Last reviewed 2026-04-22 · How we verify

BCD-089

BCD-089 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.

BCD-089 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-089 is a fully human monoclonal antibody targeting programmed death ligand 1 (PD-L1). By blocking PD-L1, the drug prevents the suppression of T-cell mediated immunity that tumors exploit, thereby reinvigorating the body's immune system to recognize and attack 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

• Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis (PHASE3)
• A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19 (PHASE3)
• The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis (PHASE2)
• First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects (PHASE1)

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-089 CI brief — competitive landscape report
• BCD-089 updates RSS · CI watch RSS
• Biocad portfolio CI