Drug intelligence / Profile preview

suciraslimab

Development stage
Phase 3
Lead developer
Sinomab Bioscience
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

**Suciraslimab (SM03)** is a recombinant humanized monoclonal antibody that targets CD22, a sialic acid-binding transmembrane protein primarily expressed on B cells. It functions as a first-in-class anti-CD22 inhibitor with a novel mechanism that modulates autoreactive B cell activity without depleting normal B cells, thereby restoring immune tolerance, enhancing SHP-1 activity, suppressing NF-κB activation, and inhibiting NLRP3/ASC signaling to reduce cytokine production (e.g., IL-1β, IL-12). Developed by SinoMab BioScience (originally by Lonn Ryonn Pharma), it has completed Phase 3 trials for rheumatoid arthritis (RA) in China, meeting primary endpoints (ACR20 at week 24) in MTX-inadequate responders, with long-term data showing sustained efficacy up to 104 weeks and a favorable safety profile (low infection/malignancy risk). It shows promise in other autoimmune diseases via B cell regulation and multi-organ protection, and preclinical/neuroinflammation data support neurodegenerative applications by promoting amyloid-beta clearance in microglia.[1][2][3][5][7][9]

Other names
舒西利单抗
02

Targets

CD22 (Cluster of Differentiation 22)

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