{"id":72435,"date":"2026-08-13T12:04:31","date_gmt":"2026-08-13T04:04:31","guid":{"rendered":"https:\/\/flcube.com\/?p=72435"},"modified":"2026-08-13T12:04:32","modified_gmt":"2026-08-13T04:04:32","slug":"hengrui-pharmas-shr-7590-injection-wins-nmpa-clinical-trial-approval-for-ulcerative-colitis-and-crohns-disease","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=72435","title":{"rendered":"Hengrui Pharma&#8217;s SHR-7590 Injection Wins NMPA Clinical Trial Approval for Ulcerative Colitis and Crohn&#8217;s Disease"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/600276:SHA\">SHA: 600276<\/a>; <a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/1276:HKG\">HKG: 1276<\/a>) announced that its <strong>SHR-7590 injection<\/strong> has received <strong>clinical trial approval<\/strong> from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for the treatment of <strong>ulcerative colitis<\/strong> and <strong>Crohn&#8217;s disease<\/strong>, advancing the company&#8217;s independently developed biologic into clinical testing in inflammatory bowel disease (IBD).<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">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: 600276; HKG: 1276)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Clinical trial approval<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>SHR-7590 injection (therapeutic biologic)<\/td><\/tr><tr><td><strong>Indications<\/strong><\/td><td>Ulcerative colitis; Crohn&#8217;s disease<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>13 Aug 2026<\/td><\/tr><tr><td><strong>Competitive Position<\/strong><\/td><td>No drug targeting the same pathway approved globally to date<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-preclinical-profile-shr-7590\" class=\"wp-block-heading\">Preclinical Profile \u2013 SHR-7590<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> A therapeutic biologic <strong>independently developed by Hengrui Pharma<\/strong><\/li>\n\n\n\n<li><strong>Anti-Inflammatory Activity:<\/strong> In animal models of <strong>inflammatory bowel disease (IBD)<\/strong>, SHR-7590 demonstrated effective <strong>inhibition of inflammation<\/strong><\/li>\n\n\n\n<li><strong>Disease Improvement:<\/strong> Animal studies showed <strong>improvement in disease scores<\/strong> and <strong>alleviation of intestinal tissue pathology<\/strong><\/li>\n\n\n\n<li><strong>First-in-Pathway Opportunity:<\/strong> Currently, <strong>no drug targeting the same pathway has been approved for marketing globally<\/strong>, positioning SHR-7590 in a potentially first-in-class competitive landscape<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Large Unmet Need:<\/strong> Ulcerative colitis and Crohn&#8217;s disease together constitute IBD, a chronic, relapsing condition with growing prevalence in China and substantial unmet need beyond existing biologics.<\/li>\n\n\n\n<li><strong>Novel Pathway Differentiation:<\/strong> A mechanism with no globally approved incumbent offers Hengrui a differentiated entry point in a market long dominated by TNF, IL-12\/23, and integrin inhibitors.<\/li>\n\n\n\n<li><strong>Hengrui&#8217;s Biologics Push:<\/strong> The clearance extends Hengrui&#8217;s pipeline beyond oncology into immunology and inflammation, a strategic growth pillar for China&#8217;s largest pharmaceutical company.<\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> Trial design, dosing, and timelines for first-in-human dosing were not disclosed.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding the clinical development potential of SHR-7590. Actual results may differ due to risks including clinical progress, safety outcomes, and competitive dynamics in IBD biologics.<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\/08\/2026081201055_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026081201055_c.\"><\/object><a id=\"wp-block-file--media-9aee9371-78a8-4640-9885-fc81e7310668\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2026081201055_c.pdf\">2026081201055_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2026081201055_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-9aee9371-78a8-4640-9885-fc81e7310668\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its SHR-7590 injection has&#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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[62,2586,4228,852],"class_list":["post-72435","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 v27.5 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui Pharma&#039;s SHR-7590 Injection Wins NMPA Clinical Trial Approval for Ulcerative Colitis and Crohn&#039;s Disease - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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