HENLIUS (02696) announced that the Investigational New Drug (IND) application for its self-developed HLX48, an antibody-drug conjugate (ADC) targeting EGFR and c-MET for the treatment of advanced/metastatic solid tumors, has been approved by China's National Medical Products Administration (NMPA).
HLX48 is a bispecific ADC targeting both c-MET and EGFR, designed for the treatment of advanced or metastatic solid tumors. The antibody component of HLX48 binds to tumor cells expressing c-MET and EGFR, inducing receptor-mediated endocytosis. This process delivers cytotoxic payloads into the tumor cells, causing DNA damage and cell death. Additionally, HLX48 exhibits a bystander effect, where the released toxin can also kill adjacent tumor cells.
Furthermore, the variable region of the HLX48 antibody specifically targets tumor cells positive for c-MET/EGFR, blocking the binding of ligands such as Epidermal Growth Factor (EGF) and Hepatocyte Growth Factor (HGF) to their respective receptors. This action inhibits the activation of downstream signaling pathways. The antibody's Fc fragment also enables Antibody-Dependent Cellular Cytotoxicity (ADCC). Consequently, HLX48 is expected to deliver dual efficacy through targeted therapy and immune modulation, inhibiting tumor growth while maintaining a favorable safety profile.
Preclinical studies have demonstrated promising anti-tumor efficacy and a good safety profile for HLX48, indicating its potential for clinical benefit. In May 2024, the Phase 1 clinical trial for HLX48 in advanced/metastatic solid tumors received approval from a relevant Human Research Ethics Committee and was filed with Australia's Therapeutic Goods Administration (TGA).
As of the date of this announcement, no bispecific ADC targeting both EGFR and c-MET has been approved for marketing globally.
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