{"id":44337,"date":"2025-10-24T23:53:53","date_gmt":"2025-10-24T15:53:53","guid":{"rendered":"https:\/\/flcube.com\/?p=44337"},"modified":"2025-10-24T23:53:53","modified_gmt":"2025-10-24T15:53:53","slug":"hansoh-pharmaceutical-submits-hs%e2%80%9110365-nda-to-nmpa-for-ret%e2%80%91positive-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=44337","title":{"rendered":"Hansoh Pharmaceutical Submits HS\u201110365 NDA to NMPA for RET\u2011Positive NSCLC"},"content":{"rendered":"\n<p>China\u2011based Hansoh Pharmaceutical\u202fGroup\u202fCo.,\u202fLtd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/3692:HKG\">HKG: 3692<\/a>) announced today that it has filed a New Drug Application (NDA) for <strong>HS\u201110365<\/strong> with the National Medical Products Administration (NMPA) of China. The application seeks approval for the treatment of adult patients with <strong>locally advanced or metastatic non\u2011small cell lung cancer (NSCLC)<\/strong> who harbor <strong>RET gene fusions<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-product-profile\">Product Profile<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug Class<\/strong><\/td><td>Class\u202f1 innovative small\u2011molecule RET\u202freceptor tyrosine kinase inhibitor<\/td><\/tr><tr><td><strong>Mechanism of Action<\/strong><\/td><td>Competitive ATP binding to intracellular tyrosine kinase domain \u2192 inhibition of RET phosphorylation \u2192 suppression of tumor cell proliferation<\/td><\/tr><tr><td><strong>Development Status<\/strong><\/td><td>Independently developed by Hansoh; NDA filed for first\u2011in\u2011class RET\u2011targeted therapy in China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NDA Submission<\/strong> \u2013 23\u202fOct\u202f2025 to NMPA<\/li>\n\n\n\n<li><strong>Target Indication<\/strong> \u2013 Adult patients with RET\u2011fusion\u2011positive NSCLC<\/li>\n\n\n\n<li><strong>Next Steps<\/strong> \u2013 NMPA review, potential clinical trial prerequisites, and eventual market launch pending approval<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-strategic-significance\">Strategic Significance<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pipeline Diversification<\/strong> \u2013 Adds a precision\u2011oncology asset to Hansoh\u2019s growing oncology portfolio.<\/li>\n\n\n\n<li><strong>Market Opportunity<\/strong> \u2013 RET fusions occur in ~1\u20132\u202f% of NSCLC cases; a highly selective inhibitor could capture a niche yet unmet need.<\/li>\n\n\n\n<li><strong>Innovation Leadership<\/strong> \u2013 Positions Hansoh as a domestic pioneer in targeted small\u2011molecule therapies for lung cancer.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This release contains forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<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\/10\/2025102300880_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025102300880_c.\"><\/object><a id=\"wp-block-file--media-c6fec629-97b8-417f-aa3a-211815978d58\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2025102300880_c.pdf\">2025102300880_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2025102300880_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-c6fec629-97b8-417f-aa3a-211815978d58\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based Hansoh Pharmaceutical\u202fGroup\u202fCo.,\u202fLtd. (HKG: 3692) announced today that it has filed a New Drug Application&#8230;<\/p>\n","protected":false},"author":1,"featured_media":44341,"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":[16,363,1182,38],"class_list":["post-44337","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-hansoh-pharmaceutical","tag-hkg-3692","tag-market-approval-filings"],"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>Hansoh Pharmaceutical Submits HS\u201110365 NDA to NMPA for RET\u2011Positive NSCLC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based Hansoh Pharmaceutical\u202fGroup\u202fCo.,\u202fLtd. 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