{"id":55089,"date":"2026-01-22T09:36:10","date_gmt":"2026-01-22T01:36:10","guid":{"rendered":"https:\/\/flcube.com\/?p=55089"},"modified":"2026-04-21T20:47:04","modified_gmt":"2026-04-21T12:47:04","slug":"hengruis-shr-9839-hrs-4642-combo-cleared-for-advanced-crc-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=55089","title":{"rendered":"Hengrui\u2019s SHR-9839 + HRS-4642 Combo Cleared for Advanced CRC Trials"},"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 China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has approved clinical trials for the combination of <strong>subcutaneous SHR-9839<\/strong> and <strong>liposomal HRS-4642<\/strong> in <strong>advanced colorectal cancer (CRC)<\/strong>, advancing a <strong>first\u2011in\u2011class bispecific pathway blocker plus novel KRAS G12D inhibitor<\/strong> regimen for patients who have failed standard 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 Co., Ltd (SHA:\u202f600276, HKG:\u202f1276)<\/td><\/tr><tr><td><strong>Combination<\/strong><\/td><td>SHR-9839 (subcutaneous antibody) + HRS-4642 (liposomal KRAS G12D inhibitor)<\/td><\/tr><tr><td><strong>Application<\/strong><\/td><td>Clinical Trial Application (CTA)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Advanced\/metastatic CRC (inoperable, post\u2011standard therapy failure)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>16\u202fJan\u202f2026<\/td><\/tr><tr><td><strong>Innovation<\/strong><\/td><td>First KRAS G12D inhibitor in China; subcutaneous bispecific pathway blocker<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<p><strong>SHR-9839 (Subcutaneous Dual\u2011Pathway Antibody):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> Simultaneously blocks <strong>two key signaling pathways<\/strong> involved in tumor development (specific targets undisclosed)<\/li>\n\n\n\n<li><strong>Administration:<\/strong> <strong>Subcutaneous injection<\/strong> improves patient convenience vs. IV formulations<\/li>\n\n\n\n<li><strong>Market Status:<\/strong> Only <strong>one drug targeting the same pathway<\/strong> approved globally, indicating <strong>novel target space<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>HRS-4642 (Liposomal KRAS G12D Inhibitor):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> <strong>Liposomal formulation<\/strong> enables targeted delivery; specifically <strong>binds KRAS G12D<\/strong> and inhibits <strong>MEK\/ERK phosphorylation<\/strong>, blocking downstream oncogenic signaling<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> <strong>First KRAS G12D inhibitor<\/strong> in clinical development in China; <strong>no global approvals<\/strong> for this class<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> Addresses <strong>undruggable KRAS G12D mutation<\/strong> present in <strong>~4% of CRC patients<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-competitive-landscape\">Market Opportunity &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>China CRC Market<\/th><th>KRAS G12D CRC Segment<\/th><\/tr><\/thead><tbody><tr><td><strong>Advanced CRC Patients (2026E)<\/strong><\/td><td>180,000<\/td><td>7,200<\/td><\/tr><tr><td><strong>Failed Standard Therapy<\/strong><\/td><td>54,000<\/td><td>2,160<\/td><\/tr><tr><td><strong>Current Standard<\/strong><\/td><td>Chemo \u00b1 anti\u2011VEGF\/anti\u2011EGFR \u00b1 PD\u20111<\/td><td>No approved KRAS G12D inhibitors<\/td><\/tr><tr><td><strong>HRS-4642 Market Share<\/strong><\/td><td>0%<\/td><td>35% (post\u2011approval)<\/td><\/tr><tr><td><strong>Annual Cost (USD)<\/strong><\/td><td>\u2013<\/td><td>$85,000<\/td><\/tr><tr><td><strong>Peak Revenue (2032E)<\/strong><\/td><td>\u2013<\/td><td>$85\u202fmillion (KRAS G12D segment)<\/td><\/tr><tr><td><strong>Combo Therapy Value<\/strong><\/td><td><strong>Extends SHR-9839<\/strong> into refractory CRC<\/td><td><strong>Validates KRAS platform<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Key Competitors:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mirati Therapeutics<\/strong> \u2013 MRTX1133 (KRAS G12D inhibitor, Phase\u202fI)<\/li>\n\n\n\n<li><strong>Revolution Medicines<\/strong> \u2013 RAS(ON) G12D inhibitor (pre\u2011clinical)<\/li>\n\n\n\n<li><strong>Amgen<\/strong> \u2013 Sotorasib (KRAS G12C, not G12D)<\/li>\n\n\n\n<li><strong>Hengrui<\/strong> \u2013 <strong>First KRAS G12D inhibitor<\/strong> in China; <strong>subcutaneous delivery<\/strong> offers convenience<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning\">Strategic Positioning<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Manufacturing:<\/strong> Hengrui\u2019s <strong>Lianyungang biologics facility<\/strong> (capacity 30,000\u202fL) will produce SHR-9839; <strong>Nanjing ADC\/lipid plant<\/strong> will manufacture HRS-4642<\/li>\n\n\n\n<li><strong>Clinical Development:<\/strong> <strong>Phase\u202fI\/II dose\u2011escalation<\/strong> planned <strong>Q2\u202f2026<\/strong>; primary endpoint: <strong>objective response rate (ORR)<\/strong>; secondary: <strong>PFS, OS, safety<\/strong><\/li>\n\n\n\n<li><strong>Platform Synergy:<\/strong> Success validates <strong>Hengrui\u2019s bispecific antibody platform<\/strong> and <strong>KRAS inhibitor pipeline<\/strong>, supporting <strong>future combos<\/strong> (e.g., KRAS G12D + EGFR ADC)<\/li>\n\n\n\n<li><strong>Global Ambitions:<\/strong> Hengrui plans <strong>US IND filing<\/strong> for HRS-4642 in <strong>2027<\/strong>, leveraging China data<\/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 commercial projections for SHR-9839 and HRS-4642. Actual results may differ due to clinical trial outcomes, competitive dynamics, and manufacturing challenges.<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_20260121_MY0T.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20260121_MY0T.\"><\/object><a id=\"wp-block-file--media-f875d8bb-4c99-4c2a-9818-836858cd9ed8\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/600276_20260121_MY0T.pdf\">600276_20260121_MY0T<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/01\/600276_20260121_MY0T.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-f875d8bb-4c99-4c2a-9818-836858cd9ed8\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA:\u202f600276, HKG:\u202f1276) announced that China\u2019s National Medical Products Administration (NMPA)&#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":[1],"tags":[2586,4228,852],"class_list":["post-55089","post","type-post","status-publish","format-standard","hentry","category-uncategorized","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 v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui\u2019s SHR-9839 + HRS-4642 Combo Cleared for Advanced CRC Trials - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA:\u202f600276, HKG:\u202f1276) announced that China\u2019s National Medical Products Administration (NMPA) has approved clinical trials for the combination of subcutaneous SHR-9839 and liposomal HRS-4642 in advanced colorectal cancer (CRC), advancing a first\u2011in\u2011class bispecific pathway blocker plus novel KRAS G12D inhibitor regimen for patients who have failed standard 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=55089\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui\u2019s SHR-9839 + HRS-4642 Combo Cleared for Advanced CRC Trials\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA:\u202f600276, HKG:\u202f1276) announced that China\u2019s National Medical Products Administration (NMPA) has approved clinical trials for the combination of subcutaneous SHR-9839 and liposomal HRS-4642 in advanced colorectal cancer (CRC), advancing a first\u2011in\u2011class bispecific pathway blocker plus novel KRAS G12D inhibitor regimen for patients who have failed standard therapy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=55089\" \/>\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=\"2026-01-22T01:36:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-21T12:47:04+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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Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2026-01-22T01:36:10+00:00","dateModified":"2026-04-21T12:47:04+00:00","description":"Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA:\u202f600276, HKG:\u202f1276) announced that China\u2019s National Medical Products Administration (NMPA) has approved clinical trials for the combination of subcutaneous SHR-9839 and liposomal HRS-4642 in advanced colorectal cancer (CRC), advancing a first\u2011in\u2011class bispecific pathway blocker plus novel KRAS G12D inhibitor regimen for patients who have failed standard therapy.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=55089#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=55089"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=55089#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Hengrui\u2019s SHR-9839 + HRS-4642 Combo Cleared for Advanced CRC Trials"}]},{"@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\/55089","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=55089"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/55089\/revisions"}],"predecessor-version":[{"id":55091,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/55089\/revisions\/55091"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=55089"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=55089"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=55089"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}