{"id":42241,"date":"2025-09-25T13:48:26","date_gmt":"2025-09-25T05:48:26","guid":{"rendered":"https:\/\/flcube.com\/?p=42241"},"modified":"2025-09-25T13:48:26","modified_gmt":"2025-09-25T05:48:26","slug":"mabwell-bioscience-hits-phase-ii-milestone-with-first%e2%80%91patient-dose-of-9mw3011-the-only-anti%e2%80%91tmprss6-monoclonal-antibody-for-polycythemia-vera","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=42241","title":{"rendered":"Mabwell Bioscience Hits Phase\u202fII Milestone with First\u2011Patient Dose of 9MW3011, the Only Anti\u2011TMPRSS6 Monoclonal Antibody for Polycythemia Vera"},"content":{"rendered":"\n<p>Shanghai\u2011listed <strong>Mabwell Bioscience (<a href=\"https:\/\/www.google.com\/finance\/quote\/688062:SHA\">SHA: 688062<\/a>)<\/strong> announced today that its anti\u2011TMPRSS6 monoclonal antibody <strong>9MW3011<\/strong> (R&amp;D code\u202f9MW3011\/DISC\u20113405) has entered the first\u2011patient, first\u2011dose cohort of a global Phase\u202fII trial. The drug, previously licensed to DISC Medicine, is poised to become the only therapeutic that targets the protease <strong>TMPRSS6<\/strong> in polycythemia vera (PV), a rare myeloproliferative neoplasm.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-why-9mw3011-matters\">Why 9MW3011 Matters<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Mechanism<\/strong><\/td><td>9MW3011 blocks TMPRSS6, a key negative regulator of the iron\u2011homeostasis hormone hepcidin, thereby up\u2011regulating endogenous hepcidin and restoring physiological iron balance.<\/td><\/tr><tr><td><strong>Clinical Status<\/strong><\/td><td>\u2022 <strong>Phase\u202fII<\/strong> \u2013 first\u2011patient dose on 24\u202fSept\u202f2025<br>\u2022 <strong>Phase\u202fIb<\/strong> \u2013 three ongoing studies in China<br>\u2022 <strong>FDA Designations<\/strong> \u2013 Fast\u2011Track &amp; Orphan Drug<\/td><\/tr><tr><td><strong>Competitive Edge<\/strong><\/td><td>Unlike exogenous hepcidin mimetics, 9MW3011 offers a biologically relevant, endogenous\u2011hepcidin\u2011driven iron\u2011regulatory effect that could translate into fewer off\u2011target effects and better tolerability.<\/td><\/tr><tr><td><strong>Target Population<\/strong><\/td><td>Patients with polycythemia vera, a disease lacking disease\u2011modifying therapies and associated with chronic iron overload and thrombosis risk.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-amp-market-context\">Regulatory &amp; Market Context<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Fast\u2011Track &amp; Orphan Drug Status<\/strong> \u2013 Accelerated review pathways from the U.S. FDA underscore the unmet need for PV therapies and the potential for a rapid market entrance.<\/li>\n\n\n\n<li><strong>Shanghai Market<\/strong> \u2013 With three Phase\u202fIb trials already active in China, Mabwell is positioned to secure early commercial traction in a 1.4\u2011billion\u2011person market that is increasingly receptive to precision oncology and rare\u2011disease solutions.<\/li>\n\n\n\n<li><strong>Global Growth<\/strong> \u2013 The worldwide PV market is projected to exceed <strong>$1.2\u202fbillion<\/strong> by 2030, driven by rising prevalence and the search for disease\u2011modifying agents.<\/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>Mabwell cautions that the Phase\u202fII results will inform dose\u2011selection and safety evaluation for a planned Phase\u202fIII study, and that regulatory milestones are subject to change based on emerging data.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai\u2011listed Mabwell Bioscience (SHA: 688062) announced today that its anti\u2011TMPRSS6 monoclonal antibody 9MW3011 (R&amp;D code\u202f9MW3011\/DISC\u20113405)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":42242,"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":[11],"tags":[62,118,1129],"class_list":["post-42241","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug","tag-clinical-trial-approval-initiation","tag-mabwell-bioscience","tag-sha-688062"],"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>Mabwell Bioscience Hits Phase\u202fII Milestone with First\u2011Patient Dose of 9MW3011, the Only Anti\u2011TMPRSS6 Monoclonal Antibody for Polycythemia Vera - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai\u2011listed Mabwell Bioscience (SHA: 688062) announced today that its anti\u2011TMPRSS6 monoclonal antibody 9MW3011 (R&amp;D code\u202f9MW3011\/DISC\u20113405) has entered the first\u2011patient, first\u2011dose cohort of a global Phase\u202fII trial. 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