{"id":72283,"date":"2026-08-11T13:02:13","date_gmt":"2026-08-11T05:02:13","guid":{"rendered":"https:\/\/flcube.com\/?p=72283"},"modified":"2026-08-11T13:02:15","modified_gmt":"2026-08-11T05:02:15","slug":"zhifei-biological-submits-clinical-trial-application-in-china-for-nasal-spray-recombinant-rsv-vaccine-based-on-chimpanzee-adenovirus-vector","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=72283","title":{"rendered":"Zhifei Biological Submits Clinical Trial Application in China for Nasal Spray Recombinant RSV Vaccine Based on Chimpanzee Adenovirus Vector"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Zhifei Biological (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/300122:SHE\">SHE: 300122<\/a>)<\/strong> announced that it has submitted a <strong>clinical trial application in China<\/strong> for its <strong>nasal spray recombinant respiratory syncytial virus vaccine (chimpanzee adenovirus vector)<\/strong>, referred to as the <strong>&#8220;nasal spray recombinant RSV vaccine.&#8221;<\/strong> The candidate is intended to prevent <strong>lower respiratory tract infections caused by RSV<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-regulatory-submission-overview\" class=\"wp-block-heading\">Regulatory Submission Overview<\/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>Sponsor<\/strong><\/td><td>Zhifei Biological (SHE: 300122)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Nasal spray recombinant respiratory syncytial virus vaccine (chimpanzee adenovirus vector)<\/td><\/tr><tr><td><strong>Submission Type<\/strong><\/td><td>Clinical trial application (China)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Prevention of lower respiratory tract infections caused by RSV<\/td><\/tr><tr><td><strong>Administration Route<\/strong><\/td><td>Nasal spray<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>10 Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-disease-background-respiratory-syncytial-virus-rsv\" class=\"wp-block-heading\">Disease Background \u2013 Respiratory Syncytial Virus (RSV)<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pathogen Profile:<\/strong> RSV is a <strong>common respiratory pathogen<\/strong><\/li>\n\n\n\n<li><strong>High\u2011Risk Populations:<\/strong> One of the <strong>primary causes of lower respiratory tract infections<\/strong> in:<\/li>\n\n\n\n<li><strong>Infants<\/strong><\/li>\n\n\n\n<li><strong>The elderly<\/strong><\/li>\n\n\n\n<li><strong>Immunocompromised individuals<\/strong><\/li>\n\n\n\n<li><strong>Unmet Need:<\/strong> RSV disease burden remains substantial across vulnerable age groups globally, driving active vaccine development worldwide.<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-product-profile-nasal-spray-recombinant-rsv-vaccine\" class=\"wp-block-heading\">Product Profile \u2013 Nasal Spray Recombinant RSV Vaccine<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Modality<\/strong><\/td><td>Recombinant vaccine<\/td><\/tr><tr><td><strong>Vector<\/strong><\/td><td><strong>Chimpanzee adenovirus vector<\/strong><\/td><\/tr><tr><td><strong>Administration<\/strong><\/td><td>Nasal spray (needle\u2011free)<\/td><\/tr><tr><td><strong>Intended Use<\/strong><\/td><td>Prevention of lower respiratory tract infections caused by RSV<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-mechanism-of-action-mucosal-immunity\" class=\"wp-block-heading\">Mechanism of Action \u2013 Mucosal Immunity<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">By inducing <strong>mucosal immune responses in the respiratory tract<\/strong> via nasal spray administration, the candidate vaccine is designed to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Establish the first line of defense<\/strong> in the respiratory system \u2014 where RSV infection begins<\/li>\n\n\n\n<li><strong>Simultaneously trigger both humoral and cellular immunity<\/strong> \u2014 a dual immune response<\/li>\n\n\n\n<li><strong>Provide a more convenient method of vaccination<\/strong> \u2014 needle\u2011free nasal spray delivery may improve uptake and accessibility<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-strategic-rationale-amp-market-impact\" class=\"wp-block-heading\">Strategic Rationale &amp; Market Impact<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mucosal Delivery Differentiation:<\/strong> Unlike intramuscular RSV vaccine candidates, Zhifei&#8217;s <strong>nasal spray approach<\/strong> aims to induce mucosal immunity directly at the site of RSV entry \u2014 potentially offering earlier and more targeted protection against lower respiratory tract infection.<\/li>\n\n\n\n<li><strong>Dual Immune Response:<\/strong> Triggering both <strong>humoral and cellular immunity<\/strong> positions the candidate as a potentially comprehensive prophylactic option, particularly for populations where cellular immunity contributes to durable protection.<\/li>\n\n\n\n<li><strong>Needle\u2011Free Advantage:<\/strong> The nasal spray route removes injection\u2011related barriers, supporting broader vaccination uptake among infants, elderly and immunocompromised populations.<\/li>\n\n\n\n<li><strong>Portfolio Expansion:<\/strong> The submission reinforces Zhifei Biological&#8217;s push into the fast\u2011growing RSV vaccine space, a market attracting major global players as the first RSV vaccines reach older adults.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the clinical trial application&#8217;s review outcome, the candidate&#8217;s development trajectory, and commercial potential. Actual results may differ due to risks including regulatory decisions, clinical trial results, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/\u667a\u98de\u751f\u7269\uff1a\u5173\u4e8e\u9f3b\u55b7\u91cd\u7ec4\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2\u75ab\u82d7\uff08\u9ed1\u7329\u7329\u817a\u75c5\u6bd2\u8f7d\u4f53\uff09\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u667a\u98de\u751f\u7269\uff1a\u5173\u4e8e\u9f3b\u55b7\u91cd\u7ec4\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2\u75ab\u82d7\uff08\u9ed1\u7329\u7329\u817a\u75c5\u6bd2\u8f7d\u4f53\uff09\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-3310a6a4-f278-47e9-8785-49abdcbb09fc\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/\u667a\u98de\u751f\u7269\uff1a\u5173\u4e8e\u9f3b\u55b7\u91cd\u7ec4\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2\u75ab\u82d7\uff08\u9ed1\u7329\u7329\u817a\u75c5\u6bd2\u8f7d\u4f53\uff09\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a.pdf\">\u667a\u98de\u751f\u7269\uff1a\u5173\u4e8e\u9f3b\u55b7\u91cd\u7ec4\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2\u75ab\u82d7\uff08\u9ed1\u7329\u7329\u817a\u75c5\u6bd2\u8f7d\u4f53\uff09\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/\u667a\u98de\u751f\u7269\uff1a\u5173\u4e8e\u9f3b\u55b7\u91cd\u7ec4\u547c\u5438\u9053\u5408\u80de\u75c5\u6bd2\u75ab\u82d7\uff08\u9ed1\u7329\u7329\u817a\u75c5\u6bd2\u8f7d\u4f53\uff09\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3310a6a4-f278-47e9-8785-49abdcbb09fc\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Zhifei Biological (SHE: 300122) announced that it has submitted a clinical trial application in China&#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_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":[90,879,878],"class_list":["post-72283","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-filings","tag-she-300122","tag-zhifei-biological"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Zhifei Biological Submits Clinical Trial Application in China for Nasal Spray Recombinant RSV Vaccine Based on Chimpanzee Adenovirus Vector - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Zhifei Biological (SHE: 300122) announced that it has submitted a clinical trial application in China for its nasal spray recombinant respiratory syncytial virus vaccine (chimpanzee adenovirus vector), referred to as the &quot;nasal spray recombinant RSV vaccine.&quot; 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