{"id":45609,"date":"2025-11-03T15:10:43","date_gmt":"2025-11-03T07:10:43","guid":{"rendered":"https:\/\/flcube.com\/?p=45609"},"modified":"2025-11-03T15:10:44","modified_gmt":"2025-11-03T07:10:44","slug":"shanghai-circodes-hm2002-gains-china-nmpa-approval-for-refractory-angina","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=45609","title":{"rendered":"Shanghai\u202fCirCode\u2019s HM2002 Gains China NMPA Approval for Refractory Angina"},"content":{"rendered":"\n<p><strong>Shanghai CirCode Biomed Co. Ltd.<\/strong> announced that its self\u2011developed <strong>circular RNA (circRNA) therapeutic\u202fHM2002<\/strong> has received <strong>clinical\u2011trial authorization from the National Medical Products Administration (NMPA)<\/strong> for the treatment of <strong>refractory angina<\/strong>. The approval follows earlier clearances in the United\u202fStates (June\u202f2025) and China (January\u202f2025) for broader ischemic\u2011heart\u2011disease indications.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-hm2002\">What Is HM2002?<\/h2>\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>Molecule Type<\/strong><\/td><td>Next\u2011generation <strong>circRNA<\/strong> drug<\/td><\/tr><tr><td><strong>Target<\/strong><\/td><td>Stable myocardial expression of <strong>Vascular Endothelial Growth Factor (VEGF)<\/strong><\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Promotes <strong>angiogenesis<\/strong> and improves myocardial perfusion, accelerating cardiac\u2011function recovery<\/td><\/tr><tr><td><strong>Advantages vs. Linear RNA<\/strong><\/td><td>\u2022 Higher molecular stability<br>\u2022 Lower immunogenicity<br>\u2022 Sustained protein expression in the heart<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td><strong>Refractory angina<\/strong> \u2013 chronic chest pain unresponsive to conventional therapy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestones\">Regulatory Milestones<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Date<\/th><th>Jurisdiction<\/th><th>Milestone<\/th><\/tr><\/thead><tbody><tr><td><strong>Jan\u202f2025<\/strong><\/td><td>China (NMPA)<\/td><td>IND clearance for ischemic heart disease<\/td><\/tr><tr><td><strong>Jun\u202f2025<\/strong><\/td><td>United\u202fStates (FDA)<\/td><td>IND clearance for ischemic heart disease<\/td><\/tr><tr><td><strong>Nov\u202f3\u202f2025<\/strong><\/td><td>China (NMPA)<\/td><td><strong>Phase\u202fI\/II trial approval for refractory angina<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The NMPA decision enables CirCode to initiate a <strong>first\u2011in\u2011human, multicenter trial<\/strong> enrolling up to <strong>120 patients<\/strong> across major Chinese cardiac centers. The study will evaluate safety, dose\u2011ranging, and preliminary efficacy over a 12\u2011month follow\u2011up period.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context\">Market Context<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Unmet Need:<\/strong> Refractory angina affects an estimated <strong>5\u20137\u202fmillion<\/strong> patients worldwide, with limited therapeutic options beyond revascularization.<\/li>\n\n\n\n<li><strong>Size of Opportunity:<\/strong> Bloomberg estimates the global refractory\u2011angina market could exceed <strong>USD\u202f3.2\u202fbillion<\/strong> by 2030.<\/li>\n\n\n\n<li><strong>Competitive Edge:<\/strong> HM2002\u2019s <strong>circRNA platform<\/strong> offers a <strong>single\u2011dose, long\u2011acting VEGF expression<\/strong> strategy, potentially reducing the need for repeated invasive procedures.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-outlook\">Strategic Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase\u202fI\/II Timeline:<\/strong> First patient dosing expected <strong>Q1\u202f2026<\/strong>; interim data read\u2011out slated for <strong>Q4\u202f2026<\/strong>.<\/li>\n\n\n\n<li><strong>Future Indications:<\/strong> CirCode plans to leverage the same circRNA\u2011VEGF construct for <strong>peripheral\u2011artery disease<\/strong> and <strong>heart\u2011failure<\/strong> programs.<\/li>\n\n\n\n<li><strong>Funding:<\/strong> The company disclosed a <strong>USD\u202f120\u202fmillion<\/strong> cash runway, supplemented by a <strong>Strategic Collaboration<\/strong> with a leading Chinese biotech that will co\u2011fund the refractory\u2011angina trial.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding HM2002\u2019s development timeline, regulatory expectations, and market potential. Actual results may differ materially due to risks including clinical outcomes, regulatory approvals, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai CirCode Biomed Co. Ltd. announced that its self\u2011developed circular RNA (circRNA) therapeutic\u202fHM2002 has received&#8230;<\/p>\n","protected":false},"author":1,"featured_media":45610,"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":[1453,62,69,63],"class_list":["post-45609","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-circode-bio","tag-clinical-trial-approval-initiation","tag-cvd","tag-mrna"],"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>Shanghai\u202fCirCode\u2019s HM2002 Gains China NMPA Approval for Refractory Angina - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai CirCode Biomed Co. 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