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九强生物(300406) - 关于公司产品获得IVDR CE认证的公告
2025-09-17 08:02
| 证券代码:300406 | 证券简称:九强生物 | 公告编号:2025-078 | | --- | --- | --- | | 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 关于公司产品获得 IVDR CE 认证的公告 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。 北京九强生物技术股份有限公司(以下简称"公司") 6 项产品于近日获得 欧盟 IVDR CE 认证,具体情况如下: | 序号 | 产品名称 | 有效期 | | 证书编号 | 预期用途 | | --- | --- | --- | --- | --- | --- | | 1 | D-二聚体测定试剂盒(胶 乳免疫比浊法) | 2030-09-10 | HX | 2165478-1 | 用于体外定量测定人血 浆中D-二聚体的含量。 | | 2 | 钾测定试剂盒(丙酮酸激 酶法) | 2030-09-10 | HX | 2165478-1 | 用于体外定量测定人血 清或血浆中钾的含量。 | | 3 | 钠测定试剂盒(半乳糖苷 酶法) | 2030-09-10 | ...
九强生物胃泌素17测定试剂盒取得医疗器械注册证书
Bei Jing Shang Bao· 2025-09-16 09:57
Core Viewpoint - Jiukang Bio has received a medical device registration certificate from the Beijing Drug Administration for its gastrin-17 assay kit, which is valid until September 11, 2030 [1] Group 1 - The product is named "Gastrin-17 Assay Kit (Magnetic Microparticle Chemiluminescent Immunoassay)" [1] - The kit is designed for the in vitro quantitative measurement of gastrin-17 (G-17) levels in human serum [1]
九强生物(300406.SZ):胃泌素17测定试剂盒取得医疗器械注册证书
Ge Long Hui A P P· 2025-09-16 08:17
Core Viewpoint - Jiukang Bio (300406.SZ) has received a medical device registration certificate from the Beijing Drug Administration for its Gastrin-17 assay kit, which is expected to enhance the company's product range and core competitiveness, positively impacting future development, although it will not significantly affect recent production operations and performance [1] Company Summary - The newly acquired medical device registration certificate pertains to the Gastrin-17 assay kit, utilizing magnetic microparticle chemiluminescent immunoassay technology [1] - This development enriches the company's product categories, which is beneficial for strengthening its core competitiveness [1] - The impact on the company's recent production and operational performance is expected to be minimal [1]
九强生物取得一项医疗器械注册证书
Zhi Tong Cai Jing· 2025-09-16 08:08
Core Viewpoint - The company Jiukang Biotechnology has received a medical device registration certificate from the Beijing Drug Administration for its product, the Gastrin-17 assay kit, which utilizes magnetic microparticle chemiluminescent immunoassay technology [1] Company Summary - Jiukang Biotechnology (300406.SZ) has announced the receipt of a medical device registration certificate [1] - The registered product is the Gastrin-17 assay kit, indicating a focus on diagnostic tools in the healthcare sector [1]
九强生物:获得胃泌素17测定试剂盒医疗器械注册证
Core Viewpoint - Jiukang Bio has received a medical device registration certificate from the Beijing Drug Administration for its Gastrin-17 assay kit, indicating a significant advancement in its product offerings in the medical diagnostics sector [1] Company Summary - Jiukang Bio (300406) announced on September 16 that it has obtained a medical device registration certificate for its Gastrin-17 assay kit, which utilizes magnetic microparticle chemiluminescent immunoassay technology [1] - The expected use of the product is for the in vitro quantitative measurement of Gastrin-17 levels in human serum [1]
九强生物:胃泌素17测定试剂盒取得医疗器械注册证书
Ge Long Hui· 2025-09-16 08:04
Core Viewpoint - Jiukang Bio (300406.SZ) has recently received a Medical Device Registration Certificate from the Beijing Drug Administration for its product, the Gastrin-17 Assay Kit (Magnetic Microparticle Chemiluminescent Immunoassay), which enhances the company's product portfolio and core competitiveness, positively impacting future development, although it will not have a significant effect on recent production operations and performance [1] Company Summary - The acquisition of the Medical Device Registration Certificate enriches the company's product categories [1] - The new product is expected to strengthen the company's core competitiveness [1] - The impact on recent production and performance is not expected to be significant [1]
九强生物(300406) - 关于取得医疗器械注册证书的公告
2025-09-16 07:52
| 证券代码:300406 | 证券简称:九强生物 公告编号:2025-077 | | --- | --- | | 债券代码:123150 | 债券简称:九强转债 | 特此公告。 北京九强生物技术股份有限公司 董事会 2025年9月16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。 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 | 胃泌素 17 测定试剂 盒(磁微粒化学发光 免疫分析法) | 京 械 注 准 20252400812 | Ⅱ | 自批准之日起有效期 至 2030 年 09 月 11 日 | 本试剂盒用于体外定量 测定人血清中胃泌素 17 (G-17)的含量。 | 上述产品医疗器械注册证的取得,丰富了公司产品类别,有利于增强公 司的核心竞争力,对公司未来发展具有正面影响,但对近期的生产经营和业 绩 ...
9月15日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-15 10:34
Group 1 - Yihau New Materials plans to reduce its shareholding by up to 1% of the company's total shares, amounting to 165,500 shares, due to personal funding needs [1] - Fuxing Pharmaceutical's subsidiary has received approval for a new indication for its drug, which is used in the treatment of certain types of breast cancer [1][2] - Shantui Co. has submitted its H-share issuance application to the China Securities Regulatory Commission, which has been accepted [3] Group 2 - Sierte's chairman plans to increase his shareholding by an amount between 3 million to 6 million yuan [4] - Borui Pharmaceutical's BGM0504 tablet has received approval for clinical trials in overweight and obese adults [5] - Ganyue Expressway reported vehicle toll service revenue of 349 million yuan for August [6] Group 3 - Chip Microelectronics has submitted its H-share issuance application to the China Securities Regulatory Commission, which has been accepted [7] - Lingrui Pharmaceutical's director plans to reduce his shareholding by up to 200,000 shares, representing 0.0353% of the total shares [8] - Jiahu Energy has adjusted its share repurchase price limit to 11.63 yuan per share [10] Group 4 - Spring Airlines reported a year-on-year increase of 12.23% in passenger turnover for August [11] - Kaida has received an invention patent for a self-calibrating sensor technology [12] - Chuanheng Co. has obtained a new utility model patent aimed at improving industrial waste utilization [14] Group 5 - Huashi Technology received a government subsidy of 2.21 million yuan, accounting for 22.71% of its latest audited net profit [15] - Shanghai Pharmaceuticals' controlling shareholder plans to increase its H-share holdings by up to 74 million shares [16] - Hongrun Construction has won a bid for a significant segment of the Shanghai Metro Line 21 project, valued at 126 million yuan [18] Group 6 - Sanfangxiang plans to invest 100 million yuan to establish a wholly-owned subsidiary focused on green technology [19] - Lao Fengxiang's subsidiaries plan to jointly invest in luxury goods sales and gold refining companies [20][21] - China Eastern Airlines reported an 8.72% year-on-year increase in passenger turnover for August [22] Group 7 - Inner Mongolia First Machinery has signed a railway freight car procurement contract worth 186 million yuan [22] - Jiuqiang Bio has received five invention patents related to diagnostic reagents [24] - Longmag Technology plans to invest 210 million yuan in its second phase project in Vietnam [25] Group 8 - Galaxy Magnetics plans to acquire 100% equity of Kyoto Longtai, with its stock suspended for trading [26] - Jinlong Co.'s controlling shareholder will have 30 million shares auctioned [27] - Haishi Co.'s controlling shareholder has released the pledge on 29.97 million shares [28] Group 9 - Qiu Tianwei plans to reduce its shareholding by up to 1.17% of the total shares [29] - Xiaocheng Technology's directors plan to reduce their shareholding by a total of 0.08% [30] - Victory Co. reported that Sunshine Life Insurance has reduced its shareholding by 4.4 million shares [31] Group 10 - Xindong Technology plans to distribute a cash dividend of 0.156 yuan per share [32] - Huaqin Technology plans to distribute a cash dividend of 0.13 yuan per share [33] - Kexing Pharmaceutical's controlling shareholder intends to transfer 5% of the company's shares [35] Group 11 - Guojin Securities has completed the repayment of its second short-term financing bond for 1.0205 billion yuan [38] - Chunhui Intelligent Control's application for asset acquisition has been accepted by the Shenzhen Stock Exchange [39] - Chaohongji has submitted its H-share issuance application to the Hong Kong Stock Exchange [40] Group 12 - Tianyue Advanced has fully exercised its over-allotment option, involving 716,180 H-shares [40] - Chengfeng Technology's vice president has resigned due to internal adjustments [41] - Yingpais plans to establish a 100 million yuan technology sports industry investment fund [43]
九强生物:取得5项专利证书
Mei Ri Jing Ji Xin Wen· 2025-09-15 08:05
Core Viewpoint - Jiukang Bio (300406) has recently received five invention patent certificates from the National Intellectual Property Administration, indicating a significant advancement in its research and development capabilities [1] Group 1: Patent Details - The patents include "6-phosphogluconate dehydrogenase mutant and its use in preparing detection reagents," "vancomycin detection kit," "preparation method of conjugates," "use of conjugates in preparing phenytoin detection reagents," and "gentamicin detection kit" [1]
九强生物(300406) - 关于公司获得发明专利证书的公告
2025-09-15 07:50
北京九强生物技术股份有限公司 关于公司获得发明专利证书的公告 | 证券代码:300406 | 证券简称:九强生物 | 公告编号:2025-076 | | --- | --- | --- | | 债券代码:123150 | 债券简称:九强转债 | | 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记 载、误导性陈述或者重大遗漏。 北京九强生物技术股份有限公司(以下简称"九强生物"或"公司")于近 期收到中华人民共和国国家知识产权局颁发的 5 项专利证书,具体情况如下: 2、本发明涉及万古霉素检测试剂盒。具体而言,本发明的 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。使用本发明的 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。 3、本发明涉及偶联物的制备方法。具体而言,本发明的 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。使用本发明的 6- ...