{"id":59327,"date":"2026-03-12T12:51:22","date_gmt":"2026-03-12T04:51:22","guid":{"rendered":"https:\/\/flcube.com\/?p=59327"},"modified":"2026-03-12T12:51:23","modified_gmt":"2026-03-12T04:51:23","slug":"hengruis-shr-2524-wins-nmpa-phase-i-approval-novel-subcutaneous-formulation-plus-bevacizumab-targets-first-line-liver-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59327","title":{"rendered":"Hengrui&#8217;s SHR-2524 Wins NMPA Phase I Approval \u2013 Novel Subcutaneous Formulation Plus Bevacizumab Targets First-Line Liver 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\/1276:HKG\">HKG: 1276<\/a>) announced <strong>NMPA clearance<\/strong> to initiate a <strong>Phase I clinical trial<\/strong> evaluating <strong>SHR-2524 injection<\/strong> in <strong>combination with bevacizumab<\/strong> as <strong>first-line treatment for advanced hepatocellular carcinoma (HCC)<\/strong>. The <strong>Category 2.1 and 2.3 modified therapeutic biological product<\/strong> represents a <strong>novel subcutaneous formulation<\/strong> with <strong>no similar products currently available domestically or internationally<\/strong>, positioning Hengrui to address the <strong>largest liver cancer market globally<\/strong> with improved <strong>patient convenience and compliance<\/strong>.<\/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>Agency<\/strong><\/td><td>National Medical Products Administration (NMPA)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Phase I clinical trial authorization (IND)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>SHR-2524 injection<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Category 2.1 and 2.3 modified therapeutic biological product<\/td><\/tr><tr><td><strong>Combination<\/strong><\/td><td>Bevacizumab (anti-VEGF antibody)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Advanced hepatocellular carcinoma (HCC) \u2013 first-line<\/td><\/tr><tr><td><strong>Study Objectives<\/strong><\/td><td>Pharmacokinetics, safety, tolerability, efficacy<\/td><\/tr><tr><td><strong>Developer<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals (SHA: 600276, HKG: 1276)<\/td><\/tr><tr><td><strong>Differentiation<\/strong><\/td><td><strong>No subcutaneous formulation of similar products available globally<\/strong><\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>12\u202fMar\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-profile-amp-strategic-value\">Product Profile &amp; Strategic Value<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>SHR-2524 Specification<\/th><\/tr><\/thead><tbody><tr><td><strong>Modification Class<\/strong><\/td><td>Category 2.1 (new dosage form) + 2.3 (new route of administration)<\/td><\/tr><tr><td><strong>Formulation Innovation<\/strong><\/td><td>Subcutaneous injection vs. existing intravenous formulations<\/td><\/tr><tr><td><strong>Target Indication<\/strong><\/td><td>Hepatocellular carcinoma (HCC) \u2013 first-line setting<\/td><\/tr><tr><td><strong>Combination Rationale<\/strong><\/td><td>SHR-2524 + bevacizumab (anti-angiogenesis backbone)<\/td><\/tr><tr><td><strong>Clinical Advantage<\/strong><\/td><td>Potential for improved patient convenience, reduced infusion center burden, enhanced compliance<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>HCC Market Context:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China Burden:<\/strong> 400,000+ annual cases; 50% of global HCC incidence; hepatitis B-driven etiology<\/li>\n\n\n\n<li><strong>Standard of Care:<\/strong> Atezolizumab + bevacizumab (IMbrave150 regimen) dominates first-line; subcutaneous alternatives limited<\/li>\n\n\n\n<li><strong>Unmet Need:<\/strong> IV infusion requirements limit access in community settings; subcutaneous enables broader distribution<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Product<\/th><th>Developer<\/th><th>Mechanism\/Class<\/th><th>Route<\/th><th>China Status<\/th><th>SHR-2524 Differentiation<\/th><\/tr><\/thead><tbody><tr><td><strong>Avastin (bevacizumab)<\/strong><\/td><td>Roche<\/td><td>Anti-VEGF mAb<\/td><td>IV<\/td><td>Approved (HCC)<\/td><td>Subcutaneous formulation convenience<\/td><\/tr><tr><td><strong>Tecentriq + Avastin<\/strong><\/td><td>Roche<\/td><td>PD-L1 + anti-VEGF<\/td><td>IV<\/td><td>Approved (1L HCC)<\/td><td>Potential subcutaneous alternative to IV combination<\/td><\/tr><tr><td><strong>Sintilimab + bevacizumab<\/strong><\/td><td>Innovent<\/td><td>PD-1 + anti-VEGF<\/td><td>IV<\/td><td>Approved (1L HCC)<\/td><td>Formulation innovation vs. standard IV<\/td><\/tr><tr><td><strong>Hengrui<\/strong><\/td><td><strong>SHR-2524<\/strong><\/td><td><strong>Modified biologic (undisclosed target)<\/strong><\/td><td><strong>Subcutaneous<\/strong><\/td><td><strong>Phase I-ready<\/strong><\/td><td><strong>First subcutaneous formulation in class; potential for combination versatility<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-development-outlook\">Development Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Phase<\/th><th>Timeline<\/th><th>Objectives<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase I<\/strong><\/td><td>2026-2027<\/td><td>PK\/PD characterization; safety\/tolerability of subcutaneous route; preliminary efficacy signals<\/td><\/tr><tr><td><strong>Phase II<\/strong><\/td><td>2027-2028<\/td><td>Expansion in HCC; biomarker stratification; combination optimization<\/td><\/tr><tr><td><strong>Phase III<\/strong><\/td><td>2028-2030<\/td><td>Head-to-head vs. standard of care (atezo\/bev); China NDA filing<\/td><\/tr><tr><td><strong>Global Strategy<\/strong><\/td><td>2029+<\/td><td>U.S.\/EU IND potential; subcutaneous formulation may support 505(b)(2) pathway<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding clinical development timelines, formulation advantages, and competitive positioning for SHR-2524 in hepatocellular carcinoma. Actual results may differ due to target\/mechanism disclosure timing, subcutaneous bioavailability challenges, and competitive dynamics in the HCC immunotherapy market.<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\/03\/2026031100670_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026031100670_c.\"><\/object><a id=\"wp-block-file--media-21122d9a-58a1-4fbb-b9a9-839b8dfb0747\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026031100670_c.pdf\">2026031100670_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/2026031100670_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-21122d9a-58a1-4fbb-b9a9-839b8dfb0747\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a&#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":[62,2586,4228,852],"class_list":["post-59327","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","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 SHR-2524 Wins NMPA Phase I Approval \u2013 Novel Subcutaneous Formulation Plus Bevacizumab Targets First-Line Liver Cancer - 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 NMPA clearance to initiate a Phase I clinical trial evaluating SHR-2524 injection in combination with bevacizumab as first-line treatment for advanced hepatocellular carcinoma (HCC). The Category 2.1 and 2.3 modified therapeutic biological product represents a novel subcutaneous formulation with no similar products currently available domestically or internationally, positioning Hengrui to address the largest liver cancer market globally with improved patient convenience and compliance.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=59327#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=59327"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=59327#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Hengrui&#8217;s SHR-2524 Wins NMPA Phase I Approval \u2013 Novel Subcutaneous Formulation Plus Bevacizumab Targets First-Line Liver Cancer"}]},{"@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\/59327","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=59327"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59327\/revisions"}],"predecessor-version":[{"id":59329,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59327\/revisions\/59329"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=59327"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=59327"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=59327"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}