Group 1 - Recent cases of Nipah virus infection have been reported in West Bengal, India, prompting countries like Thailand and Nepal to enhance preventive measures at airports and border checkpoints [1] - The World Health Organization recognizes Nipah virus as a significant global public health challenge due to its long incubation period, ability to infect various animals and humans, and high fatality rate [1] - Several Chinese gene testing companies have quickly responded to the outbreak by developing testing solutions, showcasing their technological capabilities and emergency response abilities [1] Group 2 - Guangzhou Kingmed Diagnostics Group Co., Ltd. has developed a MetaVirus NGS detection service for precise detection and analysis of Nipah virus and other pathogens, providing reports within 19 hours from sample entry [2] - Beijing Bohui Innovation Biotechnology Group has created a Nipah virus nucleic acid testing kit, utilizing the BHQ-Ⅲ automated nucleic acid analysis system to ensure safety and reduce operational risks [2] - Capbio has independently developed a Nipah virus nucleic acid testing kit, focusing on emergency responses to public health events and providing core technical support for global quarantine and disease control monitoring [1][2]

Core Viewpoint - The company, Bohui Innovation, has received a medical device registration certificate from the National Medical Products Administration for its five-item nucleic acid detection kit for reproductive tract pathogens, indicating a significant advancement in its product offerings and potential market impact [2]. Group 1 - The product is a PCR-fluorescent probe method kit for the in vitro qualitative detection of pathogens including Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum/Ureaplasma parvum, Mycoplasma hominis, and Mycoplasma genitalium [2]. - The registration certificate number is Guo Xie Zhu Zheng 20263400155, and it is valid until January 22, 2031 [2]. - This product is designed for use with male urethral swabs and female cervical swabs, expanding the company's diagnostic capabilities in the reproductive health sector [2].

Core Viewpoint - The company, Bohui Innovation, has recently received a medical device registration certificate from the National Medical Products Administration of China for its reproductive tract pathogen nucleic acid detection kit, enhancing its product offerings and competitive edge, although sales remain uncertain [1] Group 1: Product Details - The product is a five-pathogen nucleic acid detection kit (PCR - fluorescence probe method) classified as Class III medical device [1] - The registration number is 国械注准 20263400155, with a validity period from January 23, 2026, to January 22, 2031 [1] Group 2: Market Implications - The certification enriches the company's product variety, potentially improving its market competitiveness [1] - However, there is uncertainty regarding the sales performance of the newly certified product [1]

Core Viewpoint - The company has received a medical device registration certificate from the National Medical Products Administration for its reproductive tract pathogen five-item nucleic acid testing kit, which is expected to enhance its product offerings and market competitiveness [1] Group 1: Product Development - The product is designed for in vitro qualitative detection of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Ureaplasma urealyticum/Ureaplasma parvum (Uu/Up), Mycoplasma hominis (MH), and Mycoplasma genitalium (MG) in male urethral and female cervical samples [1] - The acquisition of the medical device registration certificate enriches the company's product variety, which is crucial for improving its core competitiveness and market expansion capabilities [1] Group 2: Market Impact - The actual sales performance of the product will be influenced by factors such as market promotion effectiveness and changes in the market environment, indicating a degree of uncertainty [1]

证券代码：300318 证券简称：博晖创新 公告编号：临 2026-003 北京博晖创新生物技术集团股份有限公司 关于公司获得医疗器械注册证的公告 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。 北京博晖创新生物技术集团股份有限公司（以下简称"公司"或"博晖创新"） 近日获得由国家药品监督管理局颁发的《中华人民共和国医疗器械注册证（体外 诊断试剂）》。具体情况如下： 一、医疗器械注册证的具体情况 1、产品名称：生殖道病原体五项核酸检测试剂盒（PCR-荧光探针法） 5、预期用途：本试剂盒用于体外定性检测男性尿道拭子、女性宫颈拭子样 本中的淋球菌（NG）、沙眼衣原体（CT）、人解脲脲原体（Uu/Up）、人型支原体 （MH）、生殖支原体（MG）。 二、对上市公司的影响及风险提示 上述医疗器械注册证的取得，丰富了公司产品的种类，有利于进一步提升公 司的核心竞争力和市场拓展能力，对公司未来业绩的提升具有重要的意义。 上述产品实际销售情况受市场推广效果、市场环境变化等因素影响，具有一 定的不确定性，敬请广大投资者谨慎决策，注意防范投资风险。 三、备查文件 1、医疗器械注册 ...

Core Viewpoint - The company, 博晖创新, is expected to report a net loss ranging from 117 million to 59 million yuan for 2025, with a non-recurring net loss estimated between 87 million and 44 million yuan, primarily due to declining revenues and increased competition in the market [1] Group 1: Financial Performance - The company's operating revenue has decreased year-on-year, leading to a significant decline in net profit attributable to shareholders [1] - The decline in revenue is attributed to the implementation of centralized procurement policies affecting the pricing of HPV products and a reduction in market demand for certain testing products [1] - The gross profit margin has decreased year-on-year due to intensified market competition in the biopharmaceutical sector, particularly for human albumin and intravenous immunoglobulin products [1] Group 2: Operational Challenges - A subsidiary, 博晖生物制药 (河北), incurred a compensation payment of 46 million yuan due to the termination of a business partnership [1] - Another subsidiary, 廊坊博晖, has resumed production but has not fully recovered in market sales, resulting in continued losses [1] - The company has made provisions for impairment on inventories and development expenditures related to HPV testing products due to significant price declines [1] Group 3: Non-Recurring Losses - The expected non-recurring losses for 2025 are estimated to be between 15 million and 30 million yuan, primarily due to the write-off of non-current assets, compensation payments, and government subsidies [1] - In the previous year, the non-recurring losses were reported at 308,380 yuan [1]

Core Viewpoint - The company, 博晖创新, is expected to report a net loss ranging from 117 million to 59 million yuan for 2025, with a non-recurring net loss estimated between 87 million and 44 million yuan, primarily due to declining revenues and increased competition in the market [1] Group 1: Financial Performance - The company's operating revenue has slightly declined year-on-year, with a significant drop in the selling price of HPV products due to the implementation of centralized procurement policies [1] - The net profit attributable to shareholders is expected to be in a loss state, influenced by reduced market demand for certain testing products compared to the same period last year [1] - The gross profit margin has decreased year-on-year, attributed to intensified market competition in the biopharmaceutical sector, leading to lower prices for products such as human albumin and intravenous immunoglobulin [1] Group 2: Operational Challenges - A subsidiary, 博晖生物制药 (河北), incurred a compensation payment of 46 million yuan due to the termination of a business cooperation [1] - Another subsidiary, 廊坊博晖, has resumed production but has not fully recovered in market sales, resulting in continued losses [1] - The company has made provisions for impairment on inventory and development expenses related to HPV testing products due to significant price declines [1] Group 3: Non-Recurring Losses - The expected non-recurring losses for 2025 are estimated to be between -15 million and -30 million yuan, mainly due to the write-off of non-current assets, compensation payments, and government subsidies received [1] - In the previous year, the non-recurring losses were recorded at -308.38 thousand yuan [1]

博晖创新公告，预计2025年度净利润为负值，预计归属于上市公司股东的净利润为-1.17亿元至-5900万 元，扣除非经常性损益后的净利润为-8700万元至-4400万元。报告期内，公司营业收入同比下降，归属 于上市公司股东的净利润同比下降，公司净利润预计为亏损状态。 ...

证券代码：300318 证券简称：博晖创新 公告编号：临 2026-002 北京博晖创新生物技术集团股份有限公司 一、本期业绩预计情况 1、业绩预告期间：2025 年 1 月 1 日至 2025 年 12 月 31 日。 2、业绩预告情况：预计净利润为负值 单位：万元 | 项 目 | 本报告期 | | | 上年同期 | | --- | --- | --- | --- | --- | | 归属于上市公司股东的 净利润 | -11,700 | ～ | -5,900 | 924.6 | | 扣除非经常性损益后的 净利润 | -8,700 | ～ | -4,400 | 1,232.98 | 二、与会计师事务所沟通情况 本期业绩预告相关数据是公司财务部门初步测算的结果，未经审计机构审计， 但公司就业绩预告有关重大事项与其进行了沟通，公司与审计机构在业绩预告方 面不存在重大分歧。 三、业绩变动原因说明 2025 年度业绩预告 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。 证券代码：300318 证券简称：博晖创新 公告编号：临 2026-002 （3）公司下属控股孙公司 ...

Core Viewpoint - The company BoHui Innovation (300318) announced that its subsidiary BoHui Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration to conduct clinical trials for a freeze-dried rabies vaccine using human diploid cells [1] Group 1 - BoHui Biopharmaceutical Co., Ltd. is collaborating with Beijing Baihui Biotechnology Co., Ltd. for the rabies vaccine project [1] - The approval includes a formal notification for the initiation of clinical trials [1]