Henlius Biopharmaceuticals has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for its HER2 bispecific antibody drug conjugate (ADC), JSKN003. This designation is for the treatment of gastric cancer and gastroesophageal junction cancer, paving the way for accelerated development, registration, and commercialization of the drug in the United States.
