Ge Long Hui·2025-07-29 08:54Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its self-developed B019 injection, targeting refractory systemic lupus erythematosus [1] Group 1: Product Development - B019 injection is a chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD22, designed for treating 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] - The 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 NMPA in October 2023 and December 2024, respectively [1] Group 2: Financial Investment - The project has incurred approximately RMB 149,000 in research and development expenses for the new indication as of the date of the announcement [1]