{"id":40286,"date":"2025-08-28T14:29:00","date_gmt":"2025-08-28T06:29:00","guid":{"rendered":"https:\/\/flcube.com\/?p=40286"},"modified":"2025-08-28T14:29:00","modified_gmt":"2025-08-28T06:29:00","slug":"remegens-telitacicept-hits-primary-endpoint-in-phase-iii-iga-nephropathy-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=40286","title":{"rendered":"RemeGen\u2019s Telitacicept Hits Primary Endpoint in Phase\u202fIII IgA Nephropathy Trial"},"content":{"rendered":"\n<p>China\u2011based RemeGen Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/9995:HKG\">HKG:\u202f9995<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/688331:SHA\">SHA: 688331<\/a>) on Aug, 27, 2025announced that its first\u2011in\u2011class BLyS\/APRIL dual\u2011target fusion protein, <strong>Telitacicept<\/strong>, achieved its primary endpoint in the A\u2011stage of a Phase\u202fIII clinical trial conducted in China for <strong>primary IgA nephropathy<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-key-clinical-findings\">Key Clinical Findings<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>24\u2011hour UPCR Reduction<\/strong> \u2013 Telitacicept reduced the urinary protein\u2011creatinine ratio by <strong>55\u202f%<\/strong> versus placebo at week\u202f39 (P\u202f&lt;\u202f0.0001).<\/li>\n\n\n\n<li><strong>Safety Profile<\/strong> \u2013 The drug demonstrated a favorable tolerability and safety profile, with no new safety signals reported.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-pathway\">Regulatory Pathway<\/h3>\n\n\n\n<p>RemeGen will submit a marketing application to the <strong>Center for Drug Evaluation (CDE)<\/strong> of the National Medical Products Administration (NMPA) \u201cas soon as possible,\u201d positioning the company for a potential market entry in China\u2019s growing nephrology segment.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-scientific-rationale\">Scientific Rationale<\/h3>\n\n\n\n<p>Telitacicept uniquely blocks both <strong>B\u2011lymphocyte stimulator (BLyS)<\/strong> and <strong>proliferation\u2011inducing ligand (APRIL)<\/strong>\u2014cytokines that are markedly elevated in IgA nephropathy and drive B\u2011cell hyperactivity, plasma\u2011cell expansion, and pathogenic immunoglobulin production. By dampening these pathways, the drug mitigates immune\u2011complex deposition and the ensuing renal inflammation, a mechanism not addressed by any other approved therapy in China.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based RemeGen Co., Ltd. (HKG:\u202f9995, SHA: 688331) on Aug, 27, 2025announced that its first\u2011in\u2011class BLyS\/APRIL&#8230;<\/p>\n","protected":false},"author":1,"featured_media":40288,"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":[17,375,1294],"class_list":["post-40286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-results","tag-remegen","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\u2019s Telitacicept Hits Primary Endpoint in Phase\u202fIII IgA Nephropathy Trial - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based RemeGen Co., Ltd. (HKG:\u202f9995, SHA: 688331) on Aug, 27, 2025announced that its first\u2011in\u2011class BLyS\/APRIL dual\u2011target fusion protein, Telitacicept, achieved its primary endpoint in the A\u2011stage of a Phase\u202fIII clinical trial conducted in China for primary IgA nephropathy.\" \/>\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=40286\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RemeGen\u2019s Telitacicept Hits Primary Endpoint in Phase\u202fIII IgA Nephropathy Trial\" \/>\n<meta property=\"og:description\" content=\"China\u2011based RemeGen Co., Ltd. (HKG:\u202f9995, SHA: 688331) on Aug, 27, 2025announced that its first\u2011in\u2011class BLyS\/APRIL dual\u2011target fusion protein, Telitacicept, achieved its primary endpoint in the A\u2011stage of a Phase\u202fIII clinical trial conducted in China for primary IgA nephropathy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=40286\" \/>\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=\"2025-08-28T06:29:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/2804.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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