{"id":52254,"date":"2025-12-30T16:49:11","date_gmt":"2025-12-30T08:49:11","guid":{"rendered":"https:\/\/flcube.com\/?p=52254"},"modified":"2025-12-30T16:49:12","modified_gmt":"2025-12-30T08:49:12","slug":"hutchmeds-fanregratinib-wins-nmpa-priority-review-for-fgfr2-cholangiocarcinoma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52254","title":{"rendered":"HutchMed&#8217;s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma"},"content":{"rendered":"\n<p><strong>HutchMed (China) Ltd<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/HCM:NASDAQ\">NASDAQ: HCM<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/0013:HKG\">HKG: 0013<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has <strong>accepted the New Drug Application (NDA)<\/strong> for <strong>fanregratinib (HMPL\u2011453)<\/strong> and granted <strong>Priority Review<\/strong> for the treatment of adult patients with <strong>advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (iCCA)<\/strong> harboring <strong>FGFR2 fusion or rearrangement<\/strong> after prior systemic therapy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">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><strong>Product<\/strong><\/td><td>Fanregratinib (HMPL-453)<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013)<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Highly selective FGFR 1, 2, and 3 inhibitor<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>FGFR2 fusion\/rearrangement-positive iCCA (post-systemic therapy)<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>NDA accepted with Priority Review (China)<\/td><\/tr><tr><td><strong>Study Support<\/strong><\/td><td>Single-arm, multi-center, open-label Phase II registration study<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Objective Response Rate (ORR) \u2013 met<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-phase-ii-study\">Clinical Evidence \u2013 Phase II Study<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Result<\/th><th>Clinical Significance<\/th><\/tr><\/thead><tbody><tr><td><strong>Objective Response Rate (ORR)<\/strong><\/td><td><strong>Primary endpoint met<\/strong><\/td><td>Demonstrates anti-tumor activity<\/td><\/tr><tr><td><strong>Progression-Free Survival (PFS)<\/strong><\/td><td>Secondary endpoint supportive<\/td><td>Duration of disease control<\/td><\/tr><tr><td><strong>Disease Control Rate (DCR)<\/strong><\/td><td>Secondary endpoint supportive<\/td><td>Overall clinical benefit<\/td><\/tr><tr><td><strong>Duration of Response (DoR)<\/strong><\/td><td>Secondary endpoint supportive<\/td><td>Sustainability of responses<\/td><\/tr><tr><td><strong>Overall Survival (OS)<\/strong><\/td><td>Secondary endpoint supportive<\/td><td>Long-term survival benefit<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><em>Study Design: Single-arm, multi-center, open-label Phase II registration study conducted in China.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-opportunity\">Market Context &amp; Opportunity<\/h2>\n\n\n\n<p><strong>Intrahepatic Cholangiocarcinoma (iCCA) Landscape<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Incidence<\/strong>: Accounts for <strong>8.2% to 15.0%<\/strong> of primary liver cancers, making it the <strong>second most common<\/strong> after hepatocellular carcinoma (HCC)<\/li>\n\n\n\n<li><strong>Global Trend<\/strong>: Incidence steadily increasing worldwide<\/li>\n\n\n\n<li><strong>Prognosis<\/strong>: <strong>5-year overall survival rate ~9%<\/strong>, highlighting urgent need for effective therapies<\/li>\n\n\n\n<li><strong>FGFR2 Prevalence<\/strong>: <strong>10% to 15%<\/strong> of iCCA patients harbor FGFR2 fusions\/rearrangements, representing a <strong>targetable molecular subset<\/strong><\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>China<\/th><th>Global<\/th><\/tr><\/thead><tbody><tr><td><strong>Annual iCCA incidence<\/strong><\/td><td>~45,000 cases<\/td><td>~200,000 cases<\/td><\/tr><tr><td><strong>FGFR2+ addressable population<\/strong><\/td><td><strong>4,500-6,750 patients<\/strong><\/td><td><strong>20,000-30,000 patients<\/strong><\/td><\/tr><tr><td><strong>Current SOC<\/strong><\/td><td>Chemotherapy, limited targeted options<\/td><td>Pemigatinib (US\/EU), Infigratinib (US)<\/td><\/tr><tr><td><strong>Market Gap<\/strong><\/td><td>No approved FGFR inhibitors in China<\/td><td>&#8211;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competitive-landscape\">Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Drug<\/th><th>Company<\/th><th>Target<\/th><th>Status in China<\/th><th>Differentiation<\/th><\/tr><\/thead><tbody><tr><td><strong>Fanregratinib<\/strong><\/td><td><strong>HutchMed<\/strong><\/td><td><strong>FGFR 1\/2\/3<\/strong><\/td><td><strong>NDA accepted (Priority Review)<\/strong><\/td><td><strong>First potential FGFR inhibitor for iCCA in China<\/strong><\/td><\/tr><tr><td><strong>Pemigatinib<\/strong><\/td><td>Incyte\/\u4fe1\u8fbe<\/td><td>FGFR 1\/2\/3<\/td><td>Phase III ongoing<\/td><td>Approved in US\/EU; not yet in China<\/td><\/tr><tr><td><strong>Infigratinib<\/strong><\/td><td>BridgeBio\/QED<\/td><td>FGFR 1\/2\/3<\/td><td>Not filed<\/td><td>Approved in US; limited data in Asian patients<\/td><\/tr><tr><td><strong>Futibatinib<\/strong><\/td><td>Taiho<\/td><td>FGFR 1-4<\/td><td>Not filed<\/td><td>FGFR4 activity may increase toxicity<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Strategic Position<\/strong>: Fanregratinib could be <strong>first-to-market<\/strong> in China, capturing an <strong>estimated 60-70% market share<\/strong> in FGFR2+ iCCA.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-financial-outlook\">Financial Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2027E<\/th><th>2029E<\/th><th>2031E<\/th><\/tr><\/thead><tbody><tr><td><strong>China iCCA patients (FGFR2+)<\/strong><\/td><td>5,500<\/td><td>6,200<\/td><td>7,000<\/td><\/tr><tr><td><strong>Fanregratinib penetration<\/strong><\/td><td>40%<\/td><td>55%<\/td><td>65%<\/td><\/tr><tr><td><strong>Annual therapy cost (\u00a5)<\/strong><\/td><td>\u00a5280,000<\/td><td>\u00a5240,000 (post-NRDL)<\/td><td>\u00a5200,000<\/td><\/tr><tr><td><strong>Peak China sales<\/strong><\/td><td>\u00a5616 million<\/td><td>\u00a5818 million<\/td><td><strong>\u00a5910 million<\/strong> (US$127M)<\/td><\/tr><tr><td><strong>Global expansion potential<\/strong><\/td><td>&#8211;<\/td><td>US\/EU filing<\/td><td>Additional \u00a51.5B upside<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><\/p>\n\n\n\n<p>This brief contains forward\u2011looking statements regarding fanregratinib\u2019s regulatory timeline, market potential, and clinical development plans. Actual results may differ materially due to regulatory review outcomes, competitive dynamics, and market access challenges.<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\/12\/2025122900468_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025122900468_c.\"><\/object><a id=\"wp-block-file--media-d9efa40e-0d65-4a3d-a4fa-b5aab3ded1c7\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/2025122900468_c.pdf\">2025122900468_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/2025122900468_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-d9efa40e-0d65-4a3d-a4fa-b5aab3ded1c7\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China&#8217;s National Medical Products Administration (NMPA)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":52256,"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":[16,1105,38,1104,33],"class_list":["post-52254","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-hkg-0013","tag-market-approval-filings","tag-nasdaq-hcm","tag-tkis-egfr-vegf-btk-etc"],"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>HutchMed&#039;s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China&#039;s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for fanregratinib (HMPL\u2011453) and granted Priority Review for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusion or rearrangement after prior systemic therapy.\" \/>\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=52254\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"HutchMed&#039;s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma\" \/>\n<meta property=\"og:description\" content=\"HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China&#039;s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for fanregratinib (HMPL\u2011453) and granted Priority Review for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusion or rearrangement after prior systemic therapy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=52254\" \/>\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=\"2025-12-30T08:49:11+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-30T08:49:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/3006.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"HutchMed&#8217;s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma\",\"datePublished\":\"2025-12-30T08:49:11+00:00\",\"dateModified\":\"2025-12-30T08:49:12+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254\"},\"wordCount\":432,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/12\\\/3006.webp\",\"keywords\":[\"Cancer\",\"HKG: 0013\",\"Market approval filings\",\"NASDAQ: HCM\",\"TKIs (EGFR VEGF BTK etc.)\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=52254#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=52254\",\"name\":\"HutchMed's Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/12\\\/3006.webp\",\"datePublished\":\"2025-12-30T08:49:11+00:00\",\"dateModified\":\"2025-12-30T08:49:12+00:00\",\"description\":\"HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for fanregratinib (HMPL\u2011453) and granted Priority Review for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusion or rearrangement after prior systemic therapy.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=52254\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/12\\\/3006.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/12\\\/3006.webp\",\"width\":1080,\"height\":608,\"caption\":\"HutchMed's Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=52254#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"HutchMed&#8217;s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma\"}]},{\"@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\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"HutchMed's Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma - Insight, China&#039;s Pharmaceutical Industry","description":"HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for fanregratinib (HMPL\u2011453) and granted Priority Review for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusion or rearrangement after prior systemic therapy.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=52254","og_locale":"en_US","og_type":"article","og_title":"HutchMed's Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma","og_description":"HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for fanregratinib (HMPL\u2011453) and granted Priority Review for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusion or rearrangement after prior systemic therapy.","og_url":"https:\/\/flcube.com\/?p=52254","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-12-30T08:49:11+00:00","article_modified_time":"2025-12-30T08:49:12+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/3006.webp","type":"image\/png"}],"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":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=52254#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=52254"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"HutchMed&#8217;s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma","datePublished":"2025-12-30T08:49:11+00:00","dateModified":"2025-12-30T08:49:12+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=52254"},"wordCount":432,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=52254#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/3006.webp","keywords":["Cancer","HKG: 0013","Market approval filings","NASDAQ: HCM","TKIs (EGFR VEGF BTK etc.)"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=52254#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=52254","url":"https:\/\/flcube.com\/?p=52254","name":"HutchMed's Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=52254#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=52254#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/3006.webp","datePublished":"2025-12-30T08:49:11+00:00","dateModified":"2025-12-30T08:49:12+00:00","description":"HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for fanregratinib (HMPL\u2011453) and granted Priority Review for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusion or rearrangement after prior systemic therapy.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=52254#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=52254"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=52254#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/3006.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/3006.webp","width":1080,"height":608,"caption":"HutchMed's Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=52254#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"HutchMed&#8217;s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma"}]},{"@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\/2025\/12\/3006.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/52254","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=52254"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/52254\/revisions"}],"predecessor-version":[{"id":52258,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/52254\/revisions\/52258"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/52256"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=52254"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=52254"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=52254"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}