Another car-t cell product of Keji biology was accepted by CDE

Source: on the afternoon of April 24, 2017, Sina pharmaceutical showed that another car-t cell product had been accepted by the clinic Clinical application acceptance No.: cxsl1800047, drug name: ct032 humanized anti-CD19 auto car T cell injection, submitted by Shanghai Keji Pharmaceutical Co., Ltd Keji biology was founded in Shanghai in 2014, which is an innovative enterprise focusing on car-t immunotherapy in China At present, the car-t cell products under research of the company are shown in the following figure: it is worth noting that Keji biology has submitted a car-t clinical application as early as the end of last year (December 2017), which has been accepted by CDE On the morning of March 30, 2018, the drug review information of the drug review center of the State Food and drug administration showed that the clinical application of car-t cell for solid tumor treatment (acceptance No cxsl1700203 Shanghai) declared by Keji biology, the technical review of pharmacology, toxicology, clinic and pharmacy had been extinguished, and the clinical approval document could be obtained soon in theory The drug name of this study is "target phosphatidylinositol polysaccharide-3 chimeric antigen receptor modified autogenous T cell", which is the first car-gpc3t cell preparation declared by Keji biology, and it is planned to be included in the public list of drug registration application for priority review procedure in the 26th batch The passing of this technical review marks that China's progress in cell therapy of solid tumors is ahead In addition, in May last year, Keji biology launched the world's first claudin 18.2 clinical study for the treatment of gastric cancer and pancreatic cancer In the field of blood tumor, the company has carried out the clinical research of humanized CD19 car-t in the treatment of leukemia and lymphoma, and the clinical research of BMCA car-t in the treatment of multiple myeloma In response, Dr Li Zonghai, founder and CEO of Keji biology, said: "2018 will be a key year for the accelerated development of Keji biology This year, we will launch a number of car-t new drug applications in China and the United States "