百奥泰(688177.SH)：达尔扑拜单抗注射液(BAT4406F)上市许可申请获得受理

Core Viewpoint - The company Baiotai (688177.SH) has received a notice of acceptance from the National Medical Products Administration for its investigational drug BAT4406F, which is a new generation fully human anti-CD20 antibody developed using the company's antibody Fc engineering platform [1] Group 1 - The acceptance notice for the drug application will not impact the company's recent performance as the timeline for approval cannot be estimated [1] - BAT4406F is designed to enhance antibody-dependent cellular cytotoxicity (ADCC) and targets CD20 molecules on B cells and precursor cells, as well as having high affinity for NK cells [1] - A Phase II/III registration clinical study for BAT4406F targeting minimal change disease/focal segmental glomerulosclerosis (MCD/FSGS) is currently recruiting participants at several top-tier hospitals across the country, marking the first registration study for this indication in China [1]