Drug intelligence / Profile preview

HS628

Development stage
Phase 3
Lead developer
Zhejiang Hisun Pharmaceutical
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous, Intravenous
01

Overview

HS628 is a tocilizumab biosimilar developed by Zhejiang Hisun Pharmaceutical. It is a recombinant humanized monoclonal antibody that functions as an interleukin-6 receptor alpha subunit (IL-6RA) antagonist. By binding specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), HS628 inhibits IL-6-mediated pro-inflammatory signaling, which is a key driver in the pathogenesis of various autoimmune and inflammatory diseases. The drug is primarily being evaluated in Phase III clinical trials for the treatment of moderate to severe active rheumatoid arthritis in patients who have had an inadequate response to methotrexate. Additionally, it is being developed for other indications including cytokine release syndrome and systemic onset juvenile chronic arthritis.

Brand names
ActemraTyenneAvtozmaTofidenceRoactemra
Other names
tocilizumab biosimilar
02

Targets

IL-6R (Interleukin-6 receptor subunit alpha)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)FCGRT (Neonatal crystallizable fragment receptor)

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