Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has announced that its self-developed innovative anti-PD-1 monoclonal antibody, Hanshu (斯鲁利单抗), has received acceptance for a New Drug Application (NDA) from the National Medical Products Administration (NMPA) for use in combination with platinum-based chemotherapy as neoadjuvant therapy and postoperative adjuvant therapy for PD-L1 positive, resectable gastric cancer patients. This application has been included in the priority review process, significantly shortening the review timeline to 130 working days, indicating a rapid advancement in the approval process for H drug in the perioperative treatment of gastric cancer. H drug is expected to become the first anti-PD-1 monoclonal antibody approved for this indication globally [1]. Group 1 - The company has received acceptance for its NDA for Hanshu in gastric cancer treatment [1] - The application is included in the priority review process, reducing the review timeline to 130 working days [1] - H drug is anticipated to be the first anti-PD-1 monoclonal antibody approved for this indication worldwide [1]
复宏汉霖：H药胃癌围手术适应症申报上市并被纳入优先审评