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科华生物(002022.SZ):在辅助生殖领域没有相关产品和业务
Ge Long Hui· 2025-07-31 07:19
Core Viewpoint - Kehua Bio (002022.SZ) does not have products or business in the assisted reproduction field, but it offers diagnostic products related to prenatal care [1] Group 1 - The company has diagnostic products in the field of prenatal care, including the Anti-Müllerian Hormone (AMH) assay kit (chemiluminescence method) [1] - The company also provides the Survival Motor Neuron 1 (SMN1) detection kit (PCR-melting curve method) [1]
科华生物:控股子公司的基孔肯雅热病毒RNA检测试剂盒未申请医疗器械注册证
Mei Ri Jing Ji Xin Wen· 2025-07-29 15:24
Group 1 - The company’s subsidiary, Xi'an Tianlong, has not applied for the National Medical Products Administration (NMPA) medical device registration certificate for its Chikungunya virus RNA detection kit (fluorescent PCR method) [2] - The detection kit is currently only available as a research reagent and is suitable for testing needs in customs and disease control scenarios [2] - The company will closely monitor market demand and will formulate product registration plans based on actual business needs and development strategies to actively seize related business opportunities [2]
科华生物:控股子公司基孔肯雅热病毒RNA检测试剂盒尚未申请医疗器械注册证
Core Viewpoint - The company, Kehua Bio-engineering, has stated that its subsidiary, Xi'an Tianlong, has not applied for the National Medical Products Administration's medical device registration for its chikungunya virus RNA detection kit, which is currently only available as a research reagent for customs and disease control applications [1] Group 1 - The chikungunya virus RNA detection kit is based on fluorescent PCR technology [1] - The company is monitoring market demand closely and plans to develop a product registration strategy aligned with its business needs and development strategy [1] - The company aims to actively seize related business opportunities in the future [1]
7月28日医疗器械概念上涨0.47%,板块个股爱迪特、科华生物涨幅居前
Sou Hu Cai Jing· 2025-07-28 12:46
Core Viewpoint - The medical device industry experienced a slight increase of 0.47% on July 28, with a net outflow of funds amounting to 295 million [1] Group 1: Market Performance - A total of 52 stocks in the sector rose, while 68 stocks declined [1] - The top-performing stocks included: - Aidi Te (16.88%) - Kehua Bio (10.01%) - Rejing Bio (6.88%) - Zhengchuan Co. (6.68%) - David Medical (6.55%) [1][1][1] Group 2: Fund Flow - The net capital flow for the top gainers was as follows: - Aidi Te: 106 million - Kehua Bio: 12 million - Rejing Bio: 21 million - Zhengchuan Co.: -14 million (outflow) [1][1][1] - Other notable stocks with positive fund flow included: - David Medical: -6 million (outflow) - Sainuo Medical: 6 million [1][1] Group 3: Declining Stocks - The stocks with the largest declines included: - Aohua Endoscopy (-4.09%) - Tianyi Medical (-2.73%) - Mountain Outside Mountain (-2.53%) - Ruimaite (-2.42%) - Jianfan Bio (-2.32%) [1][1][1] - Additional stocks that saw declines were: - Lude Medical (-2.22%) - Nanwei Medical (-2.14%) - San Nuo Bio (-2.13%) [1][1]
肝炎概念板块短线拉升
news flash· 2025-07-28 01:37
Group 1 - The hepatitis concept sector experienced a short-term surge, with Kewah Bio (002022) hitting the daily limit up [1] - Other companies such as Qianyuan Pharmaceutical (300254), Hendi Pharmaceutical (301211), Da'an Gene (002030), Asia-Pacific Pharmaceutical (002370), and Kangzhi Pharmaceutical (300086) also saw significant increases in their stock prices [1]
世卫组织预警,全球约550万人面临感染风险!基孔肯雅热关注度高涨,三大方向涉及公司曝光!
Mei Ri Jing Ji Xin Wen· 2025-07-27 07:07
Group 1: Overview of Chikungunya Fever - Chikungunya virus is spreading globally, with 119 countries reporting cases and approximately 5.5 million people at risk of infection [1] - In Foshan, Guangdong Province, over 4,000 confirmed cases have been reported, primarily mild cases [1] Group 2: Symptoms and Treatment - Chikungunya fever is characterized by high fever and severe joint pain, particularly affecting small joints [2] - There is currently no specific treatment or widely used vaccine; management is primarily supportive, focusing on symptom relief [3] Group 3: Market Response and Company Involvement - Investors are inquiring about companies with products related to Chikungunya fever, focusing on mosquito repellent products, testing kits, and antipyretic and analgesic medications [4] - Companies like Rainbow Group, Runben Co., and Weigao Medical have reported an increase in sales of mosquito repellent products [5][6] - Pharmaceutical companies such as Renhe Pharmaceutical and Xinhua Pharmaceutical have indicated they offer products for fever and pain relief [7] Group 4: Testing Products - Companies like Kehua Bio, YHLO Biotech, and Shuoshi Bio have developed testing kits for Chikungunya virus [8] - YHLO Biotech has a rapid screening kit for Chikungunya, currently used for research purposes [8] - The market interest in these companies has led to notable stock price increases since the news of the outbreak [8]
科华生物(002022) - 关于产品获得医疗器械注册证的公告
2025-07-25 10:15
| 证券代码:002022 | 证券简称:科华生物 | | --- | --- | | 债券代码:128124 | 公告编号:2025-035 债券简称:科华转债 | 上海科华生物工程股份有限公司 关于产品获得医疗器械注册证的公告 上海科华生物工程股份有限公司董事会 2025年7月26日 近日,上海科华生物工程股份有限公司(以下简称"公司")收到国家药品 监督管理局颁发的医疗器械注册证(体外诊断试剂)。具体情况如下: | 序号 | 产品名称 | 注册证编号 | 注册证有效期 | 适用范围/预期用途 | | --- | --- | --- | --- | --- | | | 丙型肝炎病 | | 2025年07月24日 | 本质控品配套本公司丙型 肝炎病毒抗体(Anti-HCV) | | 1 | 毒抗体质控 | 国械注准 20253401473 | 至 | 检测试剂盒(化学发光法) | | | 品 | | 2030年07月23日 | 使用,用于丙型肝炎病毒抗 | | | | | | 体检测项目的质量控制。 | 以上新产品医疗器械注册证的取得,丰富了公司产品线,将对公司业务发展 具有正面影响。公司目前尚无法预测上述 ...
科华生物:公司产品丙型肝炎病毒抗体质控品获得医疗器械注册证
news flash· 2025-07-25 10:09
科华生物:公司产品丙型肝炎病毒抗体质控品获得医疗器械注册证 智通财经7月25日电,科华生物(002022.SZ)公告称,公司收到国家药品监督管理局颁发的医疗器械注册 证,产品为丙型肝炎病毒抗体质控品,注册证编号为国械注准20253401473,有效期至2030年07月23 日。该产品本质控品配套公司丙型肝炎病毒抗体(Anti-HCV)检测试剂盒(化学发光法)使用,用于 丙型肝炎病毒抗体检测项目的质量控制。新产品的取得将丰富公司产品线,对业务发展具有正面影响。 但公司目前无法预测该产品对未来营业收入的影响,提醒投资者注意投资风险。 ...
强力枇杷露被转让;赛诺菲收购Vicebio
Policy Developments - The National Health Commission issued a work plan for the integration of medical and elderly care services, promoting the establishment of national demonstration counties and institutions [2] - The criteria for creating demonstration institutions include operating for over 5 years, a bed occupancy rate of at least 65% in the last 2 years, and over 65% of residents being elderly individuals with disabilities or dementia [2] - The plan emphasizes comprehensive health assessments for the elderly, early intervention for age-related diseases, and the use of traditional Chinese medicine and information technology to enhance service quality [2] Drug and Device Approvals - Humanwell Healthcare announced that its subsidiary received a drug registration certificate for the transdermal patch for treating mild to moderate Alzheimer's disease, with a total R&D investment of approximately RMB 19 million [4] - Kehua Bio received medical device registration certificates for two nucleic acid testing kits, valid until July 16, 2030 [5] Financial Reports - Wohua Pharmaceutical reported a 303.16% year-on-year increase in net profit for the first half of the year, with revenue of RMB 425 million, a 7.64% increase [7] Capital Market Activities - Xiangsheng Medical signed an agreement with the Gates Foundation for the joint development and promotion of innovative obstetric and breast ultrasound screening devices, receiving project funding of USD 2.1 million [9] - Sanofi announced a deal to acquire Vicebio for up to USD 1.6 billion, including an upfront payment of USD 1.15 billion and milestone payments of USD 450 million [11] Industry Developments - The National Medical Insurance Administration reported that from January to June 2025, there were 200 million instances of personal account pooling in employee medical insurance, amounting to RMB 26.177 billion [13]