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华纳药厂:自愿披露关于子公司原料药获得上市申请批准通知书的公告
2024-11-19 08:52
证券代码:688799 证券简称:华纳药厂 公告编号:2024-069 湖南华纳大药厂股份有限公司 自愿披露关于子公司原料药获得上市申请批准通知 书的公告 7、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。质量标准、标签及生产工艺照所附执 行。 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。 近日,湖南华纳大药厂股份有限公司(以下简称"公司")全资子公司湖南 华纳大药厂手性药物有限公司收到国家药品监督管理局签发的硫酸沙丁胺醇《化 学原料药上市申请批准通知书》(通知书编号:2024YS01166),并在国家药品监 督管理局药品审评中心(CDE)"原料药、药用辅料和药包材登记信息公示"平 台公示。具体情况如下: 一、原料药登记信息 1、化学原料药名称:硫酸沙丁胺醇 2、登记号:Y20230000262 3、申请事项:境内生产化学原料药上市申请 4、包装规格:0.5kg/桶。1kg/桶。2kg/桶。5kg/桶。10kg/桶。25kg/桶 5、生产企业:湖南华纳大药厂手性药物 ...
华纳药厂:自愿披露关于子公司通过药品GMP符合性检查的公告
2024-11-13 08:41
湖南华纳大药厂股份有限公司自愿披露 关于子公司通过药品 GMP 符合性检查的公告 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。 证券代码:688799 证券简称:华纳药厂 公告编号:2024-067 2024 年 11 月 14 日 3、检查范围及相关车间、生产线:原料药(泮托拉唑钠):103 车间二线、 101 车间一线;原料药(磷酸二氢钾、磷酸氢二钾三水合物):107 车间二线;原 料药(精氨酸布洛芬):101 车间二线;原料药(盐酸贝尼地平):102 车间二线 4、结论:符合要求 二、对公司的影响及风险提示 本次通过药品 GMP 符合性检查,标志着手性药物公司可以正式生产和销售 上述原料药产品,上述药品通过 GMP 符合性检查不会对公司近期业绩产生重大 影响。由于药品的生产、销售受市场环境变化等因素影响,存在不确定性,敬请 广大投资者谨慎决策,注意防范投资风险。 特此公告。 湖南华纳大药厂股份有限公司董事会 近日,湖南华纳大药厂股份有限公司(以下简称"公司")全资子公司湖南 华纳大药厂手性药物有限公司(以下简称"手 ...
华纳药厂:关于获得政府补助的公告
2024-11-13 08:41
二、补助的类型及其对上市公司的影响 根据《企业会计准则第16号——政府补助》等有关规定,公司上述获得的政 府补助款项均属于与收益相关的政府补助。上述政府补助数据未经审计,具体的 会计处理以及对公司损益的影响,最终以审计机构年度审计确认后的结果为准。 敬请投资者注意投资风险。 特此公告。 湖南华纳大药厂股份有限公司董事会 证券代码:688799 证券简称:华纳药厂 公告编号:2024-066 湖南华纳大药厂股份有限公司 关于获得政府补助的公告 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。 一、获得补助的基本情况 湖南华纳大药厂股份有限公司(以下简称"公司")及公司全资子公司、控 股子公司自2024年1月至本公告披露日,累计获得政府补助款项共计人民币 2,301.23万元,均属于与收益相关的政府补助。 2024 年 11 月 14 日 ...
华纳药厂:业绩短期承压,新药临床稳步推进
Great Wall Securities· 2024-11-07 07:30
Investment Rating - The report maintains a "Buy" rating for Warner Pharmaceuticals, expecting a price increase of over 15% relative to the industry index in the next six months [13]. Core Views - The company's performance is under short-term pressure, with revenue and profit growth below expectations due to industry challenges. However, the pace of R&D output remains stable, and self-developed innovative drugs are progressing steadily. As hospital demand recovers, performance growth is expected to return to normal [4]. - For the first three quarters of 2024, the company achieved revenue of 1.069 billion yuan, a year-on-year increase of 1.28%, and a net profit attributable to the parent company of 158 million yuan, a year-on-year increase of 0.09%. In Q3 2024, revenue was 331 million yuan, down 1.19% year-on-year, and net profit was 46 million yuan, down 0.97% year-on-year [1][2]. Financial Summary - Revenue (million yuan): 2022A: 1,293, 2023A: 1,433, 2024E: 1,527, 2025E: 1,709, 2026E: 1,873 [1][5]. - Net profit (million yuan): 2022A: 183, 2023A: 211, 2024E: 221, 2025E: 248, 2026E: 279 [1][5]. - Gross margin for the first three quarters of 2024 was 62.34%, a decrease of 2.31 percentage points year-on-year, while the net profit margin was 13.03%, down 0.67 percentage points year-on-year [2]. - R&D expenses increased by 2.24 percentage points year-on-year to 9.40% of total expenses in the first three quarters of 2024 [2]. R&D Progress - The company is advancing multiple innovative drug projects, including ZG-001, which has completed Phase 1 clinical trials and is intended for treating major depressive disorders. The drug has shown excellent safety and pharmacokinetic properties [3].
华纳药厂(688799) - 华纳药厂投资者关系活动记录表(2024年11月1日)
2024-11-05 09:34
投资者关系活动记录表 证券简称:华纳药厂 股票代码:688799 编码:2024-042 | --- | --- | --- | |--------------------|----------------------------|------------------------------------------------------------| | | | | | | | 特定对象调研; □分析师会议; | | | □ | 媒体采访; □业绩说明会; | | 投资者关系活动类别 | □ 新闻发布会; □路演活动; | | | | □ 现场参观; □其他: | | | 参与单位名称 | | 湖南楚恒资产管理有限公司、湖南博深实业集团有限公司、方正证 | | | | 券股份有限公司、中信证券股份有限公司、华福证券有限责任公 | | | | 司、国盛证券有限责任公司、天风证券股份有限公司、开源证券股 | | | | 份有限公司、上海申银万国证券研究所有限公司、广发证券股份有 | | | | 限公司、长城证券股份有限公司、光大证券股份有限公司、东吴证 | | | | 券股份有限公司、甬兴证券有限公司、华源证券 ...
华纳药厂20241101
2024-11-04 03:33
Summary of Conference Call Company and Industry Overview - The conference call discusses a pharmaceutical company focusing on innovative drugs and traditional Chinese medicine, particularly in the context of rare animal-derived medicinal materials and their substitutes [1][4][22]. Key Financial Performance - For the first three quarters of 2024, the company reported: - Total revenue of approximately 1.069 billion yuan, a year-on-year increase of 1.28% [1]. - Net profit of approximately 158 million yuan, a year-on-year increase of 0.09% [1]. - Breakdown of revenue: - Technical services revenue was approximately 801 million yuan, showing a slight decline of about 1% [2]. - Revenue from raw materials and intermediates was approximately 256 million yuan, reflecting a significant year-on-year growth of 16.76% [2]. R&D Investments and Challenges - The company invested around 100 million yuan in R&D, a year-on-year increase of over 30%, which has impacted profit growth [2][20]. - The company submitted 13 registration applications for generic drugs and received several approvals, indicating ongoing efforts in drug development [3]. Innovative Drug Development - Progress in innovative drugs includes: - ZY022 is in the IND application stage, with plans for clinical trials to begin in early 2025 [5][8]. - ZG001 and ZG002 are also in various stages of clinical trials, with partnerships for commercialization being established [8][10]. - The company is focusing on the development of substitutes for rare animal-derived materials, with supportive policies from the government [4][22]. Market Trends and Future Outlook - The pharmaceutical industry is facing pressures, but the company remains optimistic about maintaining growth through its diversified product portfolio and strategic focus on innovation [2][20]. - The company anticipates that supportive government policies will facilitate faster approval processes for its innovative products, potentially shortening clinical trial durations by up to two years [10][22]. - The company expects to continue leveraging its integrated supply chain for raw materials to enhance profitability and market competitiveness [18][20]. Regulatory and Policy Environment - Recent government announcements have emphasized support for the development of substitutes for rare animal-derived materials, which aligns with the company's strategic focus [4][22]. - The company is optimistic about the regulatory environment, believing that it will provide a conducive framework for the approval and commercialization of its innovative products [22][28]. Conclusion - The company is committed to its strategic goals of maintaining stable growth in its core business while advancing its innovative drug pipeline. The leadership expresses confidence in navigating the current market challenges and regulatory landscape to achieve its objectives [30].
华纳药厂入选中证湖南50指数成份股
Zheng Quan Shi Bao Wang· 2024-10-31 03:26
Core Points - The Hunan 50 Index was officially launched to reflect the overall performance of high-quality listed companies in Hunan Province [1] - Warner Pharmaceutical (688799.SH) was selected for the index due to its solid operational status, continuous R&D investment, and positive growth outlook [1][2] - The index aims to enhance the influence of Hunan listed companies and provide new investment channels for market investors [1] Company Performance - Since its listing in 2021, Warner Pharmaceutical has maintained stable growth, with revenue of 1.069 billion yuan and a net profit of 158 million yuan for the first three quarters of 2024 [2] - The company's total assets reached 2.38 billion yuan, indicating a strong financial position [2] - R&D investment exceeded 100 million yuan in the first three quarters of 2024, a year-on-year increase of 32.94%, accounting for 9.4% of revenue [2] Innovation and Future Outlook - Warner Pharmaceutical is advancing multiple innovative drug projects and has over 90 ongoing projects, including 9 international registration projects [2] - The company is positioned to benefit from the recent government support for the development of substitutes for rare and endangered traditional Chinese medicine materials [2] - Warner Pharmaceutical aims to enhance its profitability and competitiveness while contributing to the high-quality development of Hunan's capital market [2]
华纳药厂新基地开工!设计年产3000吨,实现“三大升级”
Zheng Quan Shi Bao Wang· 2024-10-29 02:17
Core Points - Warner Pharmaceuticals has commenced the construction of a high-end raw materials and advanced pharmaceutical intermediates project in Wangcheng Economic Development Zone, marking its second investment in the area after the chiral drug project [1] - The new project will cover over 230 acres and is expected to produce 3,000 tons of high-end raw materials and intermediates annually, contributing to the establishment of a 10 billion-level biopharmaceutical industry cluster in Wangcheng [1] Summary by Sections Project Overview - The new project is part of Warner Pharmaceuticals' strategy to enhance its production capabilities and is expected to significantly boost the local biopharmaceutical industry [1] - The company has previously established a chiral drug manufacturing facility in the same region, which has become a leading enterprise in the local biopharmaceutical sector [1] Technological Upgrades - The project will implement three major upgrades: 1. Utilizing synthetic biology research to promote a green transformation in chemical synthesis processes [2] 2. Introducing continuous reaction systems for chemical processes to enhance safety and automation in production [2] 3. Aligning with international standards to improve product quality and increase market share in international markets [2] Regional Development - The Copper Official Industrial Zone is the only provincial-level chemical park in Changsha, providing a unique advantage for the development of the biopharmaceutical industry [2] - The local government is committed to creating an optimal environment for project construction and supporting enterprises in the biopharmaceutical sector to explore new fields and achieve new heights [2]
华纳药厂:第三届监事会第十二次会议决议公告
2024-10-28 08:31
证券代码:688799 证券简称:华纳药厂 公告编号:2024-065 湖南华纳大药厂股份有限公司 第三届监事会第十二次会议决议公告 公司监事会及全体监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。 监事会认为:公司 2024 年第三季度报告的编制和审议程序符合法律、法规、 公司章程及公司内部管理制度的各项规定。公司 2024 年第三季度报告的内容和 格式符合中国证券监督管理委员会和上海证券交易所的各项规定,所包含的信息 能从各个方面真实地反映公司的经营管理和财务状况。我们保证公司 2024 年第 三季度报告所披露的信息真实、准确、完整,不存在虚假记载、误导性陈述或重 大遗漏。 特此公告。 湖南华纳大药厂股份有限公司监事会 2024 年 10 月 29 日 二、监事会会议审议情况 本次会议审议通过了如下议案: (一)审议通过《关于公司 2024 年第三季度报告的议案》 具体内容详见公司同日在上海证券交易所网站(www.sse.com.cn)披露的《湖 南华纳大药厂股份有限公司 2024 年第三季度报告》。 表决结果:3 票同意,0 票反对,0 ...
华纳药厂:第三届董事会第十二次会议决议公告
2024-10-28 08:31
证券代码:688799 证券简称:华纳药厂 公告编号:2024-064 湖南华纳大药厂股份有限公司 第三届董事会第十二次会议决议公告 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、董事会会议召开情况 湖南华纳大药厂股份有限公司(以下简称"公司")第三届董事会第十二次 会议于 2024 年 10 月 26 日以现场结合通讯方式召开,本次会议的通知于 2024 年 10 月 16 日送达公司全体董事。会议由董事长黄本东先生主持,应出席董事 7 人, 实际出席董事 7 人。会议的召集、召开、表决程序符合相关法律、法规及《湖南 华纳大药厂股份有限公司章程》(以下简称"《公司章程》")的相关规定,所作决 议合法有效。 特此公告。 湖南华纳大药厂股份有限公司董事会 二、董事会会议审议情况 本次会议审议通过了如下议案: (一)审议通过《关于公司 2024 年第三季度报告的议案》 具体内容详见公司同日在上海证券交易所网站(www.sse.com.cn)披露的《湖 南华纳大药厂股份有限公司 2024 年第三季度报告》。 本议案已经第三届 ...