{"id":72183,"date":"2026-08-10T13:38:07","date_gmt":"2026-08-10T05:38:07","guid":{"rendered":"https:\/\/flcube.com\/?p=72183"},"modified":"2026-08-10T13:38:08","modified_gmt":"2026-08-10T05:38:08","slug":"huadong-medicines-sinclair-secures-eu-mdr-ce-certification-for-kio015-chitosan-skin-booster-kytogen-defend","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=72183","title":{"rendered":"Huadong Medicine&#8217;s Sinclair Secures EU MDR CE Certification for KIO015 Chitosan Skin Booster Kytogen Defend"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Huadong Medicine<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/000963:SHE\">SHE: 000963<\/a>) announced that <strong>KIO015<\/strong> \u2014 a novel, patented <strong>carboxymethyl chitosan solution for injection<\/strong> developed by its UK subsidiary <strong>Sinclair Pharma Limited<\/strong> \u2014 has obtained <strong>EU MDR CE certification<\/strong> under the trade name <strong>Kytogen Defend<\/strong>. The clearance marks regulatory entry into the European market for what the company describes as the <strong>world&#8217;s only medical aesthetic chitosan product<\/strong> combining volumization, skin texture improvement, and deep hydration in a single treatment.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">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>Company<\/strong><\/td><td>Huadong Medicine (SHE: 000963), via UK subsidiary Sinclair Pharma Limited<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>KIO015 (trade name: Kytogen Defend)<\/td><\/tr><tr><td><strong>Product Class<\/strong><\/td><td>Carboxymethyl chitosan solution for injection<\/td><\/tr><tr><td><strong>Certification<\/strong><\/td><td>EU MDR CE certification<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>10 Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-product-profile-amp-technology\" class=\"wp-block-heading\">Product Profile &amp; Technology<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Core Ingredient:<\/strong> <strong>KiOmedine CM\u2011chitosan<\/strong>, a highly purified polysaccharide synthesized via proprietary <strong>KiOmedine technology<\/strong><\/li>\n\n\n\n<li><strong>Administration:<\/strong> Mesotherapy<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> Currently the <strong>world&#8217;s only medical aesthetic chitosan product<\/strong> capable of simultaneously delivering <strong>superficial volumization, skin texture improvement, and deep hydration<\/strong>, leveraging groundbreaking patented technology<\/li>\n\n\n\n<li><strong>Mechanism &amp; Benefits:<\/strong><\/li>\n\n\n\n<li>Protects <strong>endogenous hyaluronic acid<\/strong><\/li>\n\n\n\n<li>Mitigates <strong>oxidative stress<\/strong> in dermal cells<\/li>\n\n\n\n<li>Enhances skin <strong>moisture content, elasticity, and radiance<\/strong><\/li>\n\n\n\n<li>Targets <strong>fine lines, dryness, and overall skin quality loss<\/strong><\/li>\n\n\n\n<li><strong>Antioxidant Effect:<\/strong> Kytogen Defend demonstrates <strong>free\u2011radical scavenging capabilities<\/strong> that protect extracellular matrix components from oxidative degradation \u2014 an antioxidant effect confirmed through <strong>in vitro studies<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-licensing-history\" class=\"wp-block-heading\">Licensing History<\/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>Date<\/strong><\/td><td>September 2021<\/td><\/tr><tr><td><strong>Licensor<\/strong><\/td><td>KiOmed Pharma SA (Belgium)<\/td><\/tr><tr><td><strong>Licensee<\/strong><\/td><td>Sinclair Pharma Limited (UK subsidiary of Huadong Medicine)<\/td><\/tr><tr><td><strong>Scope<\/strong><\/td><td>Exclusive rights to develop and commercialize KiOmedine chitosan medical aesthetic products across skin aesthetic applications<\/td><\/tr><tr><td><strong>Territory<\/strong><\/td><td>Global, excluding the United States<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">In <strong>September 2021<\/strong>, <strong>Sinclair<\/strong> acquired exclusive rights from Belgium&#8217;s <strong>KiOmed Pharma SA<\/strong> to develop and commercialize <strong>KiOmedine chitosan medical aesthetic products<\/strong> across skin aesthetic applications globally, <strong>excluding the United States<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulatory Gateway:<\/strong> EU MDR CE certification \u2014 widely regarded as one of the most stringent regulatory pathways for medical devices \u2014 clears Kytogen Defend for commercial rollout across the European Economic Area under Sinclair&#8217;s established aesthetic distribution network.<\/li>\n\n\n\n<li><strong>Category Creation:<\/strong> As the only medical aesthetic chitosan product with triple-action positioning (volumization + texture + hydration), Kytogen Defend sits outside the crowded hyaluronic acid filler category, potentially opening a differentiated niche in the skin booster segment.<\/li>\n\n\n\n<li><strong>Pipeline Optionality:<\/strong> The 2021 exclusive license from KiOmed Pharma covers the broader KiOmedine chitosan platform globally (ex\u2011US), giving Sinclair and Huadong Medicine a portfolio runway beyond this first certified product.<\/li>\n\n\n\n<li><strong>Strategic Fit:<\/strong> The certification strengthens Huadong Medicine&#8217;s international medical aesthetics footprint, complementing Sinclair&#8217;s existing portfolio and reinforcing the company&#8217;s positioning in the premium aesthetic injectables market.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the commercialization of Kytogen Defend and the development of KiOmedine chitosan medical aesthetic products. Actual results may differ due to risks including market adoption, competitive dynamics, and regulatory developments.<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\/2026\/08\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u533b\u7597\u5668\u68b0\u83b7\u5f97\u6b27\u76dfMDR-CE\u8ba4\u8bc1\u7684\u516c\u544a.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\u533b\u7597\u5668\u68b0\u83b7\u5f97\u6b27\u76dfMDR CE\u8ba4\u8bc1\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-31778feb-42d5-4723-99f2-90736c34e80d\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u533b\u7597\u5668\u68b0\u83b7\u5f97\u6b27\u76dfMDR-CE\u8ba4\u8bc1\u7684\u516c\u544a.pdf\">\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u533b\u7597\u5668\u68b0\u83b7\u5f97\u6b27\u76dfMDR CE\u8ba4\u8bc1\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/\u534e\u4e1c\u533b\u836f\uff1a\u5173\u4e8e\u5168\u8d44\u5b50\u516c\u53f8\u533b\u7597\u5668\u68b0\u83b7\u5f97\u6b27\u76dfMDR-CE\u8ba4\u8bc1\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-31778feb-42d5-4723-99f2-90736c34e80d\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Huadong Medicine (SHE: 000963) announced that KIO015 \u2014 a novel, patented carboxymethyl chitosan solution for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[114,15],"class_list":["post-72183","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-huadong-medicine","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Huadong Medicine&#039;s Sinclair Secures EU MDR CE Certification for KIO015 Chitosan Skin Booster Kytogen Defend - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Huadong Medicine (SHE: 000963) announced that KIO015 \u2014 a novel, patented carboxymethyl chitosan solution for injection developed by its UK subsidiary Sinclair Pharma Limited \u2014 has obtained EU MDR CE certification under the trade name Kytogen Defend. 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