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ST葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司关于注射用头孢噻肟钠通过仿制药一致性评价的公告
2025-07-17 08:45
关于注射用头孢噻肟钠通过仿制药一致性评价的公告 证券代码:605199 证券简称:葫芦娃 公告编号:2025-049 海南葫芦娃药业集团股份有限公司 和关节感染、中枢神经系统感染。 截至本公告披露日,除了本公司外,该药品已通过一致性评价的生产厂家超过 3 家。 公司对该药品的一致性评价已累计投入研发费用为 361.39 万元人民币(未经审计)。 三、对公司的影响及投资风险 公司注射用头孢噻肟钠通过仿制药一致性评价,有利于提升该药品的市场竞争力, 对该药品的市场销售产生积极影响,同时也为公司后续产品开展仿制药一致性评价工作 积累了宝贵的经验。因药品销售易受到行业政策、招标采购、市场环境等因素影响,存 在较大不确定性。敬请广大投资者谨慎决策,注意防范投资风险。 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、准确性和完整性承担法律责任。 海南葫芦娃药业集团股份有限公司(以下简称"公司")近日收到国家药品监督管 理局核准签发的关于注射用头孢噻肟钠(以下简称"该药品")的《药品补充申请批准 通知书》,该药品通过仿制药质量和疗效一致性评价。现将有关情况公告如下: 一 ...
葫芦娃(605199) - 2025 Q2 - 季度业绩预告
2025-07-14 10:45
[Current Period Performance Forecast](index=1&type=section&id=%E4%B8%80%E3%80%81%E6%9C%AC%E6%9C%9F%E4%B8%9A%E7%BB%A9%E9%A2%84%E5%91%8A%E6%83%85%E5%86%B5) The company forecasts a significant decline in its 2025 first-half performance, with net profit attributable to shareholders expected to drop by 75.66% to 100.00% - This performance forecast applies as the company expects to be profitable, but net profit is projected to decrease by over **50%** compared to the prior year[3](index=3&type=chunk) 2025 First-Half Performance Forecast vs. 2024 First-Half | Indicator | 2025 First-Half Forecast | 2024 First-Half | Year-over-Year Change | | :--- | :--- | :--- | :--- | | Net Profit Attributable to Shareholders | 0 to 10 Million Yuan | 41.0925 Million Yuan | ↓ 75.66% to 100.00% | | Net Profit Attributable to Shareholders (Excluding Non-Recurring Items) | -22 to -12 Million Yuan | 4.5309 Million Yuan | ↓ 364.85% to 585.55% | [Prior Period Operating Performance and Financial Status](index=2&type=section&id=%E4%BA%8C%E3%80%81%E4%B8%8A%E5%B9%B4%E5%90%8C%E6%9C%9F%E7%BB%8F%E8%90%A5%E4%B8%9A%E7%BB%A9%E5%92%8C%E8%B4%A2%E5%8A%A1%E7%8A%B6%E5%86%B5) The company disclosed its restated 2024 first-half financial data as a comparative baseline, including net profit attributable to shareholders and earnings per share 2024 First-Half Financial Data | Indicator | 2024 First-Half Data | | :--- | :--- | | Total Profit | 50.2030 Million Yuan | | Net Profit Attributable to Shareholders | 41.0925 Million Yuan | | Net Profit Attributable to Shareholders (Excluding Non-Recurring Items) | 4.5309 Million Yuan | | Earnings Per Share | 0.1 Yuan | - Prior period data has been restated due to retrospective adjustments for accounting errors[6](index=6&type=chunk) [Primary Reasons for Current Period Performance Decline](index=2&type=section&id=%E4%B8%89%E3%80%81%E6%9C%AC%E6%9C%9F%E4%B8%9A%E7%BB%A9%E9%A2%84%E5%87%8F%E7%9A%84%E4%B8%BB%E8%A6%81%E5%8E%9F%E5%9B%A0) The significant decline in current period performance is primarily attributed to shifts in industry competition, leading to reduced sales revenue and profit - The performance decline is primarily due to changes in the industry competitive landscape, resulting in decreased sales revenue and reduced profit[9](index=9&type=chunk) [Risk Warning](index=2&type=section&id=%E5%9B%9B%E3%80%81%E9%A3%8E%E9%99%A9%E6%8F%90%E7%A4%BA) The company warns that the performance forecast data is a preliminary financial estimate, unaudited by certified public accountants, and thus the final results may be uncertain - This performance forecast is a preliminary calculation by the company's finance department, unaudited by certified public accountants, and its accuracy is uncertain[10](index=10&type=chunk) [Other Explanatory Matters](index=2&type=section&id=%E4%BA%94%E3%80%81%E5%85%B6%E4%BB%96%E8%AF%B4%E6%98%8E%E4%BA%8B%E9%A1%B9) The company reiterates that the forecast data is preliminary, and final accurate financial figures will be based on the officially disclosed 2025 semi-annual report - The final accurate financial data will be based on the company's officially disclosed 2025 semi-annual report, and investors are advised to be aware of investment risks[11](index=11&type=chunk)
ST葫芦娃: 海南葫芦娃药业集团股份有限公司关于获得头孢丙烯干混悬剂药品注册证书的公告
Zheng Quan Zhi Xing· 2025-07-10 16:22
Core Viewpoint - The company has received the drug registration certificate for Cefprozil Dry Suspension from the National Medical Products Administration, which will enhance its product line and positively impact its development [1][2]. Drug Information - Drug Name: Cefprozil Dry Suspension - Dosage Form: Oral Suspension - Registration Category: Chemical Drug Class 3 - Specification: 2.5g (based on C??H??N?O?S) - License Holder: Hainan Huluwa Pharmaceutical Group Co., Ltd. - Acceptance Number: CYHS2302198 - Drug Approval Number: National Drug Approval H20254800 - Approval Conclusion: The drug meets the registration requirements and has been granted a registration certificate, pending compliance inspection for production quality management [1][2]. R&D and Related Information - Cefprozil is a cephalosporin antibiotic originally developed by Bristol-Myers Squibb Company, indicated for mild to moderate infections caused by sensitive bacteria, including: 1. Streptococcal pharyngitis/tonsillitis 2. Otitis media and acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), and Moraxella catarrhalis (including beta-lactamase producing strains) 3. Acute bronchitis secondary bacterial infections and acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis (including beta-lactamase producing strains) 4. Non-complex skin and soft tissue infections caused by bacteria, although abscesses typically require surgical drainage [2]. - The company has invested a total of RMB 4.9474 million (approximately 0.49474 million) in the R&D of this product [2]. - As of the announcement date, eight other companies in China have also been approved to produce Cefprozil Dry Suspension, with a total of 13 specifications approved [2].
ST葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司关于获得头孢丙烯干混悬剂药品注册证书的公告
2025-07-10 09:15
证券代码:605199 证券简称:葫芦娃 公告编号:2025-047 海南葫芦娃药业集团股份有限公司 关于获得头孢丙烯干混悬剂药品注册证书的公告 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、准确性和完整性承担法律责任。 海南葫芦娃药业集团股份有限公司(以下简称"公司")近日收到国家药品监督管 理局(以下简称"国家药监局")核准签发的关于头孢丙烯干混悬剂的《药品注册证书》。 现将有关情况公告如下: 一、药品基本情况 药物名称:头孢丙烯干混悬剂 剂型:口服混悬剂 注册分类:化学药品 3 类 规格:2.5g(按 C₁₈H₁₉N₃O₅S 计) 上市许可持有人:海南葫芦娃药业集团股份有限公司 受理号:CYHS2302198 药品批准文号:国药准字 H20254800 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药 品注册的有关要求,批准注册,发给药品注册证书。质量标准、说明书、标签及生产工 艺照所附执行。 本品上市前需进行药品生产质量管理规范符合性检查。 二、药品研发及相关 头孢丙烯是一种头孢菌素抗生素,原研单位为 Bristol-My ...
ST葫芦娃(605199) - 立信会计师事务所(特殊普通合伙)关于2024年年度报告的信息披露监管问询函的回复
2025-07-04 10:47
7信会计师事务所(特殊普通; O CHINA SHU LUN PAN CERTIFIED PUBLIC ACCOUNTANTS LLP 立信会计师事务所(特殊普通合伙) 关于对海南葫芦娃药业集团股份有限公司 2024 年年度报告的信息披露监管问询函的回复 信会师函字[2025]第 ZA320 号 上海证券交易所上市公司管理一部: 海南葫芦娃药业集团股份有限公司(以下简称"葫芦姑"或"公司")2025 年 6月13日收到贵部下发的《关于海南葫芦娃药业集团股份有限公司 2024年年 度报告的信息披露监管间询函》(上证公函【2025】第 0838 号)(以下简称"年 报问询函"),立信会计师事务所(特殊普通合伙)(以下简称"本所"或"年审 会计师")作为葫芦娃2024年年报审计机构,对贵部间询函中要求本所发表意见 的事项回复如下: 问题 1:关于差错更正事项。年报及临时公告显示,年审会计师对公司财务 报表出具保留意见,内部控制出具否定意见,涉及公司对 2023年度财务报表进 行差错更正、控股股东向公司客户提供资金支持等事项。2023 年公司部分销售 业务提前确认收入,部分销售业务销售价格异常,以及因提前确认收入产生 ...
ST葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司关于2024年年度报告的信息披露监管问询函的回复公告
2025-07-04 10:45
海南葫芦娃药业集团股份有限公司 关于 2024 年年度报告的信息披露监管问询函的回复公告 海南葫芦娃药业集团股份有限公司(以下简称"公司")于近期收到上海证 券交易所《关于海南葫芦娃药业集团股份有限公司 2024 年年度报告的信息披露 监管问询函》(上证公函【2025】0838 号)(以下简称"《问询函》")。公 司对《问询函》涉及的问题进行了逐项核实,现将回复情况公告如下: 问题 1.关于差错更正事项。 年报及临时公告显示,年审会计师对公司财 务报表出具保留意见,内部控制出具否定意见,涉及公司对 2023 年度财务报表 进行差错更正、控股股东向公司客户提供资金支持等事项。2023 年公司部分销 售业务提前确认收入,部分销售业务销售价格异常,以及因提前确认收入产生 对应费用差异,导致公司相关定期报告披露的财务数据不准确。 请公司补充披露:(1)公司提前确认收入对应的客户名称、销售产品类 型、销售收入、更正前后的收入确认时点、确认依据以及对应费用金额、类型、 用途、归属区间的确认标准;(2)公司产品销售价格异常对应的产品名称、调 整前后价格以及对收入的影响,并列明涉及的销售客户情况;(3)控股股东向 公司客户提 ...
ST葫芦娃: 海南葫芦娃药业集团股份有限公司第三届监事会2025年第二次临时决议公告
Zheng Quan Zhi Xing· 2025-06-27 16:12
Group 1 - The third supervisory board meeting of Hainan Huluwa Pharmaceutical Group Co., Ltd. was held on June 27, 2025, in accordance with relevant laws and regulations [1][2] - The meeting was attended by all three supervisors, and the chairman of the supervisory board presided over the meeting [1][2] - The supervisory board approved the proposal to temporarily use idle raised funds to supplement the company's working capital, which aligns with regulatory requirements and does not affect the normal investment plan of the raised funds [2] Group 2 - The voting results showed unanimous support with 3 votes in favor, 0 abstentions, and 0 votes against [2] - The supervisory board believes that the temporary use of idle funds will enhance the efficiency of fund utilization and is in the best interest of all shareholders [2]
ST葫芦娃: 海南葫芦娃药业集团股份有限公司关于延期披露会计差错更正审计报告的提示性公告
Zheng Quan Zhi Xing· 2025-06-27 16:12
Core Viewpoint - The company has announced a delay in the disclosure of the audit report for correcting prior accounting errors due to the substantial workload involved in the process [1][2] Group 1 - The company's board approved a proposal to correct prior accounting errors in accordance with relevant accounting standards and regulations [1] - The audit work is being actively pursued, but the company is unable to complete it as originally planned due to the extensive nature of the tasks involved [1] - The company expresses apologies for any inconvenience caused to investors during this delay and seeks their understanding [2] Group 2 - The company is enhancing communication and collaboration with the accounting firm, increasing the number of professionals involved to expedite the audit process [2] - The company is committed to adhering to legal and regulatory requirements while ensuring the quality of the audit work [2]
ST葫芦娃: 海南葫芦娃药业集团股份有限公司关于聘任公司总经理的公告
Zheng Quan Zhi Xing· 2025-06-27 16:11
Core Viewpoint - The company has appointed Liu Jingping as the new General Manager, effective from the date of the board meeting, until the end of the current board's term [1]. Group 1: Appointment Details - The board of directors held a meeting on June 27, 2025, where they approved the appointment of Liu Jingping as General Manager [1]. - Liu Jingping's qualifications were reviewed and deemed compliant with relevant regulations, including the Company Law and the Shanghai Stock Exchange's guidelines [1]. Group 2: Liu Jingping's Background - Liu Jingping, born in 1970, holds a doctoral degree and has extensive experience in the industry [1]. - Previous positions include Chairperson of Hainan Biological Products Company from September 2001 to August 2006, and Executive Director and General Manager of Hainan Kandi Health Industry Investment Co., Ltd. from May 2006 to August 2018 [1]. - Liu has served as the General Manager of the company from February 2016 until March 4, 2025, and currently holds multiple directorships in other companies [1].
信披违规,高管离职,ST葫芦娃“内忧外患”
Core Viewpoint - ST HuLuWa faces significant governance issues and financial challenges, including delayed performance disclosures and high executive turnover, which have led to regulatory penalties and a decline in revenue from key product lines [1][2][3]. Governance and Compliance Issues - The company was penalized by the Shanghai Stock Exchange for failing to disclose a performance warning within the required timeframe, with a projected loss of 250 million to 280 million yuan for the 2024 fiscal year [1]. - High executive turnover has been a persistent issue, with the resignation of long-term chairman and general manager Liu Jingping and the brief tenure of his successor Zhang Mingrui [2][3]. - Previous compliance failures included warnings issued to the former vice president for insider trading, highlighting significant internal control weaknesses [3]. Financial Performance and Challenges - ST HuLuWa's revenue from digestive system drugs fell by 56.94% year-on-year, while sales expenses remained high, indicating pressure from both pricing strategies and cost fluctuations in raw materials [1][6]. - The company's sales expenses reached 611 million yuan in 2024, accounting for 43% of its revenue, significantly higher than many industry peers [9]. Market Dynamics and Competition - The pediatric medication market is undergoing significant changes, with public hospitals increasing their market share to 50.1% in 2024, while retail pharmacy shares have fluctuated [6]. - Competitors like Kuihua Pharmaceutical and Jichuan Pharmaceutical are rapidly expanding their market presence through unique products and strategic acquisitions [1][8]. R&D and Innovation - ST HuLuWa has 116 projects in development, including several innovative traditional Chinese medicine products, but faces challenges in maintaining sustainable R&D investment [8][9]. - The company reported a 77.79% increase in R&D expenses in 2024, but this trend reversed sharply in the first quarter of 2025, raising concerns about the continuity of its innovation pipeline [9].