NDA of BCMA CAR T Zevor-cel (CT053) accepted by China NMPA

Prof. Wenming Chen, the principal investigator of the CT053-MM-01 study, Director of Hematology Department, Beijing Chao-Yang Hospital, Capital Medical University, said: “Results from the LUMMICAR-1 study show that the fully human autologous BCMA CAR T-cell product, zevor-cel, demonstrated strong and durable efficacy in patients with relapsed/refractory multiple myeloma, and was generally well tolerated. We are delighted to see that the NDA of this CAR T-cell product with independent intellectual property rights has been officially accepted by the NMPA, and we are looking forward to its early launch and bringing clinical benefits to Chinese patients with relapsed/refractory multiple myeloma.”

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