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]

上海医药(601607.SH)发布公告，近日，公司下属上海医药集团生物治疗技术有限公司(以下简称"上药生 物治疗")自主研发的"B019"(以下简称"B019注射液"或"该项目")收到国家药品监督管理局(以下简称"国 家药监局")核准签发的《药物临床试验批准通知书》，同意其开展难治性系统性红斑狼疮(以下简称"新 适应症")的临床试验。 据悉，B019注射液是靶向CD19和CD22的嵌合抗原受体自体T细胞注射液，拟用于治疗难治性系统性红 斑狼疮。B019的嵌合抗原受体结构采用一个双顺反子载体结构，可以在T细胞上表达两个独立的嵌合抗 原受体，在互不影响的情况下分别结合B淋巴细胞表面表达的CD19或CD22蛋白，以发挥治疗作用。 B019注射液用于治疗复发或难治性急性B淋巴细胞白血病、复发或难治性B细胞非霍奇金淋巴瘤这两个 适应症的临床试验申请已分别于2023年10月、2024年12月获得国家药监局批准。 ...