Henlius Trastuzumab Receives FDA Approval in the United States

Henlius Trastuzumab Receives FDA Approval in the United States (Di lunedì 29 aprile 2024) SHANGHAI, April 29, 2024 /PRNewswire/

Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received Approval from the United States Food and Drug Administration (FDA) for HERCESSI™ (HLX02, Trastuzumab-strf, biosimilar to Herceptin® trade name: HANQUYOU in China and Zercepac® in Europe), a Trastuzumab biosimilar self-developed and -manufactured by Henlius. The product has been approved in the United States (U.S.) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction ...Leggi tutta la notizia su liberoquotidiano