{"id":78515,"date":"2026-09-03T17:14:34","date_gmt":"2026-09-03T09:14:34","guid":{"rendered":"https:\/\/flcube.com\/?p=78515"},"modified":"2026-09-03T17:14:35","modified_gmt":"2026-09-03T09:14:35","slug":"hansohs-hs-20093-risvutatug-rezetecan-nda-accepted-by-nmpa-for-small-cell-lung-cancer-after-first-global-phase-iii-os-win-for-a-b7-h3-adc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=78515","title":{"rendered":"Hansoh&#8217;s HS\u201120093 Risvutatug Rezetecan NDA Accepted by NMPA for Small Cell Lung Cancer After First Global Phase III OS Win for a B7\u2011H3 ADC"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Hansoh Pharmaceutical<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/3692:HKG\">HKG: 3692<\/a>) announced that the marketing authorization application for its independently developed <strong>HS\u201120093<\/strong> (Risvutatug Rezetecan) for injection has been accepted by China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for the treatment of adult patients with <strong>small cell lung cancer (SCLC)<\/strong> who have failed prior platinum\u2011based therapy (acceptance number: CXSS2600134). The filing is underpinned by the pivotal ARTEMIS\u2011008 Phase III trial, which in July 2026 became the first global Phase III study to demonstrate a significant overall survival benefit with a B7\u2011H3\u2011targeted antibody\u2011drug conjugate (ADC).<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">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>Agency<\/td><td><strong>National Medical Products Administration (NMPA)<\/strong>, China<\/td><\/tr><tr><td>Application Type<\/td><td>Marketing authorization application (accepted)<\/td><\/tr><tr><td>Acceptance No.<\/td><td>CXSS2600134<\/td><\/tr><tr><td>Product<\/td><td><strong>HS\u201120093<\/strong> (Risvutatug Rezetecan) for injection<\/td><\/tr><tr><td>Indication<\/td><td>Adult <strong>SCLC<\/strong> patients who have failed prior platinum\u2011based therapy<\/td><\/tr><tr><td>Date<\/td><td>Sept 3, 2026<\/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>HS\u201120093<\/strong> (Risvutatug Rezetecan), an independently developed antibody\u2011drug conjugate (ADC) from <strong>Hansoh Pharmaceutical<\/strong><\/li>\n\n\n\n<li><strong>Target:<\/strong> <strong>B7\u2011H3<\/strong>, an immune\u2011checkpoint\u2011related antigen broadly overexpressed in <strong>SCLC<\/strong> and other solid tumors<\/li>\n\n\n\n<li><strong>Innovation:<\/strong> First B7\u2011H3\u2011targeted ADC worldwide to demonstrate a significant overall survival benefit in a global Phase III trial<\/li>\n\n\n\n<li><strong>Registration Basis:<\/strong> Pivotal Phase III ARTEMIS\u2011008 study (Trial No.: ARTEMIS\u2011008) in <strong>SCLC<\/strong> patients who progressed or relapsed after platinum\u2011based therapy<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-evidence-artemis-008\" class=\"wp-block-heading\">Clinical Evidence \u2013 ARTEMIS\u2011008<\/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>Trial<\/td><td>ARTEMIS\u2011008, pivotal Phase III<\/td><\/tr><tr><td>Population<\/td><td><strong>SCLC<\/strong> patients with progression or relapse after platinum\u2011based therapy<\/td><\/tr><tr><td>Primary Endpoint<\/td><td>Overall survival (OS)<\/td><\/tr><tr><td>Result<\/td><td>Primary endpoint met (July 2026)<\/td><\/tr><tr><td>Significance<\/td><td>First global Phase III trial to show significant OS benefit with a B7\u2011H3 ADC<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The OS result represents a positive breakthrough for the B7\u2011H3 ADC field and for second\u2011line <strong>SCLC<\/strong>, one of the most treatment\u2011resistant thoracic malignancies, where survival gains beyond chemotherapy have historically been difficult to achieve.<\/p>\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>First\u2011mover evidence:<\/strong> As the first global Phase III OS win for any B7\u2011H3 ADC, <strong>HS\u201120093<\/strong> establishes the strongest clinical benchmark in its target class to date<\/li>\n\n\n\n<li><strong>Large unmet need:<\/strong> Second\u2011line <strong>SCLC<\/strong> carries a poor prognosis and limited standard\u2011of\u2011care options, positioning <strong>HS\u201120093<\/strong> for significant potential uptake if approved<\/li>\n\n\n\n<li><strong>Regulatory momentum:<\/strong> NMPA acceptance of the NDA moves <strong>Hansoh Pharmaceutical<\/strong> one step closer to a potential first\u2011in\u2011class domestic launch in this indication<\/li>\n\n\n\n<li><strong>Pipeline signal:<\/strong> The result validates <strong>Hansoh&#8217;s<\/strong> internal ADC discovery engine and strengthens its competitive standing in the rapidly expanding ADC landscape<\/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 regulatory review timeline, approval prospects, and commercial potential of <strong>HS\u201120093<\/strong> in <strong>SCLC<\/strong>. Actual results may differ materially due to regulatory, clinical, 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\/2026090200765_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026090200765_c.\"><\/object><a id=\"wp-block-file--media-1b609b97-ed27-43fe-a3d9-6249408a9f7c\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/09\/2026090200765_c.pdf\">2026090200765_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/09\/2026090200765_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-1b609b97-ed27-43fe-a3d9-6249408a9f7c\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Hansoh Pharmaceutical (HKG: 3692) announced that the marketing authorization application for its independently developed HS\u201120093&#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":[35,363,1182,38],"class_list":["post-78515","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-hansoh-pharmaceutical","tag-hkg-3692","tag-market-approval-filings"],"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>Hansoh&#039;s HS\u201120093 Risvutatug Rezetecan NDA Accepted by NMPA for Small Cell Lung Cancer After First Global Phase III OS Win for a B7\u2011H3 ADC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Hansoh Pharmaceutical (HKG: 3692) announced that the marketing authorization application for its independently developed HS\u201120093 (Risvutatug Rezetecan) for injection has been accepted by China&#039;s National Medical Products Administration (NMPA) for the treatment of adult patients with small cell lung cancer (SCLC) who have failed prior platinum\u2011based therapy (acceptance number: CXSS2600134). The filing is underpinned by the pivotal ARTEMIS\u2011008 Phase III trial, which in July 2026 became the first global Phase III study to demonstrate a significant overall survival benefit with a B7\u2011H3\u2011targeted antibody\u2011drug conjugate (ADC).\" \/>\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=78515\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hansoh&#039;s HS\u201120093 Risvutatug Rezetecan NDA Accepted by NMPA for Small Cell Lung Cancer After First Global Phase III OS Win for a B7\u2011H3 ADC\" \/>\n<meta property=\"og:description\" content=\"Hansoh Pharmaceutical (HKG: 3692) announced that the marketing authorization application for its independently developed HS\u201120093 (Risvutatug Rezetecan) for injection has been accepted by China&#039;s National Medical Products Administration (NMPA) for the treatment of adult patients with small cell lung cancer (SCLC) who have failed prior platinum\u2011based therapy (acceptance number: CXSS2600134). The filing is underpinned by the pivotal ARTEMIS\u2011008 Phase III trial, which in July 2026 became the first global Phase III study to demonstrate a significant overall survival benefit with a B7\u2011H3\u2011targeted antibody\u2011drug conjugate (ADC).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=78515\" \/>\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=\"2026-09-03T09:14:34+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-03T09:14:35+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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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The filing is underpinned by the pivotal ARTEMIS\u2011008 Phase III trial, which in July 2026 became the first global Phase III study to demonstrate a significant overall survival benefit with a B7\u2011H3\u2011targeted antibody\u2011drug conjugate (ADC).","og_url":"https:\/\/flcube.com\/?p=78515","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2026-09-03T09:14:34+00:00","article_modified_time":"2026-09-03T09:14:35+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=78515#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=78515"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Hansoh&#8217;s HS\u201120093 Risvutatug Rezetecan NDA Accepted by NMPA for Small Cell Lung Cancer After First Global Phase III OS Win for a B7\u2011H3 ADC","datePublished":"2026-09-03T09:14:34+00:00","dateModified":"2026-09-03T09:14:35+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=78515"},"wordCount":471,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["ADC \/ XDC","Hansoh Pharmaceutical","HKG: 3692","Market approval filings"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=78515#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=78515","url":"https:\/\/flcube.com\/?p=78515","name":"Hansoh's HS\u201120093 Risvutatug Rezetecan NDA Accepted by NMPA for Small Cell Lung Cancer After First Global Phase III OS Win for a B7\u2011H3 ADC - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2026-09-03T09:14:34+00:00","dateModified":"2026-09-03T09:14:35+00:00","description":"Hansoh Pharmaceutical (HKG: 3692) announced that the marketing authorization application for its independently developed HS\u201120093 (Risvutatug Rezetecan) for injection has been accepted by China's National Medical Products Administration (NMPA) for the treatment of adult patients with small cell lung cancer (SCLC) who have failed prior platinum\u2011based therapy (acceptance number: CXSS2600134). 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