Henlius Trastuzumab Receives FDA Approval in the United States

Class in: Science and technology, Sant
Subject : FDA (Food and Drug Administration) approval

SHANGHAI, May 6, 2024 /PRNewswire/ — Henlius Biotech, Inc. (2696.HK) announced that the Company’s commercial partner, Accord BioPharma Inc. (the US specialty division of Intas Pharmaceuticals, Ltd.), has received approval for US Food and Drug Administration (FDA) for HERCESSItm (HLX02, trastuzumab-strf, Herceptin biosimilar trade name: HANQUYOU in China and Zercepac in Europe), a biosimilar of trastuzumab 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 adnocarcinoma. 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) already approved its marketing in July 2020 and in August 2020, respectively.

Since its approval in the EU and China in July and August 2020, HLX02 (trade name: HANQUYOU in China, HERCESSItm in the United States, Zercepacin Europe) has been successfully approved in more than 40 countries and regions, including the United Kingdom, FranceGermany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia and Thailand, covering Asia,EuropeLatin 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.

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