{"id":34335,"date":"2025-05-28T15:52:48","date_gmt":"2025-05-28T07:52:48","guid":{"rendered":"https:\/\/flcube.com\/?p=34335"},"modified":"2025-05-28T15:52:49","modified_gmt":"2025-05-28T07:52:49","slug":"carsgens-satricabtagene-autoleucel-granted-priority-review-by-chinas-cde","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=34335","title":{"rendered":"CARsgen’s Satricabtagene Autoleucel Granted Priority Review by China’s CDE"},"content":{"rendered":"\n

China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171<\/a>) has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration has granted Priority Review status to its satricabtagene autoleucel (CT041). This investigational Claudin18.2-targeting autologous CAR-T cell therapy is designated for patients with Claudin18.2-positive advanced gastric\/gastroesophageal junction adenocarcinoma (GC\/GEJC) who have failed at least two prior lines of therapy.<\/p>\n\n\n\n

Global Recognition<\/strong>
Satricabtagene autoleucel, also known as satri-cel, received Orphan Drug Designation (ODD) from the US FDA for the treatment of GC\/GEJC in September 2020. It was further granted Regenerative Medicine Advanced Therapy (RMAT) status in January 2022. Most recently, in March of this year, the CDE awarded the drug Breakthrough Therapy Designation (BTD) for its potential in treating advanced GC\/GEJC.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the Center for Drug Evaluation…<\/p>\n","protected":false},"author":1,"featured_media":34336,"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":[16,21,379,77,1188,80],"class_list":["post-34335","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-car-t","tag-carsgen-therapeutics","tag-cell-therapy","tag-hkg-2171","tag-priority-reviews"],"yoast_head":"\nCARsgen's Satricabtagene Autoleucel Granted Priority Review by China's CDE - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration has granted Priority Review status to its satricabtagene autoleucel (CT041). 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