Beijing Mabworks Biotech Co., Ltd. announced that the National Medical Products Administration (NMPA) has approved Obexelimab β injection (MIL62), its independently developed third-generation CD20 antibody, for Neuromyelitis Optica Spectrum Disorder (NMOSD). The first domestically-produced drug approved for NMOSD in China marks a breakthrough for Mabworks’ Fc-engineered antibody platform, with Primary Membranous Nephropathy (PMN)—where Obexelimab β could become the world’s first specialized therapy—under Priority Review and final NMPA review stage.
No approved specialized therapy globally; potential disease-modifying standard-of-care
Clinical & Regulatory Progress
Indication
Status
Timeline
Strategic Value
NMOSD
NMPA approved (Jan 24, 2026)
Launched Q1 2026
First domestic entrant; orphan disease premium pricing; neurology specialist relationships
PMN
NDA accepted; Priority Review; final stage
Approval anticipated H1 2026
World’s first specialized PMN drug; nephrology blockbuster potential; global partnership attractiveness
Strategic Positioning & Market Context
Factor
Strategic Analysis
NMOSD Market
~50,000-100,000 patients in China; high disability burden; eculizumab/inebilizumab expensive and imported; Obexelimab β domestic manufacturing cost advantage
PMN Unmet Need
~1 million global patients; rituximab off-label use with variable response; no approved targeted therapy; Obexelimab β first-in-class opportunity
Third-Gen CD20 Differentiation
Fc-engineering enhances B-cell depletion vs. rituximab (first-gen) and ocrelizumab/ofatumumab (second-gen); potentially superior efficacy and durability
Final NMPA review; nephrology KOL preparation; global regulatory strategy
H1 2026
NRDL Inclusion
National Reimbursement Drug List negotiation for both indications
2026-2027
Global Expansion
US/EU IND submissions; Big Pharma partnership discussions
2026-2027
Pipeline Expansion
Additional autoimmune indications (SLE, MS, ITP)
2026+
Forward‑Looking Statements This brief contains forward‑looking statements regarding Obexelimab β PMN approval timelines, commercial performance in NMOSD and PMN, and Mabworks Biotech’s global expansion strategy. Actual results may differ due to final NMPA review outcomes, competitive dynamics with Roche’s CD20 franchise, and pricing negotiations with national reimbursement programs.-Fineline Info & Tech
By Fineline Cube 