{"id":56040,"date":"2026-02-02T18:42:35","date_gmt":"2026-02-02T10:42:35","guid":{"rendered":"https:\/\/flcube.com\/?p=56040"},"modified":"2026-04-21T20:47:03","modified_gmt":"2026-04-21T12:47:03","slug":"hengrui-ruitanning-gets-nmpa-nod-for-moderately-emetogenic-chemo-indication","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56040","title":{"rendered":"Hengrui Ruitanning Gets NMPA Nod for Moderately Emetogenic Chemo Indication"},"content":{"rendered":"\n<p><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/600276:SHA\">SHA:\u202f600276<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/1276:HKG\">HKG:\u202f1276<\/a>) announced that the <strong>National Medical Products Administration (NMPA)<\/strong> has accepted a new indication filing for <strong>Ruitanning (fosrolapitant, palonosetron)<\/strong>, seeking approval for preventing acute and delayed nausea and vomiting in adult patients receiving <strong>moderately emetogenic anti\u2011cancer agents<\/strong>. The fixed\u2011dose combination drug, first approved in <strong>May\u202f2025<\/strong> for highly emetogenic chemotherapy, is already listed on the <strong>National Reimbursement Drug List (NRDL)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-status-amp-filing-details\">Regulatory Status &amp; Filing Details<\/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>Company<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals (SHA:\u202f600276, HKG:\u202f1276)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>Ruitanning (fosrolapitant + palonosetron)<\/td><\/tr><tr><td><strong>Current Status<\/strong><\/td><td>NRDL\u2011listed since 2025<\/td><\/tr><tr><td><strong>New Indication<\/strong><\/td><td>Prevention of nausea\/vomiting from moderately emetogenic chemotherapy<\/td><\/tr><tr><td><strong>Previous Approval<\/strong><\/td><td>May\u202f2025 for highly emetogenic chemotherapy<\/td><\/tr><tr><td><strong>Filing Acceptance<\/strong><\/td><td>NMPA review initiated January\u202f2026<\/td><\/tr><tr><td><strong>Clinical Basis<\/strong><\/td><td>Phase\u202fIII trial (HR20013\u2011302)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism\">Drug Profile &amp; Mechanism<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Dual Pathway Inhibition:<\/strong> Simultaneously antagonizes <strong>NK1<\/strong> and <strong>5\u2011HT3 receptors<\/strong>, blocking the vomiting reflex through two distinct mechanisms<\/li>\n\n\n\n<li><strong>Formulation:<\/strong> Fixed\u2011dose combination capsule offering convenience over separate agents<\/li>\n\n\n\n<li><strong>Strategic Advantage:<\/strong> Addresses unmet need for simplified prophylaxis in moderate\u2011risk chemotherapy regimens, expanding beyond high\u2011risk settings<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-phase-iii-clinical-data-hr20013-302\">Phase III Clinical Data (HR20013-302)<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Result<\/th><\/tr><\/thead><tbody><tr><td><strong>Trial Design<\/strong><\/td><td>Multicenter, randomized, controlled<\/td><\/tr><tr><td><strong>Participants<\/strong><\/td><td>706 patients<\/td><\/tr><tr><td><strong>Primary Comparison<\/strong><\/td><td>Ruitanning vs. control (standard antiemetic regimen)<\/td><\/tr><tr><td><strong>Delayed Phase Complete Response<\/strong><\/td><td>Significantly better than control (p\u202f&lt;\u202f0.05)<\/td><\/tr><tr><td><strong>Overall Complete Response Rate<\/strong><\/td><td>Significantly better than control (p\u202f&lt;\u202f0.05)<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Good safety, comparable to control<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-commercial-outlook\">Market Impact &amp; Commercial Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China Antiemetics Market:<\/strong> Valued at <strong>\u00a58\u202fbillion<\/strong> : (~US$1.1\u202fbillion) in 2025, growing at <strong>12% CAGR<\/strong> driven by expanding cancer treatment access<\/li>\n\n\n\n<li><strong>Moderate Emetogenic Opportunity:<\/strong> Represents <strong>40\u201350%<\/strong> of all chemotherapy regimens, doubling addressable patient population vs. high\u2011emetogenic setting<\/li>\n\n\n\n<li><strong>NRDL Advantage:<\/strong> Existing reimbursement listing ensures rapid market penetration upon approval; no additional pricing negotiations required<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Analysts project <strong>\u00a51.5\u20132.0\u202fbillion<\/strong> (US$210\u2013280\u202fmillion) incremental annual sales from moderate\u2011emetogenic indication by 2028<\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> Expands Hengrui\u2019s supportive oncology franchise, complementing its core chemotherapy and targeted therapy portfolio<\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> NMPA technical review expected <strong>6\u20139 months<\/strong>; potential approval <strong>Q4\u202f2026<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory review timelines, commercial expectations, and revenue projections for Ruitanning. Actual results may differ due to NMPA review outcomes, competitive dynamics, and market adoption rates.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that the National Medical Products Administration (NMPA)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":56041,"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":[2586,4228,38,852],"class_list":["post-56040","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hengrui-pharmaceuticals","tag-hkg-1276","tag-market-approval-filings","tag-sha-600276"],"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>Hengrui Ruitanning Gets NMPA Nod for Moderately Emetogenic Chemo Indication - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that the National Medical Products Administration (NMPA) has accepted a new indication filing for Ruitanning (fosrolapitant, palonosetron), seeking approval for preventing acute and delayed nausea and vomiting in adult patients receiving moderately emetogenic anti\u2011cancer agents. The fixed\u2011dose combination drug, first approved in May\u202f2025 for highly emetogenic chemotherapy, is already listed on the National Reimbursement Drug List (NRDL).\" \/>\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=56040\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hengrui Ruitanning Gets NMPA Nod for Moderately Emetogenic Chemo Indication\" \/>\n<meta property=\"og:description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA:\u202f600276, HKG:\u202f1276) announced that the National Medical Products Administration (NMPA) has accepted a new indication filing for Ruitanning (fosrolapitant, palonosetron), seeking approval for preventing acute and delayed nausea and vomiting in adult patients receiving moderately emetogenic anti\u2011cancer agents. 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(SHA:\u202f600276, HKG:\u202f1276) announced that the National Medical Products Administration (NMPA) has accepted a new indication filing for Ruitanning (fosrolapitant, palonosetron), seeking approval for preventing acute and delayed nausea and vomiting in adult patients receiving moderately emetogenic anti\u2011cancer agents. 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(SHA:\u202f600276, HKG:\u202f1276) announced that the National Medical Products Administration (NMPA) has accepted a new indication filing for Ruitanning (fosrolapitant, palonosetron), seeking approval for preventing acute and delayed nausea and vomiting in adult patients receiving moderately emetogenic anti\u2011cancer agents. The fixed\u2011dose combination drug, first approved in May\u202f2025 for highly emetogenic chemotherapy, is already listed on the National Reimbursement Drug List (NRDL).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=56040#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=56040"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=56040#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0205.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0205.webp","width":1080,"height":608,"caption":"Hengrui Ruitanning Gets NMPA Nod for Moderately Emetogenic Chemo Indication"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=56040#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Hengrui Ruitanning Gets NMPA Nod for Moderately Emetogenic Chemo Indication"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/02\/0205.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/56040","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=56040"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/56040\/revisions"}],"predecessor-version":[{"id":56042,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/56040\/revisions\/56042"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/56041"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=56040"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=56040"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=56040"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}