Last reviewed 2026-04-22 · How we verify

BCD-201

BCD-201 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.

BCD-201 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-201 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 patient's immune system 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

• Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (PHASE1)
• Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial (PHASE2)
• BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia (PHASE2)
• Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (PHASE2)
• Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma (PHASE1, PHASE2)
• A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma (PHASE2)
• Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer (PHASE3)
• Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (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:

• BCD-201 CI brief — competitive landscape report
• BCD-201 updates RSS · CI watch RSS
• Biocad portfolio CI