Drug intelligence / Profile preview

HLX35 + HLX10

Development stage
Unknown
Lead developer
Henlius
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

HLX35 + HLX10 is a combination of two investigational monoclonal antibody-based immunotherapies developed by Shanghai Henlius Biotech for the treatment of advanced or metastatic solid tumors. **HLX35** is a recombinant humanized bispecific antibody targeting both **epidermal growth factor receptor (EGFR)** and **4-1BB (CD137)**, aiming to both block EGFR-mediated cell growth and activate immune effector cells via 4-1BB agonism. **HLX10** is a humanized IgG4 monoclonal antibody that targets **programmed cell death protein 1 (PD-1)**, blocking its interaction with PD-L1 and PD-L2, thereby enhancing T-cell mediated immune responses against tumor cells. The combination is designed to leverage synergistic immunomodulatory and anti-tumor activities through dual checkpoint inhibition and immune cell co-stimulation. Both HLX35 and HLX10 are administered intravenously and are currently under investigation in early-phase clinical trials for solid tumors[3][5][8].

Other names
recombinant humanized anti-EGFR and anti-4-1BB bispecific antibody injection + recombinant humanized anti-PD-1 monoclonal antibody injection
02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)PDCD1 (Programmed cell death protein 1 receptor)TNFRSF9 (CD137 extracellular domain)

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