Last reviewed 2026-04-23 · How we verify

HLX04-O

HLX04-O 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-O 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

Mechanism of action

HLX04-O is a bevacizumab biosimilar candidate developed by Shanghai Henlius Biotech. It targets VEGF, a key signaling molecule that promotes the formation of new blood vessels that tumors depend on for growth and metastasis. By neutralizing VEGF, the drug inhibits angiogenesis, starving tumors of oxygen and nutrients while also normalizing the tumor vasculature to improve drug delivery.

Approved indications

• Metastatic colorectal cancer
• Non-small cell lung cancer
• Metastatic breast cancer

Common side effects

• Hypertension
• Proteinuria
• Bleeding
• Thromboembolic events
• Gastrointestinal perforation

Key clinical trials

• Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD (PHASE3)
• A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD (PHASE3)
• Evaluate the Safety and Efficacy of HLX04-O in Subjects With wAMD (PHASE1, PHASE2)

Primary sources

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

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• HLX04-O CI brief — competitive landscape report
• HLX04-O updates RSS · CI watch RSS
• Shanghai Henlius Biotech portfolio CI