Asset profile
HLX01
Monoclonal antibody
Evidence outlook · lead readout
NCT03522415 · Moderately to Severely Active Rheumatoid Arthritis
The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.
NCT03522415: 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.
How the evidence outlook works ↗
Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
70 competitors in this universe: 5 direct rivals (same mechanism and indication), 10 same-class, 55 same-indication; 29 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| HLX01: this drug | Phase 3 | Monoclonal antibody | CD20 | ||
| PF-05280586 | Approved | Biologic (subtype unspecified) | CD20 | ||
| Rituximab | Approved | Monoclonal antibody | CD20, CD20-directed Cytolytic Antibody | ||
| Acellbia | Phase 3 | Monoclonal antibody | CD20 | ||
| CT-P10 | Phase 3 | Monoclonal antibody | CD20 | ||
| SAR448501 | Phase 1 | Multispecific antibody | CD20 | ||
| Ocrelizumab | Approved | Monoclonal antibody | CD20 | ||
| Ocrevus Zunovo | Approved | Monoclonal antibody | CD20 | ||
| Ofatumumab | Approved | Monoclonal antibody | CD20 | ||
| Ublituximab | Approved | Monoclonal antibody | CD20 | ||
| ABP 692 | Phase 3 | Monoclonal antibody | CD20 | ||
| BCD-132 | Phase 3 | Monoclonal antibody | CD20 | ||
| BCD-281 | Phase 3 | Monoclonal antibody | CD20 | ||
| CT-P53 | Phase 3 | Monoclonal antibody | CD20 | ||
| Divozilimab | Phase 3 | Monoclonal antibody | CD20 | ||
| MIL62 | Phase 3 | Monoclonal antibody | CD20 |
…and 55 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Upcoming events
(1 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2027 (1)
January 2027 (1)
What to watch
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.