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HLX04, a bevacizumab biosimilar
HLX04 is a monoclonal antibody that binds to and inhibits vascular endothelial growth factor (VEGF), blocking tumor angiogenesis and reducing blood supply to cancer cells.
HLX04 is a monoclonal antibody that binds to and inhibits vascular endothelial growth factor (VEGF), blocking tumor angiogenesis and reducing blood supply to cancer cells. Used for Metastatic colorectal cancer, Non-small cell lung cancer, Metastatic breast cancer.
At a glance
| Generic name | HLX04, a bevacizumab biosimilar |
|---|---|
| Sponsor | Shanghai Henlius Biotech |
| Drug class | Monoclonal antibody (VEGF inhibitor) |
| Target | VEGF (Vascular Endothelial Growth Factor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
As a bevacizumab biosimilar, HLX04 mimics the mechanism of the reference biologic by targeting circulating VEGF and preventing its interaction with VEGF receptors on endothelial cells. This inhibition suppresses new blood vessel formation in tumors, thereby limiting nutrient and oxygen delivery to cancer tissue and slowing tumor growth. The biosimilar is designed to have comparable efficacy and safety to the originator bevacizumab while potentially offering improved accessibility and cost-effectiveness.
Approved indications
- Metastatic colorectal cancer
- Non-small cell lung cancer
- Metastatic breast cancer
- Ovarian cancer
Common side effects
- Hypertension
- Proteinuria
- Bleeding/hemorrhage
- Thromboembolic events
- Gastrointestinal perforation
- Wound healing complications
- Fatigue
Key clinical trials
- Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (PHASE3)
- Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2, PHASE3)
- Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer (PHASE3)
- Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer (PHASE3)
- A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer (PHASE2)
- Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study (PHASE3)
- Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer (PHASE1)
- Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer (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:
- HLX04, a bevacizumab biosimilar CI brief — competitive landscape report
- HLX04, a bevacizumab biosimilar updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI