Zhi Tong Cai Jing·2025-07-29 09:09Core 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]