Shanghai Henlius Biotech's (HKG:2696) investigational new drug application for the phase I clinical trial of HLX17 was approved by the United States Food and Drug Administration (FDA), a Monday Hong Kong bourse filing said.
The international multi-center clinical trial will be conducted in patients with multiple resected solid tumours.
The potential indications of HLX17, which is a biosimilar of pembrolizumab, include melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell cancer, and various other cancers.