{"id":65866,"date":"2026-05-21T14:08:42","date_gmt":"2026-05-21T06:08:42","guid":{"rendered":"https:\/\/flcube.com\/?p=65866"},"modified":"2026-05-21T14:08:44","modified_gmt":"2026-05-21T06:08:44","slug":"mabwell-bioscience-secures-second-nmpa-approval-for-denosu-biosimilar-expanding-indication-to-bone-metastases-and-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=65866","title":{"rendered":"Mabwell Bioscience Secures Second NMPA Approval for Denosu Biosimilar, Expanding Indication to Bone Metastases and Multiple Myeloma"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Mabwell (Shanghai) Bioscience Co., Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/688062:SHA\">SHA: 688062<\/a>) announced it has received a second indication approval from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for its <strong>Denosu<\/strong> biosimilar, referencing <strong>Amgen&#8217;s Xgeva (denosumab)<\/strong>. The RANKL inhibitor is now approved for patients with <strong>bone metastases from solid tumors or multiple myeloma<\/strong> to delay or reduce skeletal-related events.<\/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>Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Denosu (denosumab biosimilar)<\/td><\/tr><tr><td><strong>Reference Product<\/strong><\/td><td>Amgen&#8217;s Xgeva (denosumab)<\/td><\/tr><tr><td><strong>Regulatory Agency<\/strong><\/td><td>National Medical Products Administration (NMPA), China<\/td><\/tr><tr><td><strong>New Indication<\/strong><\/td><td>Bone metastases from solid tumors and multiple myeloma<\/td><\/tr><tr><td><strong>Therapeutic Benefit<\/strong><\/td><td>Delay\/reduce skeletal-related events (pathologic fractures, spinal cord compression, bone radiotherapy, bone surgery)<\/td><\/tr><tr><td><strong>Previous Approval<\/strong><\/td><td>March 2025 for unresectable giant cell tumor of bone<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-indication-details\">Clinical Indication Details<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient Population:<\/strong> Adults and skeletally mature adolescents with bone metastases from solid tumors or multiple myeloma<\/li>\n\n\n\n<li><strong>Skeletal-Related Events Prevention:<\/strong> Pathologic fractures, spinal cord compression, bone radiotherapy, or bone surgery<\/li>\n\n\n\n<li><strong>Mechanism of Action:<\/strong> RANKL inhibitor that reduces osteoclast-mediated bone destruction<\/li>\n\n\n\n<li><strong>Dosing Regimen:<\/strong> Standard denosumab dosing protocol for bone metastasis indication<\/li>\n\n\n\n<li><strong>Safety Profile:<\/strong> Consistent with reference product Xgeva based on biosimilarity studies<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-market-positioning\">Strategic Market Positioning<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The expanded indication significantly broadens Denosu&#8217;s addressable market in China, where the burden of cancer-related bone complications continues to grow with aging demographics and improved cancer survival rates. The approval positions Mabwell as a key domestic supplier of critical oncology supportive care medications.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Industry analysts note that biosimilars of high-value biologics like denosumab represent a strategic priority for Chinese biopharmaceutical companies seeking to capture market share from multinational originators while supporting national healthcare cost containment objectives.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-commercial-impact-amp-market-dynamics\">Commercial Impact &amp; Market Dynamics<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Market Expansion:<\/strong> Second indication substantially increases total addressable patient population<\/li>\n\n\n\n<li><strong>Pricing Advantage:<\/strong> Expected to offer significant cost savings compared to originator Xgeva<\/li>\n\n\n\n<li><strong>Healthcare System Benefits:<\/strong> Supports China&#8217;s ongoing efforts to improve access to essential oncology medications<\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong> Positions Mabwell against other domestic biosimilar developers and Amgen&#8217;s established franchise<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Bone metastasis indication represents larger commercial opportunity than initial giant cell tumor indication<\/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 Mabwell&#8217;s commercial prospects and market positioning. Actual results may differ due to competitive dynamics, pricing pressures, and evolving regulatory requirements for biosimilars in China.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received a second indication approval&#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":[330,43,118,15,1129],"class_list":["post-65866","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-amgen","tag-biosimilars","tag-mabwell-bioscience","tag-product-approvals","tag-sha-688062"],"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>Mabwell Bioscience Secures Second NMPA Approval for Denosu Biosimilar, Expanding Indication to Bone Metastases and Multiple Myeloma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received a second indication approval from China&#039;s National Medical Products Administration (NMPA) for its Denosu biosimilar, referencing Amgen&#039;s Xgeva (denosumab). 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