Report of the production of the first trastuzumab in China

On April 25, Fosun Pharmaceutical announced that its holding subsidiaries Shanghai Fuhong Hanlin Biotechnology Co., Ltd (hereinafter referred to as "Fuhong Hanlin") and Shanghai Fuhong Hanlin biopharmaceutical Co., Ltd (hereinafter referred to as "Hanlin pharmaceutical") had received the acceptance notice (reason No.: cxss1900021), and its developed trastuzumab for injection (biological similar drug, i.e note) The recombinant anti HER2 humanized monoclonal antibody for radiation was accepted by the drug registration review of the State Drug Administration Trastuzumab for injection is a monoclonal antibody bioequivalent drug independently developed by Fosun medicine, which is mainly used for indications of metastatic breast cancer and gastric cancer As of the date of this announcement, the indications of this product for the treatment of breast cancer are in phase III clinical trials in China (excluding Hong Kong, Macao and Taiwan, the same below), Ukraine, Poland, Philippines and other countries As of the date of this announcement, trastuzumab injection listed in China is Herceptin ® of Roche According to iqviachpa (provided by iqvia, which is the world's leading provider of professional information and strategic consulting services for the pharmaceutical and health industry), in 2018, Herceptin's sales in China was about 2.7 billion yuan As of March 2019, the group has invested about 546.34 million yuan (Unaudited) in research and development of the new drug (including indications for metastatic breast cancer and gastric cancer) The following is the original announcement: