{"id":43692,"date":"2025-10-17T15:51:10","date_gmt":"2025-10-17T07:51:10","guid":{"rendered":"https:\/\/flcube.com\/?p=43692"},"modified":"2025-10-17T15:51:10","modified_gmt":"2025-10-17T07:51:10","slug":"sinclairs-maili-precise-receives-nmpa-acceptance-notice-for-class-iii-device","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43692","title":{"rendered":"Sinclair\u2019s MaiLi\u202fPrecise Receives NMPA Acceptance Notice for Class\u202fIII Device"},"content":{"rendered":"\n<p><strong>Sinclair (Hangzhou) Medical Technology Co., Ltd.<\/strong>, a wholly\u2011owned subsidiary of <strong>Huadong Medicine<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/000963:SHE\">SHE: 000963<\/a>), announced that it has received an <strong>Acceptance Notice<\/strong> from the <strong>National Medical Products Administration (NMPA)<\/strong> for the registration application of <strong>MaiLi\u202fPrecise<\/strong>, a Class\u202fIII medical device. The product is a cross\u2011linked sodium hyaluronate gel formulated with lidocaine for injection, designed to provide an immediate correction of infra\u2011orbital hollows.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-highlights\">Product Highlights<\/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>Device Class<\/strong><\/td><td>Class\u202fIII medical device<\/td><\/tr><tr><td><strong>Active Ingredient<\/strong><\/td><td>Cross\u2011linked sodium hyaluronate gel + lidocaine<\/td><\/tr><tr><td><strong>Concentration<\/strong><\/td><td>Lowest sodium hyaluronate concentration in the MaiLi series<\/td><\/tr><tr><td><strong>Clinical Benefit<\/strong><\/td><td>Immediate correction of infra\u2011orbital hollows post\u2011injection<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>Acceptance Notice from NMPA (Oct\u202f16\u202f2025)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-maili-series-overview\">MaiLi Series Overview<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Global Lineage<\/strong> \u2013 The MaiLi series originates from <strong>Kylane Laboratoires\u202fSA<\/strong>, a Swiss R&amp;D leader in medical aesthetics.<\/li>\n\n\n\n<li><strong>Sinclair\u2019s Stake<\/strong> \u2013 Sinclair holds an equity position in Kylane and possesses the <strong>global exclusive license<\/strong> for the MaiLi product line.<\/li>\n\n\n\n<li><strong>UK Presence<\/strong> \u2013 Sinclair Pharmaceuticals Limited, Sinclair\u2019s UK subsidiary, markets the series worldwide.<\/li>\n\n\n\n<li><strong>European Success<\/strong> \u2013 The products received <strong>CE certification<\/strong> in June\u202f2020 and launched in the EU market in early\u202f2021, garnering strong market feedback.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications-for-huadong-medicine\">Strategic Implications for Huadong Medicine<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Portfolio Expansion<\/strong> \u2013 The acceptance of MaiLi\u202fPrecise adds a high\u2011margin aesthetic device to Huadong\u2019s product mix.<\/li>\n\n\n\n<li><strong>Market Penetration<\/strong> \u2013 The Class\u202fIII classification positions the product for premium pricing and broader clinical adoption.<\/li>\n\n\n\n<li><strong>Synergy with Existing Offerings<\/strong> \u2013 Sinclair\u2019s expertise in hyaluronic acid gels complements Huadong\u2019s existing medical device pipeline, creating cross\u2011selling opportunities.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This release contains forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sinclair (Hangzhou) Medical Technology Co., Ltd., a wholly\u2011owned subsidiary of Huadong Medicine (SHE: 000963), announced&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43697,"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":[114,15,887,4399],"class_list":["post-43692","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-huadong-medicine","tag-product-approvals","tag-she-000963","tag-sinclair-medical-technology"],"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>Sinclair\u2019s MaiLi\u202fPrecise Receives NMPA Acceptance Notice for Class\u202fIII Device - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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