圣湘生物(688289.SH)发布公告，公司的产品全自动核酸处理系统(S-S13E-P/S-S13E-P1)于近日获得欧盟 CEIVDR认证。该设备可实现从样本到报告的全流程自动化，包括样本管开盖、移液、核酸提取、PCR 体系构建、封膜扩增及结果分析，具有处理高效、检测精准、智能控制、广泛兼容等特点。检测项目丰 富，涵盖HPV、性病、血源、呼吸道、虫媒、药物基因组等类别，适配实验室、医院、检验中心等各类 专业应用场景，在有限空间内高效满足样本检测、实验分析等多元化需求。 该款仪器本次获得欧盟CEIVDR认证，标志着公司在分子诊断技术国际化与标准化进程迈出关键一步。 这一里程碑不仅体现了产品的卓越性能与安全标准，更展现了公司引领行业创新、服务全球市场的坚定 承诺。未来，公司将持续推动技术革新与方案融合，赋能全球医疗机构与公共卫生体系，助力构建更高 效、精准、可靠的健康防控新生态。 ...

该设备可实现从样本到报告的全流程自动化，包括样本管开盖、移液、核酸提取、PCR 体系构建、封 膜扩增及结果分析，具有处理高效、检测精准、智能控制、广泛兼容等特点。检测项目丰富，涵盖 HPV、性病、血源、呼吸道、虫媒、药物基因组等类别，适配实验室、医院、检验中心等各类专业应用 场景，在有限空间内高效满足样本检测、实验分析等多元化需求。 该款仪器本次获得欧盟 CE IVDR 认证，标志着公司在分子诊断技术国际化与标准化进程迈出关键一 步。这一里程碑不仅体现了产品的卓越性能与安全标准，更展现了公司引领行业创新、服务全球市场的 坚定承诺。未来，公司将持续推动技术革新与方案融合，赋能全球医疗机构与公共卫生体系，助力构建 更高效、精准、可靠的健康防控新生态。 格隆汇12月11日丨圣湘生物(688289.SH)公布，公司的产品全自动核酸处理系统(S-S13E-P/S-S13E-P1)于 近日获得欧盟 CE IVDR 认证。 获批主体：圣湘生物科技股份有限公司，证书编号：CMB 1012-2025，预期用途：全自动核酸处理系统 （S-S13E-P/S-S13E-P1）用于临床样本中核酸的提取和纯化，并进行聚合酶链式反应（PC ...

证券代码：688289 证券简称：圣湘生物 公告编号：2025-078 圣湘生物科技股份有限公司 关于自愿披露相关产品获得欧盟 CE 认证的公告 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。 圣湘生物科技股份有限公司（以下简称"公司"）的产品全自动核酸处理系统 （S-S13E-P/S-S13E-P1）于近日获得欧盟 CE IVDR 认证，现将相关情况公告如下： | 获批主体 | 圣湘生物科技股份有限公司 | | --- | --- | | 证书编号 | CMB 1012-2025 | | 证书类型 | 欧盟CE IVDR注册证 | | 产品名称 | 英文名称：Fully Automated Nucleic Acid Processing System | | | 中文名称：全自动核酸处理系统 全自动核酸处理系统（S-S13E-P/S-S13E-P1）用于临床样本中核酸的 | | | 提取和纯化，并进行聚合酶链式反应（PCR）扩增、荧光检测以及数 | | 预期用途 | 据分析。适用于血清、血浆、咽拭子、肛拭子、粪便、生殖道 ...

Core Viewpoint - The strategic cooperation agreement between Shengxiang Biotechnology Co., Ltd. and BeiGene (Guangzhou) Innovation Technology Co., Ltd. marks a significant acceleration of Shengxiang's "integrated diagnosis and treatment" strategy [1] Group 1: Cooperation Goals - The collaboration aims to achieve full-link synergy in early screening, precise drug selection, efficacy monitoring, and safety assessment in key areas such as oncology, metabolism, immune inflammation, and children's growth and development [3] - The partnership will leverage large-scale population sample studies to identify suitable intervention targets and optimal timing, enhancing treatment levels in metabolism and immune inflammation while addressing health management challenges related to children's growth and development [3] Group 2: Technological Synergy - The core support for aligning innovative therapies with patient needs lies in precise diagnostic and treatment technologies, which will enhance innovation efficiency and ensure solutions are more aligned with clinical realities [3] - Shengxiang has initiated the construction of an integrated diagnosis and treatment ecosystem, with Shengxiang Haiji serving as the core platform in biopharmaceuticals, facilitating a strong collaboration with BeiGene's innovative research capabilities [3] Group 3: Implementation Framework - The BeiGene Biopharmaceutical Innovation Center will act as the central hub for collaboration, utilizing existing research support, clinical resources, and industrial incubation capabilities to create a comprehensive cooperation chain from technology exploration to clinical validation and practical application [4] - The partnership extends beyond technical collaboration to include joint exploration in children's health and metabolism, as well as coordinated resource layout in the industry, with the potential to expand global cooperation and promote innovative outcomes to more countries and regions [4]

Core Viewpoint - Shengxiang Biotechnology (688289.SH) announced on December 5 that part of the shares held by its major shareholder, Chen Weny, are subject to judicial freezing and enforcement, which will not affect the company's control or daily operations [1][2]. Group 1: Shareholder and Judicial Actions - The shares subject to judicial freezing include 20,720,000 shares, representing 3.58% of the total share capital, which will be adjusted to a "non-restricted sell freeze" status [2]. - The court will allow the applicant to sell up to 4 million shares through the secondary market at a price not lower than 90% of the average price over the previous 30 trading days, with a deadline for the reduction by June 20, 2026 [2]. Group 2: Company Financials and Stock Performance - Shengxiang Biotechnology raised a total of 201.92 million yuan, with a net amount of 186.93 million yuan, exceeding the original plan by 131.27 million yuan [3]. - The company was listed on the Sci-Tech Innovation Board on August 28, 2020, with an initial issuance of 40 million shares at a price of 50.48 yuan per share, and the stock reached a peak of 155.55 yuan on its first trading day [2]. - Currently, the stock is in a state of decline, having fallen below its initial offering price [2].

Summary of Conference Call Records Industry Overview - The medical device industry is experiencing overall performance pressure in 2025, but third-quarter revenues have shown a year-on-year increase, with a narrowing decline in net profit attributable to the parent company, primarily due to domestic medical insurance cost control and geopolitical influences. It is expected that normal growth rates will resume in 2026 [1][3][8]. Key Points on Medical Device Sector - **Domestic Market Dynamics**: The slowdown in hospital bidding in 2024 is impacting revenue realization, with an expected boost from the "old-for-new" policy by the end of 2025. The In Vitro Diagnostics (IVD) sector is under pressure due to centralized procurement price adjustments and tax reimbursements [1][4]. - **International Market Challenges**: Companies are strengthening their overseas presence, but initial high costs are pressuring short-term profits. The impact of US-China tariffs on low-value consumables is significant, with expectations of price recovery in the glove industry from late 2025 to 2026 after inventory digestion [1][4][11]. - **Performance Metrics**: In the first three quarters of 2025, the medical device sector reported revenues of 145.7 billion yuan, a year-on-year decline of 2.4%, and a net profit of 26.5 billion yuan, down 14.4%. However, the third quarter showed a positive revenue trend and a narrowing profit decline [3][15]. Specific Sector Insights - **IVD Sector**: The IVD sector saw a year-on-year decline of 14.5% in the first three quarters, but the third quarter showed improvement with revenues of 11.02 billion yuan, benefiting from the implementation of centralized procurement and the release of DRG/DIP 2.0 [16]. - **High-Value Consumables**: This segment experienced a revenue growth of 6.6% year-on-year, with orthopedics showing a significant growth rate of 18.7%. The recovery in cardiovascular surgeries is driving sales, and the ophthalmology sector presents potential due to low penetration rates [17]. - **Medical Equipment**: The medical equipment sector's revenue remained flat, but profit growth was slightly higher. The imaging equipment sector is benefiting from the "old-for-new" projects, with a notable recovery in the endoscope segment [15]. Vaccine Sector Performance - The vaccine sector faced significant pressure, with revenues declining nearly 50% and profits turning negative. However, there is a quarter-on-quarter improvement trend. Future focus includes the recovery of traditional vaccines and the launch of new pipeline products, such as the domestically produced nine-valent HPV vaccine [2][23]. Life Sciences Upstream Sector - The life sciences upstream sector's performance remained stable, with a year-on-year profit growth of 68% in the third quarter, driven by recovering terminal demand and improved gross margins. The sector is benefiting from the expansion of the biopharmaceutical market and policy support [24]. Regulatory Environment and Challenges - The current regulatory environment emphasizes innovation while ensuring safety and efficacy. Domestic companies face challenges in international certifications, particularly with the FDA and CE, due to quality control issues [20][21][22]. Future Outlook - The industry outlook for 2026 includes a focus on self-sufficiency, innovative devices, and accelerated realization of centralized procurement categories. The recovery of orthopedic products is already evident, and international expansion remains a key area of interest [5][7][19].

Group 1: National Medical Insurance and Commercial Health Insurance - The National Healthcare Security Administration has released the latest version of the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, which includes 114 new drugs, of which 50 are first-class innovative drugs, achieving a success rate of 88%, an increase from 76% in 2024 [1] - The updated National Medical Insurance Drug Catalog will be implemented starting January 1, 2026, marking the eighth adjustment since the establishment of the National Healthcare Security Administration and the first introduction of a commercial health insurance innovative drug catalog [1] Group 2: Haiwang Bio - Haiwang Bio announced that its stock price had deviated significantly, with a cumulative increase of over 100% from November 26 to December 5, 2025, indicating severe abnormal trading [2] - The company reported a price-to-book ratio of 7.64, which differs from industry peers, suggesting potential risks of market overheating and irrational speculation [2] Group 3: Shengxiang Bio - Shengxiang Bio disclosed that 20.72 million shares (3.58% of total shares) owned by shareholder Chen Wenyin are subject to judicial freezing, with a provision allowing for the sale of up to 4 million shares under specific conditions [3] - The judicial freeze may exert short-term pressure on the stock price, but the set minimum price for the sale provides some stability [3] Group 4: Kang En Bei Management Changes - Kang En Bei announced the resignation of Chairman Jiang Yi and board member Jiang Qian due to work adjustments, raising concerns about potential governance structure changes [4] - The departure of key executives may lead to market apprehension, but if there are no significant changes in business strategy, growth potential remains [4]

圣湘生物科技股份有限公司 关于持股 5%以上股东部分股份拟被司法冻结并 强制执行的提示性公告 证券代码：688289 证券简称：圣湘生物 公告编号：2025-077 注：本次股份减持是司法强制执行导致的，股份变动时间、数量及价格均存在不 确定性，实际变动情况以最终法院执行为准。 三、其他说明及风险提示 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。 圣湘生物科技股份有限公司（以下简称"公司"或"圣湘生物"）于近日收到湖 南省株洲市中级人民法院下发的（2025）湘 02 执 1204 号《协助执行通知书》，获悉 公司持股 5%以上股东陈文义先生所持公司的部分股份拟被司法冻结并强制执行。陈 文义先生持有公司股份 32,917,370 股，占公司总股本 5.68%，不属于公司的控股股东、 实际控制人，其股份被司法冻结和强制执行的事项不会影响公司控制权稳定，亦不会 对公司日常经营与管理造成影响。现将有关情况公告如下： 一、本事项基本情况 经向股东征询，本次股份被冻结和强制执行系出于股东及其所控制主体与债权申 请人（以下简称"申请人 ...

圣湘生物公告称，近日收到法院通知，持股5%以上股东陈文义所持公司部分股份拟被司法冻结并强制 执行。陈文义持有公司3291.74万股，占总股本5.68%。法院拟对其名下2072万股（占总股本3.58%）无 限售流通股司法冻结，并准许申请人按规定价格，通过二级市场集中竞价分批卖出不超400万股，减持 期限不晚于2026年6月20日。强制执行后，陈文义持股降至2891.74万股，占比4.99%。该事项不影响公 司控制权和日常经营。 ...

人民财讯12月5日电，圣湘生物(688289)12月5日公告，根据申请人所提申请，株洲市中级人民法院拟对 被申请人、公司股东陈文义名下的2072万股(占公司总股本的3.58%)公司无限售流通股进行司法冻结， 并立即将冻结状态调整为"不限制卖出冻结"。法院将准许申请人以不低于申请人每次向法院提出减持申 请前三十个交易日每日加权平均价格算术平均值的90%的价格，通过二级市场集中竞价的形式分批卖出 圣湘生物股票不超过400万股，减持期限不晚于2026年6月20日。 ...