{"id":24457,"date":"2022-11-10T16:11:00","date_gmt":"2022-11-10T08:11:00","guid":{"rendered":"https:\/\/flcube.com\/?p=24457"},"modified":"2025-01-31T16:14:55","modified_gmt":"2025-01-31T08:14:55","slug":"3sbios-thrombopoietin-study-in-pediatric-itp-reaches-primary-endpoint","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=24457","title":{"rendered":"3SBio&#8217;s Thrombopoietin Study in Pediatric ITP Reaches Primary Endpoint"},"content":{"rendered":"\n<p>China-based 3SBio Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/1530:HKG\">HKG: 1530<\/a>) has announced that its multi-center, randomized, double-blind, placebo-controlled study assessing the safety, efficacy, and pharmacokinetics of thrombopoietin in chronic primary immune thrombocytopenia (ITP) in children or adolescents has reached its pre-set primary endpoint. The results of the statistical analysis showed that the study group&#8217;s superiority was established compared with the control group, with a statistically significant difference in the overall effective rate (P = 0.0029). No serious adverse events or any suspicious unexpected serious adverse reactions related to the study drug were reported. The company plans to submit a supplementary new drug application for the drug in China in the near future.<\/p>\n\n\n\n<p><strong>Thrombopoietin Profile<\/strong><br>3SBio&#8217;s recombinant thrombopoietin, marketed under the brand name TPIAO, was first approved for marketing in China in May 2005 as a treatment for chemotherapy-induced thrombocytopenia. A second indication for immune thrombocytopenia (ITP) in adults was approved in 2010. The Phase III clinical study was initiated to assess its use as a pediatric therapy in 10 children&#8217;s hospitals and general hospitals in China.<\/p>\n\n\n\n<p><strong>ITP Treatment Landscape<\/strong><br>ITP, an acquired autoimmune hemorrhagic disease, requires patients to participate in treatment decision-making to achieve optimal platelet counts while minimizing adverse treatment reactions and reducing bleeding events. China&#8217;s ITP treatment guidelines recommend thrombopoietin as a second-line therapy. The successful outcome of this study underscores the potential of 3SBio&#8217;s thrombopoietin as a valuable treatment option for pediatric and adolescent patients with chronic ITP.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based 3SBio Inc. (HKG: 1530) has announced that its multi-center, randomized, double-blind, placebo-controlled study assessing&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[116,17,1061],"class_list":["post-24457","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-3sbio","tag-clinical-trial-results","tag-hkg-1530"],"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>3SBio&#039;s Thrombopoietin Study in Pediatric ITP Reaches Primary Endpoint - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based 3SBio Inc. (HKG: 1530) has announced that its multi-center, randomized, double-blind, placebo-controlled study assessing the safety, efficacy, and pharmacokinetics of thrombopoietin in chronic primary immune thrombocytopenia (ITP) in children or adolescents has reached its pre-set primary endpoint. The results of the statistical analysis showed that the study group&#039;s superiority was established compared with the control group, with a statistically significant difference in the overall effective rate (P = 0.0029). No serious adverse events or any suspicious unexpected serious adverse reactions related to the study drug were reported. 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(HKG: 1530) has announced that its multi-center, randomized, double-blind, placebo-controlled study assessing the safety, efficacy, and pharmacokinetics of thrombopoietin in chronic primary immune thrombocytopenia (ITP) in children or adolescents has reached its pre-set primary endpoint. The results of the statistical analysis showed that the study group's superiority was established compared with the control group, with a statistically significant difference in the overall effective rate (P = 0.0029). No serious adverse events or any suspicious unexpected serious adverse reactions related to the study drug were reported. 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