/strong>, has completed its <strong>Phase\u202f2 clinical trial<\/strong> for <strong>moderate\u2011to\u2011severe plaque psoriasis (PsO)<\/strong>, demonstrating a <strong>>90% PASI\u202f75 response rate<\/strong> and a <strong>>70% PASI\u202f90 response rate<\/strong> at the anticipated recommended Phase\u202f2 dose (RP2D) with a favorable safety profile.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-milestone\">Clinical 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>Product<\/strong><\/td><td>TQH3906 (oral TYK2\/JAK1 JH2 allosteric inhibitor)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Sino Biopharmaceutical (independently developed)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Moderate\u2011to\u2011severe plaque psoriasis<\/td><\/tr><tr><td><strong>Study<\/strong><\/td><td>Phase\u202f2 (NCT06542614) \u2013 randomized, double\u2011blind, placebo\u2011controlled<\/td><\/tr><tr><td><strong>Enrollment<\/strong><\/td><td>209 patients (placebo + 5 dose groups)<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>PASI\u202f75 and PASI\u202f90 response rates at Week\u202f12<\/td><\/tr><tr><td><strong>Key Result (RP2D)<\/strong><\/td><td>PASI\u202f75\u202f&gt;\u202f90%, PASI\u202f90\u202f&gt;\u202f70%<\/td><\/tr><tr><td><strong>Safety<\/strong><\/td><td>Good tolerability across all dose groups; dose\u2011response plateau achieved<\/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<ul class=\"wp-block-list\">\n<li><strong>Mechanism of Action<\/strong>: Selective allosteric inhibitor of <strong>TYK2 and JAK1<\/strong> Janus kinase homology\u202f2 (JH2) domains; modulates IL\u201123\/Th17 and IFN\/IL\u20116 pathways central to psoriasis pathogenesis<\/li>\n\n\n\n<li><strong>Administration<\/strong>: <strong>Oral, once\u2011daily<\/strong> dosing; eliminates injection burden associated with biologics<\/li>\n\n\n\n<li><strong>Differentiation<\/strong>:<\/li>\n\n\n\n<li><strong>Convenience<\/strong>: Self\u2011administered vs. clinic\u2011based injections<\/li>\n\n\n\n<li><strong>Compliance<\/strong>: Expected improvement in real\u2011world persistence rates (projected 75\u201180% vs. 60\u201165% for biologics)<\/li>\n\n\n\n<li><strong>Tolerability<\/strong>: No Grade\u202f\u2265\u202f3 lab abnormalities observed; mild GI events in &lt;10% of patients<\/li>\n\n\n\n<li><strong>Cost Structure<\/strong>: Small\u2011 molecule synthesis offers potential pricing advantage over monoclonal antibodies<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-nct06542614\">Clinical Evidence \u2013 NCT06542614<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Placebo (n\u224842)<\/th><th>TQH3906 RP2D (n\u224842)<\/th><th>Clinical Significance<\/th><\/tr><\/thead><tbody><tr><td><strong>PASI\u202f75 Response (Week\u202f12)<\/strong><\/td><td>&lt;5%<\/td><td><strong>&gt;90%<\/strong><\/td><td>Approaches efficacy of anti\u2011IL\u201117 biologics<\/td><\/tr><tr><td><strong>PASI\u202f90 Response (Week\u202f12)<\/strong><\/td><td>&lt;2%<\/td><td><strong>&gt;70%<\/strong><\/td><td>Deep skin clearance<\/td><\/tr><tr><td><strong>PASI\u202f100 Response (Week\u202f12)<\/strong><\/td><td>0%<\/td><td><strong>~40% (estimated)<\/strong><\/td><td>Complete skin clearance<\/td><\/tr><tr><td><strong>Safety Discontinuations<\/strong><\/td><td>3%<\/td><td>2%<\/td><td>Comparable tolerability<\/td><\/tr><tr><td><strong>Most Common TEAEs<\/strong><\/td><td>Headache, nasopharyngitis<\/td><td>Mild GI upset, headache<\/td><td>Manageable safety profile<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><em>Dose\u2011Response: Favorable relationship observed across 5 dose cohorts; plateau achieved at RP2D, supporting once\u2011daily dosing without titration.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-financial-outlook\">Market Opportunity &amp; Financial Outlook<\/h2>\n\n\n\n<p>China\u2019s <strong>psoriasis prevalence<\/strong> exceeds <strong>6\u20118\u202fmillion patients<\/strong>, with <strong>~2.5\u202fmillion<\/strong> classified as moderate\u2011to\u2011severe and eligible for systemic therapy.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2026E<\/th><th>2028E<\/th><th>2030E<\/th><\/tr><\/thead><tbody><tr><td><strong>Moderate\u2011to\u2011severe PsO patients<\/strong><\/td><td>2.6\u202fmillion<\/td><td>2.8\u202fmillion<\/td><td>3.0\u202fmillion<\/td><\/tr><tr><td><strong>Oral small\u2011molecule penetration<\/strong><\/td><td>5%<\/td><td>15%<\/td><td>25%<\/td><\/tr><tr><td><strong>TQH3906 peak market share<\/strong><\/td><td>\u2013<\/td><td>8%<\/td><td>18%<\/td><\/tr><tr><td><strong>Annual therapy cost (\u00a5)<\/strong><\/td><td>\u2013<\/td><td>\u00a535,000<\/td><td>\u00a528,000 (post\u2011NRDL)<\/td><\/tr><tr><td><strong>Estimated peak sales<\/strong><\/td><td>\u2013<\/td><td>\u00a5620\u202fmillion<\/td><td>\u00a51.51\u202fbillion (US$85\u2011210\u202fmillion)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Development Timeline<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase\u202f3 Initiation<\/strong>: H2\u202f2026 (expected)<\/li>\n\n\n\n<li><strong>NDA Filing<\/strong>: 2028<\/li>\n\n\n\n<li><strong>NMPA Approval<\/strong>: 2029 (potential for breakthrough therapy designation)<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Drug Class<\/th><th>Key Players (China)<\/th><th>Administration<\/th><th>PASI\u202f75 Range<\/th><th>Annual Cost (\u00a5)<\/th><\/tr><\/thead><tbody><tr><td><strong>Anti\u2011IL\u201117<\/strong><\/td><td>Novartis Cosentyx, Livzon Lizhengxua<\/td><td>Injection<\/td><td>85\u201190%<\/td><td>\u00a560,000\u201180,000<\/td><\/tr><tr><td><strong>Anti\u2011IL\u201123<\/strong><\/td><td>Janssen Tremfya, AbbVie Skyrizi<\/td><td>Injection<\/td><td>85\u201190%<\/td><td>\u00a570,000\u201190,000<\/td><\/tr><tr><td><strong>JAK Inhibitors<\/strong><\/td><td>Pfizer Xeljanz (tofacitinib)<\/td><td>Oral<\/td><td>60\u201170%<\/td><td>\u00a525,000\u201135,000<\/td><\/tr><tr><td><strong>TYK2\/JAK1 (TQH3906)<\/strong><\/td><td><strong>Sino Biopharmaceutical<\/strong><\/td><td><strong>Oral<\/strong><\/td><td><strong>&gt;90%<\/strong><\/td><td><strong>\u00a528,000\u201135,000<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Competitive Edge<\/strong>: TQH3906\u2019s <strong>efficacy matching biologics<\/strong> with <strong>oral convenience<\/strong> and <strong>cost parity with existing JAK inhibitors<\/strong> creates a compelling value proposition for both patients and payers.<\/p>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements concerning TQH3906\u2019s clinical development timelines, regulatory pathway, market penetration, and revenue forecasts. Actual results may differ materially due to competitive dynamics, pricing negotiations, and unforeseen safety signals in Phase\u202f3 trials.<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\/2025\/12\/2025122900048_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025122900048_c.\"><\/object><a id=\"wp-block-file--media-013d38e7-c2ae-463f-8735-56599791da97\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/2025122900048_c.pdf\">2025122900048_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/2025122900048_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-013d38e7-c2ae-463f-8735-56599791da97\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Sino Biopharmaceutical Limited (HKG: 1177) announced that TQH3906, a Category\u202f1 innovative oral TYK2\/JAK1 inhibitor, has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":52167,"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],"class_list":["post-52164","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-results","tag-hkg-1177","tag-sino-biopharmaceutical"],"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 Biopharmaceutical&#039;s TQH3906 Achieves 90% PASI 75 Response in Phase 2 Psoriasis Trial - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sino Biopharmaceutical Limited (HKG: 1177) announced that TQH3906, a Category\u202f1 innovative oral TYK2\/JAK1 inhibitor, has completed its Phase\u202f2 clinical trial for moderate\u2011to\u2011severe plaque psoriasis (PsO), demonstrating a &gt;90% PASI\u202f75 response rate and a &gt;70% PASI\u202f90 response rate at the anticipated recommended Phase\u202f2 dose (RP2D) with a favorable safety profile.\" \/>\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=52164\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sino Biopharmaceutical&#039;s TQH3906 Achieves 90% PASI 75 Response in Phase 2 Psoriasis Trial\" \/>\n<meta property=\"og:description\" content=\"Sino Biopharmaceutical Limited (HKG: 1177) announced that TQH3906, a Category\u202f1 innovative oral TYK2\/JAK1 inhibitor, has completed its Phase\u202f2 clinical trial for moderate\u2011to\u2011severe plaque psoriasis (PsO), demonstrating a &gt;90% PASI\u202f75 response rate and a &gt;70% PASI\u202f90 response rate at the anticipated recommended Phase\u202f2 dose (RP2D) with a favorable safety profile.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=52164\" \/>\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=\"2025-12-29T06:00:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/2903.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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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