{"id":40959,"date":"2025-09-09T11:13:19","date_gmt":"2025-09-09T03:13:19","guid":{"rendered":"https:\/\/flcube.com\/?p=40959"},"modified":"2025-09-09T11:13:20","modified_gmt":"2025-09-09T03:13:20","slug":"fosun-pharma-secures-foritinib-approval-for-alk%e2%80%91nsclc-trials-paving-way-for-targeted-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=40959","title":{"rendered":"Fosun Pharma Secures Foritinib Approval for ALK\u2011NSCLC Trials, Paving Way for Targeted Therapy"},"content":{"rendered":"\n<p>Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/2196:HKG\">HKG: 2196<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/600196:SHA\">SHA: 600196<\/a>) announced that its Class\u202f1 chemical drug <strong>Foritinib Succinate Capsules (SAF\u2011189)<\/strong> has received approval from China\u2019s National Medical Products Administration (NMPA) to proceed with clinical trials. The drug targets <strong>ALK\u2011positive<\/strong> and <strong>ROS1\u2011positive<\/strong> non\u2011small\u2011cell lung cancer (NSCLC) patients who have undergone radical tumor resection and are in the adjuvant setting (stage\u202fIB\u2011IIIA).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-what-foritinib-brings-to-the-alk-nsclc-landscape\">What Foritinib Brings to the ALK\u2011NSCLC Landscape<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Targeted Small\u2011Molecule<\/strong> \u2013 Designed to inhibit ALK and ROS1 tyrosine\u2011kinases, offering a precision\u2011medicine approach.<\/li>\n\n\n\n<li><strong>Central Nervous System (CNS) Penetration<\/strong> \u2013 Preclinical data show significant activity against CNS metastases, a common hurdle in ALK\u2011NSCLC therapy.<\/li>\n\n\n\n<li><strong>Favorable Safety Profile<\/strong> \u2013 Early clinical studies report manageable adverse events with low incidence of grade\u202f3\/4 toxicity.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-development-partnership-amp-commercialization-rights\">Development Partnership &amp; Commercialization Rights<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Entity<\/th><th>Role<\/th><th>Key Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Fosun Pharma<\/strong><\/td><td>Lead developer &amp; marketer in China<\/td><td>Holds exclusive rights to develop, trial, and commercialize Foritinib within China.<\/td><\/tr><tr><td><strong>Chongqing Fochon Pharmaceuticals<\/strong><\/td><td>Co\u2011research partner<\/td><td>Joint preclinical work with Shanghai Institute of Materia Medica.<\/td><\/tr><tr><td><strong>Shanghai Institute of Materia Medica (CAMS)<\/strong><\/td><td>Academic collaborator<\/td><td>Provided pivotal preclinical data supporting CNS efficacy.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-trial-design-amp-patient-population\">Trial Design &amp; Patient Population<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase\u202fI\/II Adjuvant Trial<\/strong> \u2013 Enrolling patients with resected stage\u202fIB\u2011IIIA ALK\u2011\/ROS1\u2011positive NSCLC.<\/li>\n\n\n\n<li><strong>Primary Endpoint<\/strong> \u2013 Disease\u2011free survival (DFS) at 24\u202fmonths.<\/li>\n\n\n\n<li><strong>Secondary Endpoints<\/strong> \u2013 Overall survival (OS), CNS relapse rate, and safety\/tolerability.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-strategic-implications-for-fosun-pharma\">Strategic Implications for Fosun Pharma<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011In\u2011Class Adjuvant Therapy<\/strong> \u2013 Addresses an unmet need for patients who have completed surgery but remain at high risk of recurrence.<\/li>\n\n\n\n<li><strong>Portfolio Expansion<\/strong> \u2013 Adds a targeted oncology asset to Fosun\u2019s growing drug pipeline.<\/li>\n\n\n\n<li><strong>Regulatory Momentum<\/strong> \u2013 NMPA approval positions Fosun for a timely Phase\u202fIII application and potential FDA interest.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\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\/09\/2025090800758_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025090800758_c.\"><\/object><a id=\"wp-block-file--media-5ae76f17-810d-4675-8be7-adf68ce44167\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025090800758_c.pdf\">2025090800758_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025090800758_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-5ae76f17-810d-4675-8be7-adf68ce44167\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its Class\u202f1 chemical&#8230;<\/p>\n","protected":false},"author":1,"featured_media":40961,"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":[16,62,893,892,33],"class_list":["post-40959","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-hkg-2196","tag-sha-600196","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>Fosun Pharma Secures Foritinib Approval for ALK\u2011NSCLC Trials, Paving Way for Targeted Therapy - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its Class\u202f1 chemical drug Foritinib Succinate Capsules (SAF\u2011189) has received approval from China\u2019s National Medical Products Administration (NMPA) to proceed with clinical trials. The drug targets ALK\u2011positive and ROS1\u2011positive non\u2011small\u2011cell lung cancer (NSCLC) patients who have undergone radical tumor resection and are in the adjuvant setting (stage\u202fIB\u2011IIIA).\" \/>\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=40959\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fosun Pharma Secures Foritinib Approval for ALK\u2011NSCLC Trials, Paving Way for Targeted Therapy\" \/>\n<meta property=\"og:description\" content=\"Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its Class\u202f1 chemical drug Foritinib Succinate Capsules (SAF\u2011189) has received approval from China\u2019s National Medical Products Administration (NMPA) to proceed with clinical trials. 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(HKG: 2196, SHA: 600196) announced that its Class\u202f1 chemical drug Foritinib Succinate Capsules (SAF\u2011189) has received approval from China\u2019s National Medical Products Administration (NMPA) to proceed with clinical trials. 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The drug targets ALK\u2011positive and ROS1\u2011positive non\u2011small\u2011cell lung cancer (NSCLC) patients who have undergone radical tumor resection and are in the adjuvant setting (stage\u202fIB\u2011IIIA).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=40959#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=40959"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=40959#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/0901.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/0901.webp","width":1080,"height":608,"caption":"Fosun Pharma Secures Foritinib Approval for ALK\u2011NSCLC Trials, Paving Way for Targeted Therapy"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=40959#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Fosun Pharma Secures Foritinib Approval for ALK\u2011NSCLC Trials, Paving Way for Targeted Therapy"}]},{"@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\/09\/0901.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/40959","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=40959"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/40959\/revisions"}],"predecessor-version":[{"id":40962,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/40959\/revisions\/40962"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/40961"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=40959"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=40959"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=40959"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}