贝达药业: 关于恩沙替尼术后辅助适应症临床研究进展的公告

Core Viewpoint - The clinical trial for Ensartinib (also known as "Baimena") for postoperative adjuvant treatment of ALK-positive non-small cell lung cancer (NSCLC) has received approval from the National Medical Products Administration (NMPA) and has shown positive interim results, achieving the primary research endpoint with significant statistical and clinical benefits [1]. Group 1: Drug Information - Ensartinib is a new generation ALK inhibitor developed jointly by the company and its subsidiary Xcovery Holdings, Inc. [1] - The drug was approved for use in patients with locally advanced or metastatic NSCLC who progressed after crizotinib treatment or were intolerant to it in November 2020 (second-line indication) [1]. - In March 2022, Ensartinib received approval for a first-line indication for ALK-positive locally advanced or metastatic NSCLC patients [1]. - The drug was included in the National Basic Medical Insurance Directory in December 2023, and the European marketing application for the first-line indication was initiated in February 2025 [1]. Group 2: Impact on the Company - The positive interim data from the postoperative adjuvant clinical trial represents a significant achievement for the company, demonstrating the competitive strength of Ensartinib [1]. - The approval of the new indication is expected to enhance product coverage and benefit more patients [1].