{"id":46868,"date":"2025-11-12T15:50:51","date_gmt":"2025-11-12T07:50:51","guid":{"rendered":"https:\/\/flcube.com\/?p=46868"},"modified":"2025-11-12T15:50:52","modified_gmt":"2025-11-12T07:50:52","slug":"nmpa-grants-marketing-authorisation-to-hefei-amvites-memantine-hydrochloride-odt-for-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=46868","title":{"rendered":"NMPA Grants Marketing Authorisation to Hefei Amvite\u2019s Memantine Hydrochloride ODT for Alzheimer\u2019s Disease"},"content":{"rendered":"\n<p>The <strong>National Medical Products Administration (NMPA)<\/strong> has approved <strong>Memantine Hydrochloride Orally Disintegrating Tablets (ODT)<\/strong> produced by <strong>Hefei Amvite Biotechnology Co., Ltd.<\/strong> for the treatment of <strong>moderate\u2011to\u2011severe Alzheimer\u2019s disease<\/strong> in adult patients.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-overview\">Product Overview<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug name<\/strong><\/td><td>Memristin\u2122 (Memantine Hydrochloride ODT)<\/td><\/tr><tr><td><strong>Manufacturer<\/strong><\/td><td>Hefei Amvite Biotechnology Co., Ltd.<\/td><\/tr><tr><td><strong>Regulatory status<\/strong><\/td><td>NMPA marketing authorisation (effective 4\u202fNov\u202f2025)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Moderate\u2011to\u2011severe Alzheimer\u2019s disease in adults<\/td><\/tr><tr><td><strong>Dosage form<\/strong><\/td><td>Orally disintegrating tablet, 10\u202fmg per tablet<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td><strong>NMDA\u2011receptor antagonist<\/strong> that protects neurons and supports cognitive recovery<\/td><\/tr><tr><td><strong>Reference product<\/strong><\/td><td>Ebixa\u00ae (Memantine Hydrochloride) \u2013 originally developed by H.\u202fLundbeck A\/S (EU approval 15\u202fMay\u202f2002; China launch July\u202f2012)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-amp-commercial-significance\">Clinical &amp; Commercial Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Therapeutic value:<\/strong> Memantine is the only approved <strong>N\u2011methyl\u2011D\u2011aspartate (NMDA) receptor antagonist<\/strong> for Alzheimer\u2019s, offering a neuroprotective approach distinct from cholinesterase inhibitors.<\/li>\n\n\n\n<li><strong>Market impact:<\/strong> China\u2019s Alzheimer\u2019s patient pool exceeds <strong>10\u202fmillion<\/strong> and is projected to grow >\u202f30\u202f% by 2030, creating a <strong>\u00a530\u2011\u00a545\u202fbillion<\/strong> market for disease\u2011modifying therapies.<\/li>\n\n\n\n<li><strong>Pricing advantage:<\/strong> The ODT formulation provides a <strong>convenient, swallow\u2011free option<\/strong> for elderly patients with dysphagia, potentially capturing market share from existing tablet and liquid formulations.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-timeline-amp-outlook\">Timeline &amp; Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Date<\/th><\/tr><\/thead><tbody><tr><td>NMPA approval announcement<\/td><td>4\u202fNov\u202f2025<\/td><\/tr><tr><td>Commercial launch in mainland China<\/td><td>Q1\u202f2026<\/td><\/tr><tr><td>Expected inclusion in provincial reimbursement lists<\/td><td>H2\u202f2026<\/td><\/tr><tr><td>Expansion to Hong\u202fKong &amp; Taiwan (regulatory filing)<\/td><td>2027<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the commercial launch, pricing, and market adoption of Memristin\u2122 in China. Actual results may differ due to regulatory, competitive, reimbursement, and clinical\u2011trial outcomes.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The National Medical Products Administration (NMPA) has approved Memantine Hydrochloride Orally Disintegrating Tablets (ODT) produced&#8230;<\/p>\n","protected":false},"author":1,"featured_media":46877,"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":[4452,42,15],"class_list":["post-46868","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-amvite-biotechnology","tag-first-mover-generic","tag-product-approvals"],"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 Grants Marketing Authorisation to Hefei Amvite\u2019s Memantine Hydrochloride ODT for Alzheimer\u2019s Disease - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The National Medical Products Administration (NMPA) has approved Memantine Hydrochloride Orally Disintegrating Tablets (ODT) produced by Hefei Amvite Biotechnology Co., Ltd. for the treatment of moderate\u2011to\u2011severe Alzheimer\u2019s disease in adult patients.\" \/>\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=46868\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NMPA Grants Marketing Authorisation to Hefei Amvite\u2019s Memantine Hydrochloride ODT for Alzheimer\u2019s Disease\" \/>\n<meta property=\"og:description\" content=\"The National Medical Products Administration (NMPA) has approved Memantine Hydrochloride Orally Disintegrating Tablets (ODT) produced by Hefei Amvite Biotechnology Co., Ltd. for the treatment of moderate\u2011to\u2011severe Alzheimer\u2019s disease in adult patients.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=46868\" \/>\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=\"2025-11-12T07:50:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-12T07:50:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1204.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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