{"id":41535,"date":"2025-09-16T15:53:58","date_gmt":"2025-09-16T07:53:58","guid":{"rendered":"https:\/\/flcube.com\/?p=41535"},"modified":"2025-09-16T15:53:59","modified_gmt":"2025-09-16T07:53:59","slug":"bioray-biopharmaceutical-secures-nmpa-approval-for-bgm0504-in-overweight-obesity-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41535","title":{"rendered":"BioRay Biopharmaceutical Secures NMPA Approval for BGM0504 in Overweight\/Obesity Trials"},"content":{"rendered":"\n<p><strong>BioRay Biopharmaceutical (<a href=\"https:\/\/www.google.com\/finance\/quote\/688166:SHA\">SHA: 688166<\/a>)<\/strong> announced today that its dual\u2011agonist drug <strong>BGM0504<\/strong> has received <strong>National Medical Products Administration (NMPA)<\/strong> approval to commence clinical trials in adults with overweight or obesity. The approval marks a significant milestone for the company\u2019s metabolic\u2011disease pipeline and positions BGM0504 as a promising candidate for both weight management and type\u20112 diabetes treatment.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-what-is-bgm0504\">What Is BGM0504?<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Dual GLP\u20111\/GIP Agonist<\/strong> \u2013 BGM0504 simultaneously targets <strong>glucagon\u2011like peptide\u20111 (GLP\u20111)<\/strong> and <strong>glucose\u2011dependent insulinotropic polypeptide (GIP)<\/strong> receptors, activating downstream pathways that regulate glucose homeostasis, appetite, and lipid metabolism.<\/li>\n\n\n\n<li><strong>Broad Therapeutic Potential<\/strong> \u2013 Preclinical data indicate that BGM0504 can lower blood sugar, induce weight loss, and ameliorate <strong>non\u2011alcoholic steatohepatitis (NASH)<\/strong>, suggesting utility across a spectrum of metabolic disorders.<\/li>\n\n\n\n<li><strong>Injectable Formulation<\/strong> \u2013 The drug is administered via subcutaneous injection and is currently in <strong>Phase\u202fIII<\/strong> trials in China for both <strong>type\u20112 diabetes<\/strong> and <strong>weight loss<\/strong>.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-clinical-development-roadmap\">Clinical Development Roadmap<\/h4>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Phase<\/th><th>Status<\/th><th>Key Milestones<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase\u202fIII (China)<\/strong><\/td><td>Ongoing<\/td><td>1\u2011Year enrollment of 1,200+ adults with overweight\/obesity; primary endpoints: % body\u2011weight loss, HbA1c reduction.<\/td><\/tr><tr><td><strong>Global Expansion<\/strong><\/td><td>Planned<\/td><td>Pending positive Phase\u202fIII outcomes, BioRay will seek regulatory approval in the United States and EU.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-market-context\">Market Context<\/h4>\n\n\n\n<p>The global obesity market is projected to exceed <strong>$300\u202fbillion<\/strong> by 2030, driven by rising prevalence and expanding indications for metabolic drugs. BGM0504\u2019s dual\u2011agonist mechanism offers a differentiated profile relative to existing GLP\u20111 monotherapies, potentially improving efficacy while maintaining a favorable safety profile.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-company-outlook\">Company Outlook<\/h4>\n\n\n\n<p>BioRay\u2019s strategic focus on metabolic diseases aligns with its broader pipeline, which includes candidates for diabetes, NASH, and other obesity\u2011related conditions. The NMPA approval for BGM0504 enhances the company\u2019s valuation prospects and strengthens its position as a leading biopharma player in China\u2019s rapidly growing metabolic\u2011disease sector.<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\/688166_20250916_IKJI.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688166_20250916_IKJI.\"><\/object><a id=\"wp-block-file--media-89ce7285-f8b4-4b20-a0c3-2a4510929411\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/688166_20250916_IKJI.pdf\">688166_20250916_IKJI<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/688166_20250916_IKJI.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-89ce7285-f8b4-4b20-a0c3-2a4510929411\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>BioRay Biopharmaceutical (SHA: 688166) announced today that its dual\u2011agonist drug BGM0504 has received National Medical&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41537,"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":[11],"tags":[2575,1179],"class_list":["post-41535","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug","tag-bioray-pharmaceutical","tag-sha-688166"],"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>BioRay Biopharmaceutical Secures NMPA Approval for BGM0504 in Overweight\/Obesity Trials - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"BioRay Biopharmaceutical (SHA: 688166) announced today that its dual\u2011agonist drug BGM0504 has received National Medical Products Administration (NMPA) approval to commence clinical trials in adults with overweight or obesity. 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