{"id":56408,"date":"2026-02-05T20:30:02","date_gmt":"2026-02-05T12:30:02","guid":{"rendered":"https:\/\/flcube.com\/?p=56408"},"modified":"2026-02-05T20:30:03","modified_gmt":"2026-02-05T12:30:03","slug":"huadong-medicine-dr10624-gets-nmpa-nod-for-hypertriglyceridemia-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56408","title":{"rendered":"Huadong Medicine DR10624 Gets NMPA Nod for Hypertriglyceridemia Study"},"content":{"rendered":"\n<p><strong>Huadong Medicine Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/000963:SHE\">SHE: 000963<\/a>) announced that its subsidiary <strong>Doer Biologics<\/strong> has received <strong>National Medical Products Administration (NMPA)<\/strong> approval for a clinical trial filing for <strong>DR10624<\/strong>, a first\u2011in\u2011class long\u2011acting trispecific agonist targeting <strong>FGF21R, GCGR, and GLP\u20111R<\/strong>, for the treatment of hypertriglyceridemia. The drug has already demonstrated strong Phase II results in severe hypertriglyceridemia (sHTG).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone-amp-drug-profile\">Regulatory Milestone &amp; Drug Profile<\/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>Huadong Medicine Co., Ltd (000963.SZ)<\/td><\/tr><tr><td><strong>Subsidiary<\/strong><\/td><td>Doer Biologics<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>DR10624<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Trispecific agonist (FGF21R + GCGR + GLP\u20111R)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Hypertriglyceridemia<\/td><\/tr><tr><td><strong>Approval<\/strong><\/td><td>NMPA clinical trial filing accepted<\/td><\/tr><tr><td><strong>Innovation<\/strong><\/td><td>First\u2011in\u2011class long\u2011acting trispecific agonist<\/td><\/tr><tr><td><strong>Structure<\/strong><\/td><td>N\u2011terminal GLP\u20111R\/GCGR chimeric peptide fused to engineered IgG1 Fc, with FGF21 mutant at C\u2011terminus<\/td><\/tr><tr><td><strong>Clinical Data<\/strong><\/td><td>Phase II sHTG study: up to 89% liver fat reduction, &gt;70% triglyceride decrease<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-data-amp-strategic-advantage\">Clinical Data &amp; Strategic Advantage<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase II Results:<\/strong> Successfully completed Phase II in severe hypertriglyceridemia, demonstrating <strong>up to 89% reduction in liver fat<\/strong> and <strong>>70% relative decrease in triglycerides<\/strong> from baseline<\/li>\n\n\n\n<li><strong>Triple Mechanism:<\/strong> Simultaneously targets <strong>FGF21R<\/strong> (metabolic regulation), <strong>GCGR<\/strong> (glucose control), and <strong>GLP\u20111R<\/strong> (insulin secretion and satiety)<\/li>\n\n\n\n<li><strong>Metabolic Benefits:<\/strong> FGF21 component enhances lipid metabolism while GLP\u20111\/GCGR components address glycemic control and weight management<\/li>\n\n\n\n<li><strong>Unmet Need:<\/strong> Severe hypertriglyceridemia affects <strong>~10\u202fmillion<\/strong> : patients in China; current therapies offer limited efficacy<\/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>Hypertriglyceridemia Market:<\/strong> China market valued at <strong>\u00a515\u202fbillion<\/strong> : (~US$2.1\u202fbillion) in 2025; growing at <strong>12% CAGR<\/strong> due to rising metabolic syndrome prevalence<\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong> Competes with <strong>fenofibrates, prescription omega\u20113s, and emerging ANGPTL3 inhibitors<\/strong>; DR10624\u2019s multi\u2011target approach offers differentiation<\/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 superior efficacy data<\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> Positions Huadong Medicine as a leader in metabolic disease innovation; validates Doer Biologics\u2019 trispecific platform for additional indications<\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> Phase III trial initiation expected <strong>Q2\u202f2026<\/strong>; US and EU regulatory 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 DR10624. 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\/02\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-1a6d68c0-8aa9-44a8-be21-3833c327b53e\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\">\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-1a6d68c0-8aa9-44a8-be21-3833c327b53e\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Huadong Medicine Co., Ltd (SHE: 000963) announced that its subsidiary Doer Biologics has received National&#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":[62,2508,114,25,887],"class_list":["post-56408","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-doer-biologics","tag-huadong-medicine","tag-potential-first-in-class","tag-she-000963"],"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>Huadong Medicine DR10624 Gets NMPA Nod for Hypertriglyceridemia Study - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Huadong Medicine Co., Ltd (SHE: 000963) announced that its subsidiary Doer Biologics has received National Medical Products Administration (NMPA) approval for a clinical trial filing for DR10624, a first\u2011in\u2011class long\u2011acting trispecific agonist targeting FGF21R, GCGR, and GLP\u20111R, for the treatment of hypertriglyceridemia. 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