Shanghai Henlius Biotech Inc. (HKG: 2696), a Chinese biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) HLX43, which is co-developed with Suzhou-based Medilink Therapeutics. The molecule is set to be evaluated in patients with advanced or metastatic solid tumors.
HLX43 is a novel ADC candidate that targets programmed death ligand 1 (PD-L1) and is the first of its kind to reach the clinical stage in China. The drug is conjugated with highly specific humanized IgG1 PD-L1 antibody molecules, cleavable novel linkers, and TOPO I small molecule inhibitors. HLX43 has demonstrated a bystander effect and has shown tumor killing efficacy in tumor models, including non-small cell lung cancer, colorectal cancer, triple negative breast cancer, and squamous cell cancer that is resistant to PD-1 monoclonal antibodies.- Flcube.com
