{"id":1391,"date":"2024-09-23T15:26:20","date_gmt":"2024-09-23T07:26:20","guid":{"rendered":"https:\/\/flcube.com\/?p=1391"},"modified":"2024-11-10T00:50:30","modified_gmt":"2024-11-09T16:50:30","slug":"sciclone-pharmaceuticals-gets-nmpa-approval-for-phase-iii-study-of-first-in-class-serd-orserdu","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=1391","title":{"rendered":"SciClone Pharmaceuticals Gets NMPA Approval for Phase III Study of First-in-Class SERD Orserdu"},"content":{"rendered":"\n<p>SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III bridging study for its drug Orserdu (elacestrant), the world&#8217;s first selective estrogen receptor degrader (SERD) originally developed by Eisai. The Phase III study, which is randomized, open, and multi-center, aims to evaluate the efficacy of elacestrant in treating Chinese postmenopausal women or men with advanced breast cancer that is estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), and carries estrogen receptor 1 (ESR1) mutations. The study will compare elacestrant&#8217;s effectiveness with the standard of care in patients who have previously received first or second-line endocrine therapy.<\/p>\n\n\n\n<p>Elacestrant, which was entrusted to Radius Health for global development in 2006, was later licensed to the Italy-based Menarini Group in July 2020, granting them exclusive global commercialization rights. In December of the previous year, SciClone entered into a licensing and cooperation agreement with Menarini, securing exclusive rights to develop and commercialize the drug in China. This followed the initiation of a real-world study in an academic hospital in Boao, Hainan province, two months prior.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National&#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":[16,62,932,152],"class_list":["post-1391","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-hkg-6600","tag-sciclone-pharmaceuticals"],"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>SciClone Pharmaceuticals Gets NMPA Approval for Phase III Study of First-in-Class SERD Orserdu - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"SciClone Pharmaceuticals Inc. (HKG: 6600, SHE: 300485), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III bridging study for its drug Orserdu (elacestrant), the world&#039;s first selective estrogen receptor degrader (SERD) originally developed by Eisai. The Phase III study, which is randomized, open, and multi-center, aims to evaluate the efficacy of elacestrant in treating Chinese postmenopausal women or men with advanced breast cancer that is estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), and carries estrogen receptor 1 (ESR1) mutations. 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