On August 25, 2017, Phase I Clinical Study of Cetuximab Injection, a major scientific and technological project in Foshan City from 2016 to 2017 undertaken by Foshan Anpuze Biomedical Co., Ltd., was officially approved by Foshan Science and Technology Bureau.

       Epitol is the first therapeutic monoclonal antibody targeting EGFR. It was originally developed by Imclone Company and approved by FDA in 2004 for the treatment of advanced colorectal cancer with EGFR positive and resistance to irinotecan. Cetuximab injection (APZ001) has been independently developed since 2010. Compared with the similar international monoclonal antibodies on the market, the samples produced by our company can achieve similar purity and biological activity. They are safe, effective, quality controllable and can replace the expensive imported original research drugs.

       This project is a phase I tolerance study in healthy people. The purpose of this study is to observe the tolerance and safety of APZ001 to human beings, and to investigate the pharmacokinetic characteristics and immunogenicity of APZ001 at different doses. At the same time, clinical data of cetuximab in healthy people were collected for the first time.

       This project has obtained the approval of the first clinical trial of monoclonal antibody in Foshan City. Therefore, under the background of strong national support for Biotechnology industry, huge domestic market demand for monoclonal antibody drugs and the increase of per capita disposable income, China's monoclonal antibody drug industry will repeat the track of rapid development of monoclonal antibody industry in Europe and the United States. Because the monoclonal antibody has been widely recognized by the society and the patent expiration of the foreign monoclonal antibody is coming soon, the development opportunities faced by Chinese monoclonal antibody manufacturers are even better than those faced by European and American enterprises at that time. It is expected that China's monoclonal antibody industry will usher in leapfrog development and become a biopharmaceutical industry. "Leading sheep".