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Rituximab plus CHOP

Sinocelltech Ltd. · Phase 3 active Small molecule Under review Quality 0/100

Rituximab plus CHOP is a Monoclonal antibody and chemotherapy regimen Small molecule drug developed by Sinocelltech Ltd.. It is currently in Phase 3 development for Non-Hodgkin's lymphoma, Chronic lymphocytic leukemia.

Rituximab targets CD20 on B cells, while CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) is a chemotherapy regimen.

Rituximab is an antibody that binds to the B-lymphocyte antigen CD20. It is used in combination with CHOP (a chemotherapy regimen) for the treatment of conditions such as Diffuse Large B Cell Lymphoma, Non-Hodgkin's Lymphoma, and Primary Extranodal Lymphoma.

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameRituximab plus CHOP
SponsorSinocelltech Ltd.
Drug classMonoclonal antibody and chemotherapy regimen
TargetCD20
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

Rituximab is a monoclonal antibody that binds to CD20 on B cells, leading to their depletion. CHOP is a combination chemotherapy regimen that targets rapidly dividing cells, including cancer cells.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Rituximab plus CHOP

What is Rituximab plus CHOP?

Rituximab plus CHOP is a Monoclonal antibody and chemotherapy regimen drug developed by Sinocelltech Ltd., indicated for Non-Hodgkin's lymphoma, Chronic lymphocytic leukemia.

How does Rituximab plus CHOP work?

Rituximab targets CD20 on B cells, while CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) is a chemotherapy regimen.

What is Rituximab plus CHOP used for?

Rituximab plus CHOP is indicated for Non-Hodgkin's lymphoma, Chronic lymphocytic leukemia.

Who makes Rituximab plus CHOP?

Rituximab plus CHOP is developed by Sinocelltech Ltd. (see full Sinocelltech Ltd. pipeline at /company/sinocelltech-ltd).

What drug class is Rituximab plus CHOP in?

Rituximab plus CHOP belongs to the Monoclonal antibody and chemotherapy regimen class. See all Monoclonal antibody and chemotherapy regimen drugs at /class/monoclonal-antibody-and-chemotherapy-regimen.

What development phase is Rituximab plus CHOP in?

Rituximab plus CHOP is in Phase 3.

What are the side effects of Rituximab plus CHOP?

Common side effects of Rituximab plus CHOP include Neutropenia, Thrombocytopenia, Anemia, Infection, Fatigue.

What does Rituximab plus CHOP target?

Rituximab plus CHOP targets CD20 and is a Monoclonal antibody and chemotherapy regimen.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing