Henlius Biotech, Inc. announced that the company’s commercial partner, Accord BioPharma Inc. (the US specialty division of Intas Pharmaceuticals, Ltd.), has received the U.S. Food and Drug Administration (FDA) approval for HERCESSI (HLX02, trastuzumab-strf, Herceptin® biosimilar trade name: HANQUYOU in China and Zercepac® in Europe), a trastuzumab biosimilar developed and manufactured by Henlius . The product has been approved in the United States (US) 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. HER2. HLX02 is a monoclonal antibody (mAb) biosimilar developed in China and approved in China , the European Union (EU) and the US, with prior marketing approvals from the European Commission (EC) and the National Administration of Medical Products (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 US, 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 is reimbursed domestically in countries and regions including China , United Kingdom, France and Germany. To date, HLX02 has benefited more than 180,000 patients.
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 2 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S. and EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation center and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.
SOURCE: PRNewswire