{"id":14016,"date":"2023-09-11T22:43:00","date_gmt":"2023-09-11T14:43:00","guid":{"rendered":"https:\/\/flcube.com\/?p=14016"},"modified":"2024-11-21T22:46:34","modified_gmt":"2024-11-21T14:46:34","slug":"abbisko-therapeutics-receives-ema-approval-for-phase-iii-study-of-pimicotinib-for-tgct","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14016","title":{"rendered":"Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT"},"content":{"rendered":"\n<p>Shanghai-based biotech Abbisko Therapeutics Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/2256:HKG\">HKG: 2256<\/a>) has announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase III clinical study for its Category 1 innovative drug ABSK021 (pimicotinib), which is being assessed as a treatment for tendon sheath giant cell tumor (TGCT).<\/p>\n\n\n\n<p><strong>Design and Structure of the Phase III Study<\/strong><br>The Phase III study is a randomized, double-blind, placebo-controlled, multi-center trial designed in two parts to evaluate the efficacy and safety of ABSK021 in TGCT. In Part 1, subjects will be randomly assigned to receive 50mg QD of ABSK021 treatment or placebo under double-blind conditions for a 28-day treatment cycle. Participants who complete Part 1 will be eligible to enter Part 2, an open-label treatment phase where all participants receive 50mg QD ABSK021 treatment for 24 weeks or choose to withdraw from the study. The primary endpoint of the study is the 25-week objective response rate (ORR), and approximately 100 subjects are aimed to be enrolled. Enrollment has commenced in the US and China, with the data to support New Drug Application (NDA) filings in Chinese, US, and European markets.<\/p>\n\n\n\n<p><strong>Pimicotinib&#8217;s Profile and Potential Impact<\/strong><br>Pimicotinib is an orally administrated, highly potent, and selective small-molecule inhibitor of CSF-1R. It has received breakthrough therapy designation (BTD) and priority review awards in China, the US, and Europe. Tendon sheath giant cell tumor (TGCT) is a locally invasive tumor characterized by swelling, pain, stiffness, and limited mobility of the affected joints, significantly impacting patients&#8217; quality of life. Currently, no targeted therapy exists in China for TGCT, although Daiichi-Sankyo\u2019s pexidartinib has been approved for use outside of the country for this indication.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval&#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":[186,16,62,921],"class_list":["post-14016","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-abbisko-therapeutics","tag-cancer","tag-clinical-trial-approval-initiation","tag-hkg-2256"],"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>Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase III clinical study for its Category 1 innovative drug ABSK021 (pimicotinib), which is being assessed as a treatment for tendon sheath giant cell tumor (TGCT).\" \/>\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=14016\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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