贝达药业：恩沙替尼术后辅助治疗适应症药品注册申请获受理

Core Viewpoint - The company has received acceptance from NMPA for the marketing authorization application of Ensartinib capsules for postoperative adjuvant therapy in ALK-positive non-small cell lung cancer (NSCLC) patients [1] Group 1: Product Development - Ensartinib is a new generation ALK inhibitor that is highly selective and potent [1] - The drug was previously approved by NMPA in November 2020 for the treatment of ALK-positive locally advanced or metastatic NSCLC patients who progressed after or are intolerant to Crizotinib [1] Group 2: Clinical Data - Mid-term results of postoperative adjuvant therapy with Ensartinib will be disclosed at the 2025 European Society for Medical Oncology (ESMO) annual meeting [1] - The 2-year disease-free survival (DFS) rate for patients receiving postoperative adjuvant therapy with Ensartinib is reported to be 86.4% [1] - The risk ratio for 2-year DFS is 0.20, indicating an 80% reduction in the risk of recurrence, significantly lowering the likelihood of disease relapse [1]