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Rituximab Monotherapy
Rituximab Monotherapy is a Monoclonal antibody (anti-CD20) Small molecule drug developed by Beijing Friendship Hospital. It is currently in Phase 3 development for B-cell non-Hodgkin's lymphoma, Chronic lymphocytic leukemia, Rheumatoid arthritis.
Rituximab is a monoclonal antibody that binds to CD20 on B cells, leading to their depletion through antibody-dependent cellular cytotoxicity and direct apoptosis.
Rituximab is a monoclonal antibody used as a binding agent to target the B-lymphocyte antigen CD20. It has been studied in clinical trials for various conditions, including Mantle Cell Lymphoma, Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, and Multiple Myeloma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Rituximab Monotherapy |
|---|---|
| Sponsor | Beijing Friendship Hospital |
| Drug class | Monoclonal antibody (anti-CD20) |
| Target | CD20 |
| Modality | Small molecule |
| Therapeutic area | Oncology, Immunology |
| Phase | Phase 3 |
Mechanism of action
Rituximab targets the CD20 antigen expressed on the surface of B lymphocytes. Upon binding, it triggers multiple mechanisms of B cell death including antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct induction of apoptosis. This results in rapid depletion of B cells, reducing autoimmune and malignant B cell populations.
Approved indications
- B-cell non-Hodgkin's lymphoma
- Chronic lymphocytic leukemia
- Rheumatoid arthritis
- Granulomatosis with polyangiitis
- Microscopic polyangiitis
Common side effects
- Infusion reactions
- Infections
- Cytopenias (anemia, thrombocytopenia, neutropenia)
- Fatigue
- Fever
- Nausea
Key clinical trials
- A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma (PHASE3)
- A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers (PHASE1)
- A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors (PHASE3)
- A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma (PHASE3)
- Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study (PHASE4)
- IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) (PHASE3)
- A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain (PHASE2)
- A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rituximab Monotherapy CI brief — competitive landscape report
- Rituximab Monotherapy updates RSS · CI watch RSS
- Beijing Friendship Hospital portfolio CI
Frequently asked questions about Rituximab Monotherapy
What is Rituximab Monotherapy?
How does Rituximab Monotherapy work?
What is Rituximab Monotherapy used for?
Who makes Rituximab Monotherapy?
What drug class is Rituximab Monotherapy in?
What development phase is Rituximab Monotherapy in?
What are the side effects of Rituximab Monotherapy?
What does Rituximab Monotherapy target?
Related
- Drug class: All Monoclonal antibody (anti-CD20) drugs
- Target: All drugs targeting CD20
- Manufacturer: Beijing Friendship Hospital — full pipeline
- Therapeutic area: All drugs in Oncology, Immunology
- Indication: Drugs for B-cell non-Hodgkin's lymphoma
- Indication: Drugs for Chronic lymphocytic leukemia
- Indication: Drugs for Rheumatoid arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing