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항목
AntibodyCurated CoreFDAApproved
tislelizumab (Tevimbra, BGB-A317, tislelizumab-jsgr)
BeOne Medicines·PD-1
213 trials·t½ ~20 days class range
Overview
Program
Tevimbra (tislelizumab)
Overview
Company
BeOne Medicines
Overview
Modality
ANTIBODY
Overview
Target
PD-1
Overview
Indication
Esophageal squamous cell carcinoma, gastric/GEJ adenocarcinoma, and first-line HER2-positive GEA with zanidatamab and chemotherapy
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Not a Keytruda substitute. The 2026 GEA label is a HER2-selected triplet with zanidatamab, not a PD-L1-unselected 1L PD-1 row.
Positioning
Known limitation
Antigen-presentation loss, alternate checkpoints, immunosuppressive TME.
Positioning
Development positioning
BeOne PD-1 with a China-heavy development history; the US HER2+ GEA triplet is the catalog reason to keep it next to Ziihera, not next to Keytruda's pan-tumor row.
MoA
Mechanism
Binds PD-1 on T cells, blocking PD-L1/PD-L2 engagement and restoring antitumor T-cell activity. Fc silencing is intended to avoid macrophage-mediated T-cell clearance.
MoA
Biomarker
PD-L1 and tumor type on older labels; HER2 IHC/ISH when given with Ziihera.
PK/PD
Half-life
~20 days class range
PK/PD
Species
OS/PFS, radiographic response
PK/PD
Animal (cat.)
Human
Toxicology
Major finding
Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled.
Toxicology
CRS
N/A
Clinical
Safety signal
Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled.
Clinical
Selected reported efficacy
ORR 87.1%
Clinical
Reported ORR
87.1%
Clinical
Reported PFS
31.5
Clinical
Result source
ClinicalTrials.gov NCT03209973
Clinical
Program phase
APPROVED
Clinical
Trial ref
NCT03209973