{"id":66950,"date":"2026-06-01T14:47:01","date_gmt":"2026-06-01T06:47:01","guid":{"rendered":"https:\/\/flcube.com\/?p=66950"},"modified":"2026-06-01T14:47:02","modified_gmt":"2026-06-01T06:47:02","slug":"henlius-biotechs-perjeta-biosimilar-hlx11-poherdy-secures-nmpa-approval-for-her2-positive-breast-cancer-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=66950","title":{"rendered":"Henlius Biotech&#8217;s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Shanghai Henlius Biotech Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/2696:HKG\">HKG: 2696<\/a>)<\/strong> announced that the <strong>National Medical Products Administration (NMPA)<\/strong> has approved the market filing for <strong>HLX11 (US trade name: Poherdy)<\/strong>, its <strong>biosimilar version of Perjeta (pertuzumab)<\/strong>, for the treatment of <strong>HER2-positive breast cancer<\/strong>. The approval encompasses both <strong>adjuvant therapy for early-stage disease<\/strong> and <strong>first-line treatment for metastatic or unresectable locally recurrent breast cancer<\/strong>, completing Henlius&#8217; global regulatory success following approvals in the <strong>United States (November 2025)<\/strong> and <strong>European Union (April 2026)<\/strong>, with ongoing marketing review in Canada.<\/p>\n\n\n\n<h2 id=\"h-regulatory-approval-details\" class=\"wp-block-heading\">Regulatory Approval Details<\/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>Company<\/strong><\/td><td>Shanghai Henlius Biotech Inc. (HKG: 2696)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>HLX11 (Poherdy) \u2013 pertuzumab biosimilar<\/td><\/tr><tr><td><strong>Reference Product<\/strong><\/td><td>Roche&#8217;s Perjeta (pertuzumab)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>01 Jun 2026<\/td><\/tr><tr><td><strong>Global Status<\/strong><\/td><td>Approved in US (Nov 2025), EU (Apr 2026), under review in Canada<\/td><\/tr><tr><td><strong>Market Significance<\/strong><\/td><td>First pertuzumab biosimilar approved in China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-indications-amp-clinical-applications\" class=\"wp-block-heading\">Indications &amp; Clinical Applications<\/h2>\n\n\n\n<h3 id=\"h-adjuvant-setting\" class=\"wp-block-heading\">Adjuvant Setting<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient Population<\/strong>: HER2-positive early breast cancer patients with <strong>high risk of recurrence<\/strong><\/li>\n\n\n\n<li><strong>Regimen<\/strong>: HLX11 + trastuzumab + chemotherapy<\/li>\n\n\n\n<li><strong>Treatment Goal<\/strong>: Reduce risk of disease recurrence following curative-intent surgery<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-metastatic-unresectable-setting\" class=\"wp-block-heading\">Metastatic\/Unresectable Setting<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient Population<\/strong>: HER2-positive, metastatic or unresectable locally recurrent breast cancer patients<\/li>\n\n\n\n<li><strong>Treatment Criteria<\/strong>: <strong>No prior anti-HER2 treatment or chemotherapy<\/strong> for metastatic disease<\/li>\n\n\n\n<li><strong>Regimen<\/strong>: HLX11 + trastuzumab + docetaxel<\/li>\n\n\n\n<li><strong>Treatment Goal<\/strong>: First-line systemic therapy for advanced disease<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-strategic-market-implications\" class=\"wp-block-heading\">Strategic Market Implications<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The NMPA approval positions Henlius to capture significant share in China&#8217;s <strong>HER2-positive breast cancer market<\/strong>, which represents approximately <strong>20\u201325% of all breast cancer cases<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Addressable Population<\/strong>: Estimated <strong>80,000\u2013100,000 new HER2-positive breast cancer patients annually<\/strong> in China<\/li>\n\n\n\n<li><strong>Pricing Advantage<\/strong>: Biosimilar expected to offer <strong>30\u201350% cost reduction<\/strong> compared to originator Perjeta<\/li>\n\n\n\n<li><strong>Franchise Synergy<\/strong>: Complements Henlius&#8217; existing <strong>trastuzumab biosimilar (HLX02\/Hercebriq)<\/strong>, enabling complete dual HER2 blockade regimens<\/li>\n\n\n\n<li><strong>Market Access<\/strong>: Immediate eligibility for inclusion in provincial reimbursement lists and hospital formularies<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">&#8220;This NMPA approval marks a pivotal milestone in our mission to make high-quality biologics accessible to Chinese patients,&#8221; said Dr. Scott Liu, Chief Executive Officer of Henlius Biotech. &#8220;With HLX11 now approved across all major global markets, we can provide comprehensive dual HER2 blockade therapy at significantly lower costs, potentially improving outcomes for thousands of breast cancer patients in China.&#8221;<\/p>\n\n\n\n<h2 id=\"h-competitive-landscape-amp-commercial-outlook\" class=\"wp-block-heading\">Competitive Landscape &amp; Commercial Outlook<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Henlius&#8217; first-mover advantage in China&#8217;s pertuzumab biosimilar market provides significant strategic benefits:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Supply Security<\/strong>: Domestic manufacturing ensures consistent availability versus imported originator product<\/li>\n\n\n\n<li><strong>Healthcare System Integration<\/strong>: Aligns with China&#8217;s national policy promoting biosimilar adoption to control healthcare costs<\/li>\n\n\n\n<li><strong>Revenue Potential<\/strong>: Analysts estimate peak annual sales of <strong>\u00a51.5\u20132.5 billion ($210\u2013350 million)<\/strong> in the Chinese market alone<\/li>\n\n\n\n<li><strong>Global Platform<\/strong>: Successful regulatory pathway across US, EU, and China validates Henlius&#8217; international development capabilities<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The company expects immediate commercial launch across major hospitals and cancer centers, with pricing negotiations underway with provincial health authorities for reimbursement inclusion.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding regulatory approvals, commercial launches, and market opportunities for HLX11. Actual results may differ due to market adoption patterns, pricing negotiations, and competitive developments.<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\/06\/2026052900667_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026052900667_c.\"><\/object><a id=\"wp-block-file--media-5dd5c392-fbb7-4798-bf44-137e3553584a\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/2026052900667_c.pdf\">2026052900667_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/2026052900667_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-5dd5c392-fbb7-4798-bf44-137e3553584a\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has&#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":[43,16,270,862,15],"class_list":["post-66950","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biosimilars","tag-cancer","tag-henlius-biotech","tag-hkg-2696","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Henlius Biotech&#039;s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has approved the market filing for HLX11 (US trade name: Poherdy), its biosimilar version of Perjeta (pertuzumab), for the treatment of HER2-positive breast cancer. The approval encompasses both adjuvant therapy for early-stage disease and first-line treatment for metastatic or unresectable locally recurrent breast cancer, completing Henlius&#039; global regulatory success following approvals in the United States (November 2025) and European Union (April 2026), with ongoing marketing review in Canada.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=66950\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Henlius Biotech&#039;s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China\" \/>\n<meta property=\"og:description\" content=\"Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has approved the market filing for HLX11 (US trade name: Poherdy), its biosimilar version of Perjeta (pertuzumab), for the treatment of HER2-positive breast cancer. The approval encompasses both adjuvant therapy for early-stage disease and first-line treatment for metastatic or unresectable locally recurrent breast cancer, completing Henlius&#039; global regulatory success following approvals in the United States (November 2025) and European Union (April 2026), with ongoing marketing review in Canada.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=66950\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-01T06:47:01+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-01T06:47:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=66950#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=66950\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Henlius Biotech&#8217;s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China\",\"datePublished\":\"2026-06-01T06:47:01+00:00\",\"dateModified\":\"2026-06-01T06:47:02+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=66950\"},\"wordCount\":492,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Biosimilars\",\"Cancer\",\"Henlius Biotech\",\"HKG: 2696\",\"Product approvals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=66950#respond\"]}],\"copyrightYear\":\"2026\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=66950\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=66950\",\"name\":\"Henlius Biotech's Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2026-06-01T06:47:01+00:00\",\"dateModified\":\"2026-06-01T06:47:02+00:00\",\"description\":\"Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has approved the market filing for HLX11 (US trade name: Poherdy), its biosimilar version of Perjeta (pertuzumab), for the treatment of HER2-positive breast cancer. The approval encompasses both adjuvant therapy for early-stage disease and first-line treatment for metastatic or unresectable locally recurrent breast cancer, completing Henlius' global regulatory success following approvals in the United States (November 2025) and European Union (April 2026), with ongoing marketing review in Canada.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=66950#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=66950\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=66950#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Henlius Biotech&#8217;s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Henlius Biotech's Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China - Insight, China&#039;s Pharmaceutical Industry","description":"Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has approved the market filing for HLX11 (US trade name: Poherdy), its biosimilar version of Perjeta (pertuzumab), for the treatment of HER2-positive breast cancer. The approval encompasses both adjuvant therapy for early-stage disease and first-line treatment for metastatic or unresectable locally recurrent breast cancer, completing Henlius' global regulatory success following approvals in the United States (November 2025) and European Union (April 2026), with ongoing marketing review in Canada.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=66950","og_locale":"en_US","og_type":"article","og_title":"Henlius Biotech's Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China","og_description":"Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has approved the market filing for HLX11 (US trade name: Poherdy), its biosimilar version of Perjeta (pertuzumab), for the treatment of HER2-positive breast cancer. The approval encompasses both adjuvant therapy for early-stage disease and first-line treatment for metastatic or unresectable locally recurrent breast cancer, completing Henlius' global regulatory success following approvals in the United States (November 2025) and European Union (April 2026), with ongoing marketing review in Canada.","og_url":"https:\/\/flcube.com\/?p=66950","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2026-06-01T06:47:01+00:00","article_modified_time":"2026-06-01T06:47:02+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=66950#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=66950"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Henlius Biotech&#8217;s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China","datePublished":"2026-06-01T06:47:01+00:00","dateModified":"2026-06-01T06:47:02+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=66950"},"wordCount":492,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Biosimilars","Cancer","Henlius Biotech","HKG: 2696","Product approvals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=66950#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=66950","url":"https:\/\/flcube.com\/?p=66950","name":"Henlius Biotech's Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2026-06-01T06:47:01+00:00","dateModified":"2026-06-01T06:47:02+00:00","description":"Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has approved the market filing for HLX11 (US trade name: Poherdy), its biosimilar version of Perjeta (pertuzumab), for the treatment of HER2-positive breast cancer. The approval encompasses both adjuvant therapy for early-stage disease and first-line treatment for metastatic or unresectable locally recurrent breast cancer, completing Henlius' global regulatory success following approvals in the United States (November 2025) and European Union (April 2026), with ongoing marketing review in Canada.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=66950#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=66950"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=66950#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Henlius Biotech&#8217;s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/66950","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=66950"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/66950\/revisions"}],"predecessor-version":[{"id":66952,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/66950\/revisions\/66952"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=66950"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=66950"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=66950"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}