{"id":43005,"date":"2025-10-10T16:10:06","date_gmt":"2025-10-10T08:10:06","guid":{"rendered":"https:\/\/flcube.com\/?p=43005"},"modified":"2025-10-10T16:10:07","modified_gmt":"2025-10-10T08:10:07","slug":"huadong-medicine-secures-nmpa-trial-approval-for-hdm2017-a-cdh17%e2%80%91targeting-adc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43005","title":{"rendered":"Huadong Medicine Secures NMPA Trial Approval for HDM2017, a CDH17\u2011Targeting ADC"},"content":{"rendered":"\n<p>China\u2011based <strong>Huadong Medicine Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/000963:SHE\">SHE: 000963<\/a>) announced that its novel antibody\u2011drug conjugate (ADC), <strong>HDM2017 Injection<\/strong>, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials in patients with advanced malignant solid tumors. The approval marks a significant milestone for Huadong\u2019s oncology pipeline and underscores the therapeutic potential of targeting Cadherin\u201117 (CDH17) in solid\u2011tumor disease.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-product-profile\">Product Profile<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism of Action<\/strong> \u2013 HDM2017 couples an anti\u2011CDH17 monoclonal antibody to a topoisomerase\u2011I inhibitor via a cleavable linker, with a drug\u2011to\u2011antibody ratio (DAR) of four.<\/li>\n\n\n\n<li><strong>Target<\/strong> \u2013 Cadherin\u201117 (CDH17), overexpressed in a subset of colorectal, pancreatic, and gastric cancers.<\/li>\n\n\n\n<li><strong>Preclinical Success<\/strong> \u2013 Demonstrated potent antitumor activity in xenograft models of CDH17\u2011positive colorectal, pancreatic, and gastric cancers, coupled with an acceptable safety profile in animal studies.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-clinical-development\">Clinical Development<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NMPA Status<\/strong> \u2013 Received authorization to initiate Phase\u202fI\/II trials in patients with advanced solid tumors.<\/li>\n\n\n\n<li><strong>Trial Design<\/strong> \u2013 The upcoming studies will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy across multiple CDH17\u2011positive tumor types.<\/li>\n\n\n\n<li><strong>Timeline<\/strong> \u2013 First\u2011in\u2011human dosing is expected in the first half of 2025, with subsequent enrollment phases planned thereafter.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Portfolio Expansion<\/strong> \u2013 HDM2017 adds a differentiated ADC to Huadong\u2019s oncology platform, complementing existing small\u2011molecule and biologic programs.<\/li>\n\n\n\n<li><strong>Market Potential<\/strong> \u2013 CDH17 is a promising biomarker for several high\u2011prevalence cancers; successful clinical outcomes could position HDM2017 as a first\u2011in\u2011class therapy.<\/li>\n\n\n\n<li><strong>Collaborative Opportunities<\/strong> \u2013 Huadong may seek partnerships or co\u2011development agreements to accelerate global regulatory approval and commercial rollout.<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\/10\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a-3.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a (3).\"><\/object><a id=\"wp-block-file--media-4037afd6-c54d-43c1-8322-7eb5c87bd080\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a-3.pdf\">\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a (3)<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u83b7\u5f97\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a-3.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-4037afd6-c54d-43c1-8322-7eb5c87bd080\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based Huadong Medicine Co., Ltd. (SHE: 000963) announced that its novel antibody\u2011drug conjugate (ADC), HDM2017&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43008,"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":[35,62,114,887],"class_list":["post-43005","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-clinical-trial-approval-initiation","tag-huadong-medicine","tag-she-000963"],"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>Huadong Medicine Secures NMPA Trial Approval for HDM2017, a CDH17\u2011Targeting ADC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based Huadong Medicine Co., Ltd. (SHE: 000963) announced that its novel antibody\u2011drug conjugate (ADC), HDM2017 Injection, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials in patients with advanced malignant solid tumors. The approval marks a significant milestone for Huadong\u2019s oncology pipeline and underscores the therapeutic potential of targeting Cadherin\u201117 (CDH17) in solid\u2011tumor disease.\" \/>\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=43005\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Huadong Medicine Secures NMPA Trial Approval for HDM2017, a CDH17\u2011Targeting ADC\" \/>\n<meta property=\"og:description\" content=\"China\u2011based Huadong Medicine Co., Ltd. (SHE: 000963) announced that its novel antibody\u2011drug conjugate (ADC), HDM2017 Injection, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials in patients with advanced malignant solid tumors. 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(SHE: 000963) announced that its novel antibody\u2011drug conjugate (ADC), HDM2017 Injection, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials in patients with advanced malignant solid tumors. 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