体外诊断

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安诺优达递表港交所 联席保荐人为建银国际和国泰君安国际
Zheng Quan Shi Bao Wang· 2025-10-09 00:40
在中国的NIPT市场,按样本检测量计算,安诺优达在2024年排名第二,市场份额为15.5%;按收入计 算,排名第三,市场份额为14.6%。公司的科研测序解决方案服务于农业、林业、畜牧业及渔业等领域 的多组学研究。 截至2025年9月23日,公司在中国拥有三家生产厂房,主要生产检测试剂盒及测序仪。 公司主营业务包括分子诊断为基础的IVD医疗器械和多组学生命科学研究服务,尤其擅长基于NGS的产 前检测IVD产品。其临床测序解决方案涵盖IVD检测试剂盒、基因测序仪及生物信息学分析软件,并提 供技术支持和实验室设计服务。 安诺优达向港交所主板递交上市申请,联席保荐人为建银国际和国泰君安国际。 ...
MIRXES-B(02629.HK):GASTROClear™获批中国国家药监局胃癌筛查IVD注册证
Ge Long Hui· 2025-10-08 22:51
GASTROClear™为全球首个获批用于胃癌早期检测的微小核酸(miRNA)血液检测方法,通过检测12种胃 癌相关miRNA标志物评估胃癌风险。此前,该产品已于2019年在新加坡获批,并于2023年获美国食品 药物管理局("FDA")"突破性器械"认定。此次在中国获国家药监局批准,标志着本公司完成了从研发到 商业化的重要跨越,也体现了其在技术创新、大规模临床试验的成果,这奠基于其在创新与市场准入方 面的长期坚持与投入。 格隆汇10月9日丨MIRXES-B(02629.HK)宣布,其核心产品GASTROClear™已获得中国国家药品监督管 理局("国家药监局")批准第三类医疗器械注册证,作为体外诊断("IVD")产品在中国用于非侵入性胃癌筛 查。该款产品为首款获国家药监局批准用于胃癌筛查的血液检测。 ...
MIRXES-B(02629)拟成立合营企业 在马来西亚就癌症早期检测及其他核酸基础检测进行研究、开发、商业化
智通财经网· 2025-10-06 08:47
Core Insights - MIRXES-B has entered into a joint venture agreement with Xeraya Opportunities Fund to establish MYRNA DIAGNOSTICS SDN. BHD., focusing on cancer early detection and nucleic acid-based testing in Malaysia [1] Company Summary - The joint venture will be owned 40% by Mirxes International Holding Limited and 60% by Xeraya, with a total capital injection of approximately $5 million [1] - The establishment of the joint venture aligns with the company's mission to make early disease detection solutions accessible globally, starting with addressing critical healthcare gaps in Malaysia [4] Industry Summary - Malaysia faces a significant cancer burden, with over 51,650 new cases and 31,633 deaths reported in 2022, and more than 60% of cases diagnosed at advanced stages [2] - The cancer incidence rate in Malaysia is projected to increase by over 70% by 2050, highlighting the urgent need for early detection, particularly for prevalent cancers such as lung, colorectal, breast, liver, and stomach cancers [2] - The joint venture aims to leverage Malaysia's strong life sciences and healthcare expertise to establish a leading cancer omics platform and enhance localized testing services [3] - The initiative will also integrate R&D and clinical operations across Singapore, China, and Malaysia to expedite regulatory approvals and innovation in diagnostic testing [3]
【科技自立·产业自强】亚辉龙:承担多项国家及省市重大科技项目 产品覆盖自身免疫、心血管等七大领域
Zheng Quan Shi Bao Wang· 2025-10-04 04:24
Core Insights - The company has established six major R&D centers and a production base in Xiangtan, Hunan, undertaking several significant national and provincial scientific projects [1] - The "High-Performance Immuno Rapid Detection System R&D" project is included in the "14th Five-Year" National Key R&D Program, addressing clinical issues such as complex interference in whole blood sample testing, low sensitivity, and long detection times [1] - Since the project's inception, the company has applied for 18 invention patents and has obtained a registration certificate for myocardial marker composite quality control products [1] - As of August 31, 2025, the company plans to apply for a total of 760 patents, with 59% being invention patents [1] - The company emphasizes industry-academia-research collaboration, establishing joint laboratories with prestigious institutions like Peking University and the Chinese Academy of Sciences to foster high-level professional talent and advance technology in the in vitro diagnostics field [1]
透景生命股价涨5.03%,中信保诚基金旗下1只基金位居十大流通股东,持有120.39万股浮盈赚取133.63万元
Xin Lang Cai Jing· 2025-09-30 03:32
Group 1 - The core viewpoint of the news is that Tongjing Life has seen a stock price increase of 5.03%, reaching 23.18 CNY per share, with a trading volume of 136 million CNY and a turnover rate of 4.41%, resulting in a total market capitalization of 3.768 billion CNY [1] - Tongjing Life, established on November 6, 2003, and listed on April 21, 2017, specializes in the research, production, and sales of in vitro diagnostic products under its own brand [1] - The revenue composition of Tongjing Life is as follows: 92.50% from reagents, 6.20% from instruments, 1.26% from services, and 0.04% from materials [1] Group 2 - Citic Prudential Fund's multi-strategy mixed fund (LOF) A (165531) has entered the top ten circulating shareholders of Tongjing Life, holding 1.2039 million shares, which is 0.87% of the circulating shares, with an estimated floating profit of approximately 1.3363 million CNY [2] - The fund was established on June 16, 2017, with a latest scale of 1.245 billion CNY, achieving a year-to-date return of 39.46%, ranking 2133 out of 8167 in its category, and a one-year return of 62.73%, ranking 1279 out of 8010 [2] Group 3 - The fund managers of Citic Prudential multi-strategy mixed fund (LOF) A are Jiang Feng and Wang Ying, with Jiang Feng having a tenure of 5 years and 171 days and a total fund asset scale of 5.782 billion CNY, achieving a best fund return of 123.41% during his tenure [3] - Wang Ying has a tenure of 8 years and 229 days with a total fund asset scale of 6.176 billion CNY, achieving a best fund return of 54.3% during her tenure [3]
浩欧博股价涨5.34%,申万菱信基金旗下1只基金重仓,持有5.61万股浮盈赚取46.21万元
Xin Lang Cai Jing· 2025-09-30 03:25
Group 1 - The core viewpoint of the news is that Jiangsu Haobio Pharmaceutical Co., Ltd. has seen a stock price increase of 5.34%, reaching 162.43 CNY per share, with a total market capitalization of 10.311 billion CNY [1] - The company, established on June 8, 2009, specializes in the research, production, and sales of in vitro diagnostic reagents, with reagent sales accounting for 89.46% of its main business revenue [1] - Other revenue sources include sales from other products at 5.86%, instrument sales at 3.84%, and rental sales at 0.85% [1] Group 2 - From the perspective of fund holdings, one fund under Shenwan Hongyuan has Haobio as a significant investment, holding 56,100 shares, which constitutes 5.74% of the fund's net value [2] - The fund, Shenwan Hongyuan Medical Pioneer Stock A, has a current scale of 120 million CNY and has experienced a loss of 2.93% this year, ranking 4172 out of 4220 in its category [2] - The fund manager, Yao Hongfu, has been in position for 3 years and 75 days, with the best and worst fund returns during his tenure being -30.26% and -31.14%, respectively [2]
塞力医疗股价涨5.04%,财通基金旗下1只基金位居十大流通股东,持有64.34万股浮盈赚取79.14万元
Xin Lang Cai Jing· 2025-09-30 03:18
Group 1 - The core point of the news is that Selys Medical experienced a stock price increase of 5.04%, reaching 25.65 CNY per share, with a trading volume of 267 million CNY and a turnover rate of 5.12%, resulting in a total market capitalization of 5.39 billion CNY [1] - Selys Medical Technology Group Co., Ltd. is located in Wuhan, Hubei Province, and was established on February 23, 2004, with its listing date on October 31, 2016. The company's main business involves centralized marketing and service for medical testing, as well as the agency and independent research, production, and sales of in vitro diagnostic products [1] - The revenue composition of Selys Medical includes IVD business at 39.91%, SPD business at 38.01%, and pure sales at 22.08% [1] Group 2 - From the perspective of the top ten circulating shareholders of Selys Medical, data shows that a fund under Caitong Fund ranks among the top ten shareholders. The Caitong Advantage Industry Rotation Mixed A Fund (011201) entered the top ten shareholders in the second quarter, holding 643,400 shares, which accounts for 0.34% of the circulating shares [2] - The Caitong Advantage Industry Rotation Mixed A Fund (011201) was established on February 9, 2021, with a latest scale of 536 million CNY. Year-to-date returns are 19.74%, ranking 4636 out of 8167 in its category; the one-year return is 22.47%, ranking 4803 out of 8010; and since inception, it has a loss of 27.14% [2]
迈克生物:9月29日召开董事会会议
Mei Ri Jing Ji Xin Wen· 2025-09-29 10:48
Group 1 - The core point of the news is that Maike Bio (SZ 300463) held its sixth board meeting on September 29, 2025, to discuss the revision of the board meeting rules [1] - For the first half of 2025, Maike Bio's revenue composition was entirely from in vitro diagnostics, accounting for 100% [2] - As of the report date, Maike Bio's market capitalization was 7 billion yuan [2] Group 2 - The competition between Nongfu Spring and Yibao has intensified, with Nongfu Spring's green bottle launch leading to a significant market share decline for Yibao, dropping nearly 5 percentage points [2]
迈克生物:公司及控股子公司实际对外担保余额约4.32亿元人民币
Mei Ri Jing Ji Xin Wen· 2025-09-29 10:43
Group 1 - The company, Maike Biological, announced a total external guarantee amount of 1.15 billion RMB, which accounts for 18.06% of the audited net assets as of December 31, 2024 [1] - The actual external guarantee balance is approximately 432 million RMB, representing 6.78% of the audited net assets as of December 31, 2024 [1] - The total guarantee amount for subsidiaries is 800 million RMB, which is 12.56% of the audited net assets as of December 31, 2024, with an actual balance of 263 million RMB, or 4.13% of the audited net assets [1] Group 2 - The company has a total external guarantee amount of 350 million RMB, accounting for 5.5% of the audited net assets as of December 31, 2024, with an actual balance of 169 million RMB, or 2.65% of the audited net assets [1] - As of the report date, the company's market capitalization is 7 billion RMB [2] - The company's revenue composition for the first half of 2025 is entirely from in vitro diagnostics, accounting for 100% [1]
硕世生物:“腺病毒抗原检测试剂盒(胶体金法)”等产品取得医疗器械注册证
Mei Ri Jing Ji Xin Wen· 2025-09-29 09:02
Group 1 - The core point of the article is that Suosheng Biotechnology has received a medical device registration certificate from the National Medical Products Administration for products including the "Adenovirus Antigen Test Kit (Colloidal Gold Method)" [1] - For the fiscal year 2024, Suosheng Biotechnology's revenue composition is 94.78% from the in vitro diagnostic industry and 5.22% from other businesses [1] - As of the report, Suosheng Biotechnology has a market capitalization of 5.4 billion yuan [1] Group 2 - The article also highlights a competitive situation in the beverage industry, where Nongfu Spring's new green bottle product has led to a significant decline in market share for Yibao, dropping nearly 5 percentage points [1]