Gelonghui, November 1st, Kojie Pharmaceutical-B (02171.HK) announced that the Food and Drug Administration (FDA) of the United States has lifted the clinical trial suspension of Zevorcerebellum injection in the United States (zevor-cel, CT053, a self-targeting BCMA CAR-T cell product), Satrirebellum injection (satri-cel, CT041, a self-targeting Claudin18.2 CAR-T cell product), and CT071 (a self-targeting GPRC5D CAR-T cell product). The clinical trial suspension is related to the findings released after the FDA inspected the company's clinical production base in Durham, North Carolina in December 2023.
科济药业-B(02171.HK):FDA解除对泽沃基奥仑赛注射液、舒瑞基奥仑赛注射液和CT071的美国临床研究暂停
SciClone Pharmaceuticals (02171.HK): FDA has lifted the U.S. clinical trial suspension on Zejovir Olinsa injection, ShuRui Olinsa injection, and CT071.
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