Drug intelligence / Profile preview

HLX35

Development stage
Phase 1
Lead developer
Henlius
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

HLX35 is a first-in-class, innovative bispecific antibody that targets both epidermal growth factor receptor (EGFR) and 4-1BB (CD137), developed for the treatment of advanced or metastatic solid tumors. By binding to EGFR on tumor cells, HLX35 suppresses EGFR activation and downstream signaling pathways to directly inhibit tumor cell proliferation. Simultaneously, through conditional binding to 4-1BB on immune cells such as T cells and NK cells in the presence of EGFR-expressing tumor cells, it acts as a co-stimulatory agonist—enhancing cytotoxic T-cell activity and stimulating memory T cells, NK cells, and dendritic cells within the tumor microenvironment. This dual mechanism is designed to synergistically kill tumor cells by combining direct antitumor effects with immune-mediated cytotoxicity. Preclinical studies have shown superior antitumor efficacy compared to monotherapy or combination therapy with separate anti-EGFR or anti–4‑1BB monoclonal antibodies[3][5][7][9].

Other names
anti-EGFR and anti-4-1BB bispecific antibodyrecombinant humanised anti-EGFR and anti-4-1BB bispecific antibody injection
02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)TNFRSF9 (CD137 extracellular domain)

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