{"id":55505,"date":"2026-01-26T20:47:42","date_gmt":"2026-01-26T12:47:42","guid":{"rendered":"https:\/\/flcube.com\/?p=55505"},"modified":"2026-01-26T20:47:43","modified_gmt":"2026-01-26T12:47:43","slug":"zhongshengs-ray1225-wins-nmpa-approval-for-obesity-sleep-apnea-study-as-phase-iii-wraps-up","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=55505","title":{"rendered":"Zhongsheng\u2019s RAY1225 Wins NMPA Approval for Obesity\u2011Sleep Apnea Study as Phase\u202fIII Wraps Up"},"content":{"rendered":"\n<p><strong>Guangdong Zhongsheng Pharmaceutical Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/002317:SHE\">SHE: 002317<\/a>) announced that China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has approved a new clinical study for <strong>RAY1225<\/strong>, a <strong>Category\u202f1 innovative dual GLP\u20111\/GIP receptor agonist<\/strong>, in patients with <strong>obesity complicated by obstructive sleep apnea (OSA)<\/strong>. The approval comes as the company completes enrollment across three Phase\u202fIII trials for obesity and type\u202f2 diabetes.<\/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>Guangdong Zhongsheng Pharmaceutical Co., Ltd (002317.SZ)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>RAY1225 (dual GLP\u20111\/GIP receptor agonist)<\/td><\/tr><tr><td><strong>Application<\/strong><\/td><td>Clinical Trial Approval (new indication)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>New Indication<\/strong><\/td><td>Obesity with obstructive sleep apnea (OSA)<\/td><\/tr><tr><td><strong>Dosing<\/strong><\/td><td>Ultra\u2011long\u2011acting, once every two weeks (Q2W)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>16\u202fJan\u202f2026<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Category\u202f1 innovative polypeptide<\/td><\/tr><tr><td><strong>Current Status<\/strong><\/td><td>Phase\u202fIII enrollment completed for obesity and T2DM trials<\/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>Mechanism:<\/strong> Dual agonist targeting <strong>GLP\u20111<\/strong> (glucagon\u2011like peptide\u20111) and <strong>GIP<\/strong> (glucose\u2011dependent insulinotropic polypeptide) receptors, enhancing satiety, glucose control, and energy expenditure<\/li>\n\n\n\n<li><strong>Pharmacokinetics:<\/strong> <strong>Ultra\u2011long\u2011acting<\/strong> formulation enables <strong>once\u2011every\u2011two\u2011weeks (Q2W)<\/strong> dosing, offering <strong>superior convenience<\/strong> vs. weekly semaglutide or tirzepatide<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> Designed for <strong>high potency<\/strong> and <strong>extended half\u2011life<\/strong> through optimized polypeptide engineering<\/li>\n\n\n\n<li><strong>OSA Rationale:<\/strong> GLP\u20111\/GIP agonists demonstrate <strong>weight\u2011dependent and independent benefits<\/strong> on upper airway collapsibility and inflammation, addressing the <strong>high unmet need<\/strong> in obese OSA patients<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-status\">Clinical Development Status<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Trial<\/th><th>Indication<\/th><th>Status<\/th><th>Comparator\/Design<\/th><\/tr><\/thead><tbody><tr><td><strong>REBUILDING\u20112<\/strong><\/td><td>Obesity\/overweight (Chinese patients)<\/td><td><strong>Enrollment completed<\/strong><\/td><td>Placebo\u2011controlled<\/td><\/tr><tr><td><strong>SHINING\u20112<\/strong><\/td><td>Type\u202f2 diabetes (monotherapy)<\/td><td><strong>Enrollment completed<\/strong><\/td><td>Placebo\u2011controlled<\/td><\/tr><tr><td><strong>SHINING\u20113<\/strong><\/td><td>Type\u202f2 diabetes (combination therapy)<\/td><td><strong>Enrollment completed<\/strong><\/td><td><strong>Versus semaglutide<\/strong><\/td><\/tr><tr><td><strong>New Study<\/strong><\/td><td>Obesity + OSA<\/td><td><strong>NMPA approved<\/strong><\/td><td>Phase\u202fII\/III planned<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitive Differentiation:<\/strong> SHINING\u20113\u2019s <strong>head\u2011to\u2011head design versus semaglutide<\/strong> positions RAY1225 as a <strong>potential best\u2011in\u2011class<\/strong> therapy; Q2W dosing offers <strong>adherence advantage<\/strong> over weekly injections<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-competitive-landscape\">Market Opportunity &amp; Competitive Landscape<\/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>Obesity Patients with OSA<\/strong><\/td><td>45\u202fmillion<\/td><td>180\u202fmillion<\/td><\/tr><tr><td><strong>Addressable for GLP\u20111\/GIP Therapy<\/strong><\/td><td>18\u202fmillion<\/td><td>72\u202fmillion<\/td><\/tr><tr><td><strong>Current Standard<\/strong><\/td><td>CPAP (device), lifestyle, weekly semaglutide<\/td><td><\/td><\/tr><tr><td><strong>Q2W GLP\u20111\/GIP Penetration<\/strong><\/td><td>0\u202f%<\/td><td>0\u202f%<\/td><\/tr><tr><td><strong>Market Value (2030E)<\/strong><\/td><td>\u00a585\u202fbillion<\/td><td>$42\u202fbillion<\/td><\/tr><tr><td><strong>RAY1225 Peak Share<\/strong><\/td><td>5\u202f%<\/td><td>2\u202f%<\/td><\/tr><tr><td><strong>Peak Revenue (2032E)<\/strong><\/td><td>\u00a54.25\u202fbillion<\/td><td>$840\u202fmillion<\/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>Zepbound<\/strong> (tirzepatide, Eli Lilly) \u2013 Weekly GIP\/GLP\u20111, approved for obesity, no OSA indication yet<\/li>\n\n\n\n<li><strong>Wegovy<\/strong> (semaglutide, Novo Nordisk) \u2013 Weekly GLP\u20111, standard of care<\/li>\n\n\n\n<li><strong>RAY1225<\/strong> \u2013 <strong>First Q2W dual agonist<\/strong> in Phase\u202fIII; <strong>potential OSA label differentiation<\/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>Manufacturing:<\/strong> Zhongsheng\u2019s <strong>Guangdong biologics facility<\/strong> (capacity 50\u202fmillion doses\/year) is GMP\u2011ready for commercial supply; <strong>Q2W formulation<\/strong> requires specialized long\u2011acting delivery technology<\/li>\n\n\n\n<li><strong>Commercial Reach:<\/strong> Existing <strong>3,000\u2011person metabolic sales force<\/strong> (diabetes portfolio) can pivot to obesity\/OSA upon launch<\/li>\n\n\n\n<li><strong>Regulatory Pathway:<\/strong> <strong>NDA submission<\/strong> for obesity\/T2DM expected <strong>Q3\u202f2026<\/strong> based on completed Phase\u202fIII data; <strong>OSA indication<\/strong> to follow as <strong>label expansion<\/strong> in 2028<\/li>\n\n\n\n<li><strong>Global Ambitions:<\/strong> Plans <strong>US IND filing<\/strong> in <strong>H2\u202f2026<\/strong>, leveraging China Phase\u202fIII data for FDA fast\u2011track eligibility<\/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 approvals, and commercial forecasts for RAY1225. Actual results may differ due to competitive dynamics, manufacturing scale\u2011up challenges, and OSA trial outcomes.<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\/\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836fRAY1225\u6ce8\u5c04\u6db2\u65b0\u589e\u9002\u5e94\u75c7\u7684\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 \u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836fRAY1225\u6ce8\u5c04\u6db2\u65b0\u589e\u9002\u5e94\u75c7\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-18f876ba-d600-4ff9-8958-930f9592f1b1\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836fRAY1225\u6ce8\u5c04\u6db2\u65b0\u589e\u9002\u5e94\u75c7\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\">\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836fRAY1225\u6ce8\u5c04\u6db2\u65b0\u589e\u9002\u5e94\u75c7\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836fRAY1225\u6ce8\u5c04\u6db2\u65b0\u589e\u9002\u5e94\u75c7\u7684\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-18f876ba-d600-4ff9-8958-930f9592f1b1\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced that China\u2019s National Medical Products Administration (NMPA)&#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":[62,4361,86,1197,399],"class_list":["post-55505","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-hot-targets","tag-obesity","tag-she-002317","tag-zhongsheng-pharmaceutical"],"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>Zhongsheng\u2019s RAY1225 Wins NMPA Approval for Obesity\u2011Sleep Apnea Study as Phase\u202fIII Wraps Up - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced that China\u2019s National Medical Products Administration (NMPA) has approved a new clinical study for RAY1225, a Category\u202f1 innovative dual GLP\u20111\/GIP receptor agonist, in patients with obesity complicated by obstructive sleep apnea (OSA). 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