Wuxi ORIGENE Biotechnology Co., Ltd. was established in Mashan in 2011, and strives to establish the world's largest monoclonal antibody preparation center in Mashan Life Science Park. The company's mission is to continuously complement and improve the relevant product lines of genomics and proteomics research, and to guide the rapid development of large-scale research in the field of human genes and protein antibodies.
At the same time, the company was granted the “Medical Device Manufacturing Enterprise License” issued by the Food and Drug Administration on September 30, 2014. At present, four diagnostic products that have obtained clinical approvals are sold to the hospital through Zhongshan Golden Bridge for auxiliary diagnosis;
The first batch of pathology products are applying to the CFDA for three types of product registrations, including Her2, Ki67, ALK and HPV;
The second batch of pathological products are ready to apply to CFDA for three types of product registration, including p53, p63, ERCC1, PR, CD2, CD5, Beta-catenin, CD4, EGFR, NCAM1, VEGFA, etc.