Bio-Thera Solutions Inc. (SHA: 688177) announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for BAT4406F, a next‑generation glyco‑optimized anti‑CD20 monoclonal antibody. The product is indicated for neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti‑aquaporin‑4 (AQP4) antibody‑positive, addressing a critical unmet need in this rare autoimmune disease.
Regulatory Milestone
Item
Detail
Company
Bio-Thera Solutions Inc. (SHA: 688177)
Product
BAT4406F injection
Drug Class
Next‑generation glyco‑optimized fully human anti‑CD20 mAb
Regulatory Action
BLA accepted by NMPA
Indication
NMOSD in AQP4‑antibody‑positive adult patients
Rare Disease Status
NMOSD included in China’s “First National List of Rare Diseases” (2018)
Clinical Status
Phase II/III completed; trial terminated early per IDMC recommendation
High affinity for Natural Killer (NK) cells → potent B‑cell depletion
Generation
Next‑gen vs. first‑generation anti‑CD20 antibodies (rituximab, ocrelizumab)
Clinical Evidence – Phase II/III Study
Milestone
Detail
Study Design
Pivotal Phase II/III for NMOSD
Interim Analysis
July 2025
Result
Significant benefits demonstrated in treatment group
IDMC Recommendation
“Terminate trial early” due to efficacy
Outcome
Patient recruitment concluded ahead of schedule
Implication
Compelling efficacy signal supports BLA submission
Strategic Implications
Rare Disease Focus: NMOSD is a devastating autoimmune disorder of the central nervous system with limited treatment options; BAT4406F addresses urgent clinical need in China.
Fc‑Engineering Differentiation:Glyco‑optimization for enhanced ADCC differentiates BAT4406F from existing anti‑CD20 therapies, potentially offering superior B‑cell depletion and clinical outcomes.
Regulatory Momentum:Early trial termination for efficacy is a strong validation signal; NMPA BLA acceptance positions Bio-Thera for potential priority review given rare disease status.
Pipeline Expansion: Success in NMOSD could support label expansion to other B‑cell‑mediated autoimmune diseases (multiple sclerosis, rheumatoid arthritis, lupus).
Market Context
Factor
Impact
NMOSD Prevalence
~ 1–2 per 100,000 globally; AQP4‑positive subset represents majority of cases
China Rare Disease Policy
NMPA prioritizes rare disease therapies; potential for accelerated approval and reimbursement
Competitive Landscape
Roche’s rituximab and Horizon’s eculizumab used off‑label; no approved anti‑CD20 specifically for NMOSD in China
Bio-Thera Positioning
BLA acceptance validates Fc‑engineering platform; establishes company in rare disease biologics
Forward‑Looking Statements This brief contains forward‑looking statements regarding NMPA review timelines, approval expectations, and commercial potential for BAT4406F. Actual results may differ due to risks including regulatory review outcomes, manufacturing scale‑up, and competitive market dynamics.-Fineline Info & Tech
By Fineline Cube