Henlius (02696.HK): HLX48 (EGFR/c-MET Dual-target ADC) Secures Australian Approval for Phase I Clinical Trial

NewTimeSpace News: Shanghai Henlius Biotech, Inc. (02696.HK) released a voluntary announcement on May 13, 2026. The Phase I clinical trial of its in-house developed HLX48, an EGFR/c-MET targeted antibody-drug conjugate, has been approved to proceed in Australia, intended for the treatment of advanced and metastatic solid tumors.

Mechanism of action: The antibody binds to tumor cells positive for c-MET/EGFR expression and induces receptor-mediated internalization into tumor cells, releasing toxin molecules to cause DNA damage and cell death, while eliminating adjacent tumor cells via the bystander killing effect of the toxin. In addition, the variable region of the antibody specifically binds to c-MET/EGFR-positive tumor cells, blocks the binding of ligands EGF/HGF to their respective receptors, thereby inhibiting the activation of downstream signaling pathways, and exerts antibody-dependent cell-mediated cytotoxicity (ADCC) through the Fc fragment. HLX48 is expected to deliver dual synergistic effects of targeted therapy and immune regulation.

Preclinical studies have demonstrated favorable anti-tumor efficacy and safety of HLX48. As of the date of this announcement, no bispecific antibody-drug conjugate targeting EGFR and c-MET has been approved worldwide.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.