Henlius Trastuzumab Receives FDA Approval in the United States.

Henlius Biotech, Inc. has announced that its business partner, Accord BioPharma Inc., has received approval from the United States Food and Drug Administration (FDA) for HERCESSI (HLX02), a trastuzumab biosimilar developed and manufactured by Henlius. The product has been approved in the United States for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. HLX02 has also been approved in more than 40 countries and regions, including China, the European Union, and the United Kingdom, and has benefited over 180,000 patients. [Extracted from the article]