Shang Hai Zheng Quan Bao·2025-07-29 17:34Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for clinical trials of its B019 injection for the treatment of refractory systemic lupus erythematosus, marking a significant step in its drug development process [1][2]. Group 1: Project Basic Information - The drug B019 is a chimeric antigen receptor (CAR) T-cell injection targeting CD19 and CD22, designed for refractory systemic lupus erythematosus [2]. - The clinical trial application for B019 was accepted on April 29, 2025, under registration number CXSL2500344, and the approval notice number is 2025LP01884 [1][2]. Group 2: R&D and Registration Status - B019 has previously received approvals for clinical trials targeting relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma, with applications approved in October 2023 and December 2024, respectively [2]. - The project is developed independently by Shanghai Pharmaceuticals' subsidiary, Shanghai Pharmaceuticals Biotherapy, which holds complete intellectual property rights [2]. - As of the announcement date, approximately 149,000 RMB has been invested in the R&D of the new indication [2]. Group 3: Market Situation - As of the announcement date, there are no other drugs on the market targeting the same indication with the same mechanism [3]. Group 4: Impact on the Company - The approval for B019's new indication does not have a significant immediate impact on the company's operations, but the company will actively promote the project in accordance with national regulations and fulfill information disclosure obligations regarding future progress [4].