{"id":48446,"date":"2025-11-17T14:54:06","date_gmt":"2025-11-17T06:54:06","guid":{"rendered":"https:\/\/flcube.com\/?p=48446"},"modified":"2025-11-17T14:54:07","modified_gmt":"2025-11-17T06:54:07","slug":"henlius-poherdy-hlx11-receives-full-fda-approval-for-all-pertuzumab-indications","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48446","title":{"rendered":"Henlius\u2019 POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications"},"content":{"rendered":"\n<p><strong>Shanghai Henlius Biotech, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced that its pertuzumab biosimilar <strong>POHERDY<\/strong> (clinical name <strong>HLX11<\/strong>) has been granted <strong>U.S. Food and Drug Administration (FDA)<\/strong> approval covering <strong>every approved indication of Roche\u2019s Perjeta<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approved-indications\">FDA\u2011Approved Indications<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Indication<\/th><th>Patient Population<\/th><th>Treatment Regimen<\/th><\/tr><\/thead><tbody><tr><td><strong>Metastatic Breast Cancer (MBC)<\/strong><\/td><td>HER2\u2011positive adults with no prior anti\u2011HER2 therapy or chemotherapy for metastatic disease<\/td><td>POHERDY\u202f+\u202ftrastuzumab\u202f+\u202fdocetaxel<\/td><\/tr><tr><td><strong>Neoadjuvant Therapy<\/strong><\/td><td>HER2\u2011positive, locally advanced, inflammatory or early\u2011stage breast cancer (\u2265\u202f2\u202fcm or node\u2011positive)<\/td><td>POHERDY\u202f+\u202ftrastuzumab\u202f+\u202fchemotherapy (part of a complete early\u2011breast\u2011cancer regimen)<\/td><\/tr><tr><td><strong>Adjuvant Therapy<\/strong><\/td><td>HER2\u2011positive early breast cancer at high risk of recurrence<\/td><td>POHERDY\u202f+\u202ftrastuzumab\u202f+\u202fchemotherapy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-why-the-approval-matters\">Why the Approval Matters<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulatory Confidence<\/strong> \u2013 The FDA\u2019s decision was based on a <strong>comprehensive comparative data package<\/strong> demonstrating that HLX11 matches Perjeta in <strong>quality, safety, and efficacy<\/strong>.<\/li>\n\n\n\n<li><strong>Market Expansion<\/strong> \u2013 POHERDY now joins a limited pool of <strong>U.S.\u2011approved pertuzumab biosimilars<\/strong>, offering oncologists a lower\u2011cost alternative without compromising clinical outcomes.<\/li>\n\n\n\n<li><strong>Global Footprint<\/strong> \u2013 In addition to the FDA clearance, the <strong>NDA<\/strong> for HLX11 has been <strong>accepted<\/strong> by the <strong>China NMPA<\/strong>, <strong>European Medicines Agency (EMA)<\/strong>, and <strong>Health Canada<\/strong>, positioning Henlius for multi\u2011regional launch.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-commercial-strategy-amp-partnerships\">Commercial Strategy &amp; Partnerships<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Organon License<\/strong> \u2013 In June\u202f2022, Henlius granted <strong>Organon<\/strong> an exclusive, worldwide license to commercialize HLX11 <strong>outside of mainland China, Hong Kong, Macau, and Taiwan<\/strong>.<\/li>\n\n\n\n<li><strong>China\u2011Only Rights<\/strong> \u2013 Henlius retains full commercial rights for the <strong>Chinese market<\/strong>, where it plans to leverage its existing sales network and oncology partnerships.<\/li>\n\n\n\n<li><strong>Revenue Outlook<\/strong> \u2013 Analysts estimate that, with an <strong>average U.S. price parity to Perjeta<\/strong>, POHERDY could generate <strong>US$300\u2011400\u202fmillion<\/strong> in annual U.S. sales within three years, assuming a <strong>10\u201115\u202f% market share<\/strong> of the pertuzumab segment.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This brief contains forward\u2011looking statements regarding regulatory approvals, market potential, and commercial expectations for POHERDY. Actual results may differ due to clinical trial outcomes, regulatory actions, competitive dynamics, and other risk factors.<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\/2025\/11\/2025111400381_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025111400381_c.\"><\/object><a id=\"wp-block-file--media-34a4efac-9efc-4087-b7e1-46b6f3a79c26\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111400381_c.pdf\">2025111400381_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111400381_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-34a4efac-9efc-4087-b7e1-46b6f3a79c26\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its pertuzumab biosimilar POHERDY (clinical name HLX11)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48448,"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":[43,270,15,163],"class_list":["post-48446","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-biosimilars","tag-henlius-biotech","tag-product-approvals","tag-roche"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Henlius\u2019 POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech, Inc. 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