Xie Junmin, financial director and Secretary of Hualan biology, said in a conference call on the morning of August 26 that the company had submitted the clinical application of Herceptin mAb to the State Administration of drug administration at the end of July this year, and the company would complete the clinical application of all four mAb drugs within this year
Xie Junmin said that at the end of July, the company submitted a clinical application for the breast cancer drug Herceptin mAb to the drug regulatory department
According to the existing drug audit procedures, it can be approved within two years if it is fast
In the next few months, the company will also successively report clinical applications for other three McAbs, striving to complete all the applications within the year
Hualan bio's monoclonal antibody project is considered to be one of the highlights of the company this year
Hualan gene, a joint-stock subsidiary of the company, has been promoting the research and development of four monoclonal antibody varieties, namely xiumeile, Herceptin, meiluohua and Avastin
At present, Herceptin monoclonal antibody of Hualan gene has not been accepted by the State Drug Administration.