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海普瑞(002399) - 关于依诺肝素钠注射液获得EMA新增生产商批准的公告
2025-06-17 09:00
证券代码: 002399 证券简称:海普瑞 公告编号:2025-026 深圳市海普瑞药业集团股份有限公司 关于依诺肝素钠注射液获得EMA新增生产商批准的公告 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。 深圳市海普瑞药业集团股份有限公司(以下简称"海普瑞"或"公司")近日 收到欧洲药品管理局(以下简称"EMA")签发的关于依诺肝素钠注射液新增成 品制造商的批准通知。现将相关情况公告如下: 一、药品相关情况 (一)通用名称:依诺肝素钠 (二)商品名:Inhixa 三、风险提示 本次坪山制剂生产场地的获批对公司现阶段业绩暂不会产生重大影响。由于 医药行业的特点,药品的生产和销售可能受到政策法规调整、市场环境变化等不确 定因素的影响。敬请广大投资者谨慎决策,注意投资风险。 (六)生产场地地址:中国深圳市坪山区坑梓街道荣田路 1 号 (七)批准文号:EMA/VR/0000262543 二、对公司的影响 海普瑞坪山园区新建预灌封制剂生产线项目于2022年正式启动,首期新建三 条预灌封生产线设计产能为3.3亿支/年,按照中国、欧美药品法规标准设计建造, 用于生产依诺肝素 ...
海普瑞:依诺肝素钠注射液获EMA新增生产商批准
news flash· 2025-06-17 08:51
海普瑞(002399)公告,公司近日收到欧洲药品管理局(EMA)签发的关于依诺肝素钠注射液新增生产商 的批准通知。批准涉及的药品为依诺肝素钠注射液,商品名为Inhixa,剂型为注射液,规格包括 20mg/0.2ml,40mg/0.4ml,60mg/0.6ml,80mg/0.8ml,100mg/1ml,120mg/0.8ml,150mg/1ml。新增生产商为深圳 市海普瑞药业集团股份有限公司,生产场地地址位于中国深圳市坪山区坑梓街道荣田路1号,批准文号 为EMA/VR/26.25万。本次获批将为公司进一步推进制剂国际化战略提供更加充足的产能保障,切实提 高公司市场竞争力。 ...
智通港股52周新高、新低统计|6月16日
智通财经网· 2025-06-16 08:46
| 蜡笔小新食品(01262) | 2.530 | 2.600 | 2.77% | | --- | --- | --- | --- | | 中国罕王(03788) | 2.320 | 2.330 | 2.64% | | 六福集团(00590) | 22.000 | 22.350 | 2.52% | | 江苏宁沪高速公路 | 11.280 | 11.420 | 2.51% | | (00177) | | | | | 科济药业-B(02171) | 24.450 | 24.800 | 2.48% | | 恒基地产(00012) | 26.900 | 27.000 | 2.47% | | 希慎兴业(00014) | 14.300 | 14.380 | 2.42% | | 港华智慧能源(01083) | 3.780 | 3.890 | 2.37% | | 恒隆集团(00010) | 12.180 | 12.240 | 2.34% | | 天津创业环保股份 | 4.040 | 4.050 | 2.27% | | (01065) | | | | | 安徽皖通高速公路 | 13.820 | 13.900 | 2.21% | ...
海普瑞(002399) - 北京中银(深圳)律师事务所关于深圳市海普瑞药业集团股份有限公司2024年年度股东大会的法律意见书
2025-05-22 11:46
北京中银(深圳)律师事务所 关于深圳市海普瑞药业集团股份有限公司 2024 年年度股东大会的 法律意见书 地址:深圳市福田区益田路 6003 号荣超商务中心 A 座 5、6 层 电话:(86-755)82531588 传真:(86-755)82531555 邮编:518026 北京中银(深圳)律师事务所 法律意见书 北京中银(深圳)律师事务所 关于深圳市海普瑞药业集团股份有限公司 2024 年年度股东大会的 法律意见书 致:深圳市海普瑞药业集团股份有限公司 北京中银(深圳)律师事务所(以下简称"本所")接受深圳市海普瑞药业集 团股份有限公司(以下简称"公司")委托,就公司召开 2024 年年度股东大会(以 下简称"本次股东大会")的有关事宜,根据《中华人民共和国公司法》(以下简 称《公司法》)《上市公司股东大会规则》等法律、法规、规章和其他规范性文 件以及《深圳市海普瑞药业集团股份有限公司章程》(以下简称《公司章程》) 的有关规定,出具本法律意见书。 为出具本法律意见书,本所及本所律师依据《律师事务所从事证券法律业务 管理办法》和《律师事务所证券法律业务执业规则(试行)》等规定,严格履行 了法定职责,遵循了勤 ...
海普瑞(002399) - 2024年年度股东大会决议公告
2025-05-22 11:46
深圳市海普瑞药业集团股份有限公司 证券代码:002399 证券简称:海普瑞 公告编号:2025-025 2024年年度股东大会决议公告 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。 特别提示: 1、本次股东大会未出现否决提案的情形; 2、本次股东大会不涉及变更以往股东大会已通过的决议。 一、会议召开情况 1、会议召开时间: (1)现场会议时间:2025年5月22日下午14:00 3、会议召开方式:现场表决与网络投票相结合的方式 4、会议召集人:公司第六届董事会 5、会议主持人:董事长李锂 6、召开会议的通知已于2025年3月29日刊登在《证券时报》《中国证券报》 《上海证券报》《证券日报》及巨潮资讯网(www.cninfo.com.cn)上(2025-009)。 本次股东大会的召集及召开符合《中华人民共和国公司法》《上市公司股东 会规则》《深圳证券交易所股票上市规则》等法律法规、规范性文件及《深圳市 海普瑞药业集团股份有限公司章程》的有关规定。 二、会议出席情况 1、股东出席情况 (2)网络投票时间:2025年5月22日 公司A股股东通过深圳证券交易所交易系 ...
海普瑞(09989) - 2024 - 年度财报
2025-04-29 22:27
Financial Performance - In 2024, the Company reported revenue of RMB 5,258,919, a decrease of 3.2% compared to RMB 5,430,974 in 2023[15] - The profit before tax for 2024 was RMB 726,229, recovering from a loss of RMB 928,334 in 2023[15] - The profit attributable to owners of the Company for 2024 was RMB 646,742, compared to a loss of RMB 783,258 in 2023[15] - Basic earnings per share for 2024 was RMB 0.44, an improvement from a loss of RMB 0.53 in 2023[15] - The Group achieved a revenue of approximately RMB5,258.9 million and a net profit of approximately RMB624.9 million, marking significant year-on-year growth[27] - The Group achieved an operating revenue of approximately RMB5,258.9 million in 2024, representing a year-on-year decrease of approximately 3.2%[49] - Gross profit increased by approximately 84.9% year-on-year to approximately RMB1,739.3 million, with a gross margin of approximately 33.1%, up by approximately 15.8 percentage points year-on-year[49] - The Group turned from loss into profit, reporting a net profit of approximately RMB624.9 million, with net profit attributable to equity holders of the Company at approximately RMB646.7 million[49] - The Group's overall operating revenue was approximately RMB5,258.9 million, a year-on-year decrease of approximately 3.2%, while gross profit increased by approximately 84.9% to RMB1,739.3 million, with a gross margin of approximately 33.1%[52] - The impairment amount for inventory in 2024 was only approximately RMB7.6 million, significantly lower than RMB855.4 million in 2023, contributing to improved gross profit margins[102] - Finance costs decreased by approximately RMB82.9 million to approximately RMB145.2 million, representing a decrease of approximately 36.3% compared to 2023[106] - Income tax expense for the reporting period was approximately RMB 101.3 million, compared to a tax credit of approximately RMB 126.2 million in 2023[111] Assets and Liabilities - Total assets decreased to RMB 17,343,524 in 2024 from RMB 19,203,417 in 2023, reflecting a decline of 9.7%[16] - Total liabilities also decreased to RMB 5,141,403 in 2024, down from RMB 7,215,040 in 2023, a reduction of 28.8%[16] - The asset-liability ratio was approximately 29.6% as of December 31, 2024, down from approximately 37.6% in 2023[127] - As of December 31, 2024, the group's cash and bank balances were approximately RMB 1,421.8 million, down from approximately RMB 1,765.6 million in 2023[118] - The group recorded short-term loans of approximately RMB 2,367.2 million and long-term loans of approximately RMB 1,081.0 million as of December 31, 2024[119] - The Group's total financial indebtedness decreased to approximately RMB3,544.8 million from RMB5,562.8 million as of December 31, 2023, representing a reduction of about 36.4%[140] - The Group's interest-bearing bank and other borrowings were approximately RMB3,448.2 million as of December 31, 2024, down from RMB5,434.6 million in the previous year, indicating a decrease of approximately 36.5%[140] - The Group's lease liabilities decreased to RMB96.6 million as of December 31, 2024, from RMB128.2 million as of December 31, 2023, a reduction of about 24.6%[140] Business Strategy and Operations - The Company emphasized its commitment to innovation-driven and globalization strategies, enhancing its global marketing network[24] - The Company aims to consolidate its leading position in the international heparin market through a vertically integrated industry chain[24] - The Company has transformed from a local enterprise to a global leader in the heparin field over the past decade[24] - The heparin business, as the core pillar, set a historical best performance with a significant leap in market share due to enhanced local operations and market penetration[28] - The CDMO business exhibited strong growth, forming a "dual-wheel drive" development pattern, enhancing market competitiveness and overall performance[29] - The Group plans to further optimize the vertical integration of the heparin industry chain to enhance product competitiveness and market share[37] - The Group aims to accelerate the clinical progress of the H1710 project and explore more opportunities for innovative drug research and development[37] - The Group will strengthen the diversified operations of SPL and Cytovance to promote sustained growth in CDMO and specialty product businesses[37] - The Group remains cautiously optimistic about its business prospects while focusing on cost control to ensure stable financial benefits and cash flow levels[38] - The Group plans to further optimize the heparin supply chain's vertical integration to enhance product competitiveness and market share[40] - The CDMO business experienced rapid growth during the Reporting Period, with both business revenue and gross margin increasing year-on-year[48] - The Group aims to enhance its global presence and brand influence while increasing market penetration in the heparin industry despite trade protectionist challenges[82] - The Group plans to optimize marketing strategies and improve sales share in the finished dosage form business, targeting growth in Asia-Pacific and Latin America[84] Research and Development - The innovative drug H1710 project completed its IND application in China, marking a breakthrough in the Group's innovation efforts[30] - H1710, a candidate drug targeting heparanase, has shown significant anti-tumor effects in various animal models and received approval for clinical trials from the National Medical Products Administration in February 2025[73] - Oregovomab, an anti-CA125 immunotherapy drug, completed a Phase II clinical trial and is under further evaluation after not meeting its intended objectives in Phase III trials[74] - RVX-208 (Apabetalone) completed Phase III clinical trial (BETonMACE) to reduce major adverse cardiovascular events in high-risk patients, receiving FDA Breakthrough Therapy Designation[79] - The Group is actively exploring cooperation opportunities to accelerate the strategic layout of innovative drugs and diversify commercialization capabilities[76] Market Performance - The annual sales volume of enoxaparin sodium formulations achieved double-digit growth, successfully expanding the global formulation market share[47] - The Group maintained its market share as one of the top two in Europe for enoxaparin sodium formulation, successfully increasing the bid-winning rate to expand market share[56] - In the United States, the Group's sales revenue showed impressive growth, benefiting from a dual strategy of self-operated and agency-driven approaches[57] - The Group obtained market entry licenses in Thailand and New Zealand, enhancing its international market share and creating new sales opportunities[61] - The Group is actively working to increase market share in China while addressing pricing pressures from the national centralized procurement platform[58] Management and Governance - The Group's executive directors have over 30 years of experience in the pharmaceutical industry, contributing to strategic planning and decision-making[142] - The Group's strategic focus includes innovative drugs and CDMO sectors, with active participation from executive directors in formulating and implementing business strategies[149][152] - The Group's management team includes experienced professionals who oversee various aspects of the business, including production capacity, logistics, and human resources[152][149] - Ms. Li Tan has over 30 years of experience in the pharmaceutical industry and is responsible for major decisions and business development activities[155] - Mr. Shan Yu also has over 30 years of experience in the pharmaceutical industry, overseeing capacity, safety, logistics, and external matters[156] - Mr. Zhang Ping has extensive experience in manufacturing and operations, having served as General Manager at Hangzhou Innovax Biotech Co., Ltd. and Head of Industry Affairs at Sanofi, managing seven plants in China[157][161] - Dr. Lu Chuan has been an independent non-executive director since December 2019 and has extensive experience in investment banking and management[158][162] - Mr. Huang Peng, an independent non-executive director, has a Ph.D. in Management and has served as an independent director for multiple companies listed on the Shanghai and Shenzhen Stock Exchanges[164] - Mr. Yi Ming, another independent non-executive director, has a Master's degree in Finance and has held senior management positions in asset management companies[165] - Mr. Zheng Zehui, chairman of the Supervisory Committee, has served as general manager of URIT Medical Electronic Sales Co., Ltd. and has a background in biochemistry[166] - Ms. Tang Haijun has been with the company since February 2001 and serves as a Supervisor, managing the GXP document control department[167] Corporate Actions - The Company completed its initial public offering and listing of its A Shares on the Shenzhen Stock Exchange on May 6, 2010, and its H Shares on the Hong Kong Stock Exchange on July 8, 2020[181] - The Group proposed a final cash dividend of RMB2.5 (tax inclusive) per ten ordinary shares, compared to nil in 2023[187] - The Group has not incurred any additional costs specifically attributable to environmental compliance during the year ended December 31, 2024[191] - The Group has no current plans for significant acquisitions or capital asset investments as of December 31, 2024[138] Reporting and Analysis - A detailed analysis of the Group's revenue and operating profit for the year ended December 31, 2024, is provided in the "Management Discussion and Analysis" section of the annual report[182] - The business review includes discussions on principal risks and uncertainties faced by the Group, as well as an analysis of performance using financial key performance indicators[183] - Important events affecting the Group during the year ended December 31, 2024, are highlighted in the annual report[183] - Future developments in the Group's business are indicated in the annual report[183] - The Group's financial performance indicators and major events impacting the business are discussed in the "Chairman's Statement" and "Management Discussion and Analysis" sections of the annual report[186] - The Group's audited consolidated results for the reporting period are detailed on pages 85 to 86 of the annual report[188] - The Group's reserves and movements for the current and prior years are presented in the consolidated statement of changes in equity on pages 89 to 90 of the annual report[200]
海普瑞2025年一季报简析:营收净利润同比双双增长
Zheng Quan Zhi Xing· 2025-04-25 22:49
据证券之星公开数据整理,近期海普瑞(002399)发布2025年一季报。根据财报显示,海普瑞营收净利润 同比双双增长。截至本报告期末,公司营业总收入13.94亿元,同比上升1.53%,归母净利润1.57亿元, 同比上升1.0%。按单季度数据看,第一季度营业总收入13.94亿元,同比上升1.53%,第一季度归母净利 润1.57亿元,同比上升1.0%。 本次财报公布的各项数据指标表现尚佳。其中,毛利率27.34%,同比减20.74%,净利率11.2%,同比减 0.51%,销售费用、管理费用、财务费用总计1.35亿元,三费占营收比9.66%,同比减45.77%,每股净资 产8.37元,同比增1.85%,每股经营性现金流0.37元,同比减38.21%,每股收益0.11元,同比增0.95% | 项目 | 2024年一季报 | 2025年一季报 | 同比增幅 | | --- | --- | --- | --- | | 营业总收入(元) | 13.73亿 | 13.94亿 | 1.53% | | 归母浄利润(元) | 1.55 Z | 1.57亿 | 1.00% | | 扣非净利润(元) | 1.57亿 | 1.89 Z ...
深圳市海普瑞药业集团股份有限公司2025年第一季度报告
登录新浪财经APP 搜索【信披】查看更多考评等级 炒股就看金麒麟分析师研报,权威,专业,及时,全面,助您挖掘潜力主题机会! 公司是否需追溯调整或重述以前年度会计数据 证券代码:002399 证券简称:海普瑞 公告编号:2025-020 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。 重要内容提示: 1.董事会、监事会及董事、监事、高级管理人员保证季度报告的真实、准确、完整,不存在虚假记载、 误导性陈述或重大遗漏,并承担个别和连带的法律责任。 2.公司负责人、主管会计工作负责人及会计机构负责人(会计主管人员)声明:保证季度报告中财务信息 的真实、准确、完整。 3.第一季度报告是否经审计 □是 √否 一、主要财务数据 (一) 主要会计数据和财务指标 □是 √否 ■ (二) 非经常性损益项目和金额 √适用 □不适用 单位:元 ■ 其他符合非经常性损益定义的损益项目的具体情况 □适用 √不适用 公司不存在其他符合非经常性损益定义的损益项目的具体情况。 将《公开发行证券的公司信息披露解释性公告第1号一一非经常性损益》中列举的非经常性损益项目界 定为经常性损益项目的情况说 ...
海普瑞(002399) - 监事会决议公告
2025-04-24 10:23
证券代码:002399 证券简称:海普瑞 公告编号:2025-023 深圳市海普瑞药业集团股份有限公司 第六届监事会第十一次会议决议公告 本公司及监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。 一、监事会会议召开情况 具体内容详见公司同日披露于《证券时报》《中国证券报》《上海证券报》《证 券日报》和巨潮资讯网www.cninfo.com.cn的《2025年第一季度报告》;及同日披露 于 香 港 联 合 交 易 所 有 限 公 司 网 站 http://www.hkexnews.hk 和 公 司 网 站 http://www.hepalink.com的H股《2025年第一季度业绩公告》。 2、《关于调整向全资子公司天道医药(香港)有限公司增资方案的议案》 表决结果:3票同意、0票弃权、0票反对。 公司于2021年12月10日召开的第五届董事会第十五次会议审议通过,公司决 定使用H股募集资金1.05亿美元以逐层增资的方式向全资子公司天道医药(香港) 有限公司增资,用于欧盟及其他全球市场拓展销售及营销网络以及基础设施的建 设。 根据外部市场环境结合公司全球业务发展的需求,决 ...
海普瑞(002399) - 董事会决议公告
2025-04-24 10:22
证券代码:002399 证券简称:海普瑞 公告编号:2025-022 深圳市海普瑞药业集团股份有限公司 第六届董事会第十五次会议决议公告 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。 一、董事会会议召开情况 表决结果:7票同意、0票弃权、0票反对。 公司于2021年12月10日召开的第五届董事会第十五次会议审议通过,公司决 定使用H股募集资金1.05亿美元以逐层增资的方式向全资子公司天道医药(香港) 有限公司增资,用于欧盟及其他全球市场拓展销售及营销网络以及基础设施的建 设。 深圳市海普瑞药业集团股份有限公司(以下简称"公司")第六届董事会第 十五次会议(以下简称"会议")通知及议案于 2025 年 4 月 10 日以电子邮件的 形式发出,会议于 2025 年 4 月 24 日下午 14:00 在深圳市南山区松坪山朗山路 21 号会议室以现场与通讯相结合的方式召开。本次会议应参与表决董事 7 人,实际 参与表决董事 7 人,其中张平先生、吕川先生、黄鹏先生、易铭先生以通讯方式 参与表决。公司监事及高级管理人员列席会议,会议由公司董事长李锂先生主持。 本次会议 ...