Betta Pharmaceuticals Co., Ltd.(300558)

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立讯精密拟发行H股;贵州茅台已回购338万股丨公告精选





2 1 Shi Ji Jing Ji Bao Dao· 2025-07-02 14:10
Group 1 - Guizhou Moutai has repurchased a total of 3.3821 million shares as of June 30, 2025, accounting for 0.2692% of the total share capital, with a total expenditure of 5.202 billion yuan [2] - Luxshare Precision is planning to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global financing capabilities and governance transparency [2] - Huazhong Xinchuang has received a project notification from a leading domestic eVTOL manufacturer for the development and supply of an intelligent cockpit multimedia display system [3] Group 2 - Meinohua expects a net profit of 46 million to 52 million yuan for the first half of 2025, representing a year-on-year increase of 142.84% to 174.52% [4] - Jiangnan Water has received a report from shareholder Lianan Life Insurance indicating an increase in shareholding by 46.99 million shares, representing 5.03% of the total share capital [5] - Huasen Pharmaceutical has received approval for clinical trials of its CX001 sustained-release tablets, marking a milestone for its innovative drug development platform [6] Group 3 - Zongshen Power anticipates a net profit growth of 70% to 100% for the first half of the year [7] - Yutong Bus reported a sales volume of 5,919 units in June, a year-on-year increase of 24.79% [7] - Guangzhou Port expects a 7.0% year-on-year increase in container throughput for June 2025 [7] Group 4 - Data Port's shareholders plan to reduce their holdings by up to 1.74% and 0.26% of the company's shares [9] - Humanwell Healthcare's shareholder plans to increase its stake by 1% to 2% [9] - Nengte Technology plans to repurchase shares worth between 300 million to 500 million yuan [10]

贝达药业(300558) - 关于国家药品监督管理局批准酒石酸泰瑞西利胶囊上市的公告
2025-07-02 11:44
贝达药业股份有限公司 关于国家药品监督管理局批准酒石酸泰瑞西利胶囊上市的公告 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。 今日,国家药品监督管理局(以下简称"国家药监局")官方网站公示, 国家药监局批准贝达药业股份有限公司(以下简称"公司")申报的酒石酸泰 瑞西利胶囊(BPI-16350,商品名:康美纳®,以下简称"泰瑞西利")上市, 现将具体情况公告如下: 证券代码:300558 证券简称:贝达药业 公告编号:2025-048 适应症:本品联合氟维司群,适用于既往接受内分泌治疗后进展的激素受体 (HR)阳性、人表皮生长因子受体 2(HER2)阴性的局部晚期或转移性成年乳腺 癌患者。 二、药品基本情况及同类药品市场状况 泰瑞西利是由公司自主研发的全新的、拥有完全自主知识产权的新分子 实体化合物,针对的靶点为细胞周期蛋白依赖性激酶 4/6(CDK4/6)。CDK4/6 是调节细胞周期的关键因子,能够触发细胞周期从生长期(G1 期)向 DNA 复制 期(S 期)转变,泰瑞西利能特异性地和 CDK4/6 结合而抑制其激酶活性,抑制癌 细胞增殖、转移等相关的信号传 ...
7月2日晚间重要公告一览
Xi Niu Cai Jing· 2025-07-02 10:18
Group 1 - CITIC Construction Investment has received approval from the China Securities Regulatory Commission to issue perpetual subordinated bonds with a total face value of no more than 20 billion yuan [1] - Bluefocus Technology has received a loan commitment of up to 900 million yuan from CITIC Bank for stock repurchase [1] - Huaren Pharmaceutical's subsidiary has received approval for the listing of Bumetanide raw materials, which are used to treat severe heart failure and hypertension emergencies [3] Group 2 - Betta Pharmaceuticals has received approval for the listing of Enasidenib capsules in Macau, aimed at treating ALK-positive locally advanced or metastatic non-small cell lung cancer [4] - Juewei Food plans to use 110 million yuan of idle fundraising for cash management, with an expected annual yield of 1.00%-1.89% [6] - China Huadian has successfully completed the issuance of 1 billion yuan medium-term notes with a coupon rate of 1.95% [9] Group 3 - Fosun Pharma's subsidiary has received a GMP certificate from the Belgian Federal Agency for Medicines and Health Products for the production facilities of two monoclonal antibodies [11] - China Nuclear Engineering has signed a civil engineering contract for the Taishan Nuclear Power Units 3 and 4 [13] - Kanglongda has faced administrative regulatory measures from the Zhejiang Securities Regulatory Bureau due to the failure of performance commitment parties to fulfill compensation obligations [15] Group 4 - Gaoling Information has received three invention patent certificates in the second quarter, covering various technological fields [16] - Weimais plans to use 190 million yuan of excess fundraising to increase capital in its subsidiary for building a new energy vehicle powertrain production base [17] - Huazhong Technology has received a project designation notice from a leading eVTOL manufacturer for the development and supply of an intelligent cockpit multimedia display system [19] Group 5 - Madi Technology expects a net profit of 25 million to 27 million yuan for the first half of 2025, marking a turnaround from a loss in the previous year [19] - Dazhong Mining's subsidiary has obtained a mining license for the Zhouyoufang Iron Mine, increasing production capacity to 6.5 million tons per year [20] - Zhongguancun's subsidiary has had its application for the listing of Arolol hydrochloride tablets accepted by the National Medical Products Administration [21] Group 6 - Tianhong Co. has signed a property management contract worth 15 million yuan with a local company [22] - Dong'an Power has secured nine new market designation agreements in the second quarter, with a projected total sales volume of 1.5 million units [24] - Zhujiang Co. has appointed Zhao Kun as the new deputy general manager [25] Group 7 - Jinyi Industrial has won a bid for a project worth 335 million yuan from the China Railway Shanghai Bureau Group [26] - Kangchen Pharmaceutical has received a clinical trial notification for its innovative drug KC1086, aimed at treating advanced solid tumors [27] - Changhua Group has received a project designation notice from a new energy vehicle company, with an expected total sales amount of 970 million yuan [29] Group 8 - Lingxiao Pump Industry plans to use 60 million yuan of idle funds to purchase financial products [31] - Mould Technology has received a project designation for exterior parts from a well-known North American electric vehicle company, with an expected total sales of 1.236 billion yuan [34] - Fulongma has pre-bid for five sanitation service projects in June, with a total contract amount of 181 million yuan [35] Group 9 - Changchun High-tech plans to issue H-shares and list on the Hong Kong Stock Exchange [36] - *ST Yuancheng is under investigation by the CSRC for suspected false financial disclosures [37] - Beilu Pharmaceutical's subsidiary has received approval for the listing of Iopamidol raw materials [38] Group 10 - Zhejiang Liming's shareholder plans to reduce their stake by up to 2.93% [39] - Zhejiang Liming's actual controller has committed not to reduce their holdings within a year [40] - SAIC Motor reported a total vehicle sales of 2.0526 million units in the first half of 2025, a year-on-year increase of 12.35% [41] Group 11 - Xinhongcheng expects a net profit increase of 50%-70% for the first half of 2025 [42] - Xianhe Co. plans to invest 11 billion yuan in a bamboo pulp paper integrated project [42] - Great Wall Motors reported a total vehicle sales of 569,800 units in the first half of 2025, a year-on-year increase of 1.81% [43] Group 12 - Dongfeng Co. received a government subsidy of 10 million yuan [44] - Zhongke Environmental Protection has acquired two water environmental companies in Guangxi for a total of 353 million yuan [45] - Anji Food's H-share public offering is priced at 60 Hong Kong dollars per share [46]
贝达药业:盐酸恩沙替尼胶囊获澳门批准上市
news flash· 2025-07-02 09:00
Core Viewpoint - The approval of Enasidenib capsules (brand name: Beimingna) by the Macao Drug Regulatory Authority marks a significant milestone for the company in treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients [1] Group 1: Product Development and Approvals - Enasidenib is a new generation ALK inhibitor developed jointly by the company and its subsidiary Xcovery [1] - The drug received approval for second-line indications from the National Medical Products Administration of China in November 2020 [1] - In March 2022, the first-line indication was approved, followed by the approval for clinical trials of postoperative adjuvant therapy in April 2022, with ongoing Phase III clinical research [1] Group 2: Market Access and Insurance Inclusion - Enasidenib was included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2023) with an agreement valid until December 31, 2025 [1] - The first-line indication is expected to receive approval from the U.S. Food and Drug Administration in December 2024 [1] Group 3: Competitive Landscape - As of the announcement date, other ALK inhibitors available in Macao include Crizotinib, Ceritinib, Alectinib, Brigatinib, and Lorlatinib [1]
贝达药业(300558) - 关于澳门药物监督管理局批准盐酸恩沙替尼胶囊上市的公告
2025-07-02 08:56
证券代码:300558 证券简称:贝达药业 公告编号:2025-047 二、药品概况及同类药品市场状况 贝达药业股份有限公司 关于澳门药物监督管理局批准盐酸恩沙替尼胶囊上市的公告 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。 近日,中华人民共和国澳门特别行政区药物监督管理局(以下简称"ISAF") 官方网站公示,ISAF 批准贝达药业股份有限公司(以下简称"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")上市。本 次获批的适应症为:本品单药适用于间变性淋巴瘤激酶(ALK)阳性的局部晚期 或转移性的非小细胞肺癌(NSCLC)患者的治疗。现将具体情况公告如下: 一、药品信息 产品名称:盐酸恩沙替尼胶囊 药品类别:新药 持有人:贝达药业股份有限公司 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 Holdings, Inc.(以下简称"Xcovery")共同开发的自主创新药。2020 年 11 月,恩沙替尼"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 ...
细胞免疫治疗概念涨3.12%,主力资金净流入29股
Zheng Quan Shi Bao Wang· 2025-07-01 10:19
Core Viewpoint - The cell immunotherapy concept has seen a significant increase of 3.12%, ranking as the second highest in concept sector gains, with notable inflows of capital into 29 stocks within this sector [2][3]. Group 1: Market Performance - As of July 1, the cell immunotherapy concept experienced a 3.12% increase, with 45 stocks rising, including Yangpu Medical at a 20% limit up, and others like Saily Medical, Yuekang Pharmaceutical, Shutaishen, and Rongchang Bio showing gains of 15.55%, 15.34%, and 13.04% respectively [2][3]. - The leading decliners in this sector included *ST Biology, He’s Eye Hospital, and ST Zhongzhu, which fell by 1.36%, 0.63%, and 0.60% respectively [2]. Group 2: Capital Inflows - The cell immunotherapy sector attracted a net inflow of 472 million yuan, with 29 stocks receiving capital inflows, and 6 stocks seeing inflows exceeding 50 million yuan [3][4]. - Saily Medical led the net inflow with 177 million yuan, followed by Huahai Pharmaceutical, Betta Pharmaceutical, and Yangpu Medical with net inflows of 135 million yuan, 81.83 million yuan, and 75.87 million yuan respectively [3][4]. Group 3: Capital Flow Ratios - The top stocks by net inflow ratio included Yangpu Medical at 36.23%, Saily Medical at 19.83%, and Huahai Pharmaceutical at 14.87% [4]. - The detailed capital flow for key stocks showed Saily Medical with a 10% increase and a turnover rate of 29.87%, while Yangpu Medical had a 19.94% increase with a turnover rate of 9.99% [4][5].
生物医药新质生产力崛起:深市企业勾勒中国创新药全球竞争新坐标
Zheng Quan Shi Bao Wang· 2025-06-30 09:26
Core Insights - The biopharmaceutical industry in China has significant growth potential, driven by a series of supportive policies aimed at promoting innovative drug development [1][2] - Companies in the Shenzhen market are focusing on independent innovation to explore new frontiers in life and health, contributing to the global pharmaceutical innovation landscape [1][2] Policy Support - The Chinese government has intensified support for the innovative drug industry, with a comprehensive policy framework established in July 2024 to enhance various aspects such as pricing management, insurance payments, and clinical trial approvals [2] - Local governments are also actively promoting the development of innovative drugs, exemplified by Beijing's plan for high-quality construction of an international pharmaceutical innovation park from 2025 to 2030 [2] Company Developments - Huadong Medicine (000963) has 133 ongoing pharmaceutical projects, with 94 focused on innovative drugs and biosimilars, including a diverse range of drug types targeting various diseases [3][5] - Haizhu Pharmaceutical (002653) has 14 innovative drug products in clinical stages, emphasizing its commitment to becoming a trusted international pharmaceutical company [3] - Betta Pharmaceuticals (300558) has over 20 years of experience in cancer drug innovation and is focused on developing proprietary drugs [3] Financial Performance - Huadong Medicine reported a 16.77% increase in R&D investment to 2.678 billion yuan in 2024, with direct R&D expenses accounting for 12.91% of its pharmaceutical revenue [5][6] - Haizhu Pharmaceutical's revenue reached 3.721 billion yuan in 2024, a 10.92% increase, with a net profit of 395 million yuan, reflecting a 34% growth [6] - Betta Pharmaceuticals achieved a revenue of 2.892 billion yuan in 2024, marking a 17.74% increase, with a net profit growth of 55.92% [7]
海思科1类创新药获批受理,深市药企政策红利下加速突围!
Sou Hu Cai Jing· 2025-06-30 00:11
Core Viewpoint - The pharmaceutical industry in Shenzhen is experiencing unprecedented development opportunities driven by continuous national policy support, with companies like Haizhi Pharmaceutical Group making significant progress in innovative drug development [1][3]. Policy Support and Industry Growth - The national government has enhanced support for the innovative drug industry, establishing a multi-dimensional policy framework that significantly reduces the time for innovative drugs to reach the market [3]. - The establishment of a dynamic adjustment mechanism for the medical insurance catalog has created a green channel for innovative drugs, accelerating the translation of innovative results into clinical applications [3]. - Local governments are also actively responding to national strategies, exemplified by Beijing's plan for the International Pharmaceutical Innovation Park, which aims to provide comprehensive services and expedite product registration processes for innovative drugs [3]. Company Innovations and Achievements - Shenzhen's innovative pharmaceutical companies have made remarkable breakthroughs, with Huadong Medicine developing a product matrix in key areas such as autoimmune diseases and oncology, successfully launching multiple innovative drugs that are now included in the medical insurance catalog [3]. - Betta Pharmaceuticals has established a complete product line targeting key lung cancer markers and is expanding into other therapeutic areas, demonstrating a long-term commitment to oncology innovation [3]. Challenges in Drug Development - Despite positive growth, Shenzhen's innovative pharmaceutical companies face significant challenges, including the complexity of the R&D process, high costs, and low success rates in clinical trials [4]. - The average time for innovative drug development is between 10 to 15 years, with a clinical trial failure rate exceeding 90%, creating substantial financial pressure on companies [4]. - There is a notable shortage of high-end interdisciplinary R&D talent, leading to high training costs and difficulties in fundraising due to the high-risk nature of innovative drug development [4]. Strategic Responses to Challenges - Companies are seeking breakthroughs through differentiated strategies, international expansion, and technological innovation, with Huadong Medicine completing over 30 business development collaborations in the past five years to enhance its R&D capabilities [4][5]. - Betta Pharmaceuticals is focusing on building an innovation ecosystem based on collaboration and shared resources, aiming to foster interaction among talent, projects, information, and funding [5]. - The industry is demonstrating a proactive approach to challenges, emphasizing the importance of innovation and transformation to secure a position in the global pharmaceutical landscape [5].
《学习时报》称加快创新药研发具有多重战略意义,创新药ETF天弘(517380)冲击三连涨,机构持续看好创新药为医药板块投资主线
2 1 Shi Ji Jing Ji Bao Dao· 2025-06-25 02:23
Group 1 - The A-share market indices showed positive performance, with the pharmaceutical sector remaining active, particularly the innovative drug ETF Tianhong (517380), which rose by 1.53% [1] - The innovative drug ETF Tianhong is the largest in the market, covering both A-shares and Hong Kong stocks, and has achieved a net value growth rate of 24.96% over the past year, outperforming its benchmark by 5.45% [1] - The Biopharmaceutical ETF (159859) also saw an increase of 0.55%, with a trading volume exceeding 20 million yuan, indicating strong investor interest [1] Group 2 - The article from "Learning Times" emphasizes the strategic importance of accelerating innovative drug research and development, highlighting the need for a sustainable investment and financing system in the pharmaceutical sector [2] - Recommendations include enhancing multi-tiered capital market support for pharmaceutical companies, encouraging long-term funds to invest in biopharmaceuticals, and creating a favorable incubation environment for the industry [2] - The article also suggests improving mechanisms for handling innovation failures and enhancing intellectual property protection to incentivize high-quality research outputs [2] Group 3 - According to Zhongtai Securities, innovative drugs represent a clear industry trend with significant growth potential, and the investment focus on innovative drugs is expected to remain unchanged throughout the year [3] - Guojin Securities expresses strong confidence in the pharmaceutical sector reversing its trend by 2025, with innovative drugs being a key investment opportunity [3] - Xiangcai Securities notes that after a decade of investment in innovative drugs, the sector is entering a phase of results realization, supported by continuous clinical data and accelerated commercialization [3]
医药行业周报:本周医药下跌4.4%,创新药械再迎审评审批端支持政策,圣诺25H1预告利润高增-20250622
Shenwan Hongyuan Securities· 2025-06-22 08:13
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical industry, indicating a positive outlook for the sector compared to the overall market performance [23]. Core Insights - The pharmaceutical sector experienced a decline of 4.4% this week, underperforming the Shanghai Composite Index, which fell by 0.5% [2][3]. - The overall valuation of the pharmaceutical sector stands at 28.7 times PE (2025E), ranking it 5th among 31 sub-industries [5][10]. - Recent policies from the National Medical Products Administration (NMPA) aim to support the development of high-end medical devices and accelerate the clinical review process for innovative drugs [12]. - Shengnuo Biopharma forecasts a significant profit increase for H1 2025, with expected net profit ranging from 77.03 million to 94.14 million yuan, marking a year-on-year growth of 253.54% to 332.10% [13]. Market Performance - The pharmaceutical and biotechnology index ranked 29th out of 31 sub-industries this week, with various segments showing declines, including chemical preparations (-5.7%) and medical devices (-3.7%) [2][5]. - The report highlights the strong growth in product revenue and licensing deals in the innovative drug sector over the past three years, with a focus on companies expected to release major products and those involved in the CXO industry [12]. Key Events - The NMPA has approved measures to encourage the innovation of high-end medical devices, including optimizing special approval processes and enhancing regulatory frameworks [12]. - The NMPA has also proposed a 30-day review process for clinical trial applications of innovative drugs, aimed at improving the efficiency of drug development [12].