B001 / Shanghai Pharma - LARVOL DELTA

Safety of New NMOSD Therapy (ACTRIMS Forum 2025) - "B001 had an acceptable safety profile in AQP4-IgG+ NMOSD patients and showed significant pharmacodynamic characteristics (B-cell depletion)."

Clinical • CNS Disorders • Immunology • Infectious Disease • Inflammation • Nephrology • Neuromyelitis Optica Spectrum Disorder • Ophthalmology

Shanghai Pharmaceuticals (601607.SH): Terminate clinical trials and subsequent development of four R&D projects: B001, B001-A, I022 (combination therapy, first-line treatment for breast cancer) and I022-K [Google translation] (iis.aastocks.com) - "Shanghai Pharmaceuticals...announced that based on a comprehensive assessment of the future market value of the R&D projects, business synergy, and subsequent development investment, it decided to terminate the clinical trials and subsequent development of the four R&D projects B001, B001-A, I022...and I022-K."

Discontinued • Trial termination • Breast Cancer • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD) (clinicaltrials.gov) - P2/3 | N=132 | Not yet recruiting | Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd

New P2/3 trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial primary completion date: Apr 2024 ➔ Dec 2024

Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder

A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd

New P1 trial • Glomerulonephritis • Renal Disease

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Neuromyelitis Optica Spectrum Disorder

Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) (clinicaltrials.gov) - P1; N=45; Not yet recruiting; Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Clinical • New P1 trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder

B001 in Patients With CD20 Positive B-cell Non Hodgkin's Lymphoma (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd; Recruiting ➔ Completed

Clinical • Trial completion • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

B001 in Patients With CD20 Positive B-cell Non Hodgkin's Lymphoma (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd; Trial completion date: Feb 2020 ➔ Feb 2021; Trial primary completion date: Jan 2020 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology