{"id":48641,"date":"2025-11-19T20:34:27","date_gmt":"2025-11-19T12:34:27","guid":{"rendered":"https:\/\/flcube.com\/?p=48641"},"modified":"2025-11-19T20:34:28","modified_gmt":"2025-11-19T12:34:28","slug":"nmpa-releases-98th-rld-catalog-for-chemical-generics-adding-48-new-specifications","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48641","title":{"rendered":"NMPA Releases 98th RLD Catalog for Chemical Generics, Adding 48 New Specifications"},"content":{"rendered":"\n<p>China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> released the <strong>ninety-eighth batch<\/strong> of the <strong>Reference Listed Drugs (RLD) Catalog<\/strong> for chemical generics, adding <strong>48 new drug specifications<\/strong> and supplementary information for <strong>14 previously listed<\/strong> specifications, primarily involving additional Marketing Authorization Holders (MAHs).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-catalog-update-summary\">Catalog Update Summary<\/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>Batch Number<\/strong><\/td><td>98th RLD Catalog<\/td><\/tr><tr><td><strong>Total Specifications<\/strong><\/td><td>62 drug specifications (or varieties)<\/td><\/tr><tr><td><strong>New Entries<\/strong><\/td><td>48 specifications entering RLD Catalog for the first time<\/td><\/tr><tr><td><strong>Supplementary Updates<\/strong><\/td><td>14 specifications (primarily adding MAHs)<\/td><\/tr><tr><td><strong>Key Change<\/strong><\/td><td>Expansion of MAH listings for existing reference drugs<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-rld-catalog-significance\">RLD Catalog Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Generic Development Pathway:<\/strong> Inclusion in the RLD Catalog is a prerequisite for generic drug manufacturers to conduct bioequivalence studies and file abbreviated new drug applications (ANDAs) in China.<\/li>\n\n\n\n<li><strong>Market Access Impact:<\/strong> The 48 new specifications unlock the pathway for <strong>dozens of generic competitors<\/strong>, potentially reducing drug prices by <strong>30\u201170%<\/strong> upon market entry.<\/li>\n\n\n\n<li><strong>MAH Flexibility:<\/strong> Adding MAHs to existing entries (14 specifications) allows multiple manufacturers to reference the same innovator product, fostering competition and supply chain resilience.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-outlook\">Market Context &amp; Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Drug Category<\/th><th>Estimated Number of New Generics Enabled<\/th><th>Market Size (2024)<\/th><th>Potential Price Reduction<\/th><\/tr><\/thead><tbody><tr><td><strong>Cardiovascular<\/strong><\/td><td>12 specifications<\/td><td>\u00a58.5\u202fbillion (US$1.2\u202fbillion)<\/td><td>40\u201160%<\/td><\/tr><tr><td><strong>Anti\u2011infectives<\/strong><\/td><td>15 specifications<\/td><td>\u00a56.2\u202fbillion (US$850\u202fmillion)<\/td><td>35\u201155%<\/td><\/tr><tr><td><strong>CNS agents<\/strong><\/td><td>8 specifications<\/td><td>\u00a54.1\u202fbillion (US$560\u202fmillion)<\/td><td>30\u201150%<\/td><\/tr><tr><td><strong>Metabolic\/Endocrine<\/strong><\/td><td>13 specifications<\/td><td>\u00a55.8\u202fbillion (US$790\u202fmillion)<\/td><td>45\u201165%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Volume\u2011Based Procurement (VBP):<\/strong> New RLD entries will likely be included in future national VBP rounds, accelerating generic substitution and hospital adoption.<\/li>\n\n\n\n<li><strong>Timeline:<\/strong> Generic manufacturers typically require <strong>12\u201118 months<\/strong> to complete BE studies and secure NMPA approval; first generics could launch by <strong>H2\u202f2027<\/strong>.<\/li>\n\n\n\n<li><strong>Revenue Impact:<\/strong> The 48 new specifications represent <strong>>\u00a525\u202fbillion<\/strong> (US$3.4\u202fbillion) in originator sales at risk of generic erosion by 2028.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the timing of generic launches, market share erosion, and VBP inclusion. Actual results may differ due to regulatory review timelines, manufacturer development capacity, and policy changes.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China&#8217;s National Medical Products Administration (NMPA) released the ninety-eighth batch of the Reference Listed Drugs&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48644,"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-48641","post","type-post","status-publish","format-standard","has-post-thumbnail","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 v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>NMPA Releases 98th RLD Catalog for Chemical Generics, Adding 48 New Specifications - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China&#039;s National Medical Products Administration (NMPA) released the ninety-eighth batch of the Reference Listed Drugs (RLD) Catalog for chemical generics, adding 48 new drug specifications and supplementary information for 14 previously listed specifications, primarily involving additional Marketing Authorization Holders (MAHs).\" \/>\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=48641\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NMPA Releases 98th RLD Catalog for Chemical Generics, Adding 48 New Specifications\" \/>\n<meta property=\"og:description\" content=\"China&#039;s National Medical Products Administration (NMPA) released the ninety-eighth batch of the Reference Listed Drugs (RLD) Catalog for chemical generics, adding 48 new drug specifications and supplementary information for 14 previously listed specifications, primarily involving additional Marketing Authorization Holders (MAHs).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48641\" \/>\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=\"2025-11-19T12:34:27+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-19T12:34:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1902.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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