{"id":52149,"date":"2025-12-29T12:54:47","date_gmt":"2025-12-29T04:54:47","guid":{"rendered":"https:\/\/flcube.com\/?p=52149"},"modified":"2025-12-29T12:54:48","modified_gmt":"2025-12-29T04:54:48","slug":"astrazeneca-secures-nmpa-approval-for-fasenra-in-egpa-demonstrating-superior-steroid-sparing-effect","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52149","title":{"rendered":"AstraZeneca Secures NMPA Approval for Fasenra in EGPA, Demonstrating Superior Steroid-Sparing Effect"},"content":{"rendered":"\n<p><strong>AstraZeneca PLC<\/strong> (AZ, <a href=\"https:\/\/www.google.com\/finance\/quote\/AZN:NASDAQ\">NASDAQ: AZN<\/a>) announced that <strong>Fasenra (benralizumab)<\/strong> has received <strong>additional approval<\/strong> from <strong>China\u2019s National Medical Products Administration (NMPA)<\/strong> for the treatment of <strong>adult eosinophilic granulomatosis with polyangiitis (EGPA)<\/strong>, a rare systemic vasculitis. The approval positions Fasenra as the <strong>first anti\u2011IL\u20115R biologic<\/strong> to demonstrate a <strong>steroid\u2011sparing advantage<\/strong> over the only prior EGPA therapy in a head\u2011to\u2011head trial.<\/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>Product<\/strong><\/td><td>Fasenra (benralizumab) \u2013 anti\u2011IL\u20115R monoclonal antibody<\/td><\/tr><tr><td><strong>New Indication<\/strong><\/td><td>Adult EGPA (eosinophilic granulomatosis with polyangiitis)<\/td><\/tr><tr><td><strong>Regulator<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>25\u202fDec\u202f2025<\/td><\/tr><tr><td><strong>Clinical Basis<\/strong><\/td><td>MANDARA Phase\u202f3 trial vs. mepolizumab (non\u2011inferiority design)<\/td><\/tr><tr><td><strong>Significance<\/strong><\/td><td><strong>First head\u2011to\u2011head win<\/strong> in EGPA showing higher oral corticosteroid (OCS) discontinuation<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-mandara-trial\">Clinical Evidence \u2013 MANDARA Trial<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Fasenra (n=101)<\/th><th>Mepolizumab (n=103)<\/th><th>Clinical Interpretation<\/th><\/tr><\/thead><tbody><tr><td><strong>Remission Rate (Week\u202f36)<\/strong><\/td><td>59.4\u202f%<\/td><td>56.3\u202f%<\/td><td>Met non\u2011inferiority (margin\u202f\u201110\u202f%)<\/td><\/tr><tr><td><strong>Complete OCS Discontinuation<\/strong><\/td><td><strong>41\u202f%<\/strong><\/td><td><strong>26\u202f%<\/strong><\/td><td><strong>Superior steroid\u2011sparing<\/strong> (p=0.03)<\/td><\/tr><tr><td><strong>Median OCS Dose Reduction<\/strong><\/td><td>75\u202f%<\/td><td>65\u202f%<\/td><td>Greater reduction in steroid burden<\/td><\/tr><tr><td><strong>OLE Phase (Switch Cohort)<\/strong><\/td><td>43.5\u202f% OCS discontinuation (post\u2011switch)<\/td><td>\u2013<\/td><td>Sustained benefit after switching<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Similar incidence of AEs; no new safety signals<\/td><td>Comparable tolerability<\/td><td>Established safety in eosinophilic diseases<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The MANDARA study was the <strong>first head\u2011to\u2011head biologic comparison<\/strong> in relapsed\/refractory EGPA and supported regulatory filings in the <strong>US (FDA sBLA under review) and EU (MAA submitted)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-development-amp-commercial-history\">Drug Development &amp; Commercial History<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Origin<\/strong>: Discovered by <strong>Kyowa Kirin<\/strong>; licensed to <strong>MedImmune<\/strong> in 2006 for US\/EU rights<\/li>\n\n\n\n<li><strong>Acquisition<\/strong>: <strong>AstraZeneca<\/strong> acquired MedImmune in 2007 for <strong>USD\u202f15.6\u202fbillion<\/strong>, gaining benralizumab and 44 pipeline assets<\/li>\n\n\n\n<li><strong>Geographic Expansion<\/strong>: Japan rights added in 2016; full Asia\u2011Pacific rights secured in 2019<\/li>\n\n\n\n<li><strong>China Launch<\/strong>: First approved in <strong>August\u202f2024<\/strong> for severe eosinophilic asthma; EGPA marks the <strong>second indication<\/strong><\/li>\n\n\n\n<li><strong>Global Sales<\/strong>: Fasenra generated <strong>USD\u202f1.4\u202fbillion<\/strong> in 2024, driven by asthma and EGPA (US\/EU) uptake<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-in-china\">Market Opportunity in China<\/h2>\n\n\n\n<p>EGPA is a <strong>rare disease<\/strong> with an estimated <strong>prevalence of 12\u201115 cases per million<\/strong> in China, suggesting a diagnosed patient population of <strong>~15,000\u201120,000<\/strong> individuals.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2026E<\/th><th>2028E<\/th><\/tr><\/thead><tbody><tr><td><strong>Diagnosed EGPA patients<\/strong><\/td><td>18,000<\/td><td>20,000<\/td><\/tr><tr><td><strong>Fasenra eligible (refractory)<\/strong><\/td><td>7,000<\/td><td>8,000<\/td><\/tr><tr><td><strong>Peak penetration<\/strong><\/td><td>45\u202f%<\/td><td>60\u202f%<\/td><\/tr><tr><td><strong>Annual treatment cost<\/strong><\/td><td>\u00a585,000<\/td><td>\u00a575,000 (post\u2011NRDL)<\/td><\/tr><tr><td><strong>China revenue potential<\/strong><\/td><td>\u00a5270\u202fmillion<\/td><td>\u00a5360\u202fmillion (US$38\u201150\u202fmillion)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The approval enables AstraZeneca to compete directly with <strong>GSK\u2019s Nucala (mepolizumab)<\/strong>, which has held a <strong>monopoly<\/strong> in China\u2019s EGPA market since its 2023 launch.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Differentiation<\/strong>: Fasenra\u2019s <strong>8\u2011week dosing<\/strong> (vs. Nucala\u2019s 4\u2011week) and <strong>superior OCS discontinuation<\/strong> support premium positioning<\/li>\n\n\n\n<li><strong>Reimbursement Pathway<\/strong>: AstraZeneca aims for <strong>2026 NRDL negotiation<\/strong>, leveraging real\u2011world OCS\u2011sparing data to justify inclusion<\/li>\n\n\n\n<li><strong>Portfolio Synergy<\/strong>: EGPA approval strengthens AZ\u2019s <strong>respiratory &amp; immunology franchise<\/strong> in China, which includes <strong>Breo Ellipta<\/strong> and <strong>Saphnelo<\/strong><\/li>\n\n\n\n<li><strong>Pipeline Leverage<\/strong>: MANDARA data may support <strong>sBLA submissions<\/strong> for <strong>eosinophilic esophagitis<\/strong> and <strong>hypereosinophilic syndrome<\/strong> in China by 2027<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief includes forward\u2011looking revenue projections, market penetration estimates, and regulatory plans for Fasenra in China and globally. Actual results may differ due to competitive responses, pricing negotiations, and market access policies.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>AstraZeneca PLC (AZ, NASDAQ: AZN) announced that Fasenra (benralizumab) has received additional approval from China\u2019s&#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":[130,871,15],"class_list":["post-52149","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-astrazeneca","tag-nasdaq-azn","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>AstraZeneca Secures NMPA Approval for Fasenra in EGPA, Demonstrating Superior Steroid-Sparing Effect - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"AstraZeneca PLC (AZ, NASDAQ: AZN) announced that Fasenra (benralizumab) has received additional approval from China\u2019s National Medical Products Administration (NMPA) for the treatment of adult eosinophilic granulomatosis with polyangiitis (EGPA), a rare systemic vasculitis. 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