On January 31, the two clinical trial applications for “Autologous Gene-Edited T-Cell Injection Targeting CD19 with Knockdown of Interleukin-6 Secretion Function” developed by Shanghai Unicar-Therapy Biomed-Pharmaceutical Technology Co., Ltd. were accepted by the CFDA (Acceptance Numbers: CXSL1800005 and CXSL1800006).It is reported that the indications for the two clinical trial applications submitted this time are CD19-positive central nervous system leukemia (CNSL) and CD19-positive acute B-lymphoblastic leukemia, respectively.To date, seven domestic companies have had their CAR-T cell therapy applications for clinical trials accepted. Among them, Nanjing Legend’s CAR-T cell therapy targets BCMA; CozyBio’s target is glypican-3 (GPC-3); while Galaxy Biopharma, Shanghai Hengrundaisheng, BoSheng JiAnKe, Mingju Bio, and Unicar-Therapy all target the CD19 molecule.
▲Compiled by WuXi AppTec based on publicly available information from the CFDA