{"id":64594,"date":"2026-05-07T13:16:34","date_gmt":"2026-05-07T05:16:34","guid":{"rendered":"https:\/\/flcube.com\/?p=64594"},"modified":"2026-05-07T13:16:34","modified_gmt":"2026-05-07T05:16:34","slug":"amgen-secures-nmpa-approval-for-evenity-romosozumab-novel-osteoporosis-treatment-for-high-risk-postmenopausal-women-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64594","title":{"rendered":"Amgen Secures NMPA Approval for Evenity (Romosozumab) \u2013 Novel Osteoporosis Treatment for High-Risk Postmenopausal Women in China"},"content":{"rendered":"\n<p><strong>Amgen Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/AMGN:NASDAQ\">NASDAQ: AMGN<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has granted <strong>marketing approval<\/strong> for <strong>Evenity (romosozumab)<\/strong>, a <strong>sclerostin (SOST)-targeted monoclonal antibody<\/strong> indicated for <strong>postmenopausal women with osteoporosis at high risk of fracture<\/strong>.<\/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>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Full marketing approval<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Evenity (romosozumab) injection<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Treatment of postmenopausal women with osteoporosis at high risk of fracture<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>7 May 2026<\/td><\/tr><tr><td><strong>Next Steps<\/strong><\/td><td>Commercial launch following pricing and reimbursement negotiations<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> Humanized monoclonal antibody (subcutaneous injection)<\/li>\n\n\n\n<li><strong>Target:<\/strong> <strong>Sclerostin (SOST)<\/strong> \u2013 a natural inhibitor of bone formation<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> <strong>Dual-action mechanism<\/strong> that simultaneously <strong>promotes bone formation<\/strong> and <strong>inhibits bone resorption<\/strong>, enabling rapid increases in bone mineral density (BMD)<\/li>\n\n\n\n<li><strong>Intellectual Property:<\/strong> Global patents held by <strong>Amgen<\/strong>, covering the romosozumab molecule and therapeutic use<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-pivotal-phase-iii-trials\">Clinical Evidence \u2013 Pivotal Phase III Trials<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Trial<\/th><th>Key Finding<\/th><th>Comparator<\/th><th>Benefit<\/th><\/tr><\/thead><tbody><tr><td><strong>FRAME<\/strong><\/td><td>73% reduction in new vertebral fractures at 12 months<\/td><td>Placebo<\/td><td>Statistically significant risk reduction<\/td><\/tr><tr><td><strong>FRAME<\/strong><\/td><td>BMD increase: 13.3% (lumbar spine), 6.8% (total hip), 5.2% (femoral neck)<\/td><td>Placebo<\/td><td>Rapid and substantial bone density gains<\/td><\/tr><tr><td><strong>ARCH<\/strong><\/td><td>~50% reduction in vertebral fracture risk<\/td><td>Alendronate alone<\/td><td>Superior efficacy with sequential therapy<\/td><\/tr><tr><td><strong>STRUCTURE<\/strong><\/td><td>Approximately 2x greater BMD gains at all measured sites<\/td><td>Teriparatide<\/td><td>Enhanced bone-forming capacity<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The integrated clinical program demonstrated that romosozumab delivers <strong>robust efficacy in reducing fracture risk<\/strong> and <strong>increasing BMD<\/strong> with a <strong>generally favorable tolerability profile<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-outlook\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China Osteoporosis Landscape:<\/strong> With over <strong>90 million people<\/strong> affected by osteoporosis in China and a rapidly aging population, effective treatments for high-risk patients represent a significant unmet need.<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Amgen projects strong uptake among the estimated <strong>25-30 million postmenopausal women<\/strong> with osteoporosis in China, particularly those at high fracture risk.<\/li>\n\n\n\n<li><strong>Competitive Position:<\/strong> Evenity&#8217;s <strong>dual-action mechanism<\/strong> differentiates it from antiresorptives (like bisphosphonates) and other bone-forming agents, offering a unique therapeutic option for appropriate patients.<\/li>\n\n\n\n<li><strong>Commercial Strategy:<\/strong> Amgen will leverage its established presence in China&#8217;s biologics market and work with healthcare providers to identify high-risk patients who would benefit most from Evenity&#8217;s rapid bone-building effects.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding regulatory approvals, clinical outcomes, and commercial expectations for Evenity. Actual results may differ due to risks including market adoption, competitive dynamics, and reimbursement decisions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Amgen Inc. (NASDAQ: AMGN) announced that China&#8217;s National Medical Products Administration (NMPA) has granted marketing&#8230;<\/p>\n","protected":false},"author":1,"featured_media":64595,"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":[330,912,15],"class_list":["post-64594","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-amgen","tag-nasdaq-amgn","tag-product-approvals"],"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>Amgen Secures NMPA Approval for Evenity (Romosozumab) \u2013 Novel Osteoporosis Treatment for High-Risk Postmenopausal Women in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Amgen Inc. 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