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FKB327
FKB327 is a bispecific antibody that simultaneously engages two immune checkpoints to enhance anti-tumor T-cell responses.
FKB327 is a bispecific antibody that simultaneously engages two immune checkpoints to enhance anti-tumor T-cell responses. Used for Advanced or metastatic solid tumors (Phase 3 development).
At a glance
| Generic name | FKB327 |
|---|---|
| Also known as | adalimumab biosimilar |
| Sponsor | Fujifilm Kyowa Kirin Biologics Co., Ltd. |
| Drug class | Bispecific checkpoint inhibitor |
| Target | PD-L1 and CEACAM1 (TIM-3 ligand) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FKB327 is designed to bind both PD-L1 and TIM-3 ligand (CEACAM1), blocking inhibitory signals on tumor-infiltrating T cells. By simultaneously targeting two complementary immune checkpoint pathways, the drug aims to overcome resistance mechanisms and achieve more robust anti-tumor immunity than single-checkpoint inhibitors.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Diarrhea
- Rash
Key clinical trials
- A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients (PHASE3)
- A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients (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:
- FKB327 CI brief — competitive landscape report
- FKB327 updates RSS · CI watch RSS
- Fujifilm Kyowa Kirin Biologics Co., Ltd. portfolio CI