{"id":45866,"date":"2025-11-05T15:23:43","date_gmt":"2025-11-05T07:23:43","guid":{"rendered":"https:\/\/flcube.com\/?p=45866"},"modified":"2025-11-05T15:23:43","modified_gmt":"2025-11-05T07:23:43","slug":"zhejiang-acea-pharma-secures-conditional-nmpa-approval-for-olgotrelvir-sodium-capsules-first-dual%e2%80%91target-covid%e2%80%9119-oral-antiviral-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=45866","title":{"rendered":"Zhejiang Acea Pharma Secures Conditional NMPA Approval for Olgotrelvir Sodium Capsules \u2013 First Dual\u2011Target COVID\u201119 Oral Antiviral in China"},"content":{"rendered":"\n<p><strong>Zhejiang Acea Pharmaceutical Co., Ltd.<\/strong> announced that China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has granted <strong>conditional marketing approval<\/strong> for <strong>Olgotrelvir Sodium (Olgotrelvir) Capsules<\/strong>, a <strong>Class\u202f1 innovative oral small\u2011molecule<\/strong> indicated for <strong>mild\u2011to\u2011moderate COVID\u201119<\/strong> in adult patients.<\/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>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Conditional, Class\u202f1 innovative drug<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Olgotrelvir Sodium Capsules (oral)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Treatment of adult patients with mild\u2011to\u2011moderate COVID\u201119<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>5\u202fNov\u202f2025<\/td><\/tr><tr><td><strong>Next Steps<\/strong><\/td><td>Full data submission within 12\u202fmonths to convert to standard approval<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> New\u2011generation small\u2011molecule antiviral (oral)<\/li>\n\n\n\n<li><strong>Target:<\/strong> <strong>3CL protease<\/strong> (main SARS\u2011CoV\u20112 replication enzyme) <strong>and<\/strong> <strong>Cathepsin\u202fL<\/strong> (host\u2011cell entry factor)<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> First <strong>dual\u2011target inhibitor<\/strong> that simultaneously blocks viral entry and replication, a novel approach not seen in any currently marketed COVID\u201119 therapeutics.<\/li>\n\n\n\n<li><strong>Intellectual Property:<\/strong> Global patents held by <strong>Acea Pharma<\/strong>, covering the dual\u2011target design and synthesis pathway.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-phase-iii-trial\">Clinical Evidence \u2013 Phase\u202fIII Trial<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Result (Olgotrelvir)<\/th><th>Comparator (Standard of Care)<\/th><th>Relative Benefit<\/th><\/tr><\/thead><tbody><tr><td><strong>Time to Viral Clearance<\/strong><\/td><td>Median 4.2\u202fdays<\/td><td>Median 7.1\u202fdays<\/td><td><strong>40\u202f% faster<\/strong><\/td><\/tr><tr><td><strong>Proportion Achieving Symptom Resolution by Day\u202f7<\/strong><\/td><td>78\u202f%<\/td><td>55\u202f%<\/td><td><strong>+23\u202fppt<\/strong><\/td><\/tr><tr><td><strong>Hospitalization Reduction (Day\u202f28)<\/strong><\/td><td>1.2\u202f% vs. 3.8\u202f%<\/td><td>\u2013<\/td><td><strong>\u2248\u202f68\u202f% risk reduction<\/strong><\/td><\/tr><tr><td><strong>Safety<\/strong><\/td><td>No Grade\u202f\u2265\u202f3 drug\u2011related AEs; mild GI upset in 12\u202f%<\/td><td>\u2013<\/td><td>Comparable tolerability<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The trial, conducted across 12 Chinese provinces with &gt;1,800 participants, met its primary endpoint of <strong>superior viral\u2011clearance speed<\/strong> and demonstrated a statistically significant reduction in progression to severe disease.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-outlook\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China COVID\u201119 Landscape:<\/strong> With intermittent waves and a large unvaccinated\u2011elderly cohort, an oral outpatient treatment that shortens infection duration is a high\u2011value asset.<\/li>\n\n\n\n<li><strong>Revenue Forecast:<\/strong> Acea projects <strong>\u00a51.2\u202fbillion<\/strong> (\u2248\u202fUS$170\u202fmillion) in 2026 sales, assuming 5\u202f% market\u2011share capture of the estimated 24\u202fmillion annual adult mild\u2011to\u2011moderate cases.<\/li>\n\n\n\n<li><strong>Competitive Edge:<\/strong> Unlike monoclonal antibodies and protease\u2011only inhibitors, Olgotrelvir\u2019s <strong>dual\u2011target<\/strong> mode may retain efficacy against emerging variants that evade single\u2011target drugs.<\/li>\n\n\n\n<li><strong>Strategic Partnerships:<\/strong> Acea is in talks with <strong>state\u2011owned distributors<\/strong> and <strong>digital health platforms<\/strong> to enable rapid prescription and home delivery, mirroring the rollout model of oral antivirals in other markets.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory timelines, clinical outcomes, and commercial expectations for Olgotrelvir. Actual results may differ due to risks including final approval conditions, market adoption, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Zhejiang Acea Pharmaceutical Co., Ltd. announced that China\u2019s National Medical Products Administration (NMPA) has granted&#8230;<\/p>\n","protected":false},"author":1,"featured_media":45870,"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":[4429,13,15],"class_list":["post-45866","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-acea-pharmaceutical","tag-covid-19","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>Zhejiang Acea Pharma Secures Conditional NMPA Approval for Olgotrelvir Sodium Capsules \u2013 First Dual\u2011Target COVID\u201119 Oral Antiviral in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Zhejiang Acea Pharmaceutical Co., Ltd. announced that China\u2019s National Medical Products Administration (NMPA) has granted conditional marketing approval for Olgotrelvir Sodium (Olgotrelvir) Capsules, a Class\u202f1 innovative oral small\u2011molecule indicated for mild\u2011to\u2011moderate COVID\u201119 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=45866\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zhejiang Acea Pharma Secures Conditional NMPA Approval for Olgotrelvir Sodium Capsules \u2013 First Dual\u2011Target COVID\u201119 Oral Antiviral in China\" \/>\n<meta property=\"og:description\" content=\"Zhejiang Acea Pharmaceutical Co., Ltd. announced that China\u2019s National Medical Products Administration (NMPA) has granted conditional marketing approval for Olgotrelvir Sodium (Olgotrelvir) Capsules, a Class\u202f1 innovative oral small\u2011molecule indicated for mild\u2011to\u2011moderate COVID\u201119 in adult patients.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=45866\" \/>\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=\"2025-11-05T07:23:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/0503.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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