{"id":48450,"date":"2025-11-17T15:06:16","date_gmt":"2025-11-17T07:06:16","guid":{"rendered":"https:\/\/flcube.com\/?p=48450"},"modified":"2025-11-17T15:06:17","modified_gmt":"2025-11-17T07:06:17","slug":"pegbios-pb%e2%80%91119-paidakang-wins-nmpa-approval-for-type-2-diabetes-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48450","title":{"rendered":"PegBio\u2019s PB\u2011119 (Paidakang) Wins NMPA Approval for Type\u202f2 Diabetes Treatment"},"content":{"rendered":"\n<p><strong>PegBio Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2565:HKG\">HKG: 2565<\/a>) announced that its next\u2011generation GLP\u20111 receptor agonist <strong>PB\u2011119<\/strong>, marketed under the brand name <strong>Paidakang<\/strong>, has received <strong>full approval from the China National Medical Products Administration (NMPA)<\/strong> for use in patients with <strong>type\u202f2 diabetes mellitus (T2DM)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-pb-119\">What Is PB\u2011119?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule class<\/strong>: Long\u2011acting glucagon\u2011like peptide\u20111 (GLP\u20111) receptor agonist.<\/li>\n\n\n\n<li><strong>Dosing<\/strong>: Once\u2011weekly subcutaneous injection.<\/li>\n\n\n\n<li><strong>Technology<\/strong>: <strong>Site\u2011specific PEGylation<\/strong> that extends plasma half\u2011life, reduces immunogenicity and mitigates gastrointestinal adverse events.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-profile\">Clinical Profile<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>End\u2011point<\/th><th>Outcome (PB\u2011119)<\/th><th>Clinical significance<\/th><\/tr><\/thead><tbody><tr><td><strong>HbA1c reduction<\/strong><\/td><td>\u22121.2\u202f% vs. baseline<\/td><td>Meets ADA target for glycaemic control<\/td><\/tr><tr><td><strong>\u03b2\u2011cell function<\/strong> (HOMA\u2011\u03b2)<\/td><td>\u2191\u202f22\u202f%<\/td><td>Improves insulin secretory capacity<\/td><\/tr><tr><td><strong>Weight change<\/strong><\/td><td>\u22123.4\u202fkg (average)<\/td><td>Supports obesity management in T2DM<\/td><\/tr><tr><td><strong>Blood pressure<\/strong><\/td><td>\u2193\u202f5\u202fmmHg systolic<\/td><td>Cardiovascular risk reduction<\/td><\/tr><tr><td><strong>Lipid profile<\/strong><\/td><td>\u2193\u202f12\u202f% LDL\u2011C, \u2191\u202f8\u202f% HDL\u2011C<\/td><td>Improves dyslipidaemia<\/td><\/tr><tr><td><strong>GI tolerability<\/strong><\/td><td>&lt;\u202f5\u202f% discontinuation (nausea\/vomiting)<\/td><td>Better patient adherence than first\u2011generation GLP\u20111 agents<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact\">Market Impact<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Unmet need<\/strong> \u2013 Over <strong>140\u202fmillion<\/strong> Chinese adults are living with T2DM; current GLP\u20111 options are limited by injection frequency and GI side\u2011effects.<\/li>\n\n\n\n<li><strong>Revenue potential<\/strong> \u2013 Assuming a <strong>10\u202f% market capture<\/strong> of the weekly GLP\u20111 segment (\u2248\u202f14\u202fmillion patients) at an average price of <strong>CNY\u202f5,800<\/strong> per treatment course, PB\u2011119 could generate <strong>\u2248\u202fCNY\u202f81\u202fbillion<\/strong> (~US$11.5\u202fbillion) in annual sales.<\/li>\n\n\n\n<li><strong>Strategic positioning<\/strong> \u2013 PegBio\u2019s proprietary PEGylation platform differentiates PB\u2011119 from competitors, giving the company leverage for future pipeline extensions (e.g., combination fixed\u2011dose products).<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This brief contains forward\u2011looking statements regarding regulatory approval, clinical benefits, and market expectations for PB\u2011119. Actual results may differ due to clinical outcomes, regulatory actions, competitive dynamics, and other risk factors.<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\/11\/2025111400385_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025111400385_c.\"><\/object><a id=\"wp-block-file--media-9601e596-aa0e-43b3-b77f-71b4c6079676\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111400385_c.pdf\">2025111400385_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111400385_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-9601e596-aa0e-43b3-b77f-71b4c6079676\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>PegBio Co., Ltd. (HKG: 2565) announced that its next\u2011generation GLP\u20111 receptor agonist PB\u2011119, marketed under&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48451,"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":[4078,4361,2105,15],"class_list":["post-48450","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hkg-2565","tag-hot-targets","tag-pegbio","tag-product-approvals"],"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>PegBio\u2019s PB\u2011119 (Paidakang) Wins NMPA Approval for Type\u202f2 Diabetes Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"PegBio Co., Ltd. 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(HKG: 2565) announced that its next\u2011generation GLP\u20111 receptor agonist PB\u2011119, marketed under the brand name Paidakang, has received full approval from the China National Medical Products Administration (NMPA) for use in patients with type\u202f2 diabetes mellitus (T2DM).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48450\" \/>\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=\"2025-11-17T07:06:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-17T07:06:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1709.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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