BCD-100

Biocad · Phase 3 active Biologic

BCD-100 is a PD-L1 inhibitor Biologic drug developed by Biocad. It is currently in Phase 3 development for Non-small cell lung cancer, Other solid tumors (under investigation). Also known as: prolgolimab, Forteca.

BCD-100 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.

BCD-100 is a small molecule anti-PD-1 treatment. It has been studied as a first-line treatment in patients with unresectable or metastatic melanoma, as well as in patients with lung cancer, renal cell carcinoma, and non-squamous non-small cell lung cancer.

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-100
Also known as	prolgolimab, Forteca
Sponsor	Biocad
Drug class	PD-L1 inhibitor
Target	PD-L1
Modality	Biologic
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

BCD-100 targets programmed death ligand 1 (PD-L1) expressed on tumor cells and immune cells, preventing the suppression of T-cell mediated immunity. By blocking the PD-L1/PD-1 axis, the drug releases the brakes on the immune system, allowing T cells 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
• Other solid tumors (under investigation)

Common side effects

• Fatigue
• Immune-related pneumonitis
• Diarrhea
• Rash
• Immune-related hepatitis

Key clinical trials

• A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma (PHASE3)
• Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma (PHASE2)
• Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS) (PHASE2, PHASE3)
• International Trial of the Efficacy and Safety of BCD-100 in Patients With Melanoma (PHASE2)
• Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA) (PHASE3)
• Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy as First Line Treatment in Patients With Advanced Non-Squamous NSCLC (PHASE3)
• Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer (CAESURA) (PHASE2)
• A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of BCD-100 in Patients With Advanced Solid Tumors (PHASE1)

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-100 CI brief — competitive landscape report
• BCD-100 updates RSS · CI watch RSS
• Biocad portfolio CI

Frequently asked questions about BCD-100

What is BCD-100?

BCD-100 is a PD-L1 inhibitor drug developed by Biocad, indicated for Non-small cell lung cancer, Other solid tumors (under investigation).

How does BCD-100 work?

BCD-100 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.

What is BCD-100 used for?

BCD-100 is indicated for Non-small cell lung cancer, Other solid tumors (under investigation).

Who makes BCD-100?

BCD-100 is developed by Biocad (see full Biocad pipeline at /company/biocad).

Is BCD-100 also known as anything else?

BCD-100 is also known as prolgolimab, Forteca.

What drug class is BCD-100 in?

BCD-100 belongs to the PD-L1 inhibitor class. See all PD-L1 inhibitor drugs at /class/pd-l1-inhibitor.

What development phase is BCD-100 in?

BCD-100 is in Phase 3.

What are the side effects of BCD-100?

Common side effects of BCD-100 include Fatigue, Immune-related pneumonitis, Diarrhea, Rash, Immune-related hepatitis.

What does BCD-100 target?

BCD-100 targets PD-L1 and is a PD-L1 inhibitor.

Related

• 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)
• Also known as: prolgolimab, Forteca