Beijing’s first CAR-T product production license approved
The Daxing Biological Pharmaceutical Industry Base of Beijing, focusing on the cell and gene sectors, has introduced more than 10 key projects to advance an innovative ecosystem throughout the industrial chain this year.
The plasmid area of GMP production in the Beijing Imunopharm Technology Co [Photo provided by Daxing district]
Recently, Beijing Imunopharm Technology Co has passed the comprehensive review of Beijing Municipal Medical Products Administration. Its over 5,000㎡GMP production base located in the industrial base got a production license for CAR-T cell treatment product. This is Beijing's first of its kind.
IM19 CAR-T cell injection, the first medicine for curing malignant tumors developed by Imunopharm, is mainly used for treating non-Hodgkin's lymphoma (NHL), acute b-lymphoblastic leukemia and lymphoma mantle cell, which has gained three clinical implied licenses from the National Medical Products Administration. The studies of the product for the three adaptation diseases have all entered the registered clinical stage.
The lentivirus area of GMP production in the Beijing Imunopharm Technology Co [Photo provided by Daxing district]
Imunopharm is devoted to developing innovative gene and cell therapies for curing malignant tumors. The company has become one of few enterprises owning the core technologies of full-line gene cell medicine.
In addition, Imunopharm has independently developed the gene-cell medicine technology platform, including CAR-T medicine screening system, large-scale plasmid preparation, and large-scale lentiviral vector preparation.