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科华生物:全资子公司科华(西安)生物工程有限公司收到陕西省药品监督管理局颁发的医疗器械注册证
Zheng Quan Ri Bao Wang· 2025-12-10 07:13
证券日报网讯12月9日晚间,科华生物(002022)发布公告称,近日,上海科华生物工程股份有限公司 全资子公司科华(西安)生物工程有限公司收到陕西省药品监督管理局颁发的医疗器械注册证,产品为全 自动化学发光免疫分析仪,注册证编号陕械注准20252220247,有效期至2030年12月02日。 ...
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
登录新浪财经APP 搜索【信披】查看更多考评等级 ■ 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 ■ 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 无法预测上述产品对公司未来营业收入的影响,敬请投资者给予关注并注意投资风险。 特此公告。 上海科华生物工程股份有限公司董事会 2025年12月10日 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,上海科华生物工程股份有限公司(以下简称"公司")全资子公司科华(西安)生物工程有限公司 收到陕西省药品监督管理局颁发的医疗器械注册证。具体情况如下: ...
12月9日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-09 10:29
Group 1 - Wanma Technology has been pre-awarded a total of 59.9434 million yuan for multiple State Grid projects, which accounts for 14.49% of its latest audited main business revenue [1] - Tianen Kang's subsidiary received a drug registration certificate for Methimazole tablets, a medication used for hyperthyroidism [2] - Taijing Technology invested 10 million yuan to establish a special fund focused on high-speed network communication chips [3] Group 2 - Youyou Foods plans to use 10 million yuan of its own funds to purchase principal-protected financial products with an expected annual yield of 0.5%-5.0% [4] - Yangfan New Materials announced the release of detention measures against its controlling shareholder, allowing him to resume his duties [5] - Xianju Pharmaceutical received approval for a supplementary application for Nicardipine injection, a calcium channel blocker used for acute hypertension [6] Group 3 - Jingu Co. plans to repurchase shares worth 30-60 million yuan for employee stock ownership plans or equity incentives [7] - Double Tower Foods' Thai subsidiary has completed the construction of its production line and is in the initial production phase [8] - Tongyi Zhong intends to invest approximately 198 million yuan in a project for the industrialization of ultra-high molecular weight polyethylene fibers [9][10] Group 4 - Zhangyue Technology received a dividend of 4.99 million yuan from its stake in Dianzhong Technology, which represents 10.12% of its audited net profit for 2024 [11] - Sihua Electronics announced the resignation of its general manager due to job transfer, with the current manager continuing until a new one is appointed [12] - Jiutian Pharmaceutical's new drug JMHT06 has received approval for clinical trials for acute gouty arthritis [13] Group 5 - Anlian Ruishi has established a joint venture for embodied intelligent robots with a registered capital of 20 million yuan [14] - Kelin Electric's application for a private placement has been accepted by the Shanghai Stock Exchange [15] - Guoyao Modern's subsidiary has received approval for the listing of Agomelatine raw materials, used in antidepressant synthesis [16] Group 6 - Xintiandi's application for the listing of Ferrous Fumarate raw materials has been approved, which is used for treating iron deficiency anemia [17] - ST Weihai, as the leading party, won a bid for a smart agriculture project worth 652 million yuan, accounting for 26.27% of its 2024 audited revenue [18] - Tian Youwei plans to purchase 100% of Krämer Automotive Systems for 1 million euros [19] Group 7 - Guangdong Yuedian A's subsidiary has successfully put into operation the third unit of its Dapu Power Plant project [20] - China Life's total premium exceeded 700 billion yuan as of November 30, 2025 [21] - Shoukai Co. achieved a total signed amount of 15.988 billion yuan in the first 11 months of 2025 [22] Group 8 - Kehua Bio's subsidiary has obtained a medical device registration certificate for an automatic chemiluminescence immunoassay analyzer [23] - Chengyi Pharmaceutical received a drug registration certificate for Torasemide tablets, which have passed the consistency evaluation [24] - Chongqing Construction won a bid for a municipal engineering project worth approximately 1.714 billion yuan [25] Group 9 - Hanjian Heshan signed a procurement contract for pipes worth 388 million yuan [26] - Jiuzhou Pharmaceutical plans to use up to 1 billion yuan of idle raised funds for cash management [27] - Xinwufeng reported an 80.97% year-on-year increase in pig sales in November 2025 [28] Group 10 - Luoniushan reported a 13.57% year-on-year increase in pig sales revenue in November 2025 [29] - Fushilai received a drug registration certificate for Alpha-Lipoic Acid tablets, used for diabetic neuropathy [30] - Dizhe Pharmaceutical presented research data on two innovative drugs at the 67th American Society of Hematology conference [31] - David Medical's subsidiary received two medical device registration certificates for single-use gastric tubes and electronic ureteral endoscope catheters [32]
科华生物:产品取得注册证,产品名称为“全自动化学发光免疫分析仪”
Mei Ri Jing Ji Xin Wen· 2025-12-09 08:05
(记者 王瀚黎) 截至发稿,科华生物市值为33亿元。 每经头条(nbdtoutiao)——处方药变"瘾品":国内首次报告普瑞巴林滥用致成瘾病例,网络平台暴 露"无病历可购药"漏洞,列管与否尚需科学考量 每经AI快讯,科华生物(SZ 002022,收盘价:6.4元)12月9日晚间发布公告称,近日,上海科华生物 工程股份有限公司全资子公司科华(西安)生物工程有限公司收到陕西省药品监督管理局颁发的医疗器 械注册证。产品名称为"全自动化学发光免疫分析仪"。 2025年1至6月份,科华生物的营业收入构成为:生物制品业占比100.0%。 ...
科华生物:子公司产品获得医疗器械注册证
人民财讯12月9日电,科华生物(002022)12月9日公告,近日,公司全资子公司科华(西安)生物工程有 限公司收到陕西省药品监督管理局颁发的医疗器械注册证,产品为全自动化学发光免疫分析仪。 ...
科华生物子公司取得一项医疗器械注册证
Zhi Tong Cai Jing· 2025-12-09 07:52
科华生物(002022)(002022.SZ)公告,公司全资子公司科华(西安)生物工程有限公司收到陕西省药品监 督管理局颁发的医疗器械注册证,产品名称为:全自动化学发光免疫分析仪。 ...
科华生物(002022.SZ)子公司取得一项医疗器械注册证
智通财经网· 2025-12-09 07:51
智通财经APP讯,科华生物(002022.SZ)公告,公司全资子公司科华(西安)生物工程有限公司收到陕西省 药品监督管理局颁发的医疗器械注册证,产品名称为:全自动化学发光免疫分析仪。 ...
科华生物(002022) - 关于产品获得医疗器械注册证的公告
2025-12-09 07:45
证券代码:002022 证券简称:科华生物 公告编号:2025-073 债券代码:128124 债券简称:科华转债 近日,上海科华生物工程股份有限公司(以下简称"公司")全资子公司科 华(西安)生物工程有限公司收到陕西省药品监督管理局颁发的医疗器械注册证。 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 | | --- | --- | --- | --- | --- | | | 全自动化学 | 陕械注准 | 2025年12月03日 | 本产品与配套的检测试剂共同 使用,在临床上用于对来源于人 | | 1 | | | 至 | 体的血清、血浆及其他体液样本 | | | 发光免疫分析仪 | 20252220247 | 2030年12月02日 | 中的被分析物进行定性或定量 | | | | | | 检测。 | 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产品对公司未来营业收入的影响,敬请 投资者给予关注并注意投资风险。 特此公告。 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 本公司及董事会 ...
科华生物:西安天隆是公司合并报表内的控股子公司
Zheng Quan Ri Bao Wang· 2025-12-05 10:43
证券日报网讯12月5日,科华生物(002022)在互动平台回答投资者提问时表示,西安天隆是公司合并 报表内的控股子公司,合并报表内控股子公司向母公司分红,为母公司带来现金流入,有助于公司优化 内部资源配置,不会影响合并报表净利润。 ...
2025年中国生物制剂行业政策、产业链、市场规模、研发支出、竞争格局及未来发展趋势研判:已成为医药行业增长最快的领域之一,市场规模将达到6752亿元[图]
Chan Ye Xin Xi Wang· 2025-12-03 01:24
Core Insights - The biopharmaceutical sector is one of the fastest-growing areas in the pharmaceutical industry, driven by an aging population and increased public health awareness [1][5] - China's biopharmaceutical market is projected to grow from CNY 312 billion in 2019 to CNY 587.1 billion in 2024, and is expected to reach CNY 675.2 billion by 2025, with a potential to hit CNY 1.149 trillion in the next five years [1][5][6] - Innovation remains the core driver of growth in the biopharmaceutical industry, which is capital-intensive and requires significant R&D investment [1][6] Industry Definition and Classification - Biopharmaceuticals are medical products manufactured using biological methods, aimed at replicating the activity of natural substances [2][4] - They can be categorized into vaccines, blood products, biopharmaceutical drugs, diagnostic reagents, and others, with further subdivisions based on source or mechanism of action [2] Current Industry Status - The global biopharmaceutical market is expected to grow from USD 286.4 billion in 2019 to USD 461.6 billion in 2024, with the original biopharmaceutical market projected to increase from USD 268.9 billion to USD 427.9 billion in the same period [5] - China plays a significant role in the global biopharmaceutical market, with rapid growth driven by favorable policies, increased R&D investment, and advancements in biotechnology [5][6] Industry Development Environment - Policies - The Chinese government has implemented various laws and policies to encourage biopharmaceutical R&D, including the Drug Registration Management Measures and regulations for clinical research and application of biomedical technologies [7] Competitive Landscape - The biopharmaceutical sector is recognized as a "new frontier" in the pharmaceutical industry, with major global players actively entering the market [9] - Key companies in China's biopharmaceutical industry include WuXi AppTec, Hengrui Medicine, ZhiFei Biological, BeiGene, and others, with a competitive landscape characterized by differentiated strategies [9] Future Development Trends - Market demand for biopharmaceuticals is expected to continue growing, supported by policy backing, technological advancements, and increased health awareness [10] - Domestic companies are transitioning from biosimilars to First-in-Class drugs, with examples like Hengrui Medicine's ADC drug showing superior efficacy [10][11] - Personalized medicine based on genetic testing is anticipated to become a trend, with increasing international recognition of Chinese innovative drugs [11]