{"id":25108,"date":"2022-10-14T12:30:00","date_gmt":"2022-10-14T04:30:00","guid":{"rendered":"https:\/\/flcube.com\/?p=25108"},"modified":"2025-02-03T12:35:08","modified_gmt":"2025-02-03T04:35:08","slug":"carsgens-bcma-targeted-car-t-therapy-ct053-gains-priority-review-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=25108","title":{"rendered":"CARsgen’s BCMA-Targeted CAR-T Therapy CT053 Gains Priority Review in China"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE) website indicates that China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd\u2019s (HKG: 2171<\/a>) B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy CT053 (zevor-cel) is set for priority review. This status relates to a market approval filing to treat adult patients with recurrent or refractory multiple myeloma (R\/R MM) who have experienced at least one immune modulator and proteasome inhibitor treatment failure in the past.<\/p>\n\n\n\n

Regulatory Milestones for CT053<\/strong>
CT053 has achieved several regulatory milestones globally. In 2019, it obtained Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designation (ODD) statuses in the US. The same year, it also received Priority Medicine (PRIME) status in the European Union, followed by ODD status in 2020. Additionally, CT053 was awarded breakthrough therapy designation (BTD) status in China in 2020 as a treatment for multiple myeloma (MM).<\/p>\n\n\n\n

Clinical Study and Future Outlook<\/strong>
The Phase Ib\/II LUMMICARSTUDY 2 study is currently assessing the safety and efficacy of CT053 in R\/R MM in North America. The priority review status granted by the CDE underscores CARsgen Therapeutics’ commitment to advancing innovative treatments for multiple myeloma. By leveraging these regulatory recognitions, CARsgen aims to expedite the availability of CT053 to patients in need.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The Center for Drug Evaluation (CDE) website indicates that China-based chimeric antigen receptor (CAR)-T cell…<\/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":[21,379,77,1188,80],"class_list":["post-25108","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-car-t","tag-carsgen-therapeutics","tag-cell-therapy","tag-hkg-2171","tag-priority-reviews"],"yoast_head":"\nCARsgen's BCMA-Targeted CAR-T Therapy CT053 Gains Priority Review in China - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) website indicates that China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd\u2019s (HKG: 2171) B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy CT053 (zevor-cel) is set for priority review. This status relates to a market approval filing to treat adult patients with recurrent or refractory multiple myeloma (R\/R MM) who have experienced at least one immune modulator and proteasome inhibitor treatment failure in the past.\" \/>\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=25108\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CARsgen's BCMA-Targeted CAR-T Therapy CT053 Gains Priority Review in China\" \/>\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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