Summary by Moomoo AI
Keji Pharmaceutical-B (stock code: 2171) announced on November 1, 2024, that the U.S. Food and Drug Administration (FDA) has lifted the U.S. clinical trial suspension on its three CAR-T cell products. These products include Zevorcel injection (zevor-cel, CT053), Satri-cel injection (satri-cel, CT041), and CT071, all of which are autologous CAR-T cell therapy products targeting BCMA, Claudin18.2, and GPRC5D respectively. The suspension of clinical trials stemmed from the inspection of the company's clinical production site in Durham, North Carolina by the FDA in December 2023. Keji Pharmaceutical is a biopharmaceutical company specializing in blood malignancies and solid tumor CAR-T cell therapy, aiming to improve the safety and efficacy of CAR-T therapy, reduce treatment costs, and become a leader in the global biopharmaceutical field through independent research and development of new technologies and product pipelines.