{"id":41828,"date":"2025-09-18T20:41:22","date_gmt":"2025-09-18T12:41:22","guid":{"rendered":"https:\/\/flcube.com\/?p=41828"},"modified":"2025-09-18T20:41:23","modified_gmt":"2025-09-18T12:41:23","slug":"jiangsu-hengrui-secures-priority-review-for-trastuzumab-rezetecan-in-her2%e2%80%91positive-breast-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41828","title":{"rendered":"Jiangsu\u202fHengrui Secures Priority Review for Trastuzumab Rezetecan in HER2\u2011Positive Breast Cancer"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA: 600276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">HKG: 1276<\/a>) announced that the <strong>National Medical Products Administration (NMPA)<\/strong> has accepted its <strong>New Drug Application (NDA)<\/strong> for <strong>trastuzumab rezetecan injection (SHR\u2011A1811)<\/strong> and granted it <strong>Priority Review<\/strong> status. The new indication targets <strong>adult patients with locally advanced or metastatic HER2\u2011positive breast cancer<\/strong> who have already received one or more anti\u2011HER2 therapies.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-trastuzumab-rezetecan\">What Is Trastuzumab Rezetecan?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Self\u2011developed anti\u2011HER2 antibody\u2011drug conjugate (ADC)<\/strong> that binds HER2\u2011expressing tumor cells and is internalized.<\/li>\n\n\n\n<li>Inside the lysosome, a protease cleaves the conjugate, liberating a <strong>potent payload<\/strong> that <strong>induces cell\u2011cycle arrest<\/strong> and drives <strong>apoptosis<\/strong>.<\/li>\n\n\n\n<li>The payload\u2019s high membrane permeability results in a <strong>\u201cbystander\u2011killing\u201d<\/strong> effect, attacking neighboring tumor cells and amplifying anti\u2011tumor activity.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestones\">Regulatory Milestones<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Date<\/th><th>Status<\/th><\/tr><\/thead><tbody><tr><td>NDA acceptance for HER2\u2011positive breast cancer<\/td><td>17\u202fSep\u202f2025<\/td><td>Priority Review<\/td><\/tr><tr><td>First domestic ADC approval for HER2\u2011mutated NSCLC<\/td><td>1\u202fMay\u202f2025<\/td><td>Breakthrough Therapy<\/td><\/tr><tr><td>Total indications with Breakthrough Designation<\/td><td>\u2013<\/td><td>9<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Trastuzumab rezetecan was first approved in May\u202f2025 for <strong>unresectable locally advanced or metastatic NSCLC<\/strong> with HER2 (ERBB2) activating mutations after at least one prior systemic therapy. The current approval broadens its reach to a heavily pre\u2011treated breast cancer population, marking a significant expansion of its therapeutic portfolio.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-significance\">Market Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>HER2\u2011positive breast cancer<\/strong> remains a high\u2011need area; patients progressing after first\u2011line anti\u2011HER2 therapy lack robust options.<\/li>\n\n\n\n<li>The <strong>bystander\u2011killing mechanism<\/strong> may overcome tumor heterogeneity, addressing residual disease that conventional ADCs may miss.<\/li>\n\n\n\n<li>With <strong>Priority Review<\/strong> and <strong>Breakthrough Therapy<\/strong> designations, Hengrui is positioned for accelerated market entry, potentially capturing a sizable share of the global HER2\u2011targeted oncology market.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-next-steps\">Next Steps<\/h2>\n\n\n\n<p>Hengrui plans to submit detailed clinical data for the breast cancer indication in the coming months, with a target for NMPA approval by Q3\u202f2026. Concurrently, the company is exploring international regulatory pathways to extend availability to the U.S. and EU markets.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41833,"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":[35,16,2586,4228,38,852],"class_list":["post-41828","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-market-approval-filings","tag-sha-600276"],"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>Jiangsu\u202fHengrui Secures Priority Review for Trastuzumab Rezetecan in HER2\u2011Positive Breast Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for trastuzumab rezetecan injection (SHR\u2011A1811) and granted it Priority Review status. The new indication targets adult patients with locally advanced or metastatic HER2\u2011positive breast cancer who have already received one or more anti\u2011HER2 therapies.\" \/>\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=41828\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jiangsu\u202fHengrui Secures Priority Review for Trastuzumab Rezetecan in HER2\u2011Positive Breast Cancer\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for trastuzumab rezetecan injection (SHR\u2011A1811) and granted it Priority Review status. 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