{"id":39340,"date":"2025-08-14T14:29:05","date_gmt":"2025-08-14T06:29:05","guid":{"rendered":"https:\/\/flcube.com\/?p=39340"},"modified":"2025-08-14T14:29:05","modified_gmt":"2025-08-14T06:29:05","slug":"remegen-announces-positive-phase-iii-results-for-telitacicept-in-primary-sjogrens-syndrome","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=39340","title":{"rendered":"RemeGen Announces Positive Phase III Results for Telitacicept in Primary Sj\u00f6gren&#8217;s Syndrome"},"content":{"rendered":"\n<p>China-based RemeGen Co., Ltd. (<a href=\"https:\/\/www.google.com\/finance\/quote\/688331:SHA\">SHA: 688331<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/9995:HKG\">HKG: 9995<\/a>), a China-based pharmaceutical firm, announced on August 14, 2025, that its Phase III clinical study for telitacicept (RC18), a self-developed innovative drug, has achieved its primary endpoint for the treatment of primary Sj\u00f6gren&#8217;s syndrome (pSS). This milestone highlights the potential of telitacicept to address a significant unmet clinical need in the treatment of this chronic autoimmune disease.<\/p>\n\n\n\n<p><strong>About Sj\u00f6gren&#8217;s Syndrome<\/strong><br>Sj\u00f6gren&#8217;s syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands. It often manifests as persistent dry mouth and dry eyes due to salivary and lacrimal gland dysfunction and can affect multiple organ systems. In China, the prevalence of Sj\u00f6gren&#8217;s syndrome ranges from 0.3% to 0.7% and is increasing, underscoring the urgent need for effective therapies.<\/p>\n\n\n\n<p><strong>Telitacicept Mechanism<\/strong><br>Telitacicept is a recombinant B-lymphocyte stimulator (BLyS)\/proliferation-inducing ligand (APRIL) dual-target fusion protein developed by RemeGen. It works by simultaneously inhibiting the binding of BLyS and APRIL to B-cell surface receptors. This action prevents the abnormal differentiation and maturation of B cells, thereby reducing pathological immune responses.<\/p>\n\n\n\n<p><strong>Clinical Approval History<\/strong><br>Since its initial approval in China in March 2021 for the treatment of systemic lupus erythematosus (SLE), telitacicept has also received approvals for rheumatoid arthritis and myasthenia gravis. The positive results from the Phase III clinical trial for pSS further reinforce its potential as a versatile treatment option for autoimmune diseases.<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\/2025\/08\/688331_20250814_QX7N.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 688331_20250814_QX7N.\"><\/object><a id=\"wp-block-file--media-f40b9dd0-0c2c-4e6f-9cd5-e4db213b5b20\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/688331_20250814_QX7N.pdf\">688331_20250814_QX7N<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/688331_20250814_QX7N.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-f40b9dd0-0c2c-4e6f-9cd5-e4db213b5b20\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995), a China-based pharmaceutical firm, announced on August&#8230;<\/p>\n","protected":false},"author":1,"featured_media":39343,"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":[65,17,1155,375,1294],"class_list":["post-39340","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-auto-immune","tag-clinical-trial-results","tag-hkg-9995","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 Announces Positive Phase III Results for Telitacicept in Primary Sj\u00f6gren&#039;s Syndrome - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995), a China-based pharmaceutical firm, announced on August 14, 2025, that its Phase III clinical study for telitacicept (RC18), a self-developed innovative drug, has achieved its primary endpoint for the treatment of primary Sj\u00f6gren&#039;s syndrome (pSS). This milestone highlights the potential of telitacicept to address a significant unmet clinical need in the treatment of this chronic autoimmune disease.\" \/>\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=39340\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RemeGen Announces Positive Phase III Results for Telitacicept in Primary Sj\u00f6gren&#039;s Syndrome\" \/>\n<meta property=\"og:description\" content=\"China-based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995), a China-based pharmaceutical firm, announced on August 14, 2025, that its Phase III clinical study for telitacicept (RC18), a self-developed innovative drug, has achieved its primary endpoint for the treatment of primary Sj\u00f6gren&#039;s syndrome (pSS). 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