Kaiser Pharmaceuticals -B (02171.HK): FDA has lifted the US clinical trial suspension for Zepoviorolinsae injection, Shiruigiolinsae injection, and CT071.

Gelonghui Finance · Oct 31 17:02

Gelonghui, November 1 | Keji Pharmaceutical-B (02171.HK) announced that the US Food and Drug Administration (“FDA”) has discontinued the US Zevorkiolensis injection (zevor-cel, CT053, an autologous CAR-T cell product targeting BCMA), shurikiolensis injection (satri-cel, CT041, an autologous CAR-T cell product targeting Claudin18.2) and CT071 (an autologous CAR-T cell product targeting GCPR5D) Clinical trials are suspended. The suspension of clinical trials is related to findings issued by the FDA after inspecting the company's clinical production site in Durham, North Carolina in December 2023.

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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

Kaiser Pharmaceuticals -B (02171.HK): FDA has lifted the US clinical trial suspension for Zepoviorolinsae injection, Shiruigiolinsae injection, and CT071.

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