Leads Biolabs' Opamtistomig (PD-L1/4-1BB Bispecific Antibody) NDA Accepted by NMPA, Poised to Become World's First Approved 4-1BB-Targeting Therapy

Nanjing Leads Biolabs announced that China’s NMPA Center for Drug Evaluation (CDE) has accepted its New Drug Application (NDA). NDA acceptance is an incremental regulatory milestone that can improve prospects for subsequent review timelines, but no approval outcome or financial impact was disclosed.

Analysis

Nanjing Leads Biolabs announced that China’s NMPA Center for Drug Evaluation (CDE) has accepted its New Drug Application (NDA). NDA acceptance is an incremental regulatory milestone that can improve prospects for subsequent review timelines, but no approval outcome or financial impact was disclosed.