Henlius Trastuzumab Receives FDA Approval in the United States

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 adenocarcinoma. HLX02 is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and U.S., with previous approvals for commercialisation by the European Commission (EC) and National Medical Products Administration (NMPA) 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 U.S., Zercepac® in Europe) has been successfully approved in more than 40 countries and regions, including the United Kingdom, 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 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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