Drug intelligence / Profile preview

nofazinlimab

Development stage
Phase 3
Lead developer
CStone Pharmaceuticals
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

Nofazinlimab is a humanized IgG4 monoclonal antibody that targets the programmed cell death protein 1 (PD-1) receptor, acting as an immune checkpoint inhibitor. By binding to PD-1, it blocks the interaction with its ligands PD-L1 and PD-L2, thereby enhancing T lymphocyte activity and promoting antitumor immune responses. Nofazinlimab is being developed primarily for the treatment of advanced hepatocellular carcinoma (HCC), often in combination with lenvatinib. It has demonstrated good safety and tolerability in early-phase studies, with preliminary evidence of antitumor activity across multiple solid tumor types. The drug has received Orphan Drug Designation from the U.S. FDA for HCC and is currently in Phase III clinical trials for this indication[1][2][3][4][5][6][7].

Other names
antibody cs1003recombinant pd-1 mab cs1003immunoglobulin g4 anti-(human programmed cell death protein 1) monoclonal cs1003
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)

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