{"id":42578,"date":"2025-09-30T16:45:00","date_gmt":"2025-09-30T08:45:00","guid":{"rendered":"https:\/\/flcube.com\/?p=42578"},"modified":"2025-09-30T16:45:01","modified_gmt":"2025-09-30T08:45:01","slug":"remegen-santen-announce-cde-acceptance-of-rc28%e2%80%91e-for-diabetic-macular-edema","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=42578","title":{"rendered":"RemeGen &amp; Santen Announce CDE Acceptance of RC28\u2011E for Diabetic Macular Edema"},"content":{"rendered":"\n<p>China\u2011based <strong>RemeGen Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/688331:SHA\">SHA: 688331<\/a>, <a href=\"HKG: 9995\">HKG: 9995<\/a>)<\/strong> and Japan\u2019s <strong>Santen Pharmaceutical Co., Ltd.<\/strong> confirmed that the <strong>Center for Drug Evaluation (CDE)<\/strong> of the <strong>National Medical Products Administration (NMPA)<\/strong> has formally accepted the <strong>New Drug Application (NDA)<\/strong> for <strong>RC28\u2011E<\/strong>, RemeGen\u2019s proprietary <strong>VEGF\/FGF dual\u2011target fusion protein<\/strong> intended to treat patients with <strong>diabetic macular edema (DME)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-rc28-e\">What is RC28\u2011E?<\/h2>\n\n\n\n<p>RC28\u2011E is a next\u2011generation ocular therapy engineered to simultaneously inhibit <strong>vascular endothelial growth factor (VEGF)<\/strong> and <strong>fibroblast growth factor (FGF)<\/strong> binding to their receptors. By blocking both pathways, the drug is expected to deliver synergistic benefits across anti\u2011inflammatory, anti\u2011fibrotic, and anti\u2011neovascularization mechanisms\u2014key drivers of DME progression.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-licensing-milestone\">Licensing Milestone<\/h2>\n\n\n\n<p>In August\u202f2025, RemeGen granted <strong>Santen<\/strong> exclusive rights to RC28\u2011E throughout <strong>Greater China and Asia<\/strong> for <strong>USD\u202f1.3\u202fbillion<\/strong>. This partnership positions Santen, a leading ophthalmology player, to accelerate development, regulatory review, and commercialization of the dual\u2011target therapy in the region.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-and-commercial-implications\">Regulatory and Commercial Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>CDE Acceptance<\/strong> removes a critical regulatory hurdle, paving the way for <strong>phase\u2011III clinical trials<\/strong> and eventual market approval in China.<\/li>\n\n\n\n<li>The <strong>dual\u2011target mechanism<\/strong> may differentiate RC28\u2011E from existing single\u2011pathway agents, potentially improving patient outcomes and expanding the treatment landscape for DME.<\/li>\n\n\n\n<li>If successful, the drug could command a premium pricing tier, benefiting both RemeGen and Santen through increased market share and revenue streams.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-next-steps\">Next Steps<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>RemeGen and Santen will coordinate <strong>clinical trial design<\/strong>, <strong>manufacturing scale\u2011up<\/strong>, and <strong>post\u2011marketing surveillance<\/strong>.<\/li>\n\n\n\n<li>A joint effort will seek <strong>NMPA approval<\/strong> in the near term, followed by <strong>international regulatory submissions<\/strong> (e.g., EMA, FDA) to broaden global access.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) and Japan\u2019s Santen Pharmaceutical Co., Ltd. confirmed&#8230;<\/p>\n","protected":false},"author":1,"featured_media":42579,"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":[1155,38,375,415,1294],"class_list":["post-42578","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hkg-9995","tag-market-approval-filings","tag-remegen","tag-santen-pharmaceutical","tag-sha-688331"],"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>RemeGen &amp; Santen Announce CDE Acceptance of RC28\u2011E for Diabetic Macular Edema - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) and Japan\u2019s Santen Pharmaceutical Co., Ltd. confirmed that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for RC28\u2011E, RemeGen\u2019s proprietary VEGF\/FGF dual\u2011target fusion protein intended to treat patients with diabetic macular edema (DME).\" \/>\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=42578\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RemeGen &amp; Santen Announce CDE Acceptance of RC28\u2011E for Diabetic Macular Edema\" \/>\n<meta property=\"og:description\" content=\"China\u2011based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) and Japan\u2019s Santen Pharmaceutical Co., Ltd. confirmed that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for RC28\u2011E, RemeGen\u2019s proprietary VEGF\/FGF dual\u2011target fusion protein intended to treat patients with diabetic macular edema (DME).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=42578\" \/>\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=\"2025-09-30T08:45:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-30T08:45:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/3013.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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