贝达药业(300558)11月26日午间公告，公司收到国家药品监督管理局（简称"NMPA"）签发的《受理通 知书》，公司申报的盐酸恩沙替尼胶囊（商品名：贝美纳®）拟用于"间变性淋巴瘤激酶（ALK）阳性 的IB期至IIIB期非小细胞肺癌（NSCLC）患者的术后辅助治疗，患者须既往接受过手术切除治疗，并由 医生决定接受或不接受辅助化疗"的上市许可申请已获得NMPA受理。 ...

2025 年 11 月 04 日 贝达药业（300558.SZ）2025 年三季报点评 摘要内容：公司发布 2025 年三季报，2025Q1-3 实现营业收入 27.17 亿元 （+15.90%），归母净利润 3.17 亿元（-23.86%），扣非归母净利润 3.37 亿 元（-6.74%）。 恩沙替尼海外商业化进展顺利，在研项目稳步推进。2025 年 6 月，公司产 品盐酸恩沙替尼胶囊（商品名：贝美纳®）于中国澳门获批上市，8 月于美 国开出首张处方，10 月于中国澳门镜湖医院开出首张处方。9 月，恩沙替 尼新辅助治疗 ALK 阳性 NSCLC 研究、恩沙替尼与放疗存在潜在协同增敏 作用研究、恩沙替尼 EMBRACE 研究中 ctDNA 监测策略的分析与比较、 MCLA-129 治疗 NSCLC 患者 I 期研究更新结果在 2025 WCLC 大会展示； 10 月，恩沙替尼术后辅助治疗数据在 2025 ESMO 年会首次披露，中期结 果显示，恩沙替尼术后辅助治疗 2 年无病生存期（DFS）率达 86.4%，2 年无病生存期风险比（HR）为 0.20，复发风险显著降低 80%。 创新生态圈布局陆续收获阶段性成 ...

Group 1 - The core point of the article is that Beida Pharmaceutical (300558.SZ) plans to issue overseas listed shares (H-shares) and apply for listing on the Hong Kong Stock Exchange to enhance its capital strength and competitiveness while advancing its internationalization process [2] - Beida Pharmaceutical will consider the interests of existing shareholders and the conditions of domestic and foreign capital markets when selecting the appropriate timing and issuance window for the listing [2] - The company has previously attempted to list in Hong Kong, submitting its prospectus in February 2021 and again in December 2021, but both attempts were unsuccessful [2] Group 2 - Beida Pharmaceutical, founded in 2003, focuses on innovative drug research and development with independent intellectual property rights, and has eight drugs currently on the market [3] - The company was listed on the Shenzhen Stock Exchange on November 7, 2016, and as of September 10, 2025, its total market capitalization is approximately 30.259 billion RMB [3][4] - The company's notable products include various cancer treatment drugs, such as the hydrochloride erlotinib tablets (Kaimena®) and the hydrochloride ensartinib capsules (Beimana®) [3]

Core Insights - The announcement highlights the approval of a clinical trial for ensartinib (Baimena®) as a postoperative adjuvant treatment for ALK-positive non-small cell lung cancer (NSCLC) by the National Medical Products Administration (NMPA) [1] - The interim analysis by the Independent Data Monitoring Committee (IDMC) showed positive results, achieving the primary endpoint with significant statistical significance and important clinical benefits [1] - Detailed data from the study will be presented at a major international academic conference later this year [1] - The company is preparing to submit a New Drug Application (NDA) for the new indication as soon as possible [1] Product Development - Ensartinib is a next-generation ALK inhibitor developed collaboratively by the company and its subsidiary, Xcovery Holdings, Inc. [1] - The drug was previously approved for use in patients with ALK-positive locally advanced or metastatic NSCLC who had progressed after or were intolerant to crizotinib 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] Market Impact - The positive interim data from the postoperative adjuvant clinical trial represents a significant achievement for the company, demonstrating the competitive strength of ensartinib [2] - The potential approval of the new indication is expected to enhance product coverage and benefit more patients [2]

Core Viewpoint - Betta Pharmaceuticals has made significant progress in the clinical research of Ensartinib for postoperative adjuvant therapy in ALK-positive non-small cell lung cancer (NSCLC), with positive interim results from an independent data monitoring committee [1] Group 1: Clinical Trial Progress - The clinical trial for Ensartinib (Baimena®) was approved by the National Medical Products Administration (NMPA) in April 2022 for use in postoperative treatment of ALK-positive NSCLC [1] - The interim analysis of the clinical trial has shown positive results, achieving the primary research endpoint with significant statistical significance and important clinical benefits [1] - Detailed data from this study will be presented at a major international academic conference later this year [1] Group 2: Future Implications - The positive interim results of the postoperative clinical trial reflect the company's focus on resource allocation and development, showcasing the competitive strength of Ensartinib [1] - The approval of the new indication is expected to enhance product coverage and benefit more patients [1] - The company is preparing to submit the NDA application for the new indication as soon as possible [1]