Last reviewed · How we verify
Bendamustine or gemcitabine
Bendamustine or gemcitabine is a Chemotherapy combination (alkylating agent + nucleoside analog) Small molecule drug developed by Shanghai Junshi Bioscience Co., Ltd.. It is currently in Phase 3 development for Hematologic malignancies (lymphoma, leukemia), Solid tumors (under investigation in phase 3).
This is a combination of two chemotherapy agents: bendamustine, which alkylates DNA and disrupts cell division, and gemcitabine, which inhibits ribonucleotide reductase and gets incorporated into DNA to cause chain termination.
This is a combination of two chemotherapy agents: bendamustine, which alkylates DNA and disrupts cell division, and gemcitabine, which inhibits ribonucleotide reductase and gets incorporated into DNA to cause chain termination. Used for Hematologic malignancies (lymphoma, leukemia), Solid tumors (under investigation in phase 3).
-
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 | Bendamustine or gemcitabine |
|---|---|
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. |
| Drug class | Chemotherapy combination (alkylating agent + nucleoside analog) |
| Target | DNA (bendamustine: alkylating agent; gemcitabine: ribonucleotide reductase inhibitor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Bendamustine is a nitrogen mustard derivative that cross-links DNA strands, preventing replication and transcription. Gemcitabine is a deoxycytidine analog that inhibits DNA synthesis by blocking ribonucleotide reductase and incorporating into the growing DNA chain, causing premature termination. Together, they provide complementary cytotoxic mechanisms targeting rapidly dividing cancer cells.
Approved indications
- Hematologic malignancies (lymphoma, leukemia)
- Solid tumors (under investigation in phase 3)
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Anemia
- Nausea and vomiting
- Fatigue
- Infection
- Hepatotoxicity
Key clinical trials
- A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) (PHASE2, PHASE3)
- Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (PHASE1, PHASE2)
- A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype (PHASE3)
- Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients (PHASE1, PHASE2)
- A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) (PHASE2)
- Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL) (PHASE1, PHASE2)
- DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12) (PHASE1, PHASE2)
- Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical 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:
- Bendamustine or gemcitabine CI brief — competitive landscape report
- Bendamustine or gemcitabine updates RSS · CI watch RSS
- Shanghai Junshi Bioscience Co., Ltd. portfolio CI
Frequently asked questions about Bendamustine or gemcitabine
What is Bendamustine or gemcitabine?
How does Bendamustine or gemcitabine work?
What is Bendamustine or gemcitabine used for?
Who makes Bendamustine or gemcitabine?
What drug class is Bendamustine or gemcitabine in?
What development phase is Bendamustine or gemcitabine in?
What are the side effects of Bendamustine or gemcitabine?
What does Bendamustine or gemcitabine target?
Related
- Drug class: All Chemotherapy combination (alkylating agent + nucleoside analog) drugs
- Target: All drugs targeting DNA (bendamustine: alkylating agent; gemcitabine: ribonucleotide reductase inhibitor)
- Manufacturer: Shanghai Junshi Bioscience Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hematologic malignancies (lymphoma, leukemia)
- Indication: Drugs for Solid tumors (under investigation in phase 3)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing