{"id":53962,"date":"2026-01-13T21:34:44","date_gmt":"2026-01-13T13:34:44","guid":{"rendered":"https:\/\/flcube.com\/?p=53962"},"modified":"2026-01-13T21:42:35","modified_gmt":"2026-01-13T13:42:35","slug":"hengruis-shr-1826-adc-earns-breakthrough-therapy-designation-for-c-met-overexpressed-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53962","title":{"rendered":"Hengrui\u2019s SHR\u20111826 ADC Earns Breakthrough Therapy Designation for c\u2011Met Overexpressed NSCLC"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA:\u202f600276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG:\u202f1276<\/a>) announced that <strong>SHR\u20111826<\/strong>, an <strong>antibody\u2011drug conjugate (ADC) targeting c\u2011Met<\/strong>, has been granted <strong>Breakthrough Therapy Designation (BTD)<\/strong> by China\u2019s <strong>Center for Drug Evaluation (CDE)<\/strong> for the treatment of <strong>locally advanced or metastatic non\u2011squamous NSCLC<\/strong> patients with <strong>high c\u2011Met overexpression<\/strong> who have progressed after prior systemic therapy.<\/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>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals (600276.SH, 1276.HK)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>SHR\u20111826 (c\u2011Met ADC)<\/td><\/tr><tr><td><strong>Designation<\/strong><\/td><td>Breakthrough Therapy Designation (BTD)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>CDE of NMPA (China)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Monotherapy for c\u2011Met overexpressed (2\u20113+, \u226550%), driver\u2011gene\u2011negative, advanced nsq\u2011NSCLC post \u22651 prior therapy<\/td><\/tr><tr><td><strong>Designation Date<\/strong><\/td><td>10\u202fJan\u202f2026<\/td><\/tr><tr><td><strong>Next Steps<\/strong><\/td><td>Priority review pathway; potential NDA submission in Q4\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism\">Drug Profile &amp; Mechanism<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism of Action:<\/strong> SHR\u20111826 is an <strong>ADC<\/strong> that binds to c\u2011Met on tumor cell surfaces, internalizes, and releases a cytotoxic payload, leading to <strong>targeted cell death<\/strong> while sparing normal tissue<\/li>\n\n\n\n<li><strong>Target Population:<\/strong> <strong>c\u2011Met overexpression (2\u20113+, \u226550%)<\/strong> occurs in ~5\u20117\u202f% of NSCLC cases; typically associated with <strong>poor prognosis<\/strong> and <strong>resistance<\/strong> to EGFR\u2011TKIs and immunotherapy<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> Designed for <strong>high specificity<\/strong> and <strong>stable linker technology<\/strong> to minimize off\u2011target toxicity; addresses unmet need in <strong>driver\u2011gene\u2011negative<\/strong> population lacking targeted options<\/li>\n\n\n\n<li><strong>Global Benchmark:<\/strong> AbbVie\u2019s <strong>Emerlis (telisotuzumab vedotin, ABBV\u2011399)<\/strong> received <strong>FDA accelerated approval<\/strong> in May\u202f2025 for similar indication, validating the c\u2011Met ADC approach<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-patient-landscape\">Market Opportunity &amp; Patient Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>China<\/th><th>Global<\/th><\/tr><\/thead><tbody><tr><td><strong>NSCLC New Cases Annually<\/strong><\/td><td>800,000<\/td><td>2,200,000<\/td><\/tr><tr><td><strong>c\u2011Met High Overexpression (\u226550%)<\/strong><\/td><td>40,000\u201156,000<\/td><td>110,000\u2011154,000<\/td><\/tr><tr><td><strong>Driver\u2011Gene\u2011Negative Subset<\/strong><\/td><td>24,000\u201134,000<\/td><td>66,000\u201192,000<\/td><\/tr><tr><td><strong>2L+ Treatment\u2011Eligible<\/strong><\/td><td>~17,000<\/td><td>~46,000<\/td><\/tr><tr><td><strong>Addressable Market Value (2030E)<\/strong><\/td><td>\u00a52.5\u202fbillion<\/td><td>$1.8\u202fbillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Unmet Need:<\/strong> Current 2L+ options (chemo, immunotherapy) offer <strong>ORR &lt;15\u202f%<\/strong> and <strong>mPFS ~3\u202fmonths<\/strong> in c\u2011Met overexpressed NSCLC<\/li>\n\n\n\n<li><strong>Pricing Benchmark:<\/strong> Emerlis US pricing: <strong>$18,000\/month<\/strong>; Hengrui expected to price SHR\u20111826 at <strong>\u00a580,000\u2011100,000\/month<\/strong> in China<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape-c-met-adcs\">Competitive Landscape: c\u2011Met ADCs<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Drug<\/th><th>Company<\/th><th>Status<\/th><th>Approval Region<\/th><th>Key Efficacy (ORR)<\/th><\/tr><\/thead><tbody><tr><td><strong>Emerlis (telisotuzumab vedotin)<\/strong><\/td><td>AbbVie<\/td><td>Accelerated approval<\/td><td>US (May\u202f2025)<\/td><td>32\u202f%<\/td><\/tr><tr><td><strong>SHR\u20111826<\/strong><\/td><td><strong>Hengrui<\/strong><\/td><td>Breakthrough designation (China)<\/td><td>China (pending)<\/td><td>TBD (Phase\u202fII data expected Q3\u202f2026)<\/td><\/tr><tr><td><strong>RC108<\/strong><\/td><td>RemeGen<\/td><td>Phase\u202fII<\/td><td>China<\/td><td>28\u202f% (preliminary)<\/td><\/tr><tr><td><strong>ABBV\u2011514<\/strong><\/td><td>AbbVie<\/td><td>Phase\u202fI<\/td><td>Global<\/td><td>Early stage<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Strategic Moat:<\/strong> BTD provides <strong>6\u2011month expedited review<\/strong> and positions SHR\u20111826 as <strong>first\u2011to\u2011market c\u2011Met ADC<\/strong> in China, ahead of AbbVie\u2019s potential China filing<\/li>\n\n\n\n<li><strong>Global Expansion:<\/strong> Hengrui planning <strong>US IND filing<\/strong> in <strong>H1\u202f2027<\/strong>, leveraging China BTD and Phase\u202fII data for FDA fast\u2011track eligibility<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-timeline-amp-revenue-forecast\">Development Timeline &amp; Revenue Forecast<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Expected Timeline<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase\u202fII completion<\/strong><\/td><td>Q3\u202f2026<\/td><\/tr><tr><td><strong>NDA submission<\/strong><\/td><td>Q4\u202f2026<\/td><\/tr><tr><td><strong>China approval<\/strong><\/td><td>Q2\u202f2027 (via BTD pathway)<\/td><\/tr><tr><td><strong>US IND filing<\/strong><\/td><td>H1\u202f2027<\/td><\/tr><tr><td><strong>Global launch<\/strong><\/td><td>2028\u20112029<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2027E<\/th><th>2028E<\/th><th>2029E<\/th><\/tr><\/thead><tbody><tr><td><strong>China Market Penetration<\/strong><\/td><td>0\u202f%<\/td><td>12\u202f%<\/td><td>25\u202f%<\/td><\/tr><tr><td><strong>Patient Volume<\/strong><\/td><td>\u2013<\/td><td>2,040<\/td><td>4,250<\/td><\/tr><tr><td><strong>Annual Cost (\u00a5)<\/strong><\/td><td>\u2013<\/td><td>\u00a590,000<\/td><td>\u00a585,000<\/td><\/tr><tr><td><strong>Hengrui China Revenue (\u00a5)<\/strong><\/td><td>\u2013<\/td><td>\u00a51.84\u202fbillion<\/td><td>\u00a53.61\u202fbillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pipeline Synergy:<\/strong> SHR\u20111826 complements Hengrui\u2019s <strong>SHR\u20111701 (PD\u2011L1\/TGF\u2011\u03b2 bispecific)<\/strong> and <strong>SHR\u20110302 (JAK1 inhibitor)<\/strong>, creating a <strong>comprehensive NSCLC portfolio<\/strong><\/li>\n\n\n\n<li><strong>Manufacturing:<\/strong> Hengrui\u2019s <strong>Nanjing ADC facility<\/strong> (capacity 5,000\u202fL) ready for commercial production; additional $50\u202fM investment planned for expansion<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development timelines, regulatory pathways, and revenue forecasts for SHR\u20111826. Actual results may differ due to clinical trial outcomes, competitive dynamics, and evolving c\u2011Met biomarker diagnostic standards.<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\/01\/600276_20260113_WH9V.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20260113_WH9V.\"><\/object><a id=\"wp-block-file--media-07a311da-8cab-4655-b446-3da8dbbe10a0\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/600276_20260113_WH9V.pdf\">600276_20260113_WH9V<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/600276_20260113_WH9V.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-07a311da-8cab-4655-b446-3da8dbbe10a0\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that SHR\u20111826, an antibody\u2011drug conjugate (ADC) targeting&#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":[35,34,2586,4228,4551],"class_list":["post-53962","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-breakthrough-therapy","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-sha-600276-2"],"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\u2019s SHR\u20111826 ADC Earns Breakthrough Therapy Designation for c\u2011Met Overexpressed NSCLC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that SHR\u20111826, an antibody\u2011drug conjugate (ADC) targeting c\u2011Met, has been granted Breakthrough Therapy Designation (BTD) by China\u2019s Center for Drug Evaluation (CDE) for the treatment of locally advanced or metastatic non\u2011squamous NSCLC patients with high c\u2011Met overexpression who have progressed after prior systemic therapy.\" \/>\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=53962\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui\u2019s SHR\u20111826 ADC Earns Breakthrough Therapy Designation for c\u2011Met Overexpressed NSCLC\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that SHR\u20111826, an antibody\u2011drug conjugate (ADC) targeting c\u2011Met, has been granted Breakthrough Therapy Designation (BTD) by China\u2019s Center for Drug Evaluation (CDE) for the treatment of locally advanced or metastatic non\u2011squamous NSCLC patients with high c\u2011Met overexpression who have progressed after prior systemic therapy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=53962\" \/>\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=\"2026-01-13T13:34:44+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-13T13:42:35+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. 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(SHA:\u202f600276, HKG:\u202f1276) announced that SHR\u20111826, an antibody\u2011drug conjugate (ADC) targeting c\u2011Met, has been granted Breakthrough Therapy Designation (BTD) by China\u2019s Center for Drug Evaluation (CDE) for the treatment of locally advanced or metastatic non\u2011squamous NSCLC patients with high c\u2011Met overexpression who have progressed after prior systemic therapy.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=53962#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=53962"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=53962#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Hengrui\u2019s SHR\u20111826 ADC Earns Breakthrough Therapy Designation for c\u2011Met Overexpressed NSCLC"}]},{"@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\/53962","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=53962"}],"version-history":[{"count":2,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/53962\/revisions"}],"predecessor-version":[{"id":53968,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/53962\/revisions\/53968"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=53962"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=53962"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=53962"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}