CBP-1008 Gets Clinical Approval by FDA

On October 16, 2020, CBP-1008, a bi-engaging ligand-mediated selective targeting drug conjugate developed by Coherent Biopharma, got clinical approval by FDA. 

With the help of COO Dr. Shao Jun, the Registration Department of Coherent Biopharma spent three months on the submission of CBP-1008 for injection, which was accepted by FDA in mid-September via electronic submission and got clinical approval on October 16th, marking the first step of CBP-1008 for injection, first of its kind developed by Coherent Biopharma, into the international market and a beginning of its global strategy. This also marks a transition in drug conjugate from single-engaging to bi-engaging selective targeting, a milestone in drug conjugates. On the basis of clinical study in China, study of CBP-1008 for injection will continue on its implications including gynecological tumors, gastrointestinal tumors and breast cancer, with international multi-center trial to be carried out at appropriate time so that patients from all over the world may benefit from CBP-1008 for injection.