Core Insights - The company announced that its self-developed drug Hansizhuang® (sulizumab injection) has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for gastric cancer, allowing for early submission for market approval [1][2] Group 1: Clinical Trial Results - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hansizhuang® combined with chemotherapy to placebo combined with chemotherapy for early gastric cancer patients [1] - The interim analysis conducted by the Independent Data Monitoring Committee (IDMC) showed significant improvement in EFS for the Hansizhuang® group, achieving pre-set superiority standards [1] - The pathological complete response (pCR) rate for Hansizhuang® was over three times that of the control group, with a significant reduction in recurrence risk and no new safety signals reported [1] Group 2: Product Information and Approvals - Hansizhuang® is an innovative anti-PD-1 monoclonal antibody that has 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 approvals in several countries/regions, including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation in the US, EU, Switzerland, and South Korea [2] - The company is actively advancing multiple clinical trials for Hansizhuang® and related combination therapies across various indications, including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]