SHANGHAI, China – October 4, 2019 – I-Mab Biopharma (“I-Mab”), 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, today 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 US 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. "
TJD5 is a differentiated monoclonal antibody against a promising immuno-oncology target. It is believed to stimulate the immuno-suppressive tumour micro-environment and to work in concert with other cancer therapies such as PD-1 and PD-L1 antibodies. TJD5 is in a Phase 1 clinical trial in the US, and is a proprietary, innovative CD73 monoclonal antibody from I-Mab’s discovery pipeline with best-in-class potential.
I-Mab is a dynamic and fast-growing global biotech company exclusively focused on developing biologics of novel or highly differentiated in the therapeutic areas of immuno-oncology and autoimmune diseases. I-Mab's mission is to bring transformational medicines to patients through innovation. I-Mab’s innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company’s Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to become a fully integrated end-to-end global biopharmaceutical company with cutting-edge discovery platforms, proven preclinical and clinical development expertise, and world-class GMP manufacturing capabilities. I-Mab is well-recognized by capital markets to have successfully raised over US$400 million in equity financing since its establishment in 2016. Its recent USD 200 million Series C financing represents one of the largest amounts ever raised by a biotech company in China.
For more information, please see the Company's website at www.i-mabbiopharma.com