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"）于近日获得三项产品认证及注册，其中两项为国家三类 医疗器械注册证，一项为欧盟CE IVDR认证，现将相关情况公告如下： 一、产品注册相关情况 ■ 二、对公司的影响 诺如病毒、轮状病毒及肠道腺病毒均为引发病毒性腹泻的常见病原体，传染性极强、分布广泛，尤其在 儿童和老年人群中易引发感染。公司此次推出的诺如病毒单检与A组轮状病毒/诺如病毒/F组肠道腺病毒 三联检两款新品，将极大提升临床对腹泻病原体的快速鉴别与精准诊断能力，为我国儿童与老年人等重 点人群的肠道健康构筑坚实防线。 EB病毒在人群中感染极为普遍，不仅是传染性单核细胞增多症的元凶，更与器官移植后淋巴增生性疾 病（PTLD）以及鼻咽癌、霍奇金淋巴瘤、胃癌等多种肿瘤的发生发展密切相关。本次EB病毒检测试剂 获得欧盟CE IVDR认证，进一步丰富了公司疱疹病毒检测产品线，亦标志着公司在产品质量、技术性能 及管理体系上全面符合国际严格标准，是公司分子诊断战略和国际化战略的重要成果之一。未 ...

Core Viewpoint - Shengxiang Biotechnology (688289.SH) has recently obtained three product certifications and registrations, enhancing its diagnostic capabilities for viral pathogens associated with gastrointestinal diseases [1] Group 1: Product Certifications - The company received two Class III medical device registrations and one EU CEIVDR certification for its products [1] - The newly launched products include a Norovirus single test and a triple test for Group A Rotavirus/Norovirus/Group F Enteric Adenovirus, aimed at improving rapid identification and precise diagnosis of diarrhea pathogens [1] Group 2: Market Impact - The products are particularly beneficial for vulnerable populations such as children and the elderly, providing a robust defense for intestinal health in these groups [1] - The EB virus detection reagent has also received EU CEIVDR certification, expanding the company's herpes virus testing product line [1] Group 3: Strategic Importance - The certifications signify that the company's products meet international quality, technical performance, and management system standards, marking a significant achievement in its molecular diagnostics and internationalization strategies [1]

Core Viewpoint - Shengxiang Bio (688289.SH) has recently obtained three product certifications and registrations, enhancing its diagnostic capabilities for viral pathogens associated with gastrointestinal diseases [1] Group 1: Product Certifications - The company received two Class III medical device registrations and one EU CEIVDR certification [1] - The newly launched products include a Norovirus single test and a triple test for Group A Rotavirus/Norovirus/Group F Enterovirus, aimed at improving rapid identification and precise diagnosis of diarrhea pathogens [1] Group 2: Market Impact - The new products are expected to significantly bolster the clinical diagnosis capabilities for key demographics, particularly children and the elderly, thereby strengthening intestinal health defenses in these vulnerable groups [1] - The EB virus detection reagent has also received EU CEIVDR certification, expanding the company's herpes virus testing product line [1] Group 3: Strategic Importance - The certifications indicate that the company's products meet stringent international standards in quality, technical performance, and management systems [1] - This achievement is a significant milestone in the company's molecular diagnostics strategy and internationalization efforts [1]

Company Overview - Huakang Biomedical Holdings Limited has established itself as an expert in male infertility diagnostics after over a decade of research in the assisted reproductive technology market [2] - The company has a professional research team and solid partnerships with hospitals and medical institutions, producing in vitro diagnostic reagents for male infertility, parasite detection, and EB virus testing [2] - Huakang Biomedical is one of the top three manufacturers in China's male infertility in vitro diagnostic reagent market [2] Financial Performance - As of December 31, 2024, Huakang Biomedical reported total revenue of 25.359 million yuan, a year-on-year increase of 2.96% [1] - The company recorded a net profit attributable to shareholders of -4.158 million yuan, with a year-on-year growth of 28.09% [1] - The gross profit margin stands at 67.32%, and the debt-to-asset ratio is 17.13% [1] Market Position and Valuation - The average price-to-earnings (P/E) ratio for the pharmaceutical and biotechnology industry is 5.28 times, with a median of 4.58 times [1] - Huakang Biomedical's P/E ratio is -39.57 times, ranking 88th in the industry [1] - Other companies in the sector have P/E ratios such as: Qingdao Haier Biomedical (0.71), Kingsray Biotechnology (1.05), Baixin International (1.21), Dongrui Pharmaceutical (2.86), and Charoen Pokphand International (4.14) [1] Future Outlook - The company plans to continue investing in research and development of fertility products and introduce high-level international assisted reproductive technologies to China [2] - Huakang Biomedical aims to expand its business along the assisted reproductive technology industry chain, leveraging its strong research capabilities to create value for society [2]