{"id":41140,"date":"2025-09-11T13:23:05","date_gmt":"2025-09-11T05:23:05","guid":{"rendered":"https:\/\/flcube.com\/?p=41140"},"modified":"2025-09-11T13:23:06","modified_gmt":"2025-09-11T05:23:06","slug":"taiji-group-secures-nmpa-approval-to-begin-clinical-trials-of-semaglutide-biosimilar","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41140","title":{"rendered":"Taiji Group Secures NMPA Approval to Begin Clinical Trials of Semaglutide Biosimilar"},"content":{"rendered":"\n<p><strong>China\u2011based Chongqing Taiji Industry (Group) Co., Ltd. (Taiji Group, <a href=\"https:\/\/www.google.com\/finance\/quote\/600129:SHA\">SHA: 600129<\/a>)<\/strong> announced that its semaglutide injection biosimilar has received approval from the China National Medical Products Administration (NMPA) to initiate clinical trials. The product targets adult patients with type\u202f2 diabetes who remain hyperglycaemic despite diet, exercise, and metformin and\/or sulfonylurea therapy, and it also aims to reduce the risk of major adverse cardiovascular events (MACE) in patients with concomitant cardiovascular disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-about-semaglutide\">About Semaglutide<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> Long\u2011acting human glucagon\u2011like peptide\u20111 (GLP\u20111) receptor agonist<\/li>\n\n\n\n<li><strong>Origins:<\/strong> Developed by Novo\u202fNordisk; approved in China in 2021<\/li>\n\n\n\n<li><strong>Current Uses:<\/strong><\/li>\n\n\n\n<li><em>Ozempic<\/em> (or <em>Rybelsus<\/em> in some markets) \u2013 type\u202f2 diabetes<\/li>\n\n\n\n<li><em>Wegovy<\/em> \u2013 weight\u2011loss therapy<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-taiji-group-s-biosimilar-edge\">Taiji Group\u2019s Biosimilar Edge<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Technology:<\/strong> Yeast high\u2011efficiency secretory expression system ensures consistent product quality and scalable manufacturing<\/li>\n\n\n\n<li><strong>Competitive Position:<\/strong> First semaglutide biosimilar to receive regulatory review in China, positioning Taiji Group to capture market share as the original product\u2019s price\u2011point pressure mounts<\/li>\n\n\n\n<li><strong>Regulatory Milestone:<\/strong> NMPA clearance for clinical trial initiation\u2014first step toward eventual market approval<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-this-means-for-stakeholders\">What This Means for Stakeholders<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Stakeholder<\/th><th>Impact<\/th><th>Next Step<\/th><\/tr><\/thead><tbody><tr><td><strong>Patients<\/strong><\/td><td>Potential access to a more affordable GLP\u20111 therapy<\/td><td>Clinical trial enrollment will begin in Q4\u202f2025<\/td><\/tr><tr><td><strong>Investors<\/strong><\/td><td>Adds a high\u2011potential growth asset to Taiji Group\u2019s portfolio<\/td><td>Monitor trial outcomes and subsequent regulatory filings<\/td><\/tr><tr><td><strong>Healthcare System<\/strong><\/td><td>May reduce long\u2011term cardiovascular costs by providing an effective, cost\u2011competitive option<\/td><td>Integration into diabetes management guidelines pending approval<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>Taiji Group will commence Phase\u202fI\/II trials later this year to assess safety, tolerability, and efficacy. Positive results could pave the way for a domestic and potentially global launch, offering a compelling alternative to Novo\u202fNordisk\u2019s branded semaglutide.<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\/09\/600129_20250910_OYUR.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600129_20250910_OYUR.\"><\/object><a id=\"wp-block-file--media-3f354e85-1a1f-475c-8513-8c98a90a5c0a\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/600129_20250910_OYUR.pdf\">600129_20250910_OYUR<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/600129_20250910_OYUR.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3f354e85-1a1f-475c-8513-8c98a90a5c0a\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based Chongqing Taiji Industry (Group) Co., Ltd. (Taiji Group, SHA: 600129) announced that its semaglutide&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41145,"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":[43,62,1017,209],"class_list":["post-41140","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-biosimilars","tag-clinical-trial-approval-initiation","tag-sha-600129","tag-taiji-industry"],"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>Taiji Group Secures NMPA Approval to Begin Clinical Trials of Semaglutide Biosimilar - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based Chongqing Taiji Industry (Group) Co., Ltd. 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(Taiji Group, SHA: 600129) announced that its semaglutide injection biosimilar has received approval from the China National Medical Products Administration (NMPA) to initiate clinical trials. 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