Date: 09-Oct-2019

I-Mab novel antibody gets IND approval in China

I-Mab Biopharma, a China and U.S.-based clinical stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases, has announced that its IND application for TJD5, a novel CD73 antibody has been approved by the National Medical Products Administration(NMPA) to initiate clinical trials in patients with advanced solid tumours in China. TJD5 is a proprietary, differentiated blocking antibody against CD73, a surface enzyme on stromal cells and cancer cells responsible for the production of adenosine, which is highly immunosuppressive. TJD5 is currently being investigated in a Phase 1 clinical trial in the U.S. to assess the tolerability and preliminary efficacy both as a single agent and in combination with TECENTRIQ® (atezolizumab), a PD-L1 antibody marketed by Roche in the U.S., and Tuoyi (toripalimab), a PD-1 antibody marketed by Junshi Biosciences in China, in patients with varying types of tumours. "We are currently conducting clinical trials with five of our novel drug candidates in China and are very pleased with the recent submission and acceptance of TJD5 by NMPA", said Jingwu Zang, MD., PhD., Founder and Chairman of I-Mab Biopharma. TJD5 is a highly differentiated and innovative potential cancer drug being developed by I-Mab and we are excited about reaching this important milestone in our efforts to bring high quality innovative treatments to improve the lives of patients."