B019 / Shanghai Pharma - LARVOL DELTA

Shanghai Pharmaceuticals’ B019 Injection Approved for SLE Clinical Trials (flcube.com) - "Shanghai Pharmaceuticals Holding...announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its B019 injection, a treatment for refractory systemic lupus erythematosus (SLE). This marks a significant milestone in the development of this innovative therapy."

New trial • Systemic Lupus Erythematosus

A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia. (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. | N=24 ➔ 33

Enrollment change • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma. (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

New P1 trial • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia. (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Bicistronic CD19/CD22-Directed CAR T-Cell Therapy Is Safe, Elicits Durable Responses in Pediatric R/R B-ALL (OncLive) - P2 | N=500 | ChiCTR2000032211 | "At a median follow-up of 13.9 months, the 1-year event-free survival (EFS) rate was 75.5%, and the 1-year overall survival (OS) rate was 93.5% among patients enrolled and treated with bicistronic CD19/CD22-directed CAR T-cell therapy (n = 343). Following CAR T-cell expansion, the 1-year EFS rates among patients who underwent bridging bone marrow transplant (n = 38) vs those who did not (n = 280) were 89.7% vs 76.8%, respectively. The respective 1-year OS rates were 95.8% vs 95.2%...Among the 172 patients with grade 1/2 CRS, the 1-year EFS rate was 80.9%; the 1-year EFS rate for the 145 patients with grade 3/4 CRS was 69.9%."

P2 data • B Acute Lymphoblastic Leukemia

Shanghai Pharmaceuticals subsidiary’s CD19/CD22 dual-target CAR-T product was approved for clinical trials again [Google translation] (vbdata.cn) - "The CD19/CD22 dual-target CAR-T product of Shanghai Pharmaceuticals' subsidiary has been approved for clinical use for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma, which is the company's second approved indication. The product uses a bicistronic vector structure to express two independent chimeric antigen receptors, which bind to CD19 or CD22 proteins to exert anti-tumor effects. Previously, the first indication of the injection has been approved for clinical use and is in the clinical phase I stage. At the same time, clinical trials initiated by researchers have shown that the product has achieved significant results in treating pediatric patients."

New trial • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Oncology

Shanghai Pharmaceuticals: CD19/CD22 CAR-T therapy IND accepted [Google translation] (bydrug.pharmcube.com) - "On September 11, the new drug clinical trial application (IND) for the 'chimeric antigen receptor autologous T cell injection targeting CD19 and CD22' developed by Shanghai Pharmaceutical Group Biotherapy Technology Co., Ltd...was accepted...The IND application for Shanghai Pharmaceuticals' CD19/CD22 dual-target CAR-T therapy has been accepted again, which means that Shanghai Pharmaceuticals has made another progress in the field of CAR-T."

New trial • Oncology