{"id":48660,"date":"2025-11-19T21:21:49","date_gmt":"2025-11-19T13:21:49","guid":{"rendered":"https:\/\/flcube.com\/?p=48660"},"modified":"2025-11-19T21:21:50","modified_gmt":"2025-11-19T13:21:50","slug":"acotecs-jingyi-balloon-catheter-wins-nmpa-approval-for-complex-coronary-lesions","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48660","title":{"rendered":"Acotec&#8217;s Jingyi Balloon Catheter Wins NMPA Approval for Complex Coronary Lesions"},"content":{"rendered":"\n<p><strong>Acotec Scientific Holdings Limited<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/6669:HKG\">HKG: 6669<\/a>) announced that China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> has approved its <strong>Jingyi Coronary Over\u2011the\u2011Wire (OTW) Balloon Dilatation Catheter<\/strong>, a semi\u2011compliant device engineered for <strong>chronic total occlusion (CTO)<\/strong> and <strong>severely calcified lesions<\/strong>, marking Acotec\u2019s entry into the premium complex PCI segment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/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>Product<\/strong><\/td><td>Jingyi Coronary Over\u2011the\u2011Wire Balloon Dilatation Catheter<\/td><\/tr><tr><td><strong>Company<\/strong><\/td><td>Acotec Scientific Holdings (HKG: 6669)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Registration approval<\/td><\/tr><tr><td><strong>Indications<\/strong><\/td><td>Dilating coronary artery\/bypass graft stenosis; post\u2011stent dilation (2.0\u20115.0\u202fmm balloons)<\/td><\/tr><tr><td><strong>Key Features<\/strong><\/td><td>Semi\u2011compliant, OTW design, optimized crossability\/pushability<\/td><\/tr><tr><td><strong>Target Lesions<\/strong><\/td><td>CTO, severe calcification<\/td><\/tr><tr><td><strong>Commercial Launch<\/strong><\/td><td>Expected Q1\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-profile\">Product Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Design:<\/strong> Semi\u2011compliant balloon with <strong>smaller distal tip profile<\/strong> and <strong>tighter folding profile<\/strong> for enhanced lesion crossing<\/li>\n\n\n\n<li><strong>Delivery System:<\/strong> Optimized catheter construction provides <strong>superior pushability<\/strong> in tortuous anatomy<\/li>\n\n\n\n<li><strong>OTW Configuration:<\/strong> Over\u2011the\u2011Wire design improves <strong>procedural efficiency<\/strong> and <strong>safety<\/strong> by enabling rapid wire exchanges and stable guidewire position<\/li>\n\n\n\n<li><strong>Size Range:<\/strong> Balloon diameters <strong>2.0\u20115.0\u202fmm<\/strong> cover both focal lesions and post\u2011stent optimization<\/li>\n\n\n\n<li><strong>Clinical Gap:<\/strong> Addresses unmet need for reliable CTO and calcified lesion dilation where standard balloons fail in <strong>15\u201120% of cases<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-outlook\">Market Context &amp; Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Metric<\/th><th>Value<\/th><\/tr><\/thead><tbody><tr><td><strong>China PCI Procedures (2024)<\/strong><\/td><td>2.1\u202fmillion<\/td><\/tr><tr><td><strong>Complex Lesion Share<\/strong><\/td><td>~15% (315,000 procedures)<\/td><\/tr><tr><td><strong>Premium Balloon Market Size<\/strong><\/td><td>\u00a54.5\u202fbillion (US$620\u202fmillion)<\/td><\/tr><tr><td><strong>Growth Rate<\/strong><\/td><td>12% CAGR (2024\u20112030)<\/td><\/tr><tr><td><strong>Jingyi ASP<\/strong><\/td><td>\u00a58,000\u201112,000 per unit (premium vs. \u00a53,000\u20115,000 standard)<\/td><\/tr><tr><td><strong>Revenue Forecast (Peak)<\/strong><\/td><td><strong>\u00a5500\u2011700\u202fmillion<\/strong> (US$70\u201195\u202fmillion) by 2028<\/td><\/tr><tr><td><strong>Market Share Target<\/strong><\/td><td>10\u201115% of complex lesion segment<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitive Landscape:<\/strong> Dominated by <strong>Boston Scientific<\/strong> (Emerge, NC), <strong>Medtronic<\/strong> (Marathon), and <strong>Abbott<\/strong> (Hi\u2011Torque) in complex lesions; domestic players <strong>MicroPort<\/strong> and <strong>Lepu<\/strong> focus on basic balloons<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> Jingyi\u2019s OTW platform offers <strong>comparable performance<\/strong> to market leaders at <strong>20\u201130% lower price<\/strong>, appealing to tier\u20112\/3 hospitals expanding PCI capabilities<\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> Elevates Acotec from <strong>basic interventional portfolio<\/strong> to <strong>premium complex lesion solutions<\/strong>, supporting average selling price (ASP) uplift across product mix<\/li>\n\n\n\n<li><strong>Reimbursement Path:<\/strong> Likely classified under existing balloon dilation catheter reimbursement codes; no additional price negotiations required<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding Jingyi\u2019s commercial launch timeline, market penetration, and revenue contribution. Actual results may differ materially due to risks including competitive responses, hospital procurement cycles, and physician adoption rates.<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\/11\/2025111800770_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025111800770_c.\"><\/object><a id=\"wp-block-file--media-6e3eec34-d61c-4206-985d-4b7d2c78f66f\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111800770_c.pdf\">2025111800770_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111800770_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-6e3eec34-d61c-4206-985d-4b7d2c78f66f\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Acotec Scientific Holdings Limited (HKG: 6669) announced that China\u2019s National Medical Products Administration (NMPA) has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48663,"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":[7,22],"tags":[133,923,15],"class_list":["post-48660","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-acotec-scientific","tag-hkg-6669","tag-product-approvals"],"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>Acotec&#039;s Jingyi Balloon Catheter Wins NMPA Approval for Complex Coronary Lesions - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Acotec Scientific Holdings Limited (HKG: 6669) announced that China\u2019s National Medical Products Administration (NMPA) has approved its Jingyi Coronary Over\u2011the\u2011Wire (OTW) Balloon Dilatation Catheter, a semi\u2011compliant device engineered for chronic total occlusion (CTO) and severely calcified lesions, marking Acotec\u2019s entry into the premium complex PCI segment.\" \/>\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=48660\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Acotec&#039;s Jingyi Balloon Catheter Wins NMPA Approval for Complex Coronary Lesions\" \/>\n<meta property=\"og:description\" content=\"Acotec Scientific Holdings Limited (HKG: 6669) announced that China\u2019s National Medical Products Administration (NMPA) has approved its Jingyi Coronary Over\u2011the\u2011Wire (OTW) Balloon Dilatation Catheter, a semi\u2011compliant device engineered for chronic total occlusion (CTO) and severely calcified lesions, marking Acotec\u2019s entry into the premium complex PCI segment.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48660\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-19T13:21:49+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-19T13:21:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1906.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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