{"id":31071,"date":"2025-04-01T18:08:16","date_gmt":"2025-04-01T10:08:16","guid":{"rendered":"https:\/\/flcube.com\/?p=31071"},"modified":"2025-04-01T18:08:18","modified_gmt":"2025-04-01T10:08:18","slug":"ucbs-rystiggo-approved-in-china-for-generalized-myasthenia-gravis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=31071","title":{"rendered":"UCB&#8217;s Rystiggo Approved in China for Generalized Myasthenia Gravis"},"content":{"rendered":"\n<p>Belgium-based biopharma UCB (<a href=\"https:\/\/www.google.com\/finance\/quote\/UCB:EBR\">EBR: UCB<\/a>) announced that it has received marketing approval from China\u2018\u2019s National Medical Products Administration (NMPA) for Rystiggo (rozanolixizumab). This chimeric monoclonal antibody is now approved for use in combination with conventional therapy for adult generalized myasthenia gravis (gMG) patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.<\/p>\n\n\n\n<p><strong>Mechanism and Significance<\/strong><br>Rystiggo, a neonatal Fc receptor blocker, offers new treatment options for AChR-positive patients and addresses the unmet need for effective therapies for MuSK-positive patients in China.<\/p>\n\n\n\n<p><strong>Clinical Trial Results<\/strong><br>Results from the pivotal Phase III MycarinG study, published in <em>Lancet Neurology<\/em> in 2023, demonstrated significant clinical benefits and good safety of Rystiggo in both AChR-positive and MuSK-positive gMG patients. Key findings include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Rapid symptom improvement and enhanced daily activity ability within one week of treatment.<\/li>\n\n\n\n<li>A 73% reduction in total IgG after the first treatment cycle, compared to a 9% reduction in the control group.<\/li>\n\n\n\n<li>An average improvement of 3.37 points in the MG-ADL score, versus a 0.78 point improvement in the control group.<\/li>\n\n\n\n<li>Particularly notable efficacy in MuSK-positive patients, with an average improvement of 7.28 points in MG-ADL, compared to a 2.28 point deterioration in the control group.<\/li>\n<\/ul>\n\n\n\n<p><strong>Long-Term Benefits and Safety<\/strong><br>The benefits of Rystiggo were shown to be sustained after a single treatment. In the open-label extension of the MycarinG study, patients received an average of 3.4 treatment cycles (17.8 infusions) per year. The safety profile indicated that the overall risk of adverse events was comparable to placebo, with most events being mild or moderate, and good long-term safety was observed.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Belgium-based biopharma UCB (EBR: UCB) announced that it has received marketing approval from China\u2018\u2019s National&#8230;<\/p>\n","protected":false},"author":1,"featured_media":31072,"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":[2015,131],"class_list":["post-31071","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-ebr-ucb","tag-ucb"],"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>UCB&#039;s Rystiggo Approved in China for Generalized Myasthenia Gravis - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Belgium-based biopharma UCB (EBR: UCB) announced that it has received marketing approval from China\u2019s National Medical Products Administration (NMPA) for Rystiggo (rozanolixizumab). This chimeric monoclonal antibody is now approved for use in combination with conventional therapy for adult generalized myasthenia gravis (gMG) patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.\" \/>\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=31071\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UCB&#039;s Rystiggo Approved in China for Generalized Myasthenia Gravis\" \/>\n<meta property=\"og:description\" content=\"Belgium-based biopharma UCB (EBR: UCB) announced that it has received marketing approval from China\u2019s National Medical Products Administration (NMPA) for Rystiggo (rozanolixizumab). This chimeric monoclonal antibody is now approved for use in combination with conventional therapy for adult generalized myasthenia gravis (gMG) patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=31071\" \/>\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=\"2025-04-01T10:08:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-01T10:08:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/04\/0112-png.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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