{"id":49055,"date":"2025-11-26T16:45:29","date_gmt":"2025-11-26T08:45:29","guid":{"rendered":"https:\/\/flcube.com\/?p=49055"},"modified":"2025-11-26T16:45:30","modified_gmt":"2025-11-26T08:45:30","slug":"hengruis-three-oncology-assets-win-nmpa-clinical-trial-approval","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=49055","title":{"rendered":"Hengrui&#8217;s Three Oncology Assets Win NMPA Clinical Trial Approval"},"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\/1276:HKG\">HKG: 1276<\/a>) announced that three of its investigational drugs received <strong>NMPA approval<\/strong> to initiate clinical trials: <strong>trastuzumab rezetecan<\/strong> (HER2 ADC), <strong>HRS\u20118364<\/strong> tablets (target undisclosed), and <strong>SHR\u20111139<\/strong> injection (pyoderma gangrenosum), strengthening its oncology and immunology pipeline.<\/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>Drug<\/th><th>Indication<\/th><th>Development Stage<\/th><th>Previous Milestones<\/th><th>Global Novelty<\/th><\/tr><\/thead><tbody><tr><td><strong>Trastuzumab rezetecan<\/strong><\/td><td>HER2\u2011amplified solid tumors (monotherapy)<\/td><td>Phase\u202fI\/II initiation<\/td><td>Approved May\u202f2025 for HER2\u2011mutant NSCLC<\/td><td>First domestic HER2 ADC<\/td><\/tr><tr><td><strong>HRS\u20118364 tablets<\/strong><\/td><td>Advanced solid tumors (monotherapy)<\/td><td>Phase\u202fI initiation<\/td><td>Target undisclosed<\/td><td>No similar drugs approved globally<\/td><\/tr><tr><td><strong>SHR\u20111139 injection<\/strong><\/td><td>Pyoderma gangrenosum<\/td><td>Phase\u202fII initiation<\/td><td>Approved for psoriasis\/UC (2023)<\/td><td>No similar biologics approved globally<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profiles\">Drug Profiles<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-trastuzumab-rezetecan\">Trastuzumab Rezetecan<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> Antibody\u2011Drug Conjugate (ADC) targeting HER2<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> Extends HER2 ADC platform beyond NSCLC into broader solid tumor indications<\/li>\n\n\n\n<li><strong>Market Edge:<\/strong> Addresses HER2\u2011amplified cancers (breast, gastric, colorectal) with limited ADC options<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-hrs-8364\">HRS\u20118364<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> Novel anti\u2011tumor small molecule (target undisclosed)<\/li>\n\n\n\n<li><strong>Strategy:<\/strong> First\u2011in\u2011class potential with global IP; mechanism protected until IND disclosure<\/li>\n\n\n\n<li><strong>Pipeline Value:<\/strong> Represents Hengrui\u2019s next\u2011generation oncology asset beyond kinase inhibitors<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-shr-1139\">SHR\u20111139<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> Therapeutic biological product (mechanism undisclosed)<\/li>\n\n\n\n<li><strong>Expansion:<\/strong> Re\u2011positions psoriasis\/UC asset for <strong>pyoderma gangrenosum<\/strong>, a rare, debilitating neutrophilic dermatosis<\/li>\n\n\n\n<li><strong>Unmet Need:<\/strong> No approved biologics globally; addresses severe ulcerative skin disease<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-outlook\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Indication<\/th><th>China Patient Pool<\/th><th>Market Size (2024)<\/th><th>Competitive Landscape<\/th><th>Peak Sales Forecast<\/th><\/tr><\/thead><tbody><tr><td><strong>HER2\u2011amplified solid tumors<\/strong><\/td><td>~150,000<\/td><td>\u00a525\u202fbillion<\/td><td>Dominated by trastuzumab biosimilars; ADCs emerging<\/td><td>\u00a5800\u202fmillion (rezetecan)<\/td><\/tr><tr><td><strong>Undisclosed solid tumor target<\/strong><\/td><td>TBD (depending on target)<\/td><td>TBD<\/td><td>First\u2011mover advantage if validated<\/td><td>\u00a5500\u202fmillion (if approved)<\/td><\/tr><tr><td><strong>Pyoderma gangrenosum<\/strong><\/td><td>~8,000\u201110,000<\/td><td>\u00a5300\u202fmillion<\/td><td>No approved biologics; steroids\/immunosuppressants standard<\/td><td>\u00a5150\u202fmillion (SHR\u20111139)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Strategic Value:<\/strong> Three approvals demonstrate Hengrui\u2019s <strong>parallel development capacity<\/strong> across ADC, small molecule, and biologic platforms<\/li>\n\n\n\n<li><strong>R&amp;D Efficiency:<\/strong> Leverages existing manufacturing and regulatory expertise from prior approvals<\/li>\n\n\n\n<li><strong>Next Catalysts:<\/strong> Phase\u202fI data for HRS\u20118364 expected <strong>H2\u202f2026<\/strong>; trastuzumab rezetecan HER2\u2011amplified data <strong>Q1\u202f2026<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding Hengrui\u2019s clinical development timelines, market potential, and competitive positioning. Actual results may differ materially due to risks including clinical trial outcomes, regulatory review, and competitive dynamics.<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\/600276_20251126_KJLT.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20251126_KJLT.\"><\/object><a id=\"wp-block-file--media-9b9492da-7186-4338-b3bc-2c81a91d2950\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/600276_20251126_KJLT.pdf\">600276_20251126_KJLT<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/600276_20251126_KJLT.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-9b9492da-7186-4338-b3bc-2c81a91d2950\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that three of its investigational&#8230;<\/p>\n","protected":false},"author":1,"featured_media":49057,"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":[35,16,62,2586,4228,852],"class_list":["post-49055","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-clinical-trial-approval-initiation","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-sha-600276"],"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>Hengrui&#039;s Three Oncology Assets Win NMPA Clinical Trial Approval - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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(SHA: 600276, HKG: 1276) announced that three of its investigational drugs received NMPA approval to initiate clinical trials: trastuzumab rezetecan (HER2 ADC), HRS\u20118364 tablets (target undisclosed), and SHR\u20111139 injection (pyoderma gangrenosum), strengthening its oncology and immunology pipeline.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=49055#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=49055"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=49055#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2610.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2610.webp","width":1080,"height":608,"caption":"Hengrui's Three Oncology Assets Win NMPA Clinical Trial Approval"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=49055#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Hengrui&#8217;s Three Oncology Assets Win NMPA Clinical Trial Approval"}]},{"@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":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2610.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/49055","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=49055"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/49055\/revisions"}],"predecessor-version":[{"id":49058,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/49055\/revisions\/49058"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/49057"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=49055"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=49055"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=49055"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}