Hualan Genetic Recombinant Anti-CTLA-4 Human Monoclonal Antibody Injection (Ipilimumab) Starting Clinical Trial
On October 10, 2018, Hualan Genetic Engineering Co., Ltd. received the clinical approval document of "Recombinant Anti-CTLA-4 Human Monoclonal Antibody Injection" issued by the State Drug Administration, with the approval number of 2018L03080. According to the drug registration procedure, Hualan Genetic Engineering Co., Ltd will organize and implement clinical trials as soon as possible in accordance with the requirements of the national drug clinical trials after obtaining the approval documents for the above drug clinical trials, and will apply the product production approval documents and GMP certificate after completing the clinical trials.
With the registered capital of RMB 100 million Yuan, Hualan Genetic Engineering Co., Ltd. was established in June 2013. In May 2014, the company obtained Pharmaceutical Production License and devoted to the R&D and manufacturing of monoclonal antibodies, recombinant human coagulation factor, hormone drugs as well as novel vaccines.
TAG:  Ipilimumab, Hualan Bio, Monoclonal Antibody, Clinical Trial Permission