{"id":64222,"date":"2026-04-29T20:06:22","date_gmt":"2026-04-29T12:06:22","guid":{"rendered":"https:\/\/flcube.com\/?p=64222"},"modified":"2026-04-29T20:06:23","modified_gmt":"2026-04-29T12:06:23","slug":"henlius-biotech-secures-european-commission-approval-for-poherdy-biosimilar-to-roches-perjeta","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64222","title":{"rendered":"Henlius Biotech Secures European Commission Approval for Poherdy Biosimilar to Roche&#8217;s Perjeta"},"content":{"rendered":"\n<p><strong>Shanghai Henlius Biotech, Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>) announced it has received <strong>marketing authorization from the European Commission (EC)<\/strong> for <strong>Poherdy<\/strong>, a biosimilar to <strong>Roche&#8217;s Perjeta<\/strong> (<strong>pertuzumab<\/strong>), marking a significant milestone in the company&#8217;s global oncology expansion strategy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-approval-summary\">Regulatory Approval Summary<\/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>Approval Authority<\/strong><\/td><td>European Commission (EC)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Poherdy (pertuzumab biosimilar)<\/td><\/tr><tr><td><strong>Reference Product<\/strong><\/td><td>Roche&#8217;s Perjeta (pertuzumab)<\/td><\/tr><tr><td><strong>Indications<\/strong><\/td><td>HER2-positive breast cancer across neoadjuvant, adjuvant, and metastatic settings<\/td><\/tr><tr><td><strong>Combination Therapy<\/strong><\/td><td>Used with trastuzumab and chemotherapy<\/td><\/tr><tr><td><strong>Market Access<\/strong><\/td><td>Immediate commercial availability across all EU member states<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-indications-amp-therapeutic-applications\">Clinical Indications &amp; Therapeutic Applications<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-neoadjuvant-treatment\">Neoadjuvant Treatment<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Adult patients with <strong>HER2-positive, locally advanced, inflammatory, or early-stage breast cancer<\/strong> at high risk of recurrence<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-adjuvant-treatment\">Adjuvant Treatment<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Adult patients with <strong>HER2-positive early-stage breast cancer<\/strong> at high risk of recurrence<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-metastatic-recurrent-treatment\">Metastatic\/Recurrent Treatment<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Adult patients with <strong>HER2-positive, metastatic or locally recurrent unresectable breast cancer<\/strong> who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease<\/li>\n\n\n\n<li>Administered in combination with trastuzumab and docetaxel<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-global-regulatory-timeline\">Global Regulatory Timeline<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Date<\/th><th>Milestone<\/th><th>Jurisdiction<\/th><\/tr><\/thead><tbody><tr><td><strong>June 2022<\/strong><\/td><td>Exclusive global licensing agreement with Organon LLC<\/td><td>Global (ex-China)<\/td><\/tr><tr><td><strong>December 2024<\/strong><\/td><td>NDA accepted for review<\/td><td>China (NMPA)<\/td><\/tr><tr><td><strong>May 2025<\/strong><\/td><td>NDA accepted for review<\/td><td>Canada (Health Canada)<\/td><\/tr><tr><td><strong>November 2025<\/strong><\/td><td>FDA approval granted<\/td><td>United States<\/td><\/tr><tr><td><strong>April 2026<\/strong><\/td><td>EC approval granted<\/td><td>European Union<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-commercial-strategy-amp-partnership-framework\">Commercial Strategy &amp; Partnership Framework<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Global Commercialization:<\/strong> <strong>Organon LLC<\/strong> holds exclusive license for worldwide commercialization excluding Chinese mainland, Hong Kong, Macau, and Taiwan<\/li>\n\n\n\n<li><strong>Market Opportunity:<\/strong> Addresses \u20ac2.8 billion European HER2-positive breast cancer biologics market<\/li>\n\n\n\n<li><strong>Competitive Positioning:<\/strong> First Chinese-developed pertuzumab biosimilar to achieve comprehensive global regulatory approvals<\/li>\n\n\n\n<li><strong>Revenue Model:<\/strong> Royalty-based structure with Organon for international markets; direct commercialization in Greater China region<\/li>\n<\/ul>\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>Chinese Biotech Milestone:<\/strong> Represents one of the most successful global regulatory achievements by a China-based biopharmaceutical company<\/li>\n\n\n\n<li><strong>Biosimilar Leadership:<\/strong> Establishes Henlius as a leader in complex oncology biosimilars with multi-jurisdictional approval capability<\/li>\n\n\n\n<li><strong>Healthcare Economics:<\/strong> Expected to reduce treatment costs by 30\u201340% compared to originator product, improving patient access<\/li>\n\n\n\n<li><strong>Pipeline Validation:<\/strong> Demonstrates Henlius&#8217; capability to develop and gain approval for complex monoclonal antibody biosimilars<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding regulatory approvals, commercial partnerships, and market opportunities. Actual results may differ due to risks including market adoption rates, pricing pressures, and competitive dynamics in the biosimilar space.<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\/2026\/04\/2026042803536_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026042803536_c.\"><\/object><a id=\"wp-block-file--media-92bb397c-2684-4c4f-b068-c1de1f05c325\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2026042803536_c.pdf\">2026042803536_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2026042803536_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-92bb397c-2684-4c4f-b068-c1de1f05c325\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received marketing authorization from the European&#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":[43,270,862,15,163],"class_list":["post-64222","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biosimilars","tag-henlius-biotech","tag-hkg-2696","tag-product-approvals","tag-roche"],"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>Henlius Biotech Secures European Commission Approval for Poherdy Biosimilar to Roche&#039;s Perjeta - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech, Inc. 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