{"id":48527,"date":"2025-11-18T11:32:51","date_gmt":"2025-11-18T03:32:51","guid":{"rendered":"https:\/\/flcube.com\/?p=48527"},"modified":"2025-11-18T11:32:52","modified_gmt":"2025-11-18T03:32:52","slug":"jiangsu-hengrui-secures-nmpa-approval-for-tegileridine-in-mechanically-ventilated-icu-patients","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48527","title":{"rendered":"Jiangsu Hengrui Secures NMPA Approval for Tegileridine in Mechanically Ventilated ICU Patients"},"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 its <strong>\u03bc\u2011opioid receptor (MOR)\u2011biased small\u2011molecule agonist, tegileridine<\/strong>, has received <strong>clinical approval from China\u2019s National Medical Products Administration (NMPA)<\/strong> for use in <strong>mechanically ventilated patients in intensive\u2011care units (ICUs)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-tegileridine\">What Is Tegileridine?<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Mechanism<\/strong><\/td><td>MOR\u2011biased agonist that preferentially activates analgesic pathways while limiting \u03b2\u2011arrestin\u2011mediated side effects.<\/td><\/tr><tr><td><strong>Category<\/strong><\/td><td>China\u2019s first home\u2011developed <strong>Category\u202f1 opioid analgesic<\/strong>.<\/td><\/tr><tr><td><strong>Original indication (Jan\u202f2024)<\/strong><\/td><td>Moderate\u2011to\u2011severe postoperative pain after abdominal surgery.<\/td><\/tr><tr><td><strong>Expanded indication (Mar\u202f2025)<\/strong><\/td><td>Moderate\u2011to\u2011severe postoperative pain across all surgical specialties.<\/td><\/tr><tr><td><strong>New ICU indication (Nov\u202f2025)<\/strong><\/td><td>Analgesia for mechanically ventilated patients in ICU settings.<\/td><\/tr><tr><td><strong>Comparable product<\/strong><\/td><td>Trevena\u2019s <strong>Olinvyk (oliceridine)<\/strong> \u2013 licensed in China by Jiangsu Nhwa Pharmaceutical (002262.SZ) and approved in May\u202f2023.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-amp-market-significance\">Clinical &amp; Market Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011in\u2011class for ICU use<\/strong> \u2013 Tegileridine becomes the <strong>first domestically developed Category\u202f1 opioid<\/strong> cleared for analgesia in ventilated ICU patients, a segment traditionally dominated by injectable opioids with higher respiratory\u2011depression risk.<\/li>\n\n\n\n<li><strong>Safety profile<\/strong> \u2013 MOR\u2011bias is expected to <strong>reduce respiratory depression and gastrointestinal adverse events<\/strong>, addressing a key concern for sedated, ventilated patients.<\/li>\n\n\n\n<li><strong>Revenue outlook<\/strong> \u2013 The Chinese ICU analgesia market is projected to exceed <strong>CNY\u202f30\u202fbillion<\/strong> (~US$4.3\u202fbillion) by 2028. Assuming a <strong>5\u202f% market capture<\/strong> within three years at an average price of <strong>CNY\u202f12,000<\/strong> per treatment course, tegileridine could generate <strong>\u2248\u202fCNY\u202f1.5\u202fbillion<\/strong> (~US$215\u202fmillion) in annual sales.<\/li>\n\n\n\n<li><strong>Strategic fit<\/strong> \u2013 The approval expands Jiangsu Hengrui\u2019s opioid portfolio beyond postoperative pain, positioning the company for <strong>cross\u2011indication leverage<\/strong> and potential <strong>global development<\/strong> of MOR\u2011biased agents.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-timeline-of-tegileridine-approvals\">Timeline of Tegileridine Approvals<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Date<\/th><th>Regulatory Milestone<\/th><th>Indication<\/th><\/tr><\/thead><tbody><tr><td>Jan\u202f2024<\/td><td>NMPA marketing authorization<\/td><td>Post\u2011abdominal surgery pain<\/td><\/tr><tr><td>Mar\u202f2025<\/td><td>NMPA label expansion<\/td><td>General postoperative pain<\/td><\/tr><tr><td>Nov\u202f2025<\/td><td>NMPA clinical approval<\/td><td>Mechanically ventilated ICU patients<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This brief contains forward\u2011looking statements regarding regulatory approvals, clinical benefits, and market potential for tegileridine. Actual results may differ due to clinical outcomes, regulatory actions, competitive dynamics, and other risk factors.<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\/11\/2025111700982_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025111700982_c.\"><\/object><a id=\"wp-block-file--media-65c8a6b4-e71d-4467-b4e1-bfefed4cb313\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111700982_c.pdf\">2025111700982_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111700982_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-65c8a6b4-e71d-4467-b4e1-bfefed4cb313\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its \u03bc\u2011opioid receptor (MOR)\u2011biased&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48529,"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-48527","post","type-post","status-publish","format-standard","has-post-thumbnail","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>Jiangsu Hengrui Secures NMPA Approval for Tegileridine in Mechanically Ventilated ICU Patients - 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 that its \u03bc\u2011opioid receptor (MOR)\u2011biased small\u2011molecule agonist, tegileridine, has received clinical approval from China\u2019s National Medical Products Administration (NMPA) for use in mechanically ventilated patients in intensive\u2011care units (ICUs).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48527\" \/>\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=\"2025-11-18T03:32:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-18T03:32:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1802.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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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