Hong Kong-listed Shanghai Henlius Biotech Inc announced on Friday that the company’s business partner, Accord BioPharma Inc, has received approval from the United States Food and Drug Administration for HERCESSI™, a trastuzumab biosimilar self-developed and manufactured by the Shanghai biopharmaceutical company.
The approval made the therapy the first China-developed monoclonal antibody biosimilar that has obtained approvals in China, the European Union and the US, with previous approvals for commercialization in Europe and China in July 2020 and August 2020, respectively.
The company said that the product was approved in the US 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.
The therapy has been approved in a total of more than 40 countries and regions, including the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia and Thailand. It has benefited more than 180,000 patients worldwide.
Company executives said that Henlius has established a quality management system in accordance with the highest quality standards. The company has three manufacturing facilities in Shanghai’s Xuhui and Songjiang districts. The current total commercial production capacity has reached 48,000 liters and is able to maintain stable supply for China, Southeast Asia, Europe and Latin America.
The company also said that by focusing on the therapy newly approved in the US, it has carried out a forward-looking international commercialization layout and worked with global business partners, such as Accord, to fully deploy the markets of the US, Canada and Europe as well as many emerging markets, covering about 100 countries and regions around the world.