Last reviewed 2026-05-31 · How we verify

BCD-085 Q4W

Biocad · Phase 3 active Small molecule Under review

BCD-085 Q4W is a PD-L1 inhibitor Small molecule drug developed by Biocad. It is currently in Phase 3 development for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3). Also known as: BCD-085.

BCD-085 is a monoclonal antibody that blocks the PD-L1 checkpoint, enabling the immune system to recognize and attack cancer cells.

BCD-085 Q4W is a treatment being studied in a clinical trial for moderate to severe plaque psoriasis. The study is a randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of two dosing regimens of BCD-085, including Q4W, to a placebo.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	BCD-085 Q4W
Also known as	BCD-085
Sponsor	Biocad
Drug class	PD-L1 inhibitor
Target	PD-L1
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

BCD-085 binds to programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing interaction with PD-1 receptors on T cells. This blockade restores anti-tumor immune responses by releasing the 'brakes' on T cell activation and proliferation. The drug is designed as a quarterly (Q4W) dosing regimen for improved patient convenience.

Approved indications

Non-small cell lung cancer
Other solid tumors (under investigation in Phase 3)

Common side effects

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

Key clinical trials

An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) 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.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

BCD-085 Q4W CI brief — competitive landscape report
BCD-085 Q4W updates RSS · CI watch RSS
Biocad portfolio CI

Frequently asked questions about BCD-085 Q4W

What is BCD-085 Q4W?

BCD-085 Q4W is a PD-L1 inhibitor drug developed by Biocad, indicated for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).

How does BCD-085 Q4W work?

BCD-085 is a monoclonal antibody that blocks the PD-L1 checkpoint, enabling the immune system to recognize and attack cancer cells.

What is BCD-085 Q4W used for?

BCD-085 Q4W is indicated for Non-small cell lung cancer, Other solid tumors (under investigation in Phase 3).

Who makes BCD-085 Q4W?

BCD-085 Q4W is developed by Biocad (see full Biocad pipeline at /company/biocad).

Is BCD-085 Q4W also known as anything else?

BCD-085 Q4W is also known as BCD-085.

What drug class is BCD-085 Q4W in?

BCD-085 Q4W belongs to the PD-L1 inhibitor class. See all PD-L1 inhibitor drugs at /class/pd-l1-inhibitor.

What development phase is BCD-085 Q4W in?

BCD-085 Q4W is in Phase 3.

What are the side effects of BCD-085 Q4W?

Common side effects of BCD-085 Q4W include Fatigue, Infusion-related reactions, Immune-related adverse events (pneumonitis, hepatitis, colitis), Decreased hemoglobin.

What does BCD-085 Q4W target?

BCD-085 Q4W targets PD-L1 and is a PD-L1 inhibitor.

Drug class: All PD-L1 inhibitor drugs
Target: All drugs targeting PD-L1
Manufacturer: Biocad — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer
Indication: Drugs for Other solid tumors (under investigation in Phase 3)
Also known as: BCD-085

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing