证券代码：300267 证券简称：尔康制药 公告编号：2025-018 湖南尔康制药股份有限公司 关于维生素 B6 注射液通过仿制药一致性评价的公告 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。 湖南尔康制药股份有限公司（以下简称"公司"）于近日收到国家药品监督管 理局核准签发的《药品补充申请批准通知书》（通知书编号：2025B02458），公司 维生素 B6 注射液 1ml:100mg 规格通过仿制药质量和疗效一致性评价，现将相关 情况公告如下： | 药品名称 | 维生素 注射液 B6 | | --- | --- | | 剂型 | 注射剂 | | 注册分类 | 化学药品 | | 规格 | 1ml:100mg | | 药品批准文号 | 国药准字 H20258096 | | 药品注册标准编号 | YBH13242025 | | 上市许可持有人 | 湖南尔康制药股份有限公司 | | 生产企业 | 湖南尔康制药股份有限公司 | | 审批结论 | 根据《中华人民共和国药品管理法》《国务院关于改革药 | | | 品医疗器械审评审批制度的意见》（国发〔2015〕44 号 ...

证券代码：300267 证券简称：尔康制药 公告编号：2025-017 湖南尔康制药股份有限公司 关于证券事务代表辞职的公告 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 湖南尔康制药股份有限公司（简称"公司"）于近日收到公司证券事务代 表范艺女士的书面辞职报告，范艺女士因个人原因申请辞去公司证券事务代表职 务，辞职后将不再担任公司及子公司任何职务。上述辞职报告自送达公司董事会 之日起生效。范艺女士所负责的相关工作已完成交接，其辞职不会影响公司相关 工作的正常运行。 特此公告。 湖南尔康制药股份有限公司 董 事 会 二〇二五年五月三十日 截至本公告披露日，范艺女士未持有公司股份。范艺女士担任公司证券事务 代表期间勤勉尽责、恪尽职守，公司董事会对其在担任公司证券事务代表期间为 公司证券上市、信息披露、规范运行等方面所做出的贡献表示衷心感谢。 根据《深圳证券交易所创业板股票上市规则》等相关规定，公司董事会将尽 快聘任符合任职资格的相关人士担任公司证券事务代表，协助公司董事会秘书开 展工作。 ...

证券代码：300267 证券简称：尔康制药 公告编号：2025-016 湖南尔康制药股份有限公司 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议案的情形。 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、会议召开和出席情况 1、召集人：公司董事会 2、召开方式：现场投票与网络投票相结合的方式 3、召开时间： 现场会议时间：2025 年 5 月 16 日（星期五）下午 14：30 网络投票时间： （1）通过深圳证券交易所交易系统进行网络投票的时间为 2025 年 5 月 16 日上午 09:15-09:25、09:30-11:30，下午 13:00-15:00； （2）通过深圳证券交易所互联网投票系统投票的具体时间为 2025 年 5 月 16 日 9:15--15:00 期间的任意时间。 4、股权登记日：2025 年 5 月 9 日（星期五） 5、现场会议召开地点：公司会议室（湖南省长沙市浏阳工业园北园开元大 道工业路一号湖南尔康制药股份有限公司会议室） 6、现场会议主持人： ...

湖南启元律师事务所 关于湖南尔康制药股份有限公司 2024年年度股东大会的 法律意见书 二0二五年五月 湖南启元律师事务所 关于湖南尔康制药股份有限公司 2024 年年度股东大会的法律意见书 致：湖南尔康制药股份有限公司 1、公司于 2025 年 4 月 23 日发布在深圳证券交易所网站（http://www.szse.cn） 上的公司第五届董事会第十三次会议决议的公告（以下简称"董事会决议"）以及 关于召开本次股东大会通知的公告（以下简称"股东大会通知"）。 湖南启元律师事务所接受湖南尔康制药股份有限公司（以下简称"公司"）的 委托，指派律师出席了公司 2024 年年度股东大会（以下简称"本次股东大会"）， 对会议进行现场律师见证，并出具本法律意见书。 本所律师根据《中华人民共和国公司法》（以下简称"《公司法》"）、《中华 人民共和国证券法》（以下简称"《证券法》"）、《上市公司股东会规则》（以下简 称"《股东会规则》"）等法律、法规和规范性文件以及《湖南尔康制药股份有限 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。 本律师出具本法律意见书基于公司已作出如下承诺：所有提供给本律师的文 ...

Core Viewpoint - The company is focusing on a dual business strategy of "pharmaceuticals + new energy materials," with significant growth driven by the African lithium mining project and technological innovation [1][6]. Group 1: Dual Business Strategy - In Q1 2025, the company achieved a net profit of 28.11 million yuan, a substantial increase of 868.91% year-on-year, primarily due to the operational capacity release of the lithium processing plant in Nigeria and cost optimization [2]. - The lithium mining project is a key step in implementing the dual business strategy, with the first processing plant in Nigeria now operating stably, and future expansion plans will be evaluated based on market demand [2]. Group 2: Pharmaceutical Sector - The company is increasing its R&D efforts, with 13 new patents added in 2024, including 2 invention patents, and steady progress in the development of heart failure drugs [3]. - The company is also expanding into overseas markets, with a pharmaceutical company established in Tanzania and a factory in Cambodia entering production [3]. Group 3: Regulatory Impact on Pharmaceutical Excipients - The implementation of new quality management regulations for pharmaceutical excipients is expected to enhance the company's market capacity and competitiveness [4]. - The regulations emphasize the responsibility of excipient manufacturers for product quality and require stricter management and oversight processes [4]. Group 4: Technological Innovation - The company has established new technology ventures focusing on electronic components and AI applications, indicating a strategic move towards integrating technology with its core business [5]. - There is a strong emphasis on AI and intelligent technology applications in the pharmaceutical excipient manufacturing sector, with plans to build an AI innovation platform [5]. Group 5: Future Outlook - The company aims to continue strengthening its dual business strategy, enhancing technological innovation, optimizing resource allocation, and improving operational efficiency to achieve steady growth in business performance [6]. - The clear strategic planning and proactive innovation spirit position the company well for high-quality development in a complex market environment [6].

Group 1 - The 2024 annual performance briefing of Erkang Pharmaceutical (300267) will be held on May 12, 2025, focusing on the optimization and upgrade of the entire drug production quality management chain through the inclusion of production quality management standards for pharmaceutical excipients [1] - The new regulations require pharmaceutical excipient manufacturers to enhance their quality management systems, ensure compliance with drug requirements, and strengthen risk management and production processes [1] - The revised "Drug Production Quality Management Standards (2010 Revision)" will promote the market capacity and competitiveness of compliant pharmaceutical excipient companies [1] Group 2 - Erkang Pharmaceutical is a leading domestic enterprise in pharmaceutical excipients, having developed into a multinational group that integrates pharmaceutical intermediates, raw materials, excipients, chemical drugs, and traditional Chinese medicine [2] - The company has established partnerships with over 3,000 pharmaceutical enterprises and currently offers 127 types of pharmaceutical excipients, 73 types of raw materials, and holds 282 approved drug numbers along with 195 domestic and international authorized patents [2]

Group 1: Company Strategy and Development - The company is focusing on a dual business strategy of "Pharmaceuticals + New Energy Materials" to enhance its competitive edge and risk management capabilities [2][12][34] - The establishment of Hunan Guanhe Technology Co., Ltd. is part of the company's efforts to develop its strategic planning and pathways [2][12] - The company is actively seeking partnerships with high-level research institutions to promote innovation in the pharmaceutical sector [3][12] Group 2: Financial Performance and Market Position - The company reported a significant increase in net profit for Q1 2025, amounting to 28.11 million yuan, attributed to the operational efficiency of its lithium mining project in Africa [15][39] - The pharmaceutical manufacturing industry in China saw a total revenue of 2,529.85 billion yuan in 2024, with a profit total of 342.07 billion yuan, reflecting a slight decline of 1.1% year-on-year [34] - The company aims to improve its market position by enhancing product quality and expanding its market share in high-end pharmaceutical materials [9][34] Group 3: Research and Development - The company has invested in 13 patents during the reporting period, including 2 invention patents and 11 utility model patents, indicating a strong focus on R&D [7][9] - The R&D expenses are primarily allocated to the development of formulations and raw materials, with ongoing projects in innovative drug development [19][21] - The company is transitioning its auxiliary materials from being mere "function providers" to "efficacy enhancers" through technological innovation [9][21] Group 4: Market Challenges and Responses - The company is addressing the challenges posed by the declining lithium carbonate futures market by strategically investing in lithium mining [2][12] - The management acknowledges the long-term low performance of the stock price and is committed to improving operational performance and investor relations [6][34][37] - The company is focused on enhancing its compliance with stringent pharmaceutical regulations to ensure product safety and quality [9][18]

Core Viewpoint - Erkang Pharmaceutical reported a net loss in its annual report for 2024, while its first-quarter results for 2025 showed significant growth in revenue and profit, indicating a mixed performance trend [1][2]. Financial Performance - In 2024, Erkang Pharmaceutical achieved an operating revenue of 1.14 billion yuan, a year-on-year decline of 36.09%, and a net loss of 373 million yuan, compared to a loss of 195 million yuan in the previous year [2]. - For the first quarter of 2025, the company reported an operating revenue of 354 million yuan, a year-on-year increase of 28.19%, and a net profit attributable to shareholders of 28.11 million yuan, marking a substantial growth of 868.91% [2]. Market Position and Competition - Erkang Pharmaceutical is one of the largest manufacturers of pharmaceutical excipients in China, but its revenue has been declining since 2020, raising concerns about its ability to maintain its leading position in the industry [2][5]. - In contrast, competitor Shanhe Pharmaceutical (300452.SZ) has shown consistent revenue growth, with a 2024 revenue of 883 million yuan, up 5.16% year-on-year [5][6]. Strategic Initiatives - To counteract declining revenues, Erkang Pharmaceutical is diversifying its business by entering the lithium mining sector and increasing its focus on traditional Chinese medicine products [2][4]. - The company has invested in a lithium mining project in Nigeria, with its first beneficiation plant expected to contribute to revenue in 2025 [17]. Industry Challenges - The pharmaceutical excipient market is facing challenges, including increased regulatory scrutiny and rising raw material costs, which are impacting the profitability of companies like Erkang Pharmaceutical [14][15]. - The overall pharmaceutical manufacturing industry in China has seen mixed results, with many companies experiencing revenue declines, particularly in the traditional Chinese medicine and biopharmaceutical sectors [11][15]. Financial Health and Inventory Management - Erkang Pharmaceutical's financial health is under pressure, with a reported net cash outflow from operating activities of 4 million yuan at the end of the first quarter of 2025 [19]. - The company has also faced inventory challenges, with a significant increase in inventory balance from 601 million yuan at the end of 2024 to 671 million yuan in the first quarter of 2025, despite recognizing inventory impairment losses [21].

Group 1: Business Strategy - The company is pursuing a dual development strategy in pharmaceuticals and new energy materials [1] - In the pharmaceutical sector, the focus is on leveraging advantages in the domestic pharmaceutical excipients industry, emphasizing "technology deepening, category expansion, and quality foundation" [1] - The new energy materials sector is enhancing resource development and innovating business models to secure the upstream supply chain [2] Group 2: Financial Performance - The first beneficiation plant of the company's Nigerian subsidiary was completed in Q4 2024, generating additional revenue of 77.27 million yuan in Q1 2025 [2] - The traditional Chinese medicine segment achieved revenue of 99.98 million yuan in 2024, marking a year-on-year growth of 461.40% [3] - R&D investment in 2024 amounted to 4.52 million yuan, representing 3.96% of total revenue [4] Group 3: Industry Trends - The pharmaceutical excipients industry faces increased pressure due to reforms in generic drug evaluations and procurement, leading to higher demands for production costs and product quality [2] - The National Medical Products Administration's announcement in January 2025 regarding the quality management norms for pharmaceutical excipients is expected to enhance market capacity and competitiveness for compliant manufacturers [2] Group 4: Future Plans - The company is establishing a pharmaceutical production base in Tanzania to meet local healthcare needs while utilizing local resources and advanced production technologies [4] - Plans to collaborate with AI technology companies to advance the industrialization of liver and gallbladder drugs are underway, with ongoing projects transitioning to pilot scale [4] - The company aims to explore capital operations through mergers and acquisitions to align with strategic goals in the pharmaceutical and new energy sectors [4]

Group 1 - The vitamin concept stocks are experiencing strong performance, with companies like Erkang Pharmaceutical, Yong'an Pharmaceutical, and Hehua Co. hitting the daily limit up [1] - The price of feed-grade vitamin D3 in China has been raised to 600 yuan per kilogram, contributing to the surge in vitamin-related stocks [1] - Erkang Pharmaceutical is recognized as the largest and most comprehensive pharmaceutical excipient company in China, integrating "raw materials + formulations" into its business model [1][3] Group 2 - Erkang Pharmaceutical has over 40 types of excipients available for vaccine production, which account for 90%-99% of the production process, indicating a shift towards domestic alternatives to imports [3] - The company recently obtained production qualifications for niacin (vitamin B3), which is crucial for anti-beriberi treatment and as an intermediate for NMN, a popular anti-aging component [3] - The global market for NMN is projected to approach 6.87 billion yuan by 2031, suggesting a potential high-value market opportunity for Erkang Pharmaceutical [3]