{"id":52271,"date":"2025-12-30T20:58:59","date_gmt":"2025-12-30T12:58:59","guid":{"rendered":"https:\/\/flcube.com\/?p=52271"},"modified":"2025-12-30T20:59:00","modified_gmt":"2025-12-30T12:59:00","slug":"recbios-rec610-shingles-vaccine-nda-accepted-by-nmpa-challenging-gsks-shingrix","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52271","title":{"rendered":"Recbio\u2019s REC610 Shingles Vaccine NDA Accepted by NMPA, Challenging GSK\u2019s Shingrix"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Jiangsu Recbio Technology Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2179:HKG\">HKG: 2179<\/a>) announced that the <strong>New Drug Application (NDA)<\/strong> for its <strong>novel adjuvanted recombinant shingles vaccine REC610<\/strong> has been officially accepted by the <strong>Center for Drug Evaluation (CDE)<\/strong> of China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> (Acceptance No.: CXSS2500145), positioning it as the first potential competitor to <strong>GSK\u2019s Shingrix<\/strong> in the world\u2019s largest shingles vaccine market.<\/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>Product<\/strong><\/td><td>REC610 (recombinant shingles vaccine)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Jiangsu Recbio Technology (2179.HK)<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>NDA accepted by CDE\/NMPA<\/td><\/tr><tr><td><strong>Acceptance Number<\/strong><\/td><td>CXSS2500145<\/td><\/tr><tr><td><strong>Submission Date<\/strong><\/td><td>29\u202fDec\u202f2025<\/td><\/tr><tr><td><strong>Adjuvant<\/strong><\/td><td>BFA01 (proprietary novel adjuvant)<\/td><\/tr><tr><td><strong>Target Population<\/strong><\/td><td>Adults \u226550 years for herpes zoster prevention<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-profile-amp-differentiation\">Product Profile &amp; Differentiation<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mechanism of Action<\/strong>: REC610 utilizes Recbio\u2019s <strong>proprietary BFA01 adjuvant<\/strong> to stimulate <strong>high levels of VZV glycoprotein E (gE)\u2011specific CD4+ T cells and antibodies<\/strong>, mimicking the natural immune response more effectively than live\u2011attenuated vaccines.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Competitive Advantages<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Cellular Immunity<\/strong>: Novel adjuvanted recombinant platform provides <strong>stronger CD4+ T cell responses<\/strong> vs. live vaccines<\/li>\n\n\n\n<li><strong>Efficacy<\/strong>: Expected to match or exceed Shingrix\u2019s <strong>>90% protective efficacy<\/strong> based on Phase\u202f2 data<\/li>\n\n\n\n<li><strong>Duration<\/strong>: Longer\u2011lasting protection (projected >7 years) vs. <strong>4\u20115 years<\/strong> for live vaccines<\/li>\n\n\n\n<li><strong>Safety<\/strong>: Recombinant platform eliminates risk of vaccine\u2011derived viral replication<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-china-s-shingles-burden\">Market Opportunity: China\u2019s Shingles Burden<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Disease Epidemiology<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Annual Incidence<\/strong>: <strong>~6\u202fmillion<\/strong> herpes zoster cases annually in China<\/li>\n\n\n\n<li><strong>Trend<\/strong>: <strong>Increasing prevalence in younger populations<\/strong> (40\u201149 age group growing at 12% CAGR)<\/li>\n\n\n\n<li><strong>Vaccination Rate<\/strong>: <strong>&lt;1%<\/strong> of eligible population (vs. <strong>>40%<\/strong> in US\/EU)<\/li>\n\n\n\n<li><strong>Addressable Market<\/strong>: <strong>250\u202fmillion<\/strong> adults \u226550 years; <strong>400\u202fmillion<\/strong> adults \u226540 years<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Market Dynamics<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Current Standard<\/strong>: <strong>Shingrix<\/strong> (GSK) launched in China in <strong>2020<\/strong>; captured <strong>>95%<\/strong> market share<\/li>\n\n\n\n<li><strong>Supply Constraints<\/strong>: Shingrix faces periodic shortages due to <strong>global demand<\/strong> and <strong>manufacturing limitations<\/strong><\/li>\n\n\n\n<li><strong>Pricing<\/strong>: Shingrix costs <strong>\u00a51,598<\/strong> per dose (2\u2011dose regimen); REC610 projected at <strong>\u00a51,200\u20111,400<\/strong> per dose to drive adoption<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Vaccine<\/th><th>Company<\/th><th>Technology<\/th><th>China Status<\/th><th>Efficacy (\u226550 yrs)<\/th><th>Price\/Dose (\u00a5)<\/th><\/tr><\/thead><tbody><tr><td><strong>Shingrix<\/strong><\/td><td>GSK<\/td><td>Adjuvanted recombinant (AS01B)<\/td><td>Marketed (2020)<\/td><td>&gt;90%<\/td><td>1,598<\/td><\/tr><tr><td><strong>REC610<\/strong><\/td><td><strong>Recbio<\/strong><\/td><td>Adjuvanted recombinant (BFA01)<\/td><td><strong>NDA accepted<\/strong><\/td><td>Phase\u202f3 data pending<\/td><td>1,200\u20111,400 (projected)<\/td><\/tr><tr><td><strong>Zostavax<\/strong><\/td><td>Merck<\/td><td>Live attenuated<\/td><td>Withdrawn<\/td><td>~51%<\/td><td>N\/A<\/td><\/tr><tr><td><strong>Others<\/strong><\/td><td>Walvax, Zhifei<\/td><td>Live attenuated (pipeline)<\/td><td>Phase\u202f3<\/td><td>~50\u201160%<\/td><td>500\u2011800 (projected)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Market Entry Strategy<\/strong>: REC610 aims to capture <strong>15\u201120%<\/strong> market share by 2028 via <strong>domestic production advantage<\/strong> and <strong>competitive pricing<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-financial-projections\">Financial Projections<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Revenue Scenario<\/th><th>2027E<\/th><th>2028E<\/th><th>2029E<\/th><\/tr><\/thead><tbody><tr><td><strong>China shingles vaccine market (\u00a5B)<\/strong><\/td><td>8.5<\/td><td>12.0<\/td><td>16.5<\/td><\/tr><tr><td><strong>REC610 market share<\/strong><\/td><td>2%<\/td><td>8%<\/td><td>15%<\/td><\/tr><tr><td><strong>Doses sold (million)<\/strong><\/td><td>0.5<\/td><td>1.9<\/td><td>3.8<\/td><\/tr><tr><td><strong>Net revenue (\u00a5 million)<\/strong><\/td><td>600<\/td><td>2,280<\/td><td>4,560<\/td><\/tr><tr><td><strong>Royalty to GSK (if applicable)<\/strong><\/td><td>None<\/td><td>None<\/td><td>None<\/td><\/tr><tr><td><strong>Gross margin<\/strong><\/td><td>85%<\/td><td>87%<\/td><td>88%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Peak Sales Potential<\/strong>: <strong>\u00a55\u20116\u202fbillion<\/strong> (US$700\u2011840\u202fM) by 2030 if NRDL inclusion achieved.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-production-amp-commercialization\">Production &amp; Commercialization<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Manufacturing<\/strong>: Recbio\u2019s <strong>Changshu facility<\/strong> (capacity: <strong>20\u202fmillion doses\/year<\/strong> by 2026) will produce REC610; dedicated shingles vaccine line operational Q1\u202f2026.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Commercialization<\/strong>: <strong>Self\u2011commercialization<\/strong> via established vaccine sales team covering <strong>2,000+ CDCs<\/strong> and <strong>10,000+ vaccination clinics<\/strong>; partnership discussions with <strong>E\u2011pharmacy platforms<\/strong> (JD Health, Ali Health) for direct\u2011to\u2011consumer channels.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding REC610\u2019s regulatory approval timeline, market penetration, pricing strategy, and peak sales forecasts. Actual results may differ materially due to NMPA review outcomes, competitive responses from GSK, market adoption rates, and potential NRDL pricing pressures.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Recbio Technology Co., Ltd. (HKG: 2179) announced that the New Drug Application (NDA) for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":52272,"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":[1292,38,1291,12],"class_list":["post-52271","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hkg-2179","tag-market-approval-filings","tag-recbio-technology","tag-vaccine"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Recbio\u2019s REC610 Shingles Vaccine NDA Accepted by NMPA, Challenging GSK\u2019s Shingrix - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Recbio Technology Co., Ltd. (HKG: 2179) announced that the New Drug Application (NDA) for its novel adjuvanted recombinant shingles vaccine REC610 has been officially accepted by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA) (Acceptance No.: CXSS2500145), positioning it as the first potential competitor to GSK\u2019s Shingrix in the world\u2019s largest shingles vaccine market.\" \/>\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=52271\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Recbio\u2019s REC610 Shingles Vaccine NDA Accepted by NMPA, Challenging GSK\u2019s Shingrix\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Recbio Technology Co., Ltd. (HKG: 2179) announced that the New Drug Application (NDA) for its novel adjuvanted recombinant shingles vaccine REC610 has been officially accepted by the Center for Drug Evaluation (CDE) of China\u2019s National Medical Products Administration (NMPA) (Acceptance No.: CXSS2500145), positioning it as the first potential competitor to GSK\u2019s Shingrix in the world\u2019s largest shingles vaccine market.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=52271\" \/>\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=\"2025-12-30T12:58:59+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-30T12:59:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/3002-1.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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