China's National Medical Products Administration (NMPA) has granted approval to I-Mab Biopharma, a China and United States-based clinical stage biopharmaceutical company, for its IND application for TJD5, a novel CD73 antibody, to start clinical trials in patients with advanced solid tumours in China, it was reported on Friday.
The product 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.
Presently, it is being investigated in a Phase one clinical trial in the United States to evaluate 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 US, and Tuoyi (toripalimab), a PD-1 antibody marketed by Junshi Biosciences in China, in patients with varying types of tumours.
Jingwu Zang, MD, PhD, founder and chairman of I-Mab Biopharma, said, '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. 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.'
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