{"id":43257,"date":"2025-10-14T15:26:40","date_gmt":"2025-10-14T07:26:40","guid":{"rendered":"https:\/\/flcube.com\/?p=43257"},"modified":"2025-10-14T15:26:41","modified_gmt":"2025-10-14T07:26:41","slug":"mabwell-bioscience-receives-nmpa-ind-approval-for-7mw4911-cdh17%e2%80%91targeting-adc-in-advanced-solid-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43257","title":{"rendered":"Mabwell Bioscience Receives NMPA IND Approval for 7MW4911 CDH17\u2011Targeting ADC in Advanced Solid Tumors"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Mabwell Bioscience<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/688062:SHA\">SHA: 688062<\/a>) announced today that the National Medical Products Administration (NMPA) has granted Investigational New Drug (IND) approval for its proprietary CDH17\u2011targeting Antibody\u2011Drug Conjugate (ADC), <strong>7MW4911<\/strong>. The approval enables the company to initiate clinical trials in patients with advanced solid tumors.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-key-highlights\">Key Highlights<\/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>Company<\/strong><\/td><td>Mabwell\u202fBioscience (SHA:\u202f688062)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>7MW4911 (CDH17\u2011targeting ADC)<\/td><\/tr><tr><td><strong>R&amp;D Code<\/strong><\/td><td>7MW4911<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>NMPA IND approval<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Advanced solid tumors<\/td><\/tr><tr><td><strong>Platform<\/strong><\/td><td>IDDC antibody conjugation technology<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-7mw4911-an-innovative-cdh17-targeted-adc\">7MW4911: An Innovative CDH17\u2011Targeted ADC<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Target<\/strong> \u2013 Cadherin\u201117 (CDH17), a membrane protein over\u2011expressed in multiple solid\u2011tumor types.<\/li>\n\n\n\n<li><strong>Antibody<\/strong> \u2013 <strong>Mab0727<\/strong>, a high\u2011specificity anti\u2011CDH17 monoclonal antibody with rapid internalization and medium affinity across species (human\/monkey).<\/li>\n\n\n\n<li><strong>Linker<\/strong> \u2013 Novel cleavable linker that releases the payload only inside the tumor cell.<\/li>\n\n\n\n<li><strong>Payload<\/strong> \u2013 Proprietary DNA Topoisomerase\u202fI inhibitor <strong>MF\u20116<\/strong>, engineered to overcome multi\u2011drug resistance (MDR).<\/li>\n\n\n\n<li><strong>Plasma stability<\/strong> \u2013 Extended half\u2011life.<\/li>\n\n\n\n<li><strong>Controlled release<\/strong> \u2013 Precise drug delivery.<\/li>\n\n\n\n<li><strong>Bystander effect<\/strong> \u2013 Enhanced activity against neighboring tumor cells.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-significance\">Strategic Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011in\u2011class<\/strong> CDH17\u2011targeted ADC in China, filling a critical unmet need in solid\u2011tumor therapy.<\/li>\n\n\n\n<li><strong>IDDC Platform<\/strong> \u2013 Scalable antibody conjugation method that can be applied to other targets.<\/li>\n\n\n\n<li><strong>Potential for Combination<\/strong> \u2013 Designed to synergize with checkpoint inhibitors and chemotherapy.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-about-mabwell-bioscience\">About Mabwell\u202fBioscience<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Mabwell\u202fBioscience is a Shanghai\u2011based biopharmaceutical company focused on novel antibody\u2011drug conjugates and targeted therapies for oncology. The company leverages its proprietary IDDC platform to develop highly selective ADCs aimed at improving efficacy and reducing off\u2011target toxicity.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">This release contains forward\u2011looking statements regarding the NMPA approval, clinical development plans, and potential market impact. These statements are based on current expectations and are subject to risks and uncertainties, including regulatory approval, clinical outcomes, and market acceptance.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Mabwell Bioscience (SHA: 688062) announced today that the National Medical Products Administration (NMPA) has granted&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43261,"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":[35,16,62,118,1129],"class_list":["post-43257","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-clinical-trial-approval-initiation","tag-mabwell-bioscience","tag-sha-688062"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Mabwell Bioscience Receives NMPA IND Approval for 7MW4911 CDH17\u2011Targeting ADC in Advanced Solid Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Mabwell Bioscience (SHA: 688062) announced today that the National Medical Products Administration (NMPA) has granted Investigational New Drug (IND) approval for its proprietary CDH17\u2011targeting Antibody\u2011Drug Conjugate (ADC), 7MW4911. 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