Last reviewed 2026-04-22 · How we verify

HLX14

HLX14 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and B7.1 to enhance anti-tumor immune responses.

HLX14 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and B7.1 to enhance anti-tumor immune responses. Used for Non-small cell lung cancer, Gastric cancer, Esophageal cancer.

At a glance

Mechanism of action

HLX14 targets programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing the suppressive signal that tumors use to evade the immune system. By blocking PD-L1, the drug restores T-cell activation and proliferation, allowing the body's immune system to recognize and attack cancer cells more effectively. This mechanism is similar to other checkpoint inhibitors in the PD-L1/PD-1 pathway.

Approved indications

• Non-small cell lung cancer
• Gastric cancer
• Esophageal cancer

Common side effects

• Fatigue
• Decreased appetite
• Nausea
• Immune-related adverse events (pneumonitis, hepatitis, colitis)

Key clinical trials

• Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects (PHASE1)
• A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture (PHASE3)

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:

• HLX14 CI brief — competitive landscape report
• HLX14 updates RSS · CI watch RSS
• Shanghai Henlius Biotech portfolio CI