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2022-04-24

Juncell Therapeutics is granted implied IND approval by NMPA for its first TIL therapy

On April 24,2022, as the first TIL therapy independently developed by Juncell Therapeutics, GC101 TIL, the autologous natural TIL injection (Acceptance no.: CXSL2200070) was officially granted implied IND approval by National Medical Products Administration (NMPA). This is the first natural TIL therapy requiring no lymphodepletion and no IL-2 injection worldwide, which has been clinically validated for its efficacy and safety. GC101 TIL can greatly improve the safety and accessibility of TIL therapy.

GC101 demonstrated good safety and efficacy in the IIT study. 2 patients achieved complete response (CR) and 3 patients achieved partial response (PR). The duration of CR has exceeded 8 and 6 months, respectively. The representative clinical results were published in Journal for Immunotherapy of Cancer.