Betta Pharmaceuticals Co., Ltd.(300558)
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11月26日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-26 10:21
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]
贝达药业:关于盐酸恩沙替尼胶囊术后辅助治疗适应症药品注册申请获得受理的公告
Zheng Quan Ri Bao· 2025-11-26 08:09
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]
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
Guo Ji Jin Rong Bao· 2025-11-26 04:22
贝达药业公告,公司申报的盐酸恩沙替尼胶囊拟用于ALK阳性的IB期至IIIB期非小细胞肺癌患者的术后 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。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NMPA批准上市。2025年10月,恩沙替尼术后辅助治疗数据在2025年欧洲肿瘤 内科学会(ESMO)年会上首次披露,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,复发风险降低80%,显著减少了疾病复发的可能。 ...
贝达药业(300558.SZ):盐酸恩沙替尼胶囊术后辅助治疗适应症药品注册申请获得受理
Ge Long Hui A P P· 2025-11-26 04:06
格隆汇11月26日丨贝达药业(300558.SZ)公布,公司收到国家药品监督管理局(以下简称"NMPA")签发的 《受理通知书》(受理号:CXHS2500142、CXHS2500143),公司申报的盐酸恩沙替尼胶囊(商品名:贝 美纳?,以下简称"恩沙替尼")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。 ...
贝达药业:盐酸恩沙替尼胶囊术后辅助治疗适应症药品注册申请获受理
Xin Lang Cai Jing· 2025-11-26 03:57
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。 ...
贝达药业(300558) - 关于盐酸恩沙替尼胶囊术后辅助治疗适应症药品注册申请获得受理的公告
2025-11-26 03:44
证券代码:300558 证券简称:贝达药业 公告编号:2025-072 贝达药业股份有限公司 关于盐酸恩沙替尼胶囊术后辅助治疗适应症药品注册申请获得受理的 公告 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。 贝达药业股份有限公司(以下简称"贝达药业"或"公司")收到国家 药品监督管理局(以下简称"NMPA")签发的《受理通知书》(受理号: CXHS2500142、CXHS2500143),公司申报的盐酸恩沙替尼胶囊(商品名:贝美 纳®,以下简称"恩沙替尼")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,现将具体情况公告如下: 一、申请注册药品的基本情况 产品名称:盐酸恩沙替尼胶囊 恩沙替尼"适用于 ALK 阳性的局部晚期或转移性的 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 ...
贝达药业涨2.14%,成交额6811.19万元,主力资金净流入438.16万元
Xin Lang Cai Jing· 2025-11-26 02:16
11月26日,贝达药业盘中上涨2.14%,截至10:02,报50.52元/股,成交6811.19万元,换手率0.32%,总 市值212.55亿元。 资金流向方面,主力资金净流入438.16万元,大单买入1300.33万元,占比19.09%,卖出862.17万元,占 比12.66%。 分红方面,贝达药业A股上市后累计派现6.69亿元。近三年,累计派现1.84亿元。 机构持仓方面,截止2025年9月30日,贝达药业十大流通股东中,兴全商业模式混合(LOF)A(163415) 位居第五大流通股东,持股582.70万股,为新进股东。易方达创业板ETF(159915)位居第六大流通股 东,持股545.55万股,相比上期减少91.23万股。兴全合润混合A(163406)位居第七大流通股东,持股 540.17万股,为新进股东。中欧医疗健康混合A(003095)、南方中证500ETF(510500)退出十大流通 股东之列。 责任编辑:小浪快报 资料显示,贝达药业股份有限公司位于浙江省杭州市临平区经济技术开发区兴中路355号,香港铜锣湾希 慎道33号利园1期19楼1919室,成立日期2003年1月7日,上市日期2016年11月 ...
把握回调后的机会,积极布局2026年
ZHONGTAI SECURITIES· 2025-11-24 10:14
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [5]. Core Insights - The report emphasizes the importance of seizing opportunities following market corrections, particularly in anticipation of improvements in 2026. It notes that the pharmaceutical sector's fundamentals remain strong despite recent market fluctuations, and it is currently at a valuation bottom. The report suggests focusing on innovative drugs and companies with potential for operational improvements in 2025 [7][11]. Summary by Sections Industry Overview - The pharmaceutical sector consists of 498 listed companies with a total market capitalization of approximately 70,594.11 billion [2]. - The sector has experienced a decline of 6.88% recently, with various sub-sectors such as pharmaceutical commerce and biopharmaceuticals also facing downturns [11]. Market Dynamics - The report highlights a significant market correction, with the Shanghai Composite Index down by 3.77% and the pharmaceutical sector underperforming [11]. - It notes that the overall performance of the pharmaceutical sector has been positive since the beginning of the year, with a return of 13.69%, slightly outperforming the broader market [18]. Investment Opportunities - The report identifies key companies to watch, including: - CDMO leaders: WuXi AppTec, WuXi Biologics, and WuXi AppTec [11]. - Front-end CROs: Tigermed, ProPhase, and Zhaoyan New Drug [11]. - Medical devices: United Imaging Healthcare and HaiTai New Light [11]. - Biopharmaceuticals: I-Mab Biopharma and Hualan Biological Engineering [11]. - It also suggests focusing on companies with innovative drug pipelines and those that are transitioning from biotech to biopharma [11]. Company Performance - The report provides a list of recommended stocks, including: - WuXi AppTec (66.45), rated "Buy" - Three Life Pharmaceuticals (29.34), rated "Buy" - Tigermed (49.59), rated "Buy" - Xiansheng Pharmaceutical (12.85), rated "Buy" - Betta Pharmaceuticals (48.60), rated "Buy" [5][31]. Regulatory and Market Trends - The report discusses recent regulatory developments, including a call from the vaccine industry association to avoid low-cost bidding practices to stabilize profit margins for leading vaccine companies [11][12]. - It also notes significant acquisitions and advancements in drug development, such as Johnson & Johnson's acquisition of Halda Therapeutics for $30.5 billion [11].
贝达药业跌2.08%,成交额7919.70万元,主力资金净流出848.00万元
Xin Lang Cai Jing· 2025-11-21 02:31
Core Points - Boda Pharmaceutical's stock price decreased by 2.08% on November 21, reaching 49.06 CNY per share, with a market capitalization of 20.641 billion CNY [1] - The company has experienced a year-to-date stock price decline of 8.69%, with a 9.68% drop over the last five trading days and a 23.44% decline over the past 60 days [1] - As of September 30, 2025, Boda Pharmaceutical reported a revenue of 2.717 billion CNY, a year-on-year increase of 15.90%, while the net profit attributable to shareholders decreased by 23.86% to 317 million CNY [2] Financial Performance - The company has distributed a total of 669 million CNY in dividends since its A-share listing, with 184 million CNY distributed over the last three years [3] - As of September 30, 2025, the number of shareholders decreased by 7.99% to 29,500, while the average number of circulating shares per person increased by 8.68% to 14,198 shares [2] Shareholder Structure - Among the top ten circulating shareholders, Xingshan Commercial Model Mixed Fund A is the fifth largest with 5.827 million shares, marking a new entry [3] - E Fund's Growth Enterprise Board ETF, ranked sixth, reduced its holdings by 912,300 shares to 5.456 million shares [3] - Xingshan Helun Mixed Fund A is the seventh largest shareholder with 5.402 million shares, also a new entry [3]
贝达药业跌2.01%,成交额1.68亿元,主力资金净流出2280.79万元
Xin Lang Cai Jing· 2025-11-19 05:33
Core Viewpoint - Benda Pharmaceutical's stock has experienced a decline in recent trading sessions, with a notable drop in both share price and market capitalization, indicating potential challenges in the company's performance and investor sentiment [1][2]. Company Performance - As of September 30, Benda Pharmaceutical reported a revenue of 2.717 billion yuan, reflecting a year-on-year growth of 15.90%. However, the net profit attributable to shareholders decreased by 23.86% to 317 million yuan [2]. - The company's stock price has fallen by 5.40% year-to-date, with a 5.71% decline over the past five trading days, a 12.75% drop over the last 20 days, and a significant 27.60% decrease over the past 60 days [1]. Shareholder Information - The number of shareholders decreased by 7.99% to 29,500, while the average number of circulating shares per person increased by 8.68% to 14,198 shares [2]. - Benda Pharmaceutical has distributed a total of 669 million yuan in dividends since its A-share listing, with 184 million yuan distributed over the past three years [3]. Institutional Holdings - As of September 30, 2025, notable institutional shareholders include Xingquan Commercial Model Mixed Fund (LOF) A, which is the fifth-largest shareholder with 5.827 million shares, and E-Fund's Growth Enterprise Board ETF, which has reduced its holdings by 912,300 shares [3].