{"id":59158,"date":"2026-03-10T13:51:47","date_gmt":"2026-03-10T05:51:47","guid":{"rendered":"https:\/\/flcube.com\/?p=59158"},"modified":"2026-03-10T13:51:48","modified_gmt":"2026-03-10T05:51:48","slug":"nmpa-removes-ocaliva-from-gqce-reference-list-obeticholic-acid-stripped-over-safety-concerns-benefit-risk-profile","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=59158","title":{"rendered":"NMPA Removes OCALIVA from GQCE Reference List \u2013 Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile"},"content":{"rendered":"\n<p>China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> released the <strong>102nd batch of reference drugs for generic quality consistency evaluation (GQCE)<\/strong>, simultaneously announcing the <strong>fourth batch of delisted reference drugs<\/strong>. <strong>Obeticholic Acid Tablets (OCALIVA)<\/strong> in <strong>5\u202fmg and 10\u202fmg strengths<\/strong> have been <strong>removed from the reference list<\/strong> due to <strong>post-marketing studies failing to confirm clinical benefit while demonstrating serious risks<\/strong>, marking a rare <strong>regulatory reversal<\/strong> on a previously approved innovative drug and impacting generic development pathways for the <strong>FXR agonist class<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-action-overview\">Regulatory Action Overview<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Element<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Authority<\/strong><\/td><td>National Medical Products Administration (NMPA)<\/td><\/tr><tr><td><strong>Action Type<\/strong><\/td><td>Reference drug delisting from GQCE list<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Obeticholic Acid Tablets (trade name: OCALIVA)<\/td><\/tr><tr><td><strong>Strengths Affected<\/strong><\/td><td>5\u202fmg, 10\u202fmg<\/td><\/tr><tr><td><strong>Reason for Removal<\/strong><\/td><td>Post-marketing studies: lack of confirmed benefit + serious risks demonstrated<\/td><\/tr><tr><td><strong>Batch Context<\/strong><\/td><td>102nd GQCE reference batch released; 4th delisting batch; 19 new specs added, 14 modified<\/td><\/tr><tr><td><strong>Effective Date<\/strong><\/td><td>March 2026 (announcement date)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-regulatory-history\">Drug Profile &amp; Regulatory History<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>OCALIVA\/Obeticholic Acid Specification<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug Class<\/strong><\/td><td>Farnesoid X receptor (FXR) agonist<\/td><\/tr><tr><td><strong>Original Indication<\/strong><\/td><td>Primary biliary cholangitis (PBC) \u2013 2016 U.S. approval; conditional China approval<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Activates FXR to regulate bile acid synthesis and flow<\/td><\/tr><tr><td><strong>NASH Development<\/strong><\/td><td>Phase III trials (REGENERATE, REVERSE) \u2013 primary indication pursued<\/td><\/tr><tr><td><strong>Post-Marketing Issues<\/strong><\/td><td>Pruritus (severe), LDL cholesterol elevation, cardiovascular signal<\/td><\/tr><tr><td><strong>Global Status<\/strong><\/td><td>FDA approved for PBC; NASH indication rejected; EU conditional marketing authorization<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>China GQCE Context:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Reference Drug Role:<\/strong> Innovative drugs listed as quality benchmarks for generic bioequivalence studies<\/li>\n\n\n\n<li><strong>Delisting Impact:<\/strong> Generic manufacturers can no longer use OCALIVA as reference; development pathway blocked<\/li>\n\n\n\n<li><strong>Precedent:<\/strong> Rare action indicating fundamental safety\/efficacy reassessment<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-safety-amp-efficacy-concerns\">Safety &amp; Efficacy Concerns<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Issue<\/th><th>Evidence Base<\/th><th>Regulatory Response<\/th><\/tr><\/thead><tbody><tr><td><strong>Lack of Confirmed Benefit<\/strong><\/td><td>Post-marketing studies failed to demonstrate expected clinical outcomes<\/td><td>Delisting removes regulatory endorsement<\/td><\/tr><tr><td><strong>Serious Risks<\/strong><\/td><td>Pruritus (treatment-limiting), hepatotoxicity signal, cardiovascular adverse events<\/td><td>Risk-benefit profile deemed unfavorable<\/td><\/tr><tr><td><strong>NASH Trial Failures<\/strong><\/td><td>REGENERATE interim analysis showed fibrosis improvement but mixed results; full data disappointing<\/td><td>Original approval rationale undermined<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-amp-industry-implications\">Market &amp; Industry Implications<\/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>Generic Development<\/strong><\/td><td>Chinese generic manufacturers pursuing obeticholic acid must halt; R&amp;D investment lost<\/td><\/tr><tr><td><strong>FXR Class Impact<\/strong><\/td><td>TERN-101, cilofexor, and other FXR agonists face heightened regulatory scrutiny<\/td><\/tr><tr><td><strong>Innovator Consequences<\/strong><\/td><td>Intercept Pharmaceuticals (OCALIVA originator) faces China market access loss; global restructuring likely<\/td><\/tr><tr><td><strong>NASH Pipeline<\/strong><\/td><td>Non-FXR mechanisms (GLP-1, PPAR, THR-\u03b2) gain relative attractiveness<\/td><\/tr><tr><td><strong>Regulatory Signal<\/strong><\/td><td>NMPA demonstrates willingness to reverse prior approvals based on real-world evidence; pharmacovigilance strengthening<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape-shift\">Competitive Landscape Shift<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Mechanism<\/th><th>Product<\/th><th>Developer<\/th><th>Status<\/th><th>Post-OCALIVA Impact<\/th><\/tr><\/thead><tbody><tr><td><strong>FXR Agonist<\/strong><\/td><td>OCALIVA (obeticholic acid)<\/td><td>Intercept<\/td><td><strong>Delisted (China)<\/strong><\/td><td>Class reputation damaged<\/td><\/tr><tr><td><strong>FXR Agonist<\/strong><\/td><td>TERN-101<\/td><td>Terns Pharma<\/td><td>Phase II<\/td><td>Development risk increased<\/td><\/tr><tr><td><strong>THR-\u03b2 Agonist<\/strong><\/td><td>Resmetirom (Madrigal)<\/td><td>Madrigal<\/td><td>Approved (U.S.)<\/td><td>Relative safety advantage<\/td><\/tr><tr><td><strong>GLP-1\/GIP<\/strong><\/td><td>Tirzepatide, semaglutide<\/td><td>Lilly, Novo<\/td><td>NASH Phase III<\/td><td>Metabolic approach gains traction<\/td><\/tr><tr><td><strong>PPAR<\/strong><\/td><td>Lanifibranor<\/td><td>Inventiva<\/td><td>Phase III<\/td><td>Alternative mechanism benefit<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory precedent, class-wide safety implications, and market dynamics following the OCALIVA delisting. Actual results may differ due to ongoing safety reviews, manufacturer responses, and competitive dynamics in the NASH and cholestatic liver disease markets.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China&#8217;s National Medical Products Administration (NMPA) released the 102nd batch of reference drugs for generic&#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":[4],"tags":[103,14],"class_list":["post-59158","post","type-post","status-publish","format-standard","hentry","category-policy-regulatory","tag-gqce-testing","tag-nmpa"],"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>NMPA Removes OCALIVA from GQCE Reference List \u2013 Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China&#039;s National Medical Products Administration (NMPA) released the 102nd batch of reference drugs for generic quality consistency evaluation (GQCE), simultaneously announcing the fourth batch of delisted reference drugs. 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Obeticholic Acid Tablets (OCALIVA) in 5\u202fmg and 10\u202fmg strengths have been removed from the reference list due to post-marketing studies failing to confirm clinical benefit while demonstrating serious risks, marking a rare regulatory reversal on a previously approved innovative drug and impacting generic development pathways for the FXR agonist class.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=59158#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=59158"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=59158#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"NMPA Removes OCALIVA from GQCE Reference List \u2013 Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile"}]},{"@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_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59158","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=59158"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59158\/revisions"}],"predecessor-version":[{"id":59159,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/59158\/revisions\/59159"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=59158"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=59158"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=59158"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}