{"id":57910,"date":"2026-02-25T13:43:32","date_gmt":"2026-02-25T05:43:32","guid":{"rendered":"https:\/\/flcube.com\/?p=57910"},"modified":"2026-04-21T20:47:02","modified_gmt":"2026-04-21T12:47:02","slug":"hengruis-angptl3-antibody-shr-1918-nda-accepted-by-nmpa-priority-review-for-rare-disease-hofh","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=57910","title":{"rendered":"Hengrui&#8217;s ANGPTL3 Antibody SHR-1918 NDA Accepted by NMPA \u2013 Priority Review for Rare Disease HoFH"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (<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>)<\/strong> announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has accepted the <strong>New Drug Application (NDA)<\/strong> for <strong>SHR-1918 injection<\/strong>, a <strong>Category\u202f1 novel drug<\/strong>, and granted <strong>priority review<\/strong> status. The indication covers <strong>adult and adolescent patients aged 12 and above<\/strong> with <strong>homozygous familial hypercholesterolemia (HoFH)<\/strong>, offering a potential new treatment option for this rare and severe genetic lipid disorder.<\/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>Subsidiary<\/strong><\/td><td>Shengdi Pharmaceutical (developer)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>SHR-1918 injection<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Category\u202f1 novel biologic<\/td><\/tr><tr><td><strong>Regulatory Action<\/strong><\/td><td>NDA accepted + Priority review granted<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Homozygous familial hypercholesterolemia (HoFH)<\/td><\/tr><tr><td><strong>Patient Population<\/strong><\/td><td>Adults and adolescents (\u2265\u202f12 years)<\/td><\/tr><tr><td><strong>Prior Designation<\/strong><\/td><td>Breakthrough Therapy Designation (Sept\u202f2024)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-shr-1918\">Drug Profile \u2013 SHR-1918<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class:<\/strong> <strong>Fully human monoclonal antibody<\/strong><\/li>\n\n\n\n<li><strong>Target:<\/strong> <strong>ANGPTL3 (angiopoietin\u2011like protein 3)<\/strong> \u2013 liver\u2011secreted protein regulating lipid metabolism<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Inhibition of ANGPTL3 activity \u2192 reduction of serum <strong>triglycerides (TG)<\/strong> and <strong>LDL\u2011cholesterol (LDL\u2011C)<\/strong><\/li>\n\n\n\n<li><strong>Development Status:<\/strong> NDA under priority review; Phase III completed<\/li>\n\n\n\n<li><strong>Clinical Profile:<\/strong> Significant efficacy with favorable safety demonstrated in clinical studies<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-summary\">Clinical Evidence Summary<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>SHR-1918 Performance<\/th><\/tr><\/thead><tbody><tr><td><strong>LDL\u2011C Reduction<\/strong><\/td><td>Significant lowering demonstrated<\/td><\/tr><tr><td><strong>Triglyceride Reduction<\/strong><\/td><td>Significant TG lowering<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Favorable tolerability<\/td><\/tr><tr><td><strong>Patient Population<\/strong><\/td><td>HoFH patients with severe, refractory hypercholesterolemia<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Rare Disease Focus:<\/strong> HoFH is an <strong>ultra\u2011rare genetic disorder<\/strong> (prevalence ~\u202f1\u202fin\u202f300,000) with limited treatment options; SHR-1918 addresses critical unmet need for patients failing statins and PCSK9 inhibitors.<\/li>\n\n\n\n<li><strong>ANGPTL3 Validation:<\/strong> Targeting <strong>ANGPTL3<\/strong> (vs. PCSK9 or LDL receptor) offers a <strong>complementary mechanism<\/strong> for lipid lowering, with potential in broader dyslipidemia populations pending future studies.<\/li>\n\n\n\n<li><strong>Priority Review Acceleration:<\/strong> NMPA <strong>priority review<\/strong> status reflects HoFH severity and SHR-1918&#8217;s <strong>Breakthrough Therapy<\/strong> pedigree, potentially shortening time\u2011to\u2011approval.<\/li>\n\n\n\n<li><strong>Hengrui Innovation Pipeline:<\/strong> As a <strong>Category\u202f1 novel biologic<\/strong>, SHR-1918 demonstrates Hengrui&#8217;s <strong>internal R&amp;D capabilities<\/strong> beyond its established generics and oncology franchise.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context\">Market Context<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Factor<\/th><th>Impact<\/th><\/tr><\/thead><tbody><tr><td><strong>HoFH Market Size<\/strong><\/td><td>Ultra\u2011rare but high\u2011value indication; annual treatment costs typically $300K+ per patient<\/td><\/tr><tr><td><strong>Competitive Landscape<\/strong><\/td><td>Regeneron&#8217;s Evkeeza (evinacumab) is approved ANGPTL3 antibody; SHR-1918 would be first\u2011in\u2011class in China<\/td><\/tr><tr><td><strong>China Rare Disease Policy<\/strong><\/td><td>NMPA priority review and Breakthrough Designation reflect supportive regulatory environment for orphan drugs<\/td><\/tr><tr><td><strong>Pipeline Expansion<\/strong><\/td><td>Successful HoFH approval could support broader dyslipidemia indications (severe hypertriglyceridemia, HeFH)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding NMPA approval timelines, commercial launch expectations, and label expansion potential for SHR-1918. Actual results may differ due to risks including regulatory review outcomes, pricing negotiations, and competitive dynamics in the lipid\u2011lowering market.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that China&#8217;s 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":[7,11],"tags":[2586,4228,38,80,852],"class_list":["post-57910","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-market-approval-filings","tag-priority-reviews","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&#039;s ANGPTL3 Antibody SHR-1918 NDA Accepted by NMPA \u2013 Priority Review for Rare Disease HoFH - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that China&#039;s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for SHR-1918 injection, a Category\u202f1 novel drug, and granted priority review status. The indication covers adult and adolescent patients aged 12 and above with homozygous familial hypercholesterolemia (HoFH), offering a potential new treatment option for this rare and severe genetic lipid disorder.\" \/>\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=57910\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui&#039;s ANGPTL3 Antibody SHR-1918 NDA Accepted by NMPA \u2013 Priority Review for Rare Disease HoFH\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that China&#039;s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for SHR-1918 injection, a Category\u202f1 novel drug, and granted priority review status. 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