{"id":66453,"date":"2026-05-27T15:01:22","date_gmt":"2026-05-27T07:01:22","guid":{"rendered":"https:\/\/flcube.com\/?p=66453"},"modified":"2026-05-27T15:01:23","modified_gmt":"2026-05-27T07:01:23","slug":"hengrui-pharmaceuticals-and-kailera-therapeutics-report-strong-phase-iii-results-for-oral-glp-1-agonist-hrs-7535-in-type-2-diabetes","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=66453","title":{"rendered":"Hengrui Pharmaceuticals and Kailera Therapeutics Report Strong Phase III Results for Oral GLP-1 Agonist HRS-7535 in Type 2 Diabetes"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA: 600276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG: 1276<\/a>) and its U.S. partner <strong>Kailera Therapeutics<\/strong> announced positive topline results from the <strong>Phase III OUTSTAND-1 trial<\/strong> evaluating <strong>HRS-7535<\/strong> (KAI-7535 outside Greater China), a once-daily oral small-molecule GLP-1 receptor agonist, in <strong>284 Chinese adults with type 2 diabetes<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-clinical-trial-results-outstand-1-phase-iii\" class=\"wp-block-heading\">Clinical Trial Results \u2013 OUTSTAND-1 Phase III<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>30 mg Dose<\/th><th>60 mg Dose<\/th><th>90 mg Dose<\/th><\/tr><\/thead><tbody><tr><td><strong>Primary Endpoint<\/strong><br>HbA1c Reduction (32 weeks)<\/td><td>-1.40%<\/td><td>-1.55%<\/td><td>-1.68%<\/td><\/tr><tr><td><strong>Key Secondary Endpoint<\/strong><br>Patients Achieving HbA1c &lt;7.0%<\/td><td>83.5%<\/td><td>86.2%<\/td><td>89.6%<\/td><\/tr><tr><td><strong>Study Population<\/strong><\/td><td>284 Chinese adults with type 2 diabetes<\/td><td><\/td><td><\/td><\/tr><tr><td><strong>Treatment Duration<\/strong><\/td><td>32 weeks<\/td><td><\/td><td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-product-profile-amp-differentiation\" class=\"wp-block-heading\">Product Profile &amp; Differentiation<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> Self-developed oral GLP-1 receptor agonist<\/li>\n\n\n\n<li><strong>Dosing Convenience:<\/strong> Once-daily administration with <strong>no food or fasting restrictions<\/strong><\/li>\n\n\n\n<li><strong>Patient Flexibility:<\/strong> Can be taken with food and water without impacting efficacy or absorption<\/li>\n\n\n\n<li><strong>Development Status:<\/strong> Lead candidate in Hengrui&#8217;s comprehensive GLP-1 franchise<\/li>\n\n\n\n<li><strong>Global Branding:<\/strong> HRS-7535 (Greater China) \/ KAI-7535 (ex-Greater China)<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-broader-development-portfolio\" class=\"wp-block-heading\">Broader Development Portfolio<\/h2>\n\n\n\n<h3 id=\"h-diabetes-program-outstand-series\" class=\"wp-block-heading\">Diabetes Program \u2013 OUTSTAND Series<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>OUTSTAND-1:<\/strong> Completed Phase III in type 2 diabetes (reported)<\/li>\n\n\n\n<li>Additional studies ongoing to support regulatory submissions<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-weight-management-program-harbor-series\" class=\"wp-block-heading\">Weight Management Program \u2013 HARBOR Series<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Multiple Phase II\/III trials active in China<\/li>\n\n\n\n<li>Targeting obesity and weight-related comorbidities<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-chronic-kidney-disease-program-renew-ckd-trial\" class=\"wp-block-heading\">Chronic Kidney Disease Program \u2013 RENEW-CKD Trial<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Phase II\/III study evaluating renal protective effects<\/li>\n\n\n\n<li>Addresses significant unmet need in diabetic kidney disease<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-strategic-partnership-framework\" class=\"wp-block-heading\">Strategic Partnership Framework<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Aspect<\/th><th>Hengrui Pharmaceuticals<\/th><th>Kailera Therapeutics<\/th><\/tr><\/thead><tbody><tr><td><strong>Territory<\/strong><\/td><td>Greater China (China, Hong Kong, Macau, Taiwan)<\/td><td>Ex-Greater China (global)<\/td><\/tr><tr><td><strong>Rights Granted<\/strong><\/td><td>Retained exclusive rights<\/td><td>Exclusive development, manufacturing, and commercialization rights<\/td><\/tr><tr><td><strong>Agreement Date<\/strong><\/td><td>May 2024<\/td><td>May 2024<\/td><\/tr><tr><td><strong>Current Development<\/strong><\/td><td>OUTSTAND, HARBOR, and RENEW-CKD trials in China<\/td><td>Global Phase II obesity trial (data expected 2027)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-market-context-amp-competitive-landscape\" class=\"wp-block-heading\">Market Context &amp; Competitive Landscape<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>GLP-1 Market Size:<\/strong> $25+ billion global market projected to exceed $50 billion by 2030<\/li>\n\n\n\n<li><strong>Oral Delivery Advantage:<\/strong> Addresses patient preference for pill-based vs. injectable therapies<\/li>\n\n\n\n<li><strong>Competitive Positioning:<\/strong> Competes with Novo Nordisk&#8217;s Rybelsus while offering potential dosing flexibility advantages<\/li>\n\n\n\n<li><strong>Commercial Timeline:<\/strong> Regulatory submissions expected in 2027 following completion of additional Phase III studies<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Peak sales estimates range from $1-3 billion annually depending on global market penetration<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding clinical development, regulatory timelines, and commercial expectations for HRS-7535\/KAI-7535. Actual results may differ due to risks including regulatory decisions, competitive dynamics, clinical trial outcomes, and market access challenges.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) and its U.S. partner Kailera Therapeutics&#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":[17,39,2586,4228,956,852],"class_list":["post-66453","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-results","tag-diabetes","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-kailera-therapeutics","tag-sha-600276"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui Pharmaceuticals and Kailera Therapeutics Report Strong Phase III Results for Oral GLP-1 Agonist HRS-7535 in Type 2 Diabetes - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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