{"id":41858,"date":"2025-09-19T14:54:10","date_gmt":"2025-09-19T06:54:10","guid":{"rendered":"https:\/\/flcube.com\/?p=41858"},"modified":"2025-09-19T14:54:11","modified_gmt":"2025-09-19T06:54:11","slug":"hengrui-pharma-secures-nmpa-approval-for-two-novel-immune%e2%80%91inflammatory-drugs","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41858","title":{"rendered":"Hengrui Pharma Secures NMPA Approval for Two Novel Immune\u2011Inflammatory Drugs"},"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 China\u2019s National Medical Products Administration (NMPA) has granted approval for clinical trials of two independently developed biologics: <strong>SHR\u20113045 injection<\/strong> for rheumatoid arthritis (RA) and <strong>SHR\u20111139 injection<\/strong> for ulcerative colitis (UC). The approvals mark the first step toward bringing these innovative therapies to patients in China and potentially beyond.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-are-shr-3045-and-shr-1139\">What Are SHR\u20113045 and SHR\u20111139?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>SHR\u20113045<\/strong> is designed to inhibit the function of key immune cells that drive inflammation in RA, aiming to suppress joint swelling, pain, and functional decline.<\/li>\n\n\n\n<li><strong>SHR\u20111139<\/strong> seeks to combine anti\u2011inflammatory action with preservation of the intestinal epithelial barrier, offering a dual mechanism that could improve mucosal healing and reduce flare\u2011ups in UC.<\/li>\n<\/ul>\n\n\n\n<p>Both agents are therapeutic biologics produced under Hengrui\u2019s proprietary platform, and no comparable drugs have been approved for marketing in either domestic or international markets.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-significance\">Strategic Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Clinical Development<\/strong>: The NMPA approvals allow Hengrui to initiate Phase\u202fI\/II studies, potentially accelerating the timeline for a global launch.<\/li>\n\n\n\n<li><strong>Portfolio Diversification<\/strong>: Adding RA and UC indications expands Hengrui\u2019s presence in the rapidly growing immune\u2011inflammatory disease sector, which is projected to exceed <strong>US$12\u202fbillion<\/strong> by 2030.<\/li>\n\n\n\n<li><strong>Regulatory Momentum<\/strong>: Successful trials could pave the way for subsequent approvals in the U.S. and EU, positioning Hengrui as a key contender in the biologics arena.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-next-steps\">Next Steps<\/h2>\n\n\n\n<p>Hengrui plans to commence Phase\u202fI safety studies for SHR\u20113045 and SHR\u20111139 in the next quarter. The company will also engage with key opinion leaders and patient advocacy groups to refine trial designs and ensure robust data collection. If early results are favorable, Hengrui aims to pursue accelerated approval pathways in China and seek regulatory submissions in other major markets by 2028.<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\/09\/600276_20250919_52W6.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20250919_52W6.\"><\/object><a id=\"wp-block-file--media-0ff80383-eff3-4256-848f-7b78a6c6e4a6\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/600276_20250919_52W6.pdf\">600276_20250919_52W6<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/600276_20250919_52W6.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-0ff80383-eff3-4256-848f-7b78a6c6e4a6\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China\u2019s National Medical Products&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41861,"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":[65,62,2586,4228,852],"class_list":["post-41858","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-auto-immune","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 v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui Pharma Secures NMPA Approval for Two Novel Immune\u2011Inflammatory Drugs - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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