Henlius Biotech, Inc. announced that the Company's commercial partner, Accord BioPharma Inc., has received approval from the United States Food and Drug Administration for HERCESSI™ (HLX02, trastuzumab-strf, biosimilar of Herceptin ® trade name: HANQUYOU in China and Zercepac ® in Europe ), a trastuzumab biosimilar developed and manufactured by Henlius. The product was approved in the United States for the 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 adenocarcinoma. HLX02 is a biosimilar monoclonal antibody developed by China and approved in China, the European Union (EU) and the United States. The European Commission (EC) and the National Medical Products Administration (NMPA) have already approved its marketing in July 2020 and August 2020, respectively.

Since its approval in the EU and China in July and August 2020, HLX02 (trade name: HANQUYOU in China, HERCESSI™ in the United States, Zercepac ®  in Europe ) has been successfully approved in more than 40 countries and regions, including UK, France , Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia and Thailand, covering Asia, Europe , Latin America, North America and Oceania, and it is reimbursed nationally in several countries and regions, including China, the United Kingdom (UK), France and Germany. To date, HLX02 has benefited more than 180,000 patients.

Source: prnewswire.com