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항목
ADCCurated CorestaleApproved
disitamab vedotin (Disitamab Vedotin, RC48)
RemeGen·HER2
159 trials
Overview
Program
Disitamab Vedotin (RC48)
Overview
Company
RemeGen
Overview
Modality
ADC
Overview
Target
HER2
Overview
Indication
HER2+ urothelial, gastric, breast
Overview
Phase
APPROVED
Overview
Status
ACTIVE
Overview
Content status
Curated Core
Overview
Data Confidence
Editorial scope · Curated Core
Overview
Development Signal
Development Signal · Established
Overview
Approval status
Approved (flag incomplete)
Positioning
Key differentiator
Novel anti-HER2 mAb with distinct epitope
Positioning
Known limitation
resistance mechanisms, optimize payload delivery, and minimize off-target toxicity
Positioning
Development positioning
2L+
Technology
Payload
MMAE
Technology
Linker
Cleavable
MoA
Mechanism
Disitamab vedotin binds a distinct HER2 epitope (different from trastuzumab), internalizes, and releases MMAE via cleavable linker, causing microtubule disruption and apoptosis.
MoA
Biomarker
HER2 expression (IHC); activity in HER2+ urothelial and gastric cancers.
Toxicology
Species
Cynomolgus monkey
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets.
Toxicology
CRS
N/A
Clinical
Safety signal
Hematologic toxicity and peripheral neuropathy class effects of MMAE; ILD reported at lower frequency than DXd ADCs in published datasets.
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts