{"id":43033,"date":"2025-10-10T17:06:49","date_gmt":"2025-10-10T09:06:49","guid":{"rendered":"https:\/\/flcube.com\/?p=43033"},"modified":"2025-10-10T17:06:50","modified_gmt":"2025-10-10T09:06:50","slug":"xingqi-pharma-secures-nmpa-approval-for-sq%e2%80%91129-a-novel-treatment-for-diabetic-macular-edema","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43033","title":{"rendered":"Xingqi Pharma Secures NMPA Approval for SQ\u2011129, a Novel Treatment for Diabetic Macular Edema"},"content":{"rendered":"\n<p>China\u2011based Shenyang Xingqi Pharmaceutical Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/300573:SHE\">SHE: 300573<\/a>) announced today that the <strong>China National Medical Products Administration (NMPA)<\/strong> has granted approval for the company\u2019s <strong>SQ\u2011129 intravitreal sustained\u2011release injection<\/strong> to commence clinical trials. The investigational product is aimed at adult patients suffering from <strong>diabetic macular edema (DME)<\/strong>, as well as those with macular edema secondary to <strong>branch retinal vein occlusion (BRVO)<\/strong> or <strong>central retinal vein occlusion (CRVO)<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-product-overview\">Product Overview<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Drug Class<\/strong> \u2013 Category\u202f2.2 chemical \u2013 a long\u2011acting intravitreal formulation designed to maintain therapeutic drug levels within the vitreous cavity.<\/li>\n\n\n\n<li><strong>Mechanism<\/strong> \u2013 While detailed pharmacodynamics remain proprietary, pre\u2011clinical studies indicate that SQ\u2011129 reduces vascular permeability and inflammation, thereby mitigating retinal edema.<\/li>\n\n\n\n<li><strong>Safety Profile<\/strong> \u2013 Pharmacological and pharmacotoxicological data demonstrate a favorable safety margin, with no dose\u2011limiting toxicities observed in animal models.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NMPA Clearance<\/strong> \u2013 Approval to conduct Phase\u202f1\/2 clinical trials represents a critical step toward potential market entry, as the NMPA\u2019s Category\u202f2.2 designation allows accelerated development pathways for ocular therapeutics.<\/li>\n\n\n\n<li><strong>Trial Design<\/strong> \u2013 The forthcoming studies will evaluate safety, tolerability, and preliminary efficacy in patients with DME, BRVO\u2011 and CRVO\u2011associated macular edema, using a randomized, double\u2011blind, placebo\u2011controlled framework.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-market-significance\">Market Significance<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Unmet Need<\/strong> \u2013 Currently, no approved sustained\u2011release intravitreal therapy exists for DME or retinal vein occlusion\u2011related macular edema in either China or globally, positioning SQ\u2011129 as a potentially first\u2011in\u2011class candidate.<\/li>\n\n\n\n<li><strong>Competitive Edge<\/strong> \u2013 By combining a robust safety profile with a sustained\u2011release platform, Xingqi Pharma aims to reduce injection frequency, improve patient adherence, and lower overall treatment costs.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-outlook\">Outlook<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Next Steps<\/strong> \u2013 Xingqi will initiate the first\u2011in\u2011human study in the second half of 2025, with a projected timeline of 18\u201324\u202fmonths to complete Phase\u202f2 and submit a New Drug Application (NDA) to the NMPA.<\/li>\n\n\n\n<li><strong>Strategic Impact<\/strong> \u2013 Successful development could establish Xingqi as a leading player in ocular therapeutics and open opportunities for licensing or partnership in international markets.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\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\/10\/\u5174\u9f50\u773c\u836f\uff1a\u5173\u4e8eSQ-129\u73bb\u7483\u4f53\u7f13\u91ca\u6ce8\u5c04\u6db2\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u5174\u9f50\u773c\u836f\uff1a\u5173\u4e8eSQ-129\u73bb\u7483\u4f53\u7f13\u91ca\u6ce8\u5c04\u6db2\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-58301cab-f925-4f06-9a82-a87b4a076237\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/\u5174\u9f50\u773c\u836f\uff1a\u5173\u4e8eSQ-129\u73bb\u7483\u4f53\u7f13\u91ca\u6ce8\u5c04\u6db2\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\">\u5174\u9f50\u773c\u836f\uff1a\u5173\u4e8eSQ-129\u73bb\u7483\u4f53\u7f13\u91ca\u6ce8\u5c04\u6db2\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/\u5174\u9f50\u773c\u836f\uff1a\u5173\u4e8eSQ-129\u73bb\u7483\u4f53\u7f13\u91ca\u6ce8\u5c04\u6db2\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-58301cab-f925-4f06-9a82-a87b4a076237\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based Shenyang Xingqi Pharmaceutical Co., Ltd. (SHE: 300573) announced today that the China National Medical&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43036,"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":[62,44,1231,3708],"class_list":["post-43033","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-ophthalmology","tag-she-300573","tag-xingqi-pharmaceutical"],"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>Xingqi Pharma Secures NMPA Approval for SQ\u2011129, a Novel Treatment for Diabetic Macular Edema - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based Shenyang Xingqi Pharmaceutical Co., Ltd. (SHE: 300573) announced today that the China National Medical Products Administration (NMPA) has granted approval for the company\u2019s SQ\u2011129 intravitreal sustained\u2011release injection to commence clinical trials. The investigational product is aimed at adult patients suffering from diabetic macular edema (DME), as well as those with macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).\" \/>\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=43033\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Xingqi Pharma Secures NMPA Approval for SQ\u2011129, a Novel Treatment for Diabetic Macular Edema\" \/>\n<meta property=\"og:description\" content=\"China\u2011based Shenyang Xingqi Pharmaceutical Co., Ltd. (SHE: 300573) announced today that the China National Medical Products Administration (NMPA) has granted approval for the company\u2019s SQ\u2011129 intravitreal sustained\u2011release injection to commence clinical trials. 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(SHE: 300573) announced today that the China National Medical Products Administration (NMPA) has granted approval for the company\u2019s SQ\u2011129 intravitreal sustained\u2011release injection to commence clinical trials. The investigational product is aimed at adult patients suffering from diabetic macular edema (DME), as well as those with macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=43033#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=43033"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=43033#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/1010.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/1010.webp","width":1080,"height":608,"caption":"Xingqi Pharma Secures NMPA Approval for SQ\u2011129, a Novel Treatment for Diabetic Macular Edema"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=43033#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Xingqi Pharma Secures NMPA Approval for SQ\u2011129, a Novel Treatment for Diabetic Macular Edema"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/1010.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/43033","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=43033"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/43033\/revisions"}],"predecessor-version":[{"id":43037,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/43033\/revisions\/43037"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/43036"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=43033"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=43033"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=43033"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}