Core Viewpoint - The company has received acceptance for the New Drug Application (NDA) of its self-developed drug Hanshuan® (sulizumab injection) for a new indication in the treatment of PD-L1 positive, resectable gastric cancer patients, which is now prioritized for review by the National Medical Products Administration (NMPA) [1][2] Group 1 - The NDA acceptance is based on a Phase 3 clinical study that demonstrated the efficacy and safety of Hanshuan® combined with chemotherapy compared to placebo combined with chemotherapy, significantly extending the event-free survival (EFS) of patients [1] - The study met the predefined superiority criteria and showed better safety and tolerability compared to standard chemotherapy [1] Group 2 - Hanshuan® is an innovative anti-PD-1 monoclonal antibody that has already been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The drug has also received orphan drug designation in several regions, including the US, EU, Switzerland, and South Korea, and is approved in multiple countries such as the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [2] - The company is actively advancing multiple clinical trials for Hanshuan® and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]
复宏汉霖(02696.HK)：汉斯状®(斯鲁利单抗注射液)联合化疗用于胃癌新辅助/辅助治疗的上市注册申请(NDA)获国家药品监督管理局(NMPA)受理，并已纳入优先审评