{"id":78536,"date":"2026-09-03T17:39:06","date_gmt":"2026-09-03T09:39:06","guid":{"rendered":"https:\/\/flcube.com\/?p=78536"},"modified":"2026-09-03T17:39:07","modified_gmt":"2026-09-03T09:39:07","slug":"zhongsheng-files-china-trial-application-to-expand-onradivir-into-high-risk-influenza-a-patients-broadening-its-first-in-class-pb2-inhibitor-franchise","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=78536","title":{"rendered":"Zhongsheng Files China Trial Application to Expand Onradivir into High\u2011Risk Influenza A Patients, Broadening Its First\u2011in\u2011Class PB2 Inhibitor Franchise"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Zhongsheng Pharmaceutical<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/002317:SHE\">SHE: 002317<\/a>) announced that it has submitted a clinical trial application in China for a new indication of <strong>onradivir<\/strong>, its self\u2011developed Category 1 innovative drug, for the treatment of <strong>influenza A<\/strong> in patients at high risk of complications. The filing extends the clinical footprint of <strong>onradivir<\/strong> \u2014 the world&#8217;s first influenza RNA polymerase PB2 protein inhibitor, approved in China in May 2025 \u2014 beyond uncomplicated disease into a higher\u2011acuity population where antiviral efficacy carries the greatest medical value.<\/p>\n\n\n\n<h2 id=\"h-regulatory-amp-label-expansion-timeline\" class=\"wp-block-heading\">Regulatory &amp; Label Expansion Timeline<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Status<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td>New indication trial application<\/td><td>Submitted (Sept 2, 2026)<\/td><td><strong>Onradivir<\/strong> for <strong>influenza A<\/strong> in patients at high risk of complications<\/td><\/tr><tr><td>Uncomplicated influenza A in adults<\/td><td>Approved (May 2025)<\/td><td>First approved indication in China<\/td><\/tr><tr><td>Adolescents aged 12\u201317 (uncomplicated influenza A)<\/td><td>Supplemental application accepted by <strong>NMPA<\/strong><\/td><td>Onradivir tablets<\/td><\/tr><tr><td>Onradivir granules<\/td><td>Marketing application accepted; priority review granted by <strong>NMPA<\/strong><\/td><td>New formulation for broader patient access<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> <strong>Onradivir<\/strong>, a self\u2011developed Category 1 innovative drug from <strong>Zhongsheng Pharmaceutical<\/strong><\/li>\n\n\n\n<li><strong>Target \/ Class:<\/strong> World&#8217;s first influenza RNA polymerase PB2 protein inhibitor<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> Distinct mechanism of action compared with existing neuraminidase inhibitors and cap\u2011dependent endonuclease inhibitors, with global independent intellectual property rights<\/li>\n\n\n\n<li><strong>Current Indication:<\/strong> Treatment of uncomplicated <strong>influenza A<\/strong> in adult patients (approved in China, May 2025)<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>High\u2011risk expansion:<\/strong> Moving <strong>onradivir<\/strong> into patients at high risk of complications targets the population where antiviral treatment delivers the greatest clinical benefit \u2014 and where physicians most actively prescribe<\/li>\n\n\n\n<li><strong>Multi\u2011front label build:<\/strong> With the adolescent supplemental application accepted and the granules formulation under priority review, <strong>Zhongsheng Pharmaceutical<\/strong> is simultaneously broadening <strong>onradivir&#8217;s<\/strong> age range and formulation flexibility<\/li>\n\n\n\n<li><strong>First\u2011in\u2011class moat:<\/strong> As the world&#8217;s first PB2 inhibitor with global independent IP, <strong>onradivir<\/strong> holds differentiated positioning in a market dominated by older\u2011mechanism antivirals<\/li>\n\n\n\n<li><strong>Lifecycle strategy:<\/strong> The sequential indication, population, and formulation expansions form a classic lifecycle management playbook that can support sustained uptake of <strong>onradivir<\/strong> across influenza seasons in China<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong> \u2014 This brief contains forward\u2011looking statements regarding the clinical trial application, regulatory review outcomes, and commercial potential of <strong>onradivir<\/strong> across its indications and formulations. Actual results may differ materially due to clinical, regulatory, competitive, and market risks. No investment decision should be made solely on the basis of this brief.<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\/09\/\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u7247\u65b0\u589e\u9002\u5e94\u75c7\u4e34\u5e8a\u8bd5\u9a8c\u6ce8\u518c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\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\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u7247\u65b0\u589e\u9002\u5e94\u75c7\u4e34\u5e8a\u8bd5\u9a8c\u6ce8\u518c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-cfc2132f-a6b6-459d-b731-1f4aa3dfcf47\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/09\/\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u7247\u65b0\u589e\u9002\u5e94\u75c7\u4e34\u5e8a\u8bd5\u9a8c\u6ce8\u518c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a.pdf\">\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u7247\u65b0\u589e\u9002\u5e94\u75c7\u4e34\u5e8a\u8bd5\u9a8c\u6ce8\u518c\u7533\u8bf7\u83b7\u5f97\u53d7\u7406\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/09\/\u4f17\u751f\u836f\u4e1a\uff1a\u5173\u4e8e\u63a7\u80a1\u5b50\u516c\u53f8\u6536\u5230\u4e00\u7c7b\u521b\u65b0\u836f\u6602\u62c9\u5730\u97e6\u7247\u65b0\u589e\u9002\u5e94\u75c7\u4e34\u5e8a\u8bd5\u9a8c\u6ce8\u518c\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-cfc2132f-a6b6-459d-b731-1f4aa3dfcf47\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Zhongsheng Pharmaceutical (SHE: 002317) 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":[17,1197,399],"class_list":["post-78536","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-clinical-trial-results","tag-she-002317","tag-zhongsheng-pharmaceutical"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Zhongsheng Files China Trial Application to Expand Onradivir into High\u2011Risk Influenza A Patients, Broadening Its First\u2011in\u2011Class PB2 Inhibitor Franchise - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Zhongsheng Pharmaceutical (SHE: 002317) announced that it has submitted a clinical trial application in China for a new indication of onradivir, its self\u2011developed Category 1 innovative drug, for the treatment of influenza A in patients at high risk of complications. 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