上海医药(601607.SH):B019新适应症获得临床试验批准
智通财经网·2025-07-29 08:30

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its self-developed B019 injection, targeting refractory systemic lupus erythematosus [1] Group 1 - B019 injection is a chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD22, designed for the treatment of refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual-synonymous vector to express two independent CARs on T-cells, allowing for simultaneous binding to CD19 or CD22 proteins on B lymphocytes without interference [1] - Clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma were approved by the NMPA in October 2023 and December 2024, respectively [1]