{"id":75751,"date":"2026-08-21T12:00:11","date_gmt":"2026-08-21T04:00:11","guid":{"rendered":"https:\/\/flcube.com\/?p=75751"},"modified":"2026-08-21T12:00:13","modified_gmt":"2026-08-21T04:00:13","slug":"hengrui-wins-nmpa-approval-for-hrs-5965-complement-factor-b-inhibitor-for-complement-inhibitor-naive-pnh-patients","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=75751","title":{"rendered":"Hengrui Wins NMPA Approval for HRS\u20115965 \u2013 Complement Factor B Inhibitor for Complement Inhibitor\u2011Naive PNH Patients"},"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 China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has approved its <strong>Category 1 drug HRS\u20115965<\/strong> for the treatment of adult patients with <strong>paroxysmal nocturnal hemoglobinuria (PNH)<\/strong> who have not previously been treated with complement inhibitors.<\/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>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Category 1 innovative drug<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>HRS\u20115965 (complement factor B inhibitor)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Adult PNH patients na\u00efve to complement inhibitor therapy<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>21 Aug 2026<\/td><\/tr><tr><td><strong>Next Steps<\/strong><\/td><td>Commercial launch and post\u2011marketing commitments; details not disclosed<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> HRS\u20115965, a complement factor B inhibitor developed in\u2011house by Hengrui<\/li>\n\n\n\n<li><strong>Target:<\/strong> Complement factor B, a key driver of the alternative complement pathway implicated in PNH\u2011related hemolysis<\/li>\n\n\n\n<li><strong>Positioning:<\/strong> Approved specifically for complement inhibitor\u2011na\u00efve adult PNH patients, addressing an underserved segment of a rare and potentially life\u2011threatening hematologic disease<\/li>\n\n\n\n<li><strong>Classification:<\/strong> Category 1 \u2014 the highest innovation tier under China&#8217;s drug review framework<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-evidence-phase-iii-trial-hrs-5965-301\" class=\"wp-block-heading\">Clinical Evidence \u2013 Phase III Trial (HRS\u20115965\u2011301)<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint (Weeks 18\u201324)<\/th><th>Result (HRS\u20115965)<\/th><\/tr><\/thead><tbody><tr><td><strong>Hemoglobin Response Rate<\/strong> (Hb increase \u2265 2 g\/dL from baseline)<\/td><td><strong>95 %<\/strong><\/td><\/tr><tr><td><strong>Hemoglobin Normalization Rate<\/strong> (Hb \u2265 12 g\/dL)<\/td><td><strong>70 %<\/strong><\/td><\/tr><tr><td><strong>Mean Hb Increase from Baseline<\/strong><\/td><td><strong>+5.5 g\/dL<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The approval was based on <strong>HRS\u20115965\u2011301<\/strong>, a multicenter, randomized, open\u2011label, active\u2011controlled Phase 3 trial. Comparator identity and additional secondary endpoints were not disclosed in the announcement.<\/p>\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>PNH Landscape:<\/strong> PNH is a rare, potentially life\u2011threatening blood disorder in which uncontrolled complement activity destroys red blood cells, causing severe anemia, fatigue and thrombosis risk. The complement inhibitor space has historically been dominated by intravenous C5\u2011targeting therapies, with newer oral agents reshaping the competitive field.<\/li>\n\n\n\n<li><strong>Hengrui&#8217;s Positioning:<\/strong> The approval gives Hengrui \u2014 one of China&#8217;s largest research\u2011driven drugmakers, dual\u2011listed in Shanghai (600276) and Hong Kong (1276) \u2014 an entry point in the rare\u2011disease complement space alongside its core oncology franchise.<\/li>\n\n\n\n<li><strong>Differentiation Angle:<\/strong> An upstream factor B inhibitor approved for complement inhibitor\u2011na\u00efve patients could appeal to physicians seeking hemoglobin normalization without prior exposure to other complement therapies; head\u2011to\u2011head comparisons versus incumbent agents remain undisclosed.<\/li>\n\n\n\n<li><strong>Revenue Outlook:<\/strong> Commercial launch timing, pricing and sales forecasts 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\u2011looking statements regarding regulatory developments, clinical outcomes, and commercial expectations for HRS\u20115965. Actual results may differ due to risks including market adoption, competitive dynamics, and post\u2011marketing requirements.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China&#8217;s National Medical Products&#8230;<\/p>\n","protected":false},"author":1,"featured_media":75752,"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":[2586,4228,15,24,852],"class_list":["post-75751","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-product-approvals","tag-rare-orphan-disease-drugs","tag-sha-600276"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui Wins NMPA Approval for HRS\u20115965 \u2013 Complement Factor B Inhibitor for Complement Inhibitor\u2011Naive PNH Patients - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China&#039;s National Medical Products Administration (NMPA) has approved its Category 1 drug HRS\u20115965 for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously been treated with complement inhibitors.\" \/>\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=75751\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui Wins NMPA Approval for HRS\u20115965 \u2013 Complement Factor B Inhibitor for Complement Inhibitor\u2011Naive PNH Patients\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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(SHA: 600276; HKG: 1276) announced that China's National Medical Products Administration (NMPA) has approved its Category 1 drug HRS\u20115965 for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously been treated with complement inhibitors.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=75751#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=75751"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=75751#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2101.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2101.webp","width":1080,"height":608,"caption":"Hengrui Wins NMPA Approval for HRS\u20115965 \u2013 Complement Factor B Inhibitor for Complement Inhibitor\u2011Naive PNH Patients"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=75751#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Hengrui Wins NMPA Approval for HRS\u20115965 \u2013 Complement Factor B Inhibitor for Complement Inhibitor\u2011Naive PNH Patients"}]},{"@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_sharing_enabled":true,"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/2101.webp","_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/75751","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=75751"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/75751\/revisions"}],"predecessor-version":[{"id":75753,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/75751\/revisions\/75753"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/75752"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=75751"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=75751"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=75751"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}