Last reviewed 2026-04-22 · How we verify

BCD-057

BCD-057 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.

BCD-057 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, Other solid tumors (under investigation).

At a glance

Mechanism of action

BCD-057 is a fully human monoclonal antibody designed to target programmed death ligand 1 (PD-L1) on tumor cells and immune cells. By blocking the PD-L1/PD-1 axis, the drug prevents tumor cells from suppressing T-cell activity, thereby reinvigorating the immune system's ability to recognize and eliminate cancer cells. This mechanism is similar to other checkpoint inhibitors in the immuno-oncology space.

Approved indications

• Non-small cell lung cancer
• Other solid tumors (under investigation)

Common side effects

• Fatigue
• Infusion-related reactions
• Immune-related adverse events (pneumonitis, hepatitis, colitis)

Key clinical trials

• A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects (PHASE1)
• Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers (PHASE1)
• Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis (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:

• BCD-057 CI brief — competitive landscape report
• BCD-057 updates RSS · CI watch RSS
• Biocad portfolio CI