{"id":22465,"date":"2023-01-30T21:02:00","date_gmt":"2023-01-30T13:02:00","guid":{"rendered":"https:\/\/flcube.com\/?p=22465"},"modified":"2025-01-21T21:04:14","modified_gmt":"2025-01-21T13:04:14","slug":"abbiskos-absk021-receives-fda-breakthrough-therapy-designation-for-tgct","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22465","title":{"rendered":"Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT"},"content":{"rendered":"\n

Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256<\/a>) has announced receiving breakthrough therapy designation (BTD) status from the US FDA for its Category 1 drug ABSK021, also known as pimicotinib. The designation is for the treatment of inoperable tenosynovial giant cell tumor (TGCT) and is based on positive Phase Ib data.<\/p>\n\n\n\n

Clinical Results and Development<\/strong>
The Phase Ib study for pimicotinib in advanced TGCT demonstrated a 68% objective response rate (ORR) along with a favorable safety and pharmacokinetic\/pharmacodynamic (PK\/PD) profile. In July of last year, pimicotinib was awarded BTD status in China for the same TGCT indication. Abbisko has advanced pimicotinib to Phase III clinical trials in China, initiated in October 2022.<\/p>\n\n\n\n

Partnership and Future Indications<\/strong>
In July 2021, Abbisko entered into a licensing agreement with Sperogenix Therapeutics to co-develop pimicotinib for rare nervous system diseases, with amyotrophic lateral sclerosis (ALS) as the first indication. This partnership underscores Abbisko’s commitment to expanding the therapeutic potential of pimicotinib beyond TGCT into other high-unmet-need areas.<\/a>-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD)…<\/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":[186,34,16,921],"class_list":["post-22465","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-abbisko-therapeutics","tag-breakthrough-therapy","tag-cancer","tag-hkg-2256"],"yoast_head":"\nAbbisko's ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD) status from the US FDA for its Category 1 drug ABSK021, also known as pimicotinib. The designation is for the treatment of inoperable tenosynovial giant cell tumor (TGCT) and is based on positive Phase Ib data.\" \/>\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=22465\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Abbisko's ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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