{"id":38773,"date":"2025-08-07T14:08:33","date_gmt":"2025-08-07T06:08:33","guid":{"rendered":"https:\/\/flcube.com\/?p=38773"},"modified":"2025-08-07T14:08:34","modified_gmt":"2025-08-07T06:08:34","slug":"sino-biopharmaceuticals-rovadicitinib-granted-breakthrough-therapy-designation-for-chronic-graft-versus-host-disease","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=38773","title":{"rendered":"Sino Biopharmaceutical&#8217;s Rovadicitinib Granted Breakthrough Therapy Designation for Chronic Graft-versus-Host Disease"},"content":{"rendered":"\n<p>China-based Sino Biopharmaceutical Limited (<a href=\"https:\/\/www.google.com\/finance\/quote\/1177:HKG\">HKG: 1177<\/a>) announced that its self-developed JAK\/ROCK dual small molecule inhibitor, rovadicitinib tablets (TQ05105), has been granted Breakthrough Therapy Designation (BTD) by China&#8217;s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). The drug is intended for the treatment of chronic graft-versus-host disease (cGVHD).<\/p>\n\n\n\n<p><strong>Global Innovation<\/strong><br>Rovadicitinib is one of the globally leading JAK\/ROCK dual-target inhibitors in development. A marketing application for the indication of intermediate-to-high-risk myelofibrosis (MF) was submitted and accepted in July 2024. The drug is currently in a Phase III clinical trial for cGVHD in China and has also received approval to conduct a Phase II trial in the U.S.<\/p>\n\n\n\n<p><strong>Clinical Trial Results<\/strong><br>Previous results from an Ib\/IIa study published in the journal <em>Blood<\/em> demonstrated promising outcomes. In 44 patients with moderate to severe glucocorticoid-refractory or -dependent cGVHD:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>No dose-limiting toxicities were observed.<\/li>\n\n\n\n<li>There were no drug-related discontinuations.<\/li>\n\n\n\n<li>The Best Overall Response (BOR) rate was 86.4%.<\/li>\n\n\n\n<li>The 12-month Failure-Free Survival (FFS) rate was 85.2%.<\/li>\n\n\n\n<li>88.6% of subjects were able to reduce their steroid dose.<\/li>\n\n\n\n<li>59.1% of subjects experienced symptom improvement.<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\/08\/2025080601700_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025080601700_c.\"><\/object><a id=\"wp-block-file--media-f3be4cd3-d201-462c-aee2-e84d1b1d795f\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/2025080601700_c.pdf\">2025080601700_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/2025080601700_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-f3be4cd3-d201-462c-aee2-e84d1b1d795f\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based Sino Biopharmaceutical Limited (HKG: 1177) announced that its self-developed JAK\/ROCK dual small molecule inhibitor,&#8230;<\/p>\n","protected":false},"author":1,"featured_media":38776,"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":[908,15,313],"class_list":["post-38773","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-hkg-1177","tag-product-approvals","tag-sino-biopharmaceutical"],"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>Sino Biopharmaceutical&#039;s Rovadicitinib Granted Breakthrough Therapy Designation for Chronic Graft-versus-Host Disease - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Sino Biopharmaceutical Limited (HKG: 1177) announced that its self-developed JAK\/ROCK dual small molecule inhibitor, rovadicitinib tablets (TQ05105), has been granted Breakthrough Therapy Designation (BTD) by China&#039;s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). The drug is intended for the treatment of chronic graft-versus-host disease (cGVHD).\" \/>\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=38773\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sino Biopharmaceutical&#039;s Rovadicitinib Granted Breakthrough Therapy Designation for Chronic Graft-versus-Host Disease\" \/>\n<meta property=\"og:description\" content=\"China-based Sino Biopharmaceutical Limited (HKG: 1177) announced that its self-developed JAK\/ROCK dual small molecule inhibitor, rovadicitinib tablets (TQ05105), has been granted Breakthrough Therapy Designation (BTD) by China&#039;s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). 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