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Zuberitamab
Zuberitamab is a Small molecule drug developed by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. It is currently in Phase 2 development. Also known as: Zebutumab, Induction phase, Maintenance phase.
Zuberitamab is a monoclonal antibody that targets the B-lymphocyte antigen CD20. It is being studied in clinical trials for the treatment of conditions such as Marginal Zone Lymphoma (MZL) and Primary Membranous Nephropathy.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Zuberitamab |
|---|---|
| Also known as | Zebutumab, Induction phase, Maintenance phase |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Treatment of BTKi+Hi-CVP Regimen for Previously Untreated MZL (PHASE2)
- ZSDT for the Treatment of R/R Mantle Cell Lymphoma After BTK Inhibitor Failure: a Multi-center Prospective Clinical Trial (PHASE4)
- Zuberitamab for EBV Infection Post-Allo-HSCT (PHASE2)
- Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma (NA)
- A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy (PHASE2)
- Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma (PHASE2)
- BR Combined With OR in Treatment-naïve Marginal Zone Lymphoma (PHASE2)
- Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL (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:
- Zuberitamab CI brief — competitive landscape report
- Zuberitamab updates RSS · CI watch RSS
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences portfolio CI
Frequently asked questions about Zuberitamab
What is Zuberitamab?
Who makes Zuberitamab?
Is Zuberitamab also known as anything else?
What development phase is Zuberitamab in?
Related
- Manufacturer: Cancer Institute and Hospital, Chinese Academy of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Zebutumab, Induction phase, Maintenance phase
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing