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九强生物(300406) - 关于取得医疗器械注册证书的公告
2026-03-03 07:42
| 证券代码:300406 | 证券简称:九强生物 公告编号:2026-011 | | --- | --- | | 债券代码:123150 | 债券简称:九强转债 | 北京九强生物技术股份有限公司 关于取得医疗器械注册证书的公告 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。 北京九强生物技术股份有限公司(以下简称"公司")于近日收到北京 市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 类别 | 注册证有效期 | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | | 1 | 总蛋白测定试剂盒 (双缩脲法) | 京 械 注 20262400061 | 准 | Ⅱ | 自批准之日起有效期 至 2031 年 02 月 27 日 | 本试剂盒用于体外定量 测定人血清或血浆中总 蛋白(TP)的含量。 | 上述产品医疗器械注册证的取得,丰富了公司在体外诊断生化细分领域 产品线的品种,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 司未来的经营将产生积极 ...
九强生物(300406) - 关于持股5%以上股东减持股份计划期限届满的公告
2026-03-02 10:30
证券代码:300406 证券简称:九强生物 公告编号:2026-010 债券代码:123150 债券简称:九强转债 北京九强生物技术股份有限公司 关于持股5%以上股东减持股份计划期限届满的公告 持股5%以上的自然人股东ZHOU XIAOYAN女士保证向本公司提供的信息内容真实、 准确、完整,没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一致。 北京九强生物技术股份有限公司(以下简称"公司"或"九强生物")于 2025年11月11日披露了《关于持股5%以上股东减持股份计划预披露公告》(公 告编号:2025-102)持有公司股份30,769,636股(占当时公司总股本比例为 5.25%,占当时剔除公司回购账户股份后总股本比例为5.28%,)的自然人股 东ZHOU XIAOYAN女士计划自上述预披露公告披露之日起十五个交易日后的三 个月内(即2025年12月3日至2026年3月2日)以集中竞价和/或大宗交易方式 减持本公司股份,计划减持数量不超过2,214,173股(占当时公司总股本比 例为0.38%,占当时剔除公司回购账户股份后总股本比例为0.38%)。 上述减 ...
iza-bren公告III期结果;君实生物等药企发布业绩快报 | 健讯Daily
2 1 Shi Ji Jing Ji Bao Dao· 2026-02-28 00:19
国家药监局:2025年共收到创新医疗器械特别审批申请457项 近日,国家药监局发布2025年度创新医疗器械等产品注册审批情况。2025年,国家药监局按照《创新医 疗器械特别审查程序》《医疗器械优先审批程序》继续做好相关产品的审查工作,共收到创新医疗器械 特别审批申请457项,其中104项获准进入创新医疗器械特别审查程序;收到优先申请38项,其中26项获 准优先审批。 国家药监局:2025年475个中药材生产基地通过检查 央视新闻消息显示,记者从2026年全国中药注册管理和质量安全监管工作会上了解到:截至2025年年 底,全国475个中药材生产基地通过延伸检查,种植面积近124万亩,可以提供101种中药材,供给215家 中药生产企业生产275个品种。国家药监局表示,2025年监管部门聚焦中药风险预警,督促中药生产企 业主动强化监测预警,及时采取措施有效控制风险、消除隐患。完善中药说明书安全性信息,印发《已 上市中药变更药品说明书中安全性内容的申报资料撰写要求》。发布5批公告,涉及666个批准文号,完 成相关补充申请21个。 药械审批 上海医药:普瑞巴林胶囊获得菲律宾药品注册证书 2月27日,上海医药(60160 ...
九强生物(300406) - 关于取得医疗器械注册证书的公告
2026-02-27 07:40
| 证券代码:300406 | 证券简称:九强生物 公告编号:2026-009 | | --- | --- | | 债券代码:123150 | 债券简称:九强转债 | 2026年2月27日 | 序号 | 产品名称 | 注册证编号 | 注册 类别 | 注册证有效期 | 预期用途 | | --- | --- | --- | --- | --- | --- | | 1 | 白蛋白测定试剂盒 (溴甲酚绿法) | 京 械 注 准 20262400050 | Ⅱ | 自批准之日起有效期 至 2031 年 02 月 12 日 | 本试剂盒用于体外定量 测定人血清和血浆中的 白蛋白(ALB)含量。 | 上述产品医疗器械注册证的取得,丰富了公司在体外诊断生化细分领域 产品线的品种,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 司未来的经营将产生积极影响。上述产品实际销售情况取决于未来市场推广 效果,公司目前尚无法预测其对公司未来业绩的影响,敬请投资者注意投资 风险。 特此公告。 北京九强生物技术股份有限公司 董事会 北京九强生物技术股份有限公司 关于取得医疗器械注册证书的公告 本公司及董事会全体成员保证信息披露的内容真 ...
九强生物2月25日获融资买入588.67万元,融资余额2.06亿元
Xin Lang Cai Jing· 2026-02-26 01:36
机构持仓方面,截止2025年9月30日,九强生物十大流通股东中,华宝中证医疗ETF(512170)位居第 八大流通股东,持股834.46万股,相比上期减少140.85万股。 声明:市场有风险,投资需谨慎。本文基于第三方数据库自动发布,不代表新浪财经观点,任何在本文 出现的信息均只作为参考,不构成个人投资建议。如有出入请以实际公告为准。如有疑问,请联系 biz@staff.sina.com.cn。 责任编辑:小浪快报 资料显示,北京九强生物技术股份有限公司位于北京市海淀区花园东路15号旷怡大厦5层,成立日期 2001年3月29日,上市日期2014年10月30日,公司主营业务涉及一家以生化诊断、血凝检测、血型检测 和肿瘤病理检测的研发、生产和销售。主营业务收入构成为:体外检测试剂95.09%,体外检测仪器 3.06%,其他业务收入0.96%,检验服务0.53%,仪器租赁收入0.36%。 截至9月30日,九强生物股东户数1.81万,较上期减少2.48%;人均流通股23502股,较上期增加2.54%。 2025年1月-9月,九强生物实现营业收入10.12亿元,同比减少18.24%;归母净利润2.72亿元,同比减少 2 ...
研判2026!中国诊断试剂行业发展历程、产业链、发展现状、竞争格局、发展趋势分析:行业规模持续上涨,产品逐渐向高端化转型[图]
Chan Ye Xin Xi Wang· 2026-02-26 01:16
Core Viewpoint - The diagnostic reagent industry in China is experiencing fluctuations in market size due to the impact of COVID-19, with a projected recovery and growth expected by 2025, reaching a market size of 140 billion yuan, an 8% increase year-on-year [6][7]. Industry Overview - Diagnostic reagents are essential tools in medicine and biology for detecting diseases, infections, and other medical conditions through interactions with biological samples [4][6]. - The market is primarily dominated by in vitro diagnostic reagents, while in vivo diagnostics remain relatively small [6]. Market Size and Trends - The market for in vitro diagnostic reagents in China has shown an upward trend since 2015, with rapid growth from 2020 to 2022 due to the pandemic, but a 14% decline in 2023 due to reduced demand for COVID-19 diagnostic reagents [6][7]. - The market is expected to recover in 2024, with projections indicating a market size of 140 billion yuan by 2025, reflecting an 8% year-on-year growth [6][7]. Competitive Landscape - The diagnostic reagent market includes both domestic companies like Mindray Medical, Antu Bio, and Wanfu Bio, and international firms such as Roche Diagnostics and Abbott, all competing for market share [8]. - Domestic companies are noted for their strong R&D capabilities and significant market presence [8]. Industry Development Stages - The diagnostic reagent industry in China has progressed through four stages: nascent, initial, extensive development, and rapid growth, with significant advancements in technology and regulatory improvements since the 21st century [5]. Industry Chain - The industry chain consists of upstream raw materials (diagnostic enzymes, antigens, antibodies, etc.), the midstream diagnostic reagent production, and downstream applications in medical institutions and third-party diagnostic organizations [6]. Market Segmentation - The in vitro diagnostic reagent market is segmented, with immunodiagnostic reagents holding a 32% market share, followed by molecular diagnostic reagents at 19%, and biochemical diagnostic reagents at 18% [7]. Future Trends - The industry is expected to focus on high-end product upgrades, with companies increasing R&D investments to enhance product value amidst price pressures from centralized procurement [9]. - There is a trend towards market penetration in lower-tier cities and global expansion, with domestic products entering emerging markets in Southeast Asia and Africa [10]. - The industry is evolving towards a model centered on clinical value and personalized medicine, integrating diagnostic solutions with treatment recommendations [11].
九强生物(300406) - 关于公司获得发明专利证书的公告
2026-02-10 07:44
| 证券代码:300406 | | --- | | 债券代码:123150 | 证券代码:300406 证券简称:九强生物 公告编号:2026-008 债券代码:123150 债券简称:九强转债 一、专利基本情况 | 序号 | 专利号 | 专利名称 | 专利权人 | 专利类型 | 申请日期 | 授权日期 | | 证书号 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | ZL202310 811498.9 | 偶联物的制 备方法 | 九强生物 | 发明 | 2019.12.27 | 2026.02.10 | 第 | 8702944 | 号 | 注:发明专利权期限为自申请日起二十年。 发明专利摘要: 本专利涉及偶联物的制备方法。具体而言,本专利的 6-磷酸葡萄糖脱氢酶 突变体相较于野生型 6-磷酸葡萄糖脱氢酶包含选自以下的一个突变或其组合: D306C、D375C、G426C。使用本专利的 6-磷酸葡萄糖脱氢酶突变体所制备的检测 试剂盒,其特异性强、灵敏度高、操作方便、检测时间短、定量准确,适合高通 量检测。 二、对公司 ...
A股公告精选 | 招商蛇口(001979.SZ)1月销售额近80亿,销售面积超27万平方米
智通财经网· 2026-02-09 12:04
Group 1: Zhejiang Longsheng - Zhejiang Longsheng announced a price increase for certain types of disperse dyes, with the price of disperse black rising by 5,000 yuan per ton recently [1] - The price adjustment is driven by the increase in the cost of reducing agents, which are important intermediates in dye production [1] - The company has a total dye production capacity of approximately 300,000 tons per year and a high degree of integration in its supply chain, which contributes to its competitive advantage [1] Group 2: Sanwei Biotech - Sanwei Biotech reported the final ruling of the U.S. Department of Commerce regarding anti-dumping and countervailing duties on erythritol from China, with a countervailing duty rate of 8.63% for the company [2] - The company did not qualify for a separate anti-dumping rate and faces a unified rate of 184.26%, which is a reduction from the initial ruling [2] - The overall effective tax rate for the company when exporting through specific channels is 93.58%, which may weaken its cost competitiveness in the U.S. market [2] Group 3: Zhiguang Electric - Zhiguang Electric's subsidiary signed a sales contract for energy storage systems worth 1.004 billion yuan, which is expected to positively impact the company's financial status and operational performance [3] Group 4: Yuanjie Technology - Yuanjie Technology plans to invest approximately 1.251 billion yuan to build a second phase of its optoelectronic communication semiconductor chip and device R&D and production base [4] - The project aims to enhance the company's market share and competitiveness in the global optical chip sector by expanding capacity and optimizing processes [4] Group 5: Jinhui Shares - Jinhui Shares announced a cash acquisition of 100% equity in Fusheng Mining for 210 million yuan, which includes mining rights for the Laoshengou gold mine with an annual production capacity of 50,000 tons [5] - The mine is located in a region with favorable geological conditions and high-grade gold resources [5] Group 6: Hainan Mining - Hainan Mining is planning to acquire 69.9% of Fengrui Fluorine Industry through a combination of issuing shares and cash payments, which will expand its fluorite mining business [6] - The company will issue shares to no more than 35 specific investors to raise matching funds for the acquisition [6] Group 7: Dingxin Communications - Dingxin Communications announced that its director and vice president was fined 120,000 yuan for engaging in short-term trading of the company's stock [7] Group 8: Mengguli - Mengguli plans to invest 929 million yuan to build a project for producing 30,000 tons of lithium-ion battery cathode materials annually, with a construction period of 36 months [8] - The project will be executed in two phases, with the first phase focusing on high-voltage lithium cobalt oxide and NCA materials [8] Group 9: Aifute - Aifute intends to acquire 100% of Shengpu Shares through a combination of share issuance and cash payment, with the stock set to resume trading [9] - Shengpu specializes in precision fluid control equipment, which is crucial for manufacturing processes in various industries [9] Group 10: Hengdian Film - Hengdian Film's stock experienced abnormal trading fluctuations, with a cumulative price increase of 83.98% over the past 10 trading days, indicating potential market overreaction [10] - The company warns of risks associated with a rapid decline in stock price due to significant deviations from its fundamental value [10] Group 11: Perfect World - Perfect World reported that its actual controller reduced holdings by 1.247 million shares during a period of abnormal stock price fluctuations [11] - The company confirmed that there were no significant changes in its operational environment or undisclosed information affecting stock prices [11] Group 12: Runtou Shares - Runtou Shares noted a recent price increase of approximately 5,000 yuan per ton for disperse black dyes, driven by rising prices of reducing agents [12] - The company operates in a highly competitive dye industry, with China being the largest producer and consumer of dyes globally [12]
2月9日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-09 10:13
Group 1 - XianDao Intelligent has set the final price for its H-share public offering at HKD 45.8 per share, with expected listing on February 11, 2026 [1] - Jida Communication is a candidate for a project with China Mobile, with an estimated service fee of approximately CNY 51.04 million [2] - Bowei Alloy's controlling shareholder plans to increase holdings by CNY 100 million to 150 million from February 10 to August 9, 2026 [3] Group 2 - Xiamen Airport reported 16,368 aircraft takeoffs and landings in January 2026, a year-on-year decrease of 4.82%, with passenger throughput of 2.38 million, down 3.84% [4] - Yitong Century has won a bid for a project worth CNY 107 million, providing comprehensive maintenance services for China Tower [5] - Huayi Brothers' controlling shareholder's 70 million shares are subject to judicial auction, representing 42.89% of his holdings and 2.52% of the company's total shares [6] Group 3 - Lianhuan Pharmaceutical received approval for the sale of Tadalafil tablets (20mg) in Ghana [7] - Aonong Biological reported a pig sales volume of 166,600 in January 2026, a year-on-year increase of 35.36% [8] - Xiantan Co. achieved chicken product sales revenue of CNY 546 million in January 2026, a year-on-year increase of 54.9% [9] Group 4 - Zhengbang Technology reported a January sales revenue of CNY 816 million from pig sales, a year-on-year increase of 19.69% [10] - Qianjin Pharmaceutical's net profit for 2025 grew by 24.74% to CNY 288 million [11] - Xinhua Pharmaceutical received a drug registration certificate for glucosamine sulfate capsules [12] Group 5 - Yuandong Bio completed the first dosing of its EP-0210 monoclonal antibody in a Phase I clinical trial for inflammatory bowel disease [13] - Jiaokong Technology signed a contract for the Sydney Metro West Line signal system subcontracting project worth AUD 93.53 million [14] - Dangsheng Technology signed a strategic cooperation framework agreement with Huineng Technology in solid-state batteries and the new energy industry [15] Group 6 - Jinhui Co. plans to acquire 100% of Fusheng Mining for CNY 210 million [16] - Cangzhou Mingzhu announced Guangzhou Light Industry as its new controlling shareholder after a share transfer [17] - Dingxin Technology's vice president was fined CNY 120,000 for short-term trading [18][19] Group 7 - China Modern Pharmaceutical's subsidiary passed a GMP compliance inspection for its production line [20] - Chaosheng Electronics plans to increase capital by CNY 400 million in its subsidiary to enhance competitiveness [21] - Lonyu Mountain reported a 25.03% year-on-year increase in pig sales revenue in January 2026 [22] Group 8 - Sanbo Brain Science's chairman has been released from investigation, and the company is operating normally [23] - Hainan Mining is planning to acquire control of Luoyang Fengrui Fluorine Industry and will resume trading on February 10, 2026 [24] - Dongwei Technology's net profit for 2025 increased by 86.81% [25] Group 9 - Yuanjie Technology plans to invest CNY 1.251 billion in a semiconductor chip and device R&D production base [26] - Metro Design signed a contract for an energy management project with Guangzhou Metro Group worth CNY 924 million [27] - Zhongmin Energy intends to acquire 51% of Fujian Yongtai Mintou Pumped Storage Co. for CNY 864 million [28] Group 10 - Dianzhi Technology plans to repurchase shares worth CNY 100 million to 200 million [29] - China Baoan was not selected as a restructuring investor for the Singshan Group [30] - Zhiguang Electric's subsidiary signed a CNY 1.004 billion contract for energy storage systems [31] Group 11 - Zhifei Biological received approval for a clinical trial of its herpes zoster vaccine [32] - KQ Bio received a new veterinary drug registration certificate for a vaccine against porcine circovirus type 2 [33] - Huanxu Electronics reported a 4% year-on-year increase in consolidated revenue for January 2026 [34] Group 12 - Xiangjia Co. reported a 10.42% year-on-year increase in live poultry sales revenue in January 2026 [35] - Kemin Foods' subsidiary reported a 68.29% year-on-year increase in pig sales revenue in January 2026 [36] - Liyuan Technology signed a procurement contract worth CNY 54.98 million [37] Group 13 - Jiuqiang Bio received a medical device registration certificate for a fibrin degradation product detection kit [38] - Zhongguancun's subsidiary passed the consistency evaluation for Tramadol Hydrochloride tablets [39] - Rundou Co. received a drug registration certificate for Candesartan Etil [40]
九强生物:关于公司取得医疗器械注册证书的公告
Zheng Quan Ri Bao· 2026-02-09 10:09
Core Viewpoint - Jiukang Bio has received a medical device registration certificate from the Beijing Drug Administration for its fibrin (original) degradation product determination kit (latex immunoturbidimetry method) [2] Group 1 - The product is named fibrin (original) degradation product determination kit [2] - The approval was granted by the Beijing Drug Administration [2] - The announcement was made on February 9 [2]