证券代码：002030 证券简称：达安基因 公告编号：2025-051 广州达安基因股份有限公司 关于取得一个医疗器械注册证的提示性公告 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。 近日，广州达安基因股份有限公司（以下简称"公司"）取得国家药品监督管 理局颁发的医疗器械注册证一个，具体为： 医疗器械名称：基孔肯雅病毒核酸检测试剂盒（荧光 PCR 法），注册证编号： 国械注准 20253401955。有效期自批准之日起至 2030 年 9 月 24 日。预期用途： 本试剂盒用于体外定性检测基孔肯雅热病疑似病例、其他需要进行基孔肯雅热感 染诊断或鉴别诊断者的血清样本中基孔肯雅病毒核酸。有关"疑似病例"等人群 的定义参照《基孔肯雅热防控技术指南》等文件执行。该产品在使用上应当遵守 《基孔肯雅热防控技术指南》等文件的相关要求。开展基孔肯雅病毒核酸检测， 应符合《基孔肯雅热防控技术指南》等的要求，做好生物安全工作。本试剂盒检 测结果仅供临床参考，不得作为临床诊断的唯一标准。建议结合患者临床表现和 其他实验室检测对病情进行综合分析。 上述医疗器械注册证的取得丰富了公司 ...

Group 1 - The company has significant advantages in the industry, maintaining a high retention rate among top-tier hospitals and optimizing its product structure to expand into new markets while solidifying its traditional strengths [2] - The company is focusing on the IVD field and is open to mergers and acquisitions that align with its strategic goals, aiming to capture opportunities along the industry chain [3] - The company emphasizes research and development, with a clear plan to enhance its product competitiveness through various technological platforms [4] Group 2 - The company is in the process of cultivating its overseas market, which currently contributes a small portion of its revenue, while also benefiting from the domestic trend of replacing imported products with local alternatives [5] - The company is committed to high-quality development by enhancing communication with investors through various channels, including regular reports and performance briefings [6]

Group 1: Company Strengths and Market Position - The company maintains a high customer retention rate among top-tier hospitals, which is a core asset [3] - The company is actively expanding into new markets such as research and disease control while optimizing its product structure [3] - The domestic in vitro diagnostic market is maturing, accelerating the process of local products replacing imports, providing growth opportunities [4] Group 2: Future Strategies and Innovations - The company is focused on vertical deepening and horizontal integration within the IVD field, with a newly established strategic planning department to identify investment opportunities [3] - Continuous innovation in product development is prioritized, with a focus on enhancing precision and speed in molecular diagnostics [4] - The company is exploring mergers and acquisitions that align with its existing business to enhance the industry chain [3] Group 3: Market Expansion and Competition - The company's overseas business currently represents a small portion of revenue, primarily in Latin America and Southeast Asia, and requires time for development [4] - The company is committed to enhancing its service quality and market competitiveness through a diverse range of diagnostic technologies [4] - The company actively communicates with investors through various channels to improve understanding and recognition of its business strategies [4]

Group 1: Financial Performance - The company's revenue in the first half of the year decreased by 15.44% compared to the same period last year, primarily due to changes in industry demand and adjustments in procurement prices [2][3] - The company's cash funds decreased by 47.18% since the beginning of the year, attributed to an increase in cash management limits for idle funds, which will not affect normal operations or future investment plans [3][4] - As of June 30, 2025, revenue from the South China region accounted for 45%, while revenue from outside South China accounted for 55% [4] Group 2: Strategic Plans and Market Expansion - The company is open to mergers and acquisitions that can create synergies with existing operations and extend the industrial chain, supported by the establishment of a strategic planning department [3][4] - Future market expansion will focus on enhancing the marketing system and exploring overseas markets to increase overall market share [4][5] - The company plans to deepen its marketing system and focus on new product development to stabilize market size amid declining sales of certain products [7][8] Group 3: Research and Development - R&D expenses decreased year-on-year but accounted for approximately 38% of the company's revenue, reflecting a commitment to research despite the decline [6][7] - The company emphasizes innovation in product development, with new products typically taking 3-5 years from initiation to certification [4][6] - A dynamic review mechanism for ongoing projects will be implemented to adjust R&D efforts based on market dynamics and end-user needs [4][8] Group 4: Competitive Strategy - The company maintains a multi-diagnostic technology platform, focusing on infectious diseases, precision medicine, and public health, to enhance service quality and market competitiveness [5][7] - Challenges in overseas markets include geopolitical policies and competition, with the company primarily serving clients in Latin America and Southeast Asia [6][7] - The company aims to improve operational efficiency through strategic adjustments and cost reduction measures in response to industry policies and market demands [7][8]

Core Points - The company held its third extraordinary general meeting of shareholders on September 15, 2025, with no resolutions being rejected [1][2] - The meeting was conducted through a combination of on-site and online voting [3] Meeting Details - The meeting took place at 14:30 on September 15, 2025, at the company's lecture hall in Guangzhou [4][5] - A total of 723 shareholders and their authorized representatives attended, representing 461,356,913 shares, which is 32.8732% of the total shares [6][22] - The meeting was legally compliant with relevant laws and regulations [5][20] Voting Results - The following resolutions were passed: 1. Amendment to the Articles of Association: Approved by 450,940,523 shares (97.7422% of votes) [9][26] 2. Revision of Board Meeting Rules: Approved by 451,794,639 shares (97.9274% of votes) [10][27] 3. Revision of Shareholder Meeting Rules: Approved by 451,805,532 shares (97.9297% of votes) [11][28] - The voting results indicate a significant majority in favor of the proposed amendments, with a notable dissent from minority investors on some resolutions [9][10][11] Legal Opinion - The legal opinion provided by the law firm confirmed that the meeting's procedures, participant qualifications, and voting processes were in accordance with the law [13][30]

证券代码：002030 证券简称：达安基因 公告编号：2025-050 3、本次股东会以现场投票与网络投票相结合的方式召开。 一、会议召开和出席情况 （一）会议召开情况 1、会议召开时间： 广州达安基因股份有限公司 2025 年第三次临时股东会决议公告 本公司及董事会全体成员保证信息披露内容的真实、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、本次股东会未出现否决议案的情形。 2、本次股东会未涉及变更前次股东会决议。 （1）现场会议召开时间：2025 年 9 月 15 日下午 14:30 （2）网络投票时间：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 9 月 15 日上午 9:15—9:25，9:30—11:30 和下午 13:00—15:00；通过深圳 证券交易所互联网投票系统投票的时间为 2025 年 9 月 15 日上午 9:15 至 2025 年 9 月 15 日下午 15:00 期间的任意时间。 2、会议召开地点：广州市高新技术开发区科学城香山路 19 号公司一楼讲学 厅 3、会议召开方式：现场投票与网络投票相结合的方式 4、会议召集人：公司董事会 5、会议主 ...

1. 经公司 2024 年第三次临时股东会审议通过的《公司章程》； 2. 公司 2025 年 8 月 30 日刊登于《证券时报》《上海证券报》《经济参 考报》、巨潮资讯网（www.cninfo.com.cn）及深圳证券交易所网站的 《广州达安基因股份有限公司第九届董事会第一次会议决议公告》； 3. 公司于 2025 年 8 月 30 日刊登于《证券时报》《上海证券报》《经济 参考报》、巨潮资讯网（www.cninfo.com.cn）及深圳证券交易所网站 的《广州达安基因股份有限公司第八届监事会第七次会议决议公告》； 4. 公司 2025 年 8 月 30 日刊登于《证券时报》《上海证券报》《经济参 考报》、巨潮资讯网（www.cninfo.com.cn）及深圳证券交易所网站的 《广州达安基因股份有限公司关于召开 2025 年第三次临时股东会通知 的公告》（以下简称《股东会通知》）； 5. 本次股东会股权登记日（2025 年 9 月 9 日）的股东名册； 6. 出席现场会议的股东的到会登记记录及凭证资料； 北京市金杜（广州）律师事务所 关于广州达安基因股份有限公司 2025 年第三次临时股东会的法律意见书 致： ...

Group 1 - The company, Da An Gene, announced that it has recently obtained a medical device registration certificate issued by the National Medical Products Administration [2]

格隆汇9月8日丨达安基因(002030.SZ)公布，公司取得国家药品监督管理局颁发的医疗器械注册证一 个，具体为：医疗器械名称：人类免疫缺陷病毒1型（HIV-1）DNA检测试剂盒（PCR-荧光探针法）， 注册证编号：国械注准20253401805。有效期自批准之日起至2030年9月4日。预期用途：本产品用于体 外定性检测人全血样本中的人类免疫缺陷病毒1型脱氧核糖核酸（HIV-1DNA）（仅M组）。 ...

Group 1 - The company, DaAn Gene (002030.SZ), has recently obtained a medical device registration certificate from the National Medical Products Administration [1] - The registered product is an HIV-1 DNA test kit (PCR fluorescent probe method), with the registration number: Guo Xie Zhu Zheng 20253401805 [1] - The certificate is valid from the date of approval until September 4, 2030, and the product is intended for in vitro qualitative detection of HIV-1 DNA in human whole blood samples [1]