Head-to-head evidence
HLX01 vs Rituximab
Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.
Rheumatoid Arthritis
Shared mechanism: CD20 · full Rheumatoid Arthritis pipeline
HLX01
Developed by Shanghai Henlius Biotech
NCT03522415 · Phase 3 · completed
This randomised, quadruple-blind trial compared HLX01 plus methotrexate with placebo plus methotrexate in 275 patients with rheumatoid arthritis. At 24 weeks, 60.7% of patients on HLX01 reached an ACR20 response against 35.9% on placebo (P<0.001), a clear result on a validated measure of disease activity.
Rituximab
Marketed by Roche
NCT00468546 · Phase 3 · completed
The REFLEX phase 3 trial: randomized, double-blind, placebo-controlled, 520 participants with rheumatoid arthritis who had failed anti-TNF therapy, all on background methotrexate. The primary endpoint, ACR20 response at week 24, was reached by 153 of 298 participants on rituximab (51.3%) versus 36 of 201 on placebo (17.9%). ClinicalTrials.gov records no statistical analysis for the comparison, but a 33-percentage-point difference on a validated clinical response endpoint at this sample size is arithmetically undeniable, so the primary is read as met (significance inferred from counts).
Next expected readout: July 2027 · NCT06581562 (registry estimate)
The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: HLX01's landscape · Rituximab's landscape