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博瑞医药(688166) - 自愿披露关于噻托溴铵吸入粉雾剂获得药物临床试验批准通知书的公告
2025-07-08 15:15
博瑞生物医药(苏州)股份有限公司 自愿披露关于噻托溴铵吸入粉雾剂获得 药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 博瑞生物医药(苏州)股份有限公司(以下简称"公司")控股子公司艾 特美(苏州)医药科技有限公司(以下简称"艾特美")近日收到国家药品监督管 理局(以下简称"国家药监局")签发的《药物临床试验批准通知书》,同意艾特 美噻托溴铵吸入粉雾剂开展用于慢性阻塞性肺疾病(COPD)的临床试验。 相关风险提示: 1、根据国家药品注册相关法律法规要求,药品在获得《药物临床试验批准通 知书》后,尚需按照通知书内容开展临床试验,完成临床试验后还需提交上市申 请并经国家药监局批准后方可生产上市,短期内对公司经营业务不会产生较大影 响。 2、药品的研发周期长、审批环节多、研发投入大,各环节均受多维度因素影 响,不可预测因素较多,敬请广大投资者谨慎决策,注意防范投资风险。公司将 积极推进上述研发项目,并按相关法律法规要求及时对后续进展情况履行信息披 露义务。 | 药品名称 | 噻托溴铵吸 ...
博瑞医药(688166) - 自愿披露关于噻托溴铵吸入粉雾剂获得药物临床试验批准通知书的公告
2025-07-08 09:00
证券代码:688166 证券简称:博瑞医药 公告编号:2025-044 博瑞生物医药(苏州)股份有限公司 自 愿披露关于噻托溴铵吸入粉雾剂获得 药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 博瑞生物医药(苏州)股份有限公司(以下简称"公司")控股子公司艾 特美(苏州)医药科技有限公司(以下简称"艾特美")近日收到国家药品监督 管理局(以下简称"国家药监局")签发的《药物临床试验批准通知书》,同意艾 特美噻托溴铵吸入粉雾剂开展用于慢性阻塞性肺疾病(COPD)的临床试验。 相关风险提示: 1、根据国家药品注册相关法律法规要求,药品在获得《药物临床试验批准 通知书》后,尚需按照通知书内容开展临床试验,完成临床试验后还需提交上市 申请并经国家药监局批准后方可生产上市,短期内对公司经营业务不会产生较大 影响。 2、药品的研发周期长、审批环节多、研发投入大,各环节均受多维度因素 影响,不可预测因素较多,敬请广大投资者谨慎决策,注意防范投资风险。公司 将积极推进上述研发项目,并按相关法律法 ...
博瑞医药:噻托溴铵吸入粉雾剂获药物临床试验批准
news flash· 2025-07-08 08:46
Core Viewpoint - The announcement indicates that the subsidiary Aitemei (Suzhou) Pharmaceutical Technology Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of Tiotropium Bromide Inhalation Powder for the treatment of Chronic Obstructive Pulmonary Disease (COPD) [1] Group 1 - Aitemei has been granted a Clinical Trial Approval Notice for Tiotropium Bromide Inhalation Powder, which is intended for use in COPD [1] - The projected domestic sales for Tiotropium Bromide Inhalation Powder are 555 million yuan in 2022, 522 million yuan in 2023, and 493 million yuan in 2024 [1] - The drug must undergo clinical trials and receive further approval before it can be manufactured and marketed, indicating that there will be no significant short-term impact on the company's operations [1]
博瑞医药(688166) - 可转债转股结果暨股份变动公告
2025-07-01 08:47
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 证券代码:688166 证券简称:博瑞医药 公告编号:2025-043 转债代码:118004 转债简称:博瑞转债 博瑞生物医药(苏州)股份有限公司 可转债转股结果暨股份变动公告 转股情况:"博瑞转债"自 2022 年 7 月 11 日起开始进入转股期。2025 年 4 月 1 日至 2025 年 6 月 30 日期间,"博瑞转债"共有人民币 10,408,000 元已 转换为公司股票,转股数量为 298,728 股,占"博瑞转债"转股前公司已发行股 份总额的 0.0729%。截至 2025 年 6 月 30 日,"博瑞转债"共有人民币 10,567,000 元已转换为公司股票,转股数量为 303,278 股,占"博瑞转债"转股前公司已发 行股份总额的 0.0740%。 未转股可转债情况:截至 2025 年 6 月 30 日,"博瑞转债"尚未转股的 可转债金额为 454,427,000 元,占"博瑞转债"发行总量的 97.7262%。 一、可转债发行上市概况 ...
医药生物行业周报:《2025年基本医保目录及商保创新药目录调整申报操作指南》出炉,继续看好创新药-20250701
Guoyuan Securities· 2025-07-01 05:53
Investment Rating - The report maintains a "Recommended" investment rating for the healthcare sector [7]. Core Insights - The healthcare sector has shown a mixed performance, with the Shenyin Wanguo Pharmaceutical Bio Index rising by 1.60% from June 23 to June 27, 2025, underperforming the CSI 300 Index by 0.35 percentage points [2][12]. - Year-to-date, the pharmaceutical sector has increased by 6.24%, outperforming the CSI 300 Index by 6.57 percentage points, ranking 11th among 31 sectors [2][14]. - As of June 27, 2025, the valuation of the pharmaceutical sector stands at 27.54 times (TTM overall method, excluding negative values), with a premium of 140.94% compared to the CSI 300 [2][17]. Summary by Sections 1. Market Performance - The pharmaceutical sector's performance from June 23 to June 27, 2025, was a 1.60% increase, ranking 23rd among 31 sectors [12]. - The year-to-date performance shows a 6.24% increase, ranking 11th among 31 sectors [14]. 2. Important Events - The National Healthcare Security Administration released the "2025 Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory Adjustment Application Guidelines," marking a significant step for commercial health insurance in the multi-level medical security system [4][21]. 3. Industry Perspective - The inclusion of the commercial insurance innovative drug directory indicates an enhanced role for commercial insurance in the multi-level medical security system, providing greater opportunities for the industry [5][22]. - The report expresses optimism for innovative drugs, overseas expansion, and the clearing of procurement in specific segments, suggesting a focus on companies involved in these areas [22].
募资管理使用违规被警示 博瑞医药近五年屡遭监管点名
Bei Ke Cai Jing· 2025-07-01 04:58
Core Viewpoint - The company, Borui Biopharmaceuticals, has received a warning letter from the Jiangsu Securities Regulatory Bureau due to violations in the management and disclosure of raised funds, highlighting ongoing compliance issues and financial struggles [1][2][4]. Group 1: Regulatory Actions - The Jiangsu Securities Regulatory Bureau issued a warning letter to Borui Biopharmaceuticals and its CFO, Zou Yuanlai, for failing to ensure proper use of raised funds and timely disclosure of related information [2][4]. - Borui Biopharmaceuticals has faced multiple regulatory measures over the past five years, including a warning for unclear disclosures regarding the production status of antiviral drugs [5][6]. Group 2: Financial Performance - The company has experienced a continuous decline in net profit for three consecutive years, with figures of 240 million RMB, 203 million RMB, and 189 million RMB for 2022, 2023, and 2024 respectively, representing year-on-year declines of 1.77%, 15.51%, and 6.57% [7]. - In Q1 2025, Borui Biopharmaceuticals reported a revenue of 249 million RMB, down 26.81% year-on-year, and a net profit of 12.96 million RMB, down 79.77% year-on-year, attributed to reduced sales and increased depreciation from ongoing projects [7]. Group 3: Financial Pressure and Funding Strategies - The company's cash reserves have been declining, with figures of 1.18 billion RMB, 969 million RMB, and 765 million RMB at the end of 2022, 2023, and 2024 respectively, and 813 million RMB as of March 30, 2025 [8]. - To alleviate financial pressure, Borui Biopharmaceuticals plans to raise up to 500 million RMB through a private placement and has announced the issuance of up to 300 million RMB in medium-term notes for research and operational funding [9].
科创生物医药ETF(588250)上涨近1%,药品追溯码全面应用
Sou Hu Cai Jing· 2025-07-01 02:12
Group 1 - The Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index (000683) increased by 0.93% as of July 1, 2025, with notable gains from stocks such as Rongchang Biopharmaceutical (688331) up 7.21% and Shanghai Yizhong (688091) up 3.61% [1] - Starting July 1, 2025, a new policy mandates that all drug sales must include a verification code for medical insurance reimbursement, with full traceability of drug codes required by January 1, 2026, which is expected to enhance drug circulation regulation and impact the entire pharmaceutical industry chain [1] - The current bull market in innovative drugs is driven by the improvement of China's pharmaceutical innovation capabilities, with a trend towards international collaboration in new drug development expected to enhance profitability and market potential for Chinese pharmaceutical companies [2] Group 2 - As of June 30, 2025, the top ten weighted stocks in the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index accounted for 50.3% of the index, including companies like United Imaging Healthcare (688271) and BeiGene (688235) [3] - The Sci-Tech Biopharmaceutical ETF closely tracks the performance of the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index, which includes 50 large-cap companies in various biopharmaceutical sectors [2]
7月度金股:指数搭台,成长唱戏-20250630
Soochow Securities· 2025-06-30 01:33
Core Insights - The report emphasizes a focus on the technology sector for investment opportunities, particularly in growth stocks, as the market index has shown upward momentum [2][6]. - The report outlines a selection of ten key stocks, highlighting their respective industries, market capitalizations, earnings per share (EPS) forecasts, and price-to-earnings (PE) ratios for 2026 and 2027 [2][68]. Group 1: Key Stock Recommendations - **Neway Valve (603699.SH)**: A leading global industrial valve manufacturer, benefiting from a surge in LNG and marine engineering sectors, with expected overseas order growth of over 50% year-on-year in the first half of 2025 [11][12]. - **Yongxing Environmental (601033.SH)**: The sole operator of waste incineration in Guangzhou, with a projected capacity utilization rate of 79% and a commitment to high dividends, expecting a 174% increase in free cash flow in 2024 [17][18]. - **Aerospace Electronics (600879.SH)**: Focused on aerospace electronics and unmanned systems, with anticipated high growth driven by the commercial space industry and demand for satellite communication technologies [26][27]. - **Miaokelando (600882.SH)**: Positioned for long-term growth in the dairy sector, with a focus on product innovation and cost management, expecting significant revenue growth in the upcoming quarters [31][32]. - **Laopu Gold (6181.HK)**: A high-end gold jewelry brand with strong revenue growth, projected to achieve 8.51 billion yuan in revenue in 2024, benefiting from the expanding market for traditional gold products [36][38]. - **Jingzhida (688627.SH)**: Engaged in the semiconductor testing equipment sector, with significant market potential and expected strong performance due to key customer orders [42][43]. - **Shensanda A (000032.SZ)**: Positioned to benefit from the increasing demand for AI infrastructure and applications, with a strong foothold in public data services [47][48]. - **Sanqi Interactive (002555.SZ)**: Anticipating strong performance from new game releases, particularly the upcoming "Douluo Dalu: Hunting Soul World," with high player interest [53][56]. - **CATL (300750.SZ)**: Expected to maintain strong profit growth, with projected net profits of 66.1 billion yuan in 2025, driven by increasing demand for electric vehicle batteries [59][60]. - **Borui Pharmaceutical (688166.SH)**: Forecasted to achieve net profits of 2.6 billion yuan in 2025, with significant potential in the Amylin pipeline, which has attracted substantial investment interest [63][64]. Group 2: Financial Data Overview - The report provides detailed financial forecasts for the ten key stocks, including projected revenues and net profits for 2025 to 2027, highlighting the growth potential across various sectors [68]. - For instance, Neway Valve is expected to generate 74.53 billion yuan in revenue in 2025, with a net profit of 14.49 billion yuan, reflecting strong operational performance [68]. - CATL's projected revenue for 2025 is 472.43 billion yuan, with a net profit forecast of 66.13 billion yuan, indicating robust growth in the electric vehicle battery market [68].
博瑞医药(688166) - 关于公司及高管收到江苏证监局警示函的公告
2025-06-27 11:31
证券代码:688166 证券简称:博瑞医药 公告编号:2025-042 博瑞生物医药(苏州)股份有限公司 关于公司及高管收到江苏证监局警示函的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 一、 警示函主要内容 博瑞生物医药(苏州)股份有限公司、邹元来: 2019 年 11 月 27 日,公司召开董事会审议通过了《关于使用暂时闲置募集 资金进行现金管理的议案》,同意公司使用不超过人民币 3.8 亿元的暂时闲置募 集资金进行现金管理,使用期限不超过 12 个月,自董事会审议通过之日起 12 个月内有效。2020 年 11 月 26 日,上述董事会决议期限届满,公司未及时赎回 闲置募集资金现金管理的产品。 博瑞生物医药(苏州)股份有限公司(以下简称"公司")及财务总监邹元 来于近日收到中国证券监督管理委员会江苏监管局下达的《江苏证监局关于对博 瑞生物医药(苏州)股份有限公司、邹元来采取出具警示函措施的决定》([2025]83 号)(以下简称"警示函"),现将主要内容公告如下: 根据《上市公司信息披露管理办法》(证监会令第 ...
江苏证监局关于对博瑞生物医药(苏州)股份有限公司、邹元来采取出具警示函措施的决定
Xin Lang Cai Jing· 2025-06-27 08:22
Group 1 - The company, Borui Biopharmaceutical (Suzhou) Co., Ltd., approved a proposal to use up to RMB 380 million of temporarily idle raised funds for cash management, with a usage period not exceeding 12 months from the date of board approval [1] - The company failed to redeem the cash management products in a timely manner by the deadline of November 26, 2020, and did not hold a board meeting to review the cash management situation until December 11, 2020, violating disclosure obligations [1] - The actions of the company were found to be in violation of the relevant regulations regarding information disclosure and management of raised funds [1] Group 2 - The financial director, Zou Yuanlai, did not fulfill his responsibilities in ensuring the proper use of raised funds and timely disclosure of related information, which also constituted a violation of regulations [2] - The Jiangsu Securities Regulatory Bureau decided to issue a warning letter as an administrative regulatory measure and record it in the securities and futures market integrity file [2] - The company is required to enhance compliance awareness and submit a written report to the regulatory bureau within 10 working days of receiving the decision [2]