Core Viewpoint - Shanghai Pharmaceuticals (601607) has received approval from the National Medical Products Administration for its self-developed drug "B019" to conduct clinical trials for refractory systemic lupus erythematosus [1] Group 1: Product Development - B019 is a chimeric antigen receptor (CAR) T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual promoter vector, allowing T-cells to express two independent CARs that can bind to CD19 or CD22 proteins on B lymphocytes without interference [1] Group 2: Clinical Trial Approvals - Clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma have been approved by the National Medical Products Administration in October 2023 and December 2024, respectively [1]

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]