{"id":12130,"date":"2023-11-02T22:02:00","date_gmt":"2023-11-02T14:02:00","guid":{"rendered":"https:\/\/flcube.com\/?p=12130"},"modified":"2024-11-11T22:09:17","modified_gmt":"2024-11-11T14:09:17","slug":"chongqing-precision-biotechnologys-pcar-19b-receives-cde-nod-for-breakthrough-therapy-designation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=12130","title":{"rendered":"Chongqing Precision Biotechnology’s PCAR-19B Receives CDE Nod for Breakthrough Therapy Designation"},"content":{"rendered":"\n

The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co., Ltd’s PCAR-19B cell autologous reinfusion preparation is on track to receive breakthrough therapy designation (BTD). This designation recognizes the potential of PCAR-19B as a treatment for patients aged 3 to 21 years old with CD19-positive relapsed\/refractory (R\/R) acute lymphoblastic leukemia (ALL).<\/p>\n\n\n\n

Therapeutic Potential of PCAR-19B<\/strong>
The Category 1 biologic preparation, PCAR-19B, is a CD19-targeted chimeric antigen receptor (CAR)-T cell therapy under development for the treatment of children and adults with R\/R ALL. In a Phase I clinical study, PCAR-19B demonstrated good safety and the capability to achieve complete remission (CR) in an adult with R\/R CD19+B-ALL, highlighting its potential efficacy in treating this patient population.<\/p>\n\n\n\n

Global and Chinese CAR-T Cell Therapy Landscape<\/strong>
Over the last six years, a total of nine CAR-T cell therapies have been approved globally, including six CD19-targeted products. In China, JW Therapeutics’ relmacabtagene autoleucel and Fosun Pharma\u2019s Yescarta (axicabtagene ciloleucel) are both CD19-targeted CAR-T cell therapies available on the market, indicating a growing interest and development in this therapeutic area.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co.,…<\/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":[34,16,21,77,1831],"class_list":["post-12130","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-breakthrough-therapy","tag-cancer","tag-car-t","tag-cell-therapy","tag-precision-biotechnology"],"yoast_head":"\nChongqing Precision Biotechnology's PCAR-19B Receives CDE Nod for Breakthrough Therapy Designation - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The China's Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co., Ltd's PCAR-19B cell autologous reinfusion preparation is on track to receive breakthrough therapy designation (BTD). 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