{"id":48884,"date":"2025-11-24T21:54:51","date_gmt":"2025-11-24T13:54:51","guid":{"rendered":"https:\/\/flcube.com\/?p=48884"},"modified":"2025-11-24T21:54:53","modified_gmt":"2025-11-24T13:54:53","slug":"zhongshengs-onradivir-granules-enroll-first-phase-3-pediatric-influenza-patient","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48884","title":{"rendered":"Zhongsheng&#8217;s Onradivir Granules Enroll First Phase 3 Pediatric Influenza Patient"},"content":{"rendered":"\n<p><strong>Guangdong Zhongsheng Pharmaceutical Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/002317:SHE\">SHE: 002317<\/a>) announced the enrollment and dosing of the first participant in a <strong>Phase\u202f3 clinical trial<\/strong> of <strong>onradivir granules<\/strong> for treating <strong>simple influenza A in children aged 2\u201111 years<\/strong>, expanding the pediatric application of the world&#8217;s first PB2\u2011targeting antiviral approved for adults in May\u202f2025.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-trial-milestone\">Clinical Trial 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>Onradivir granules<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Guangdong Zhongsheng Pharmaceutical (002317.SZ)<\/td><\/tr><tr><td><strong>Trial Phase<\/strong><\/td><td>Phase\u202f3<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Simple influenza A in children (2\u201111\u202fyears)<\/td><\/tr><tr><td><strong>Study Design<\/strong><\/td><td>Multi\u2011center, randomized, double\u2011blind, placebo\u2011controlled<\/td><\/tr><tr><td><strong>First Enrollment<\/strong><\/td><td>24\u202fNov\u202f2025<\/td><\/tr><tr><td><strong>Next Steps<\/strong><\/td><td>Full enrollment targeted Q4\u202f2026; adolescent expansion (12\u201117\u202fyears) planned<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile\">Drug Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> Novel <strong>RNA polymerase PB2 subunit inhibitor<\/strong> targeting influenza A virus replication<\/li>\n\n\n\n<li><strong>Adult Formulation:<\/strong> <strong>Onradivir tablets (Anruiwei)<\/strong> approved by NMPA in <strong>May\u202f2025<\/strong> as first\u2011in\u2011class Category\u202f1 innovative drug<\/li>\n\n\n\n<li><strong>Key Features:<\/strong> <strong>Rapid onset, potent antiviral activity, low resistance barrier<\/strong><\/li>\n\n\n\n<li><strong>Pediatric Advantage:<\/strong> Granule formulation facilitates administration for children and patients with swallowing difficulties<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-development-status\">Clinical Development Status<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Phase<\/th><th>Status<\/th><th>Key Findings<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase\u202f2 (Adult &amp; Pediatric)<\/strong><\/td><td>Completed<\/td><td>Positive efficacy; favorable safety profile<\/td><\/tr><tr><td><strong>Phase\u202f3 (Pediatric 2\u201111)<\/strong><\/td><td>Initiated<\/td><td>First patient dosed<\/td><\/tr><tr><td><strong>Phase\u202f3 (Adolescent 12\u201117)<\/strong><\/td><td>Planned<\/td><td>Protocol development underway<\/td><\/tr><\/tbody><\/table><\/figure>\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>Metric<\/th><th>Value<\/th><\/tr><\/thead><tbody><tr><td><strong>China Influenza Cases (Annual)<\/strong><\/td><td>~<strong>15\u201120\u202fmillion<\/strong> pediatric cases<\/td><\/tr><tr><td><strong>Antiviral Market Size (Pediatric)<\/strong><\/td><td>\u00a53.5\u202fbillion (US$480\u202fmillion)<\/td><\/tr><tr><td><strong>Current Standard<\/strong><\/td><td>Neuraminidase inhibitors (oseltamivir, zanamivir)<\/td><\/tr><tr><td><strong>Peak Sales Forecast (Onradivir Granules)<\/strong><\/td><td><strong>\u00a51.2\u20111.8\u202fbillion<\/strong> (US$160\u2011240\u202fmillion) by 2030<\/td><\/tr><tr><td><strong>Market Capture Target<\/strong><\/td><td>25\u201130% of pediatric influenza A prescriptions<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitive Edge:<\/strong> First PB2 inhibitor with pediatric data; potential for <strong>Breakthrough Therapy Designation<\/strong> based on novel mechanism<\/li>\n\n\n\n<li><strong>Regulatory Path:<\/strong> Phase\u202f3 data could support NDA filing <strong>H2\u202f2027<\/strong>; NRDL inclusion likely given unmet pediatric need<\/li>\n\n\n\n<li><strong>Global Potential:<\/strong> PB2 target validated across influenza A subtypes; U.S. pediatric IND filing possible <strong>2028<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding onradivir granules\u2019 clinical development, regulatory timeline, and market potential. Actual results may differ materially due to risks including clinical trial outcomes, competitive dynamics, and regulatory review timelines.<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\/2025\/11\/\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u9897\u7c92III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5b8c\u6210\u9996\u4f8b\u53c2\u4e0e\u8005\u5165\u7ec4\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u9897\u7c92III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5b8c\u6210\u9996\u4f8b\u53c2\u4e0e\u8005\u5165\u7ec4\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-26ec3e13-8fe1-46ca-9527-597c4a94ce19\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u9897\u7c92III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5b8c\u6210\u9996\u4f8b\u53c2\u4e0e\u8005\u5165\u7ec4\u7684\u516c\u544a.pdf\">\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u9897\u7c92III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5b8c\u6210\u9996\u4f8b\u53c2\u4e0e\u8005\u5165\u7ec4\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u9897\u7c92III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5b8c\u6210\u9996\u4f8b\u53c2\u4e0e\u8005\u5165\u7ec4\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-26ec3e13-8fe1-46ca-9527-597c4a94ce19\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Guangdong Zhongsheng Pharmaceutical Co., Ltd. (SHE: 002317) announced the enrollment and dosing of the first&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48887,"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":[62,1197,399],"class_list":["post-48884","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-she-002317","tag-zhongsheng-pharmaceutical"],"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>Zhongsheng&#039;s Onradivir Granules Enroll First Phase 3 Pediatric Influenza Patient - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Guangdong Zhongsheng Pharmaceutical Co., Ltd. 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