{"id":54288,"date":"2026-01-15T22:54:46","date_gmt":"2026-01-15T14:54:46","guid":{"rendered":"https:\/\/flcube.com\/?p=54288"},"modified":"2026-01-15T22:54:47","modified_gmt":"2026-01-15T14:54:47","slug":"huadong-medicines-dr10624-wins-fda-nod-for-masld-study-first-triple-agonist-to-enter-clinic","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=54288","title":{"rendered":"Huadong Medicine\u2019s DR10624 Wins FDA Nod for MASLD Study, First Triple Agonist to Enter Clinic"},"content":{"rendered":"\n<p><strong>Huadong Medicine Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/000963:SHE\">SHE:\u202f000963<\/a>) announced that the <strong>U.S. Food and Drug Administration (FDA)<\/strong> has approved an <strong>Investigational New Drug (IND)<\/strong> application for <strong>DR10624<\/strong>, a <strong>first\u2011in\u2011class long\u2011acting triple\u2011specific agonist<\/strong>, to initiate a clinical study in <strong>metabolic dysfunction\u2011associated steatotic liver disease (MASLD)<\/strong>. The drug has already completed a <strong>Phase\u202fII study in severe hypertriglyceridemia (SHTG)<\/strong> with positive results.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory 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>Company<\/strong><\/td><td>Huadong Medicine Co., Ltd (SZ:\u202f000963)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>DR10624 (triple\u2011specific agonist)<\/td><\/tr><tr><td><strong>Application<\/strong><\/td><td>IND approval<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>US FDA<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Metabolic dysfunction\u2011associated steatotic liver disease (MASLD)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>14\u202fJan\u202f2026<\/td><\/tr><tr><td><strong>Clinical Stage<\/strong><\/td><td>Phase\u202fII completed for SHTG; Phase\u202fI ready for MASLD<\/td><\/tr><tr><td><strong>Innovation<\/strong><\/td><td>First triple agonist targeting FGF21R, GCGR, and GLP\u20111R<\/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>Targets:<\/strong> <strong>FGF21 receptor (FGF21R), glucagon receptor (GCGR), and GLP\u20111 receptor (GLP\u20111R)<\/strong><\/li>\n\n\n\n<li><strong>Structure:<\/strong> Fusion protein comprising:<\/li>\n\n\n\n<li><strong>N\u2011terminal chimeric peptide<\/strong> targeting GLP\u20111R\/GCGR<\/li>\n\n\n\n<li><strong>Engineered IgG1 Fc fragment<\/strong> for extended half\u2011life<\/li>\n\n\n\n<li><strong>Recombinant FGF21 mutant<\/strong> fused at C\u2011terminus<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Simultaneously activates three key metabolic pathways to improve <strong>lipid metabolism, glucose control, and liver fat reduction<\/strong><\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> <strong>First\u2011in\u2011class triple agonist<\/strong> vs. single\u2011target (GLP\u20111) or dual\u2011target (GIP\/GLP\u20111) competitors<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence\">Clinical Evidence<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Study<\/th><th>Indication<\/th><th>Status<\/th><th>Key Findings<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase\u202fII<\/strong><\/td><td>Severe hypertriglyceridemia (SHTG)<\/td><td>Completed<\/td><td>Positive top\u2011line results following unblinding<\/td><\/tr><tr><td><strong>Phase\u202fI<\/strong><\/td><td>Advanced solid tumors<\/td><td>Ongoing (US)<\/td><td>Focus on patients with brain metastases<\/td><\/tr><tr><td><strong>Next<\/strong><\/td><td>MASLD<\/td><td>IND approved<\/td><td>Phase\u202fI initiation planned Q2\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity\">Market Opportunity<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>China<\/th><th>Global<\/th><\/tr><\/thead><tbody><tr><td><strong>MASLD Patients<\/strong><\/td><td>180\u202fmillion<\/td><td>900\u202fmillion<\/td><\/tr><tr><td><strong>MASH\/MASLD\u2011Cirrhosis (2030E)<\/strong><\/td><td>45\u202fmillion<\/td><td>180\u202fmillion<\/td><\/tr><tr><td><strong>SHTG Patients<\/strong><\/td><td>8\u202fmillion<\/td><td>30\u202fmillion<\/td><\/tr><tr><td><strong>Addressable Market (2030E)<\/strong><\/td><td>$12\u202fbillion<\/td><td>$45\u202fbillion<\/td><\/tr><tr><td><strong>Triple Agonist Penetration<\/strong><\/td><td>0\u202f%<\/td><td>0\u202f%<\/td><\/tr><tr><td><strong>DR10624 Peak Revenue (2032E)<\/strong><\/td><td>\u00a53.5\u202fbillion<\/td><td>$1.8\u202fbillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Key Competitors:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>GLP\u20111 agonists:<\/strong> Novo Nordisk (semaglutide), Eli Lilly (tirzepatide) \u2013 diabetes\/MASH<\/li>\n\n\n\n<li><strong>FGF21 analogs:<\/strong> Akero Therapeutics (efruxifermin), 89bio (pegozafermin) \u2013 MASH only<\/li>\n\n\n\n<li><strong>Dual agonists:<\/strong> Eli Lilly (tirzepatide \u2013 GIP\/GLP\u20111) \u2013 metabolic diseases<\/li>\n\n\n\n<li><strong>DR10624<\/strong> \u2013 <strong>First triple agonist<\/strong> with <strong>liver\u2011directed FGF21 activity<\/strong> plus <strong>GLP\u20111\/GCGR benefits<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning\">Strategic Positioning<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Platform Value:<\/strong> DR10624 represents Huadong\u2019s <strong>first global innovative asset<\/strong> with <strong>potential in multiple metabolic diseases<\/strong> (MASLD, SHTG, obesity, NASH)<\/li>\n\n\n\n<li><strong>Development Path:<\/strong> <strong>Fast\u2011track FDA designation<\/strong> likely for MASLD given unmet need; <strong>China NDA<\/strong> planned for <strong>2029<\/strong> following US Phase\u202fII data<\/li>\n\n\n\n<li><strong>Manufacturing:<\/strong> Huadong\u2019s <strong>Hangzhou biologics facility<\/strong> (capacity 5,000\u202fL) will produce DR10624 for global trials<\/li>\n\n\n\n<li><strong>Commercial Reach:<\/strong> Existing <strong>4,000\u2011person endocrinology sales force<\/strong> can rapidly launch upon approval<\/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 commercial projections for DR10624. Actual results may differ due to clinical trial outcomes, competitive dynamics, and market access challenges.<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\/01\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u7f8e\u56fdFDA\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\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\u7f8e\u56fdFDA\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-93e615f1-dd20-44b1-9812-efa5ade52f4a\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u7f8e\u56fdFDA\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u7684\u516c\u544a.pdf\">\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u7f8e\u56fdFDA\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u83b7\u5f97\u7f8e\u56fdFDA\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-93e615f1-dd20-44b1-9812-efa5ade52f4a\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Huadong Medicine Co., Ltd (SHE:\u202f000963) announced that the U.S. Food and Drug Administration (FDA) has&#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":[62,114,887],"class_list":["post-54288","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-huadong-medicine","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\u2019s DR10624 Wins FDA Nod for MASLD Study, First Triple Agonist to Enter Clinic - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Huadong Medicine Co., Ltd (SHE:\u202f000963) announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for DR10624, a first\u2011in\u2011class long\u2011acting triple\u2011specific agonist, to initiate a clinical study in metabolic dysfunction\u2011associated steatotic liver disease (MASLD). 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