Core Viewpoint - The company Fuhong Hanlin (02696) has received acceptance for its New Drug Application (NDA) for Hansuzhuang (sulizumab injection) in combination with platinum-based chemotherapy for the treatment of PD-L1 positive, resectable gastric cancer patients, which has been prioritized for review by the National Medical Products Administration (NMPA) [1] Group 1 - The NDA acceptance is aimed at expediting the review process for the new indication of Hansuzhuang [1] - The application is based on a Phase 3 clinical study that compared Hansuzhuang combined with chemotherapy against placebo combined with chemotherapy for the neoadjuvant/adjuvant treatment of gastric cancer patients [1] - The study results demonstrated that Hansuzhuang combined with chemotherapy significantly extended the event-free survival (EFS) of patients, meeting the predefined superiority criteria, and showed better safety and tolerability compared to standard chemotherapy [1]
复宏汉霖(02696)：汉斯状®联合化疗用于胃癌新辅助/辅助治疗的上市注册申请获国家药监局受理，并已纳入优先审评