12 月7日，贝达药业股份有限公司（简称"贝达药业" 300558.SZ）发布公告称，公司产品盐酸埃克替尼 片、 盐酸恩沙替尼胶囊、甲磺酸贝福替尼胶囊以及伏罗尼布片纳入《国家基本医疗保险、生育保险和 工伤保险药品目录（2025年）。 南都N视频记者注意到，贝达药业资深副总裁兼首席运营官万江在其企业公众号中表示，四款创新药物 顺利续约2025年国家医保目录，体现了国家医保部门对贝达药业自主创新能力和药物临床价值的充分认 可。目前，贝达已上市创新药的全部适应症均纳入国家医保目录。 据公告，埃克替尼是公司自主研发的、我国第一个拥有自主知识产权的治疗肺癌的靶 向药，该药品是 一种强效、高选择性的小分子口服表皮生长因子受体酪氨酸激酶 抑制剂（EGFR-TKI）。 恩沙替尼是一种新型强效、高选择性的新一代ALK抑制剂，是公司和控股子 公司Xcovery共同开发的自 主创新药。 贝福替尼是第三代EGFR-TKI，是全新的、拥有自主知识产权的国家1类创新药。 伏罗尼布是具有全新化学结构的新一代多靶点酪氨酸激酶血管内皮生长因子 受体（VEGFR）/ 血小板 衍化生长因子受体（PDGFR）抑制剂，可抑制肿瘤血管 生成及生长，可用 ...

证券日报网讯12月7日晚间，贝达药业（300558）发布公告称，公司产品盐酸埃克替尼片、盐酸恩沙替 尼胶囊、甲磺酸贝福替尼胶囊以及伏罗尼布片纳入《国家基本医疗保险、生育保险和工伤保险药品目录 (2025年)》。 ...

Core Viewpoint - The announcement indicates that several products from the company have been included in the National Medical Insurance Drug List for 2025, which is expected to enhance accessibility and positively impact sales, although the exact effect on current performance cannot be accurately estimated [1] Group 1 - The products included are: - Hydrochloride Alectinib Tablets - Hydrochloride Ensartinib Capsules - Mesylate Bafetinib Capsules - Vorinostat Tablets These products will be effective from January 1, 2026, to December 31, 2027 [1] - Additionally, the product Bevacizumab Injection has been included in the National Medical Insurance Category B Drug List [1] Group 2 - Inclusion in the medical insurance list is expected to improve product accessibility [1] - The impact on sales is anticipated to be positive, although the company cannot currently provide an accurate estimate of the effect on its performance [1]

Policy Developments - The National Healthcare Security Administration exposed a healthcare fraud industry chain in Shanghai, leading to the prosecution of an individual for fraud, resulting in significant losses to the national healthcare fund [1] - The crackdown on healthcare fraud has become more systematic and normalized in recent years, highlighting the importance of protecting the healthcare fund [1] Drug and Device Approvals - Anglicon received a drug registration certificate for Ertugliflozin Metformin Extended-Release Tablets, aimed at improving blood sugar control in adults with type 2 diabetes [2] - Betta Pharmaceuticals announced that its application for the marketing authorization of Ensartinib Capsules for treating ALK-positive non-small cell lung cancer has been accepted by the European Medicines Agency [3] - Innovent Biologics received approval for its IL-23p19 monoclonal antibody for the treatment of moderate to severe plaque psoriasis in adults [4] - Warner Pharmaceuticals obtained a drug registration certificate for Formoterol Fumarate Inhalation Solution, intended for the maintenance treatment of COPD [5] - Shanghai Pharmaceuticals announced that its Tramadol Hydrochloride Injection passed the consistency evaluation for generic drugs, which may enhance its market competitiveness [6] Major Industry Events - Biontech received a milestone payment of $250 million from Bristol-Myers Squibb related to the Iza-bren project, with potential for additional payments based on future milestones [7] - Jining Pharmaceutical plans to invest 893 million yuan in a hospital expansion project to meet the growing health demands in the region [8] - Maiwei Biotech completed Phase IIa clinical trials for its innovative drug 9MW1911 in COPD patients, showing significant reductions in acute exacerbation rates [9] Shareholder Actions - Sanofi Biotech announced plans for shareholders to reduce their holdings by a total of 0.0240% of shares due to personal financial needs [10] Management Changes - Sinopharm Holdings announced management changes, including the resignation of several executives and the appointment of new leadership, which will take effect upon shareholder approval [11]

本文源自：市场资讯 作者：公告君 贝达药业控股子公司Xcovery Holdings, Inc.递交的盐酸恩沙替尼胶囊（拟用于间变性淋巴瘤激酶 （ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成年患者的治疗）的上市许可申请已获得 欧洲药品管理局（EMA）受理。该药物是新型强效、高选择性ALK抑制剂，已在国内获批二线及一线 适应症，2024年12月获美国FDA批准上市，此次为EMA正式受理其上市申请。 声明：市场有风险，投资需谨慎。本文为AI基于第三方数据生成，仅供参考，不构成个人投资建议。 ...

证券日报网讯 11月28日晚间，贝达药业发布公告称，今日，公司控股子公司XcoveryHoldings，Inc.（简 称"Xcovery"）收到欧洲药品管理局（简称"EMA"）通知，Xcovery递交的盐酸恩沙替尼胶囊（简称"恩 沙替尼"）"拟用于间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成年 患者的治疗"的上市许可申请已获得EMA受理。 （文章来源：证券日报） ...

Core Viewpoint - Xcovery, a subsidiary of BeiGene, has received acceptance from the European Medicines Agency (EMA) for its marketing authorization application for ensartinib capsules, intended for the treatment of adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) [1] Group 1 - Xcovery is a controlling subsidiary of BeiGene [1] - The application submitted by Xcovery is specifically for ensartinib capsules [1] - The target patient population for this treatment includes adults with ALK-positive locally advanced or metastatic NSCLC [1]

智通财经APP讯，贝达药业(300558.SZ)发布公告，今日，公司控股子公司Xcovery收到欧洲药品管理局 (简称"EMA")通知，Xcovery递交的盐酸恩沙替尼胶囊(简称"恩沙替尼")"拟用于间变性淋巴瘤激酶(ALK) 阳性的局部晚期或转移性非小细胞肺癌(NSCLC)成年患者的治疗"的上市许可申请已获得EMA受理。 恩沙替尼是一种新型强效、高选择性的新一代ALK抑制剂，其"适用于此前接受过克唑替尼治疗后进展 的或者对克唑替尼不耐受的ALK阳性的局部晚期或转移性NSCLC患者的治疗"(二线适应症)于2020年11 月获得国家药品监督管理局(简称"NMPA")批准上市，恩沙替尼"适用于ALK阳性的局部晚期或转移性 NSCLC患者的治疗"(新增一线适应症)于2022年3月获得NMPA批准。 ...

Core Viewpoint - Betta Pharmaceuticals has received acceptance from the National Medical Products Administration (NMPA) for its application of crizotinib capsules (brand name: Baimena®) for postoperative adjuvant therapy in ALK-positive non-small cell lung cancer (NSCLC) patients [2] Group 1 - The NMPA issued an acceptance notice for the application with reference numbers CXHS2500142 and CXHS2500143 [2] - The indication for the drug is specifically for patients with stage IB to IIIB ALK-positive NSCLC who have previously undergone surgical resection [2] - The decision for patients to receive adjuvant chemotherapy is at the discretion of their physician [2]

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]