证券代码：300558 证券简称：贝达药业 公告编号：2025-074 贝达药业股份有限公司（以下简称"贝达药业"或"公司"）于 2024 年 12 月 4 日召开第四届董事会第二十次会议及第四届监事会第十七次会议，审议通过了 《关于使用部分闲置募集资金暂时补充流动资金的议案》，同意在不影响公司募集 资金投资计划正常进行的前提下，使用不超过 2.5 亿元人民币的闲置募集资金暂时 补充流动资金，使用期限自董事会审议通过之日起不超过 12 个月。具体情况详见 公司披露在巨潮资讯网（http://www.cninfo.com.cn）上的《关于使用部分闲置募集 资金暂时补充流动资金的公告》（公告编号：2024-093）。 在使用此部分闲置募集资金暂时补充流动资金期间，公司严格遵守《上市公司 募集资金监管规则》《深圳证券交易所创业板股票上市规则》及《深圳证券交易所 上市公司自律监管指引第 2 号——创业板上市公司规范运作》的相关规定，仅用于 与主营业务相关的生产经营使用，资金使用安排合理，不存在变相改变募集资金用 途或者影响募集资金投资项目的正常进行，不存在损害股东利益的情况。 截至 2025 年 12 月 1 日，公 ...

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。 ...

Key Points - Guizhou Moutai elected Chen Hua as the chairman of the fourth board of directors and plans to repurchase shares between RMB 1.5 billion and RMB 3 billion [1] - Tianfeng Securities is under investigation by the China Securities Regulatory Commission for suspected violations of information disclosure and illegal financing [1] Share Buybacks - Demai Technology raised the upper limit for share repurchase to RMB 45 per share [5] - Jianbang Technology plans to repurchase shares worth between RMB 15 million and RMB 30 million [5] - Huayuan Holdings intends to repurchase shares worth between RMB 30 million and RMB 60 million [5] Major Investments - Jinling Pharmaceutical plans to invest RMB 893 million in hospital expansion projects [7] - Dongfang Mingzhu intends to invest approximately RMB 500 million to establish a partnership and acquire part of the equity of New H3C [7] - Chang'an Automobile aims to establish a robotics company to develop innovative products and solutions [7] Mergers and Acquisitions - Kaizhong Co. plans to acquire 60% of Anhui Tuosheng's equity, with stock resuming trading on December 1 [7] - Youa Co. has resumed the review process for issuing shares and cash to purchase assets [7] - Jiasheng Technology intends to acquire controlling interest in Shudun Information Technology Co., with stock continuing to be suspended [7] Financing Activities - Shenzhen Energy plans to apply for a public bond issuance with a total scale not exceeding RMB 20 billion [7] - Huakong Saige has terminated its specific object stock issuance [7]

Core Viewpoint - Xcovery Holdings, 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) [2] Group 1 - The marketing authorization application for ensartinib has been officially accepted by the EMA [2] - The drug is specifically aimed at treating adult patients with ALK-positive locally advanced or metastatic NSCLC [2]

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。 ...

证券代码：300558 证券简称：贝达药业 公告编号：2025-073 贝达药业股份有限公司 注册分类：新活性物质的完整申请 申请人：Xcovery Holdings, Inc. 申请事项：上市许可申请 二、药品基本情况及同类药品市场状况 关于盐酸恩沙替尼胶囊上市许可申请获得欧洲药品管理局受理的公告 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（以下简称"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。 2023 年 12 月，恩沙替尼纳入《国家基本医疗保险、工伤保险和生育保险药品目录 （2023 年）》（协议有效期至 2025 年 12 月 31 日）。 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 今日，贝达药业股份有限公司（以下简称"公司"） ...

Group 1 - Aolide plans to raise no more than 300 million yuan through a simplified procedure for issuing shares to specific targets, with net proceeds allocated to the production base project for OLED display core materials and to supplement working capital [1] - Wanbang's subsidiary has obtained a 10-year exclusive agency for sildenafil oral suspension, which is suitable for patients with swallowing difficulties [2] - Titan Technology and its affiliate plan to jointly invest in increasing capital for its subsidiary, Micro Detection, raising its registered capital from 10 million yuan to 50 million yuan [3] Group 2 - Jindike will not issue new batches of quadrivalent influenza virus split vaccine this year, having produced approximately 1.56 million doses [4] - Aladdin intends to purchase 35% equity of Youke for 61.25 million yuan, funded by its own or raised capital [5] - Gujia Home's application for a private placement of A-shares has been approved by the Shanghai Stock Exchange [7] Group 3 - Honghe Technology's application for a private placement of A-shares has been approved by the China Securities Regulatory Commission [9] - Guangdian Yuntong has won contracts totaling 308 million yuan for the construction of an artificial intelligence application pilot base [10] - Shanghai Mechanical plans to repurchase B-shares worth no more than 278 million yuan [11] Group 4 - Weiling Co. is planning a change of control, with shares representing 7.76% of the total being transferred [14] - Jiugang Hongxing intends to invest 200 million yuan to establish a wholly-owned subsidiary focusing on high-quality special steel materials [16] - Zhongjian Technology has submitted an application for H-share listing [17] Group 5 - Sainuo Medical has received registration approval for its coronary product in Pakistan [18] - Huafeng Aluminum plans to acquire 100% equity of Huafeng Puen for 100 million yuan [20] - Fuda Co. intends to establish a wholly-owned subsidiary with an investment of 30 million yuan [22] Group 6 - Su Yan Jingshen's application for a private placement of shares has been approved by the Shanghai Stock Exchange [24] - Zhongchuang Co. has set the inquiry transfer price at 25.75 yuan per share [25] - Jinpu Garden has had a lawsuit involving 26.557 million yuan accepted by the court [29] Group 7 - ICBC has approved the appointment of Zhao Guid as vice president [30] - Betta Pharmaceuticals has had its drug registration application for ensartinib accepted [32] - Times New Materials plans to invest 6 million euros to establish a wholly-owned subsidiary in Serbia [34] Group 8 - China State Construction has appointed Chen Yong as vice president [36] - Dayang Electric plans to invest 10 million yuan to establish an industrial fund [38] - Advanced Digital has appointed Liu Zhigang as deputy general manager [39] Group 9 - Tianqi Co. plans to transfer 7% equity of Youqi Intelligent for 130 million yuan [40] - Xinguo has submitted an application for H-share issuance and listing [42] - Jinhongshun's shareholder has terminated a share reduction plan [43] Group 10 - Wanrun Co.'s actual controller plans to increase shareholding between 365 million yuan and 730 million yuan [44] - Suzhou High-tech plans to sell 47% equity of its medical device subsidiary for 604 million yuan [45] - Huayou Cobalt's subsidiary has signed a product supply agreement with Yiwei Lithium Energy for approximately 127,800 tons of materials [47] Group 11 - China Communications has won 10 important projects totaling approximately 2.539 billion yuan [49] - Nopushin plans to raise no more than 1.45 billion yuan through a private placement [50] - Yun Aluminum plans to acquire minority stakes in three subsidiaries for a total of 2.267 billion yuan [51] Group 12 - Xiamen Tungsten plans to establish a 500 million yuan merger fund with multiple parties [52] - Aotewei has signed a contract worth approximately 700 million yuan [54] - Hemai Co.'s shareholders plan to reduce their holdings by no more than 3% [56]

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]