On January 7, 2021, the anti-human CD19-CD22 T cell injection of Hrain Biotechnology Co., Ltd. (acceptance number CXSL2000289), as the first dual-target CAR-T registration clinical application in China, obtained an implied license. The product will be used to treat relapsed/refractory B-cell acute lymphoblastic leukemia.
"Anti-human CD19-CD22 T cell injection" is a genetically engineered autologous CAR-T cell product targeting CD19-CD22. Its mechanism of action is that it is genetically engineered ex vivo by a viral vector to make T cells carry CD19 and CD22 binary CAR element. This genetically modified T cell can specifically recognize CD19 and/or CD22 molecules on the surface of B cells, making the product expected to more thoroughly remove tumor foci in the body and effectively reduce the probability of relapse after the CAR-T treatment.
The application of this product was accepted by the CDE on October 16, 2020, and after being undertaken on October 20, it only took two months to obtain the implied license for clinical trials. So far, Hrain has obtained four clinical approvals, leading the way in the domestic cell therapy industry. Three of the approved clinical trials are simultaneously carried out in well-known Grade-A tertiary hospitals in China, and Hrain is one of the companies that have initiated the most CAR-T registered clinical trials in China.