I-Mab gets IND approval for TJC4 antibody

I-Mab Biopharma ("I-Mab"), a clinical stage biotech company exclusively focusing on discovery and development of innovative biologics in immuno-oncology and autoimmune diseases, announces that the National Medical Products Administration (NMPA) has approved its investigational new drug (IND) application for TJC4, a differentiated fully human CD47 monoclonal antibody internally developed for the treatment of advanced malignant tumors. Previously on June 24, 2019, I-Mab announced the first patient dosing of TJC4 in a phase I clinical study in the US.

As a pivotal drug candidate from I-Mab's innovative pipeline, TJC4 is a potential global best-in-class CD47 Monoclonal Antibody. Unlike other known CD47 antibodies under development, it binds to a unique epitope on CD47 that leads to minimal red blood cell binding, resulting in neither hemagglutination in vitro nor anemia in cynomolgus monkeys in toxicological studies.

"We are delighted to receive the IND clearance of TJC4 from the NMPA to start clinical studies in China. This is another significant progress after we initiated the phase 1 study in the United States," Expressed by Dr. Joan Shen, Head of R&D at I-Mab, "By design and from the pre-clinical data, we believe TJC4 has the great potential to become a best-in-class agent treating cancer patients worldwide."