HENLIUS (02696): The phase I clinical trial of HLX48 (an antibody drug conjugate targeting EGFR and c-MET for the treatment of advanced/metastatic solid tumors) for injection has been approved to be conducted in Australia.

HENLIUS (02696) announced that recently, the Phase 1 clinical trial of HLX48 (an antibody-drug conjugate targeting EGFR and c-MET) developed by the company for the treatment of advanced/metastatic solid tumors has received approval from the relevant human research ethics committee and has been registered for clinical trials by the Therapeutic Goods Administration of Australia. HLX48 is a bispecific antibody-drug conjugate targeting c-MET and EGFR developed independently by the company, intended for the treatment of advanced/metastatic solid tumors. The antibody of HLX48 binds to tumor cells expressing c-MET/EGFR and induces receptor-mediated internalization into tumor cells, releasing toxic molecules causing DNA damage and cell death, and killing adjacent tumor cells through a bystander effect of the toxin. In addition, the variable region of the HLX48 antibody specifically binds to tumor cells expressing c-MET/EGFR, blocking the binding of the ligands epidermal growth factor (EGF)/hepatocyte growth factor (HGF) to their respective receptors, thereby inhibiting the activation of downstream signaling pathways and exerting antibody-mediated cell cytotoxicity through the Fc crystallizable fragment (ADCC). Therefore, HLX48 is expected to achieve dual enhancement of targeted therapy and immunomodulation, inhibiting tumor growth with good safety profile. Preclinical studies have shown that HLX48 has good anti-tumor efficacy and safety, and is expected to provide clinical benefits. As of the date of this announcement, there are no globally approved bispecific antibody-drug conjugates targeting EGFR and c-MET.