百奥泰生物制药股份有限公司关于达尔扑拜单抗注射液（BAT4406F）上市许可申请获得受理的公告

Group 1 - The core announcement is that Baiotai Biopharmaceutical Co., Ltd. has received acceptance for the marketing authorization application of its drug BAT4406F from the National Medical Products Administration [1][3] - BAT4406F is a new generation fully human anti-CD20 antibody developed using the company's antibody Fc engineering platform, designed to treat adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for aquaporin-4 (AQP4) antibodies [4] - The drug is currently undergoing a Phase II/III registration clinical study targeting minimal change disease/focal segmental glomerulosclerosis (MCD/FSGS), which is the first registration study for this indication in China [4] Group 2 - The drug is classified as a Class 1 therapeutic biological product, with a specification of 100mg/5mL, and the acceptance number is CXSS2600022 [2] - The acceptance of the marketing authorization application does not have an immediate impact on the company's recent performance, as the timeline for the review and approval process is uncertain [1][2]