Last reviewed 2026-04-23 · How we verify

HLX13

HLX13 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.

HLX13 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses. Used for Non-small cell lung cancer, Gastric cancer, Other solid tumors (in development).

At a glance

Mechanism of action

HLX13 is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1) on tumor cells and immune cells. By blocking the PD-L1/PD-1 axis, it prevents the suppression of T-cell activity, allowing the immune system to recognize and attack cancer cells more effectively. This mechanism is similar to other checkpoint inhibitors in the immuno-oncology space.

Approved indications

• Non-small cell lung cancer
• Gastric cancer
• Other solid tumors (in development)

Common side effects

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

Key clinical trials

• Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma (PHASE1)
• A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma (PHASE3)
• A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects (PHASE1)

Primary sources

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