Differentiated Antibody Drug Developer
BEIJING—Beijing Mabworks Biotechnology Co., Ltd. announced that its flagship product Beijixin® (generic name: obinutuzumab β) has received a Level 1 recommendation with Evidence Quality A in the newly released Expert Consensus on Biological Targeted Therapy for Neuromyelitis Optica Spectrum Disorders in China (2026 Edition), for the treatment of aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive adult patients with NMOSD.
The designation marks the first time the consensus has recommended a domestically developed, originally researched biological targeted therapy, signaling a shift in how Chinese neurologists approach this rare and devastating autoimmune disease of the central nervous system.
The recommendation is grounded in Phase III clinical trial data that Mabworks presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2025) in the Late-Breaking Abstract session. The study demonstrated that Beijixin® monotherapy reduced the risk of NMOSD relapse by 93.1%, with statistically significant advantages in controlling both clinical relapses and radiological disease activity.
The consensus document, organized by the Neuroimmunology and Related Diseases Professional Committee of the Neuroscience Society of Beijing and published in the Chinese Journal of Neuroimmunology and Neurology—the only neurology academic journal in China focused on neuroimmunology—reflects a broader transformation in NMOSD care. Treatment paradigms have been migrating away from traditional immunosuppressants toward more precisely targeted biological therapies, the document notes.
Beijixin®, already approved for marketing in China, is the first domestically developed drug to receive approval for this indication. It is also the world's first CD20 antibody approved for NMOSD, offering patients a treatment option that the company says is both more effective and more accessible than existing alternatives.
The drug is a glycoengineered, third-generation humanized CD20 monoclonal antibody. The approved dosing regimen calls for intravenous infusions of 1,000 mg at weeks 1, 3, 25, and 27, followed by maintenance dosing every six months.
Beyond NMOSD, Mabworks has been expanding Beijixin®'s label. In June 2026, the drug received approval in China for primary membranous nephropathy (PMN), making it the first approved therapy worldwide specifically indicated for pMN. The company is also conducting Phase III trials in systemic lupus erythematosus (SLE) and follicular lymphoma (FL), with potential to extend into additional autoimmune disease indications.
Mabworks, a national high-tech enterprise and Beijing specialized and innovative small-and-medium enterprise, focuses on the research, development, and industrialization of innovative antibody targeted therapies for autoimmune diseases and oncology. The company operates a Beijing Key Laboratory, a Beijing Engineering Laboratory, a postdoctoral workstation, and an academician and expert workstation.