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觅瑞通过港交所聆讯:已实现miRNA早筛产品的商业化,具有全球化端对端能力
IPO早知道· 2025-05-12 03:16
核心产品GASTROClear™是全球市场上唯一一款获批准进行胃癌筛查的分子诊断IVD产 品。 本文为IPO早知道原创 作者| Stone Jin 微信公众号|ipozaozhidao 据 IPO早知道消息, Mirxes Holding Company Limited (以下简称 "觅瑞")日前通过港交所聆 讯并于5月12日披露通过聆讯后的资料集,中金公司和建银国际担任联席保荐人。 成立于 2014年 的觅瑞作为 一家微小核糖核酸(「 miRNA」)技术公司,致力于使疾病筛查诊断 解决方案在亚洲关键市场(包括新加坡及中国)触手可及。 截至 2025 年 5 月 7 日 , 觅 瑞 有 一 种 核 心 产 品 ( 即 GASTROClear™) 、 两 种 其 他 商 业 化 产 品 (即 LungClear™ 及 Fortitude™) 以 及 六 种 处 于 临 床 前 阶 段 的 候 选 产 品 。 其 中 , 核 心 产 品 GASTROClear™ 是 一个由 12种miRNA生物 标志物 组成的用于胃癌筛查的基于血液的 miRNA检 测组 ,其已于 2019年5月获得新加坡卫生科学局的C类体外诊断 ...
医药生物行业周报(5月第2周):减肥药重要性再度提升-20250512
Century Securities· 2025-05-12 00:41
[Table_Author] 分析师:王俐媛 1) 周度回顾。上周(4 月 28 日-5 月 9 日)医药生物板块 收涨 1.5%,跑输 wind 全 A(2.32%)和沪深 300(1.56%)。 从板块来看,线下药店(5.64%)、医疗设备(4.49%) 和医疗研发外包(2.78%)涨幅居前,疫苗(-0.45%)、 血液制品(-0.43%)和体外诊断(-0.17%)跌幅居前。 从个股来看,常山药业(26.28%)、海创药业(25.85%) 减肥药概念涨幅居前。 2) 减肥药重要性再度提升。5月7日,世界卫生组织(WHO) 回应称,自 2022 年以来,世卫组织一直在针对不同年 龄组(儿童、青少年和成年人)制定一套关于肥胖预 防、护理和治疗的新指南。关于使用 GLP-1 药物和 GLP- 1 RA/GIP 双受体激动剂治疗成年肥胖患者的指南预计 在 2025 年 8 月或 9 月会出台最终方案。该指南的目的 在于明确 GLP1 药物的临床适应症、应用以及规划方面 的考量,包括这类药物如何以及在何时能够作为包括 临床干预和生活方式干预的慢性病管理模式的一部分 加以应用。减重已成为全社会关注的问题,以 GLP- ...
质疑专业背景与公司主业不符 达安基因新一届董事会提名遭两名董事反对
Mei Ri Jing Ji Xin Wen· 2025-05-09 14:33
上述人士的从业背景也正是张斌反对的主要原因。张斌表示,此次被提名的九名董事候选人中,除三名 独立董事外,只有一人具备生物技术及工程学专业底蕴并有IVD行业研发与经营管理经验。 每经记者|金喆 每经编辑|陈俊杰 5月9日晚间,达安基因(002030.SZ,股价5.82元,市值81.68亿元)发布公告,当日公司召开了第八届 董事会2025年第三次临时会议。在《关于提名公司第九届董事会非独立董事候选人的预案》中,董事黄 珞和张斌投出反对票。 《每日经济新闻》记者注意到,两人均认为被提名的董事候选人与公司主业匹配度不高。黄珞认为应引 进具备技术前瞻性与商业敏锐度的战略型掌舵人,而不是聘用"同质化纯金融背景为主"的团队。张斌则 表示,新一届董事会在把握行业技术与市场发展方面存在显著的不确定性。 达安基因是国内老牌IVD(体外诊断试剂)企业,主要产品为体外诊断试剂,但在去年出现2004年上市 以来的首次亏损。年报显示,2024年,达安基因营收约8.53亿元,同比下降27.27%,净利润约-9.25亿 元,同比下降983.98%。 5月9日晚间,记者试图联系达安基因相关人士采访,截至发稿未获得回复。 两名董事反对新一届董事 ...
中源协和: 中源协和细胞基因工程股份有限公司2024年年度股东大会会议资料
Zheng Quan Zhi Xing· 2025-05-09 09:12
Core Points - The company is holding a shareholder meeting on May 20, 2025, to discuss various agenda items including the independent director's report for 2024 and voting on resolutions [1][2] - The company reported a revenue of 1.585 billion yuan for 2024, a slight decrease of 0.27% compared to the previous year, with a net profit of 100 million yuan, down 5.73% [10][11] - The company has made significant progress in stem cell drug development, with multiple clinical trials approved and ongoing for new treatments [12][22] - The company is focusing on enhancing its governance structure and compliance, having received various quality management certifications [17][18] Company Operations - The board of directors has operated in compliance with relevant laws and regulations, approving 32 resolutions with a 100% approval rate [5][6] - The company has established a governance structure involving the shareholder meeting, board of directors, and supervisory board, ensuring clear responsibilities and effective operation [10] - The company has implemented a comprehensive quality management system, achieving ISO certifications in quality, environmental management, and occupational health and safety [17][18] Financial Performance - The company reported a total asset value of 5.249 billion yuan as of December 31, 2024, a decrease of 3% from the previous year [30] - The company’s cash flow from operating activities was negative 64 million yuan, indicating challenges in cash generation [30] - The company has initiated a share buyback program, repurchasing shares worth 200 million yuan, which is 199.32% of its net profit for the year [31] Future Plans - The company aims to deepen its research and development in stem cell therapies and expand its market presence both domestically and internationally [22][24] - The company plans to enhance its automated production capabilities and improve the efficiency of its cell therapy products [23] - The company is committed to building a comprehensive health management ecosystem for families, integrating various health services and insurance collaborations [25]
科华生物收盘上涨9.84%,最新市净率1.00,总市值32.71亿元
Sou Hu Cai Jing· 2025-05-09 08:40
5月9日,科华生物今日收盘6.36元,上涨9.84%,最新市净率1.00,创84天以来新低,总市值32.71亿 元。 资金流向方面,5月9日,科华生物主力资金净流入3798.45万元,近5日总体呈流入状态,5日共流入 3559.83万元。 来源:金融界 最新一期业绩显示,2025年一季报,公司实现营业收入3.88亿元,同比-12.50%;净利润-53259784.78 元,同比-84.79%,销售毛利率37.39%。 序号股票简称PE(TTM)PE(静)市净率总市值(元)29科华生物-4.92-5.111.0032.71亿行业平均 48.9847.404.56104.17亿行业中值36.1637.662.3446.18亿1天益医疗-1712.92-2934.031.8321.83亿2澳华内 镜-592.52297.184.7562.44亿3诺唯赞-411.67-486.902.2688.10亿4爱朋医疗-344.10261.424.1528.23亿5博晖 创新-324.60515.093.4647.63亿6硕世生物-125.58-1835.121.1336.73亿7奥精医疗-121.29-177.781.60 ...
进入创新通道!又一款体外诊断产品
思宇MedTech· 2025-05-09 08:06
Group 1: Tuberculosis Overview - Tuberculosis (TB) is a serious infectious disease caused by Mycobacterium tuberculosis, posing a significant global public health threat [3] - In 2021, China accounted for 7.4% of the global TB incidence, ranking third worldwide, with a treatment success rate for drug-resistant TB at only 53% compared to 95% for regular TB [3][6] - In 2021, there were 1.6 million deaths from TB globally, making it the 13th leading cause of death, just after COVID-19 [6] Group 2: Drug-Resistant Tuberculosis - The emergence of drug-resistant TB (MDR-TB and XDR-TB) complicates TB control efforts, leading to increased treatment difficulty, lower cure rates, and higher mortality [5] - In 2021, there were 450,000 new cases of MDR/RR-TB, with a treatment success rate of only 60% [6] Group 3: Limitations of Traditional Testing Methods - Traditional drug resistance testing methods are time-consuming, often taking weeks to months, and have low sensitivity and specificity [7] - Rapid molecular testing can provide quicker results but is limited in identifying a comprehensive range of drug resistance mutations [7] Group 4: Reversible Terminator Sequencing (RTS) - RTS is a high-precision DNA sequencing technology that allows for single-base resolution sequencing, significantly improving accuracy and sensitivity [8] - The technology is suitable for rapid diagnosis and clinical applications, completing the sequencing process in a short time [8] Group 5: Targeted Next-Generation Sequencing (tNGS) - tNGS integrates multiplex PCR/hybrid capture with next-generation sequencing, providing precise analysis of specific gene regions and comprehensive drug resistance information [9] - The tNGS method can analyze multiple antibiotic resistance genes simultaneously, aiding in early diagnosis and personalized treatment strategies [16] Group 6: Gold Standard Testing Kit - The Mycobacterium tuberculosis complex drug resistance gene mutation detection kit (RTS) combines tNGS with multiplex PCR, covering 13 resistance genes and over 200 mutation sites [13] - The kit can provide results in under 12 hours, with a sequencing run time of less than 5 hours, allowing for rapid detection of drug resistance [13] Group 7: Clinical Data and Performance - Clinical studies show that tNGS has an average consistency of 95.10% with phenotypic antimicrobial susceptibility testing (AST) and 97.05% with whole genome sequencing (WGS) [18] - In 158 bronchoalveolar lavage fluid samples, tNGS had a positivity rate of 87.95%, outperforming Xpert MTB/RIF [18] Group 8: Competitor Products - Cepheid's Xpert MTB/RIF offers rapid detection of Mycobacterium tuberculosis and rifampicin resistance with a sensitivity of 133 bacteria/mL, providing results in 2 hours [19] - Hain Lifescience's GenoType MTBDRplus uses linear probe hybridization for detecting TB and drug resistance, with a 48-hour turnaround time [20] - Becton Dickinson's BD MAX MDR-TB detects multiple drug resistance genes with high sensitivity and specificity, providing results in 2 hours [21] Group 9: Company Profile - Guangzhou Jinquirui Biotechnology Co., Ltd. focuses on the development, production, and sales of precision medical in vitro diagnostic products, established in 2016 [22] - The company has developed various technologies, including multiplex PCR and tNGS, and has received multiple core technology patents [24] - Jinquirui is one of the few companies in China providing a comprehensive solution for tumor and infection diagnostics, including gene sequencing instruments and clinical applications [24]
5月9日早间重要公告一览
Xi Niu Cai Jing· 2025-05-09 05:26
Group 1 - Shengxiang Bio plans to increase its investment in Hunan Shengwei Kunteng Biotechnology Co., Ltd. by 100 million yuan to enhance its industrial chain layout in the POCT field, resulting in a 44.6441% stake in Shengwei Kunteng after the investment [1] - Yaguang Technology's subsidiary Chengdu Yaguang signed a product pre-production agreement worth 101 million yuan, accounting for 10.56% of the company's audited revenue for the last fiscal year [1] Group 2 - Chutianlong's shareholder plans to reduce its stake by up to 3%, equating to 13.83 million shares, due to personal funding needs [2] - Naipu Mining intends to invest up to 45 million USD in Swiss Veritas Resources AG, acquiring a 22.5% stake to extend its industrial chain [2][3] Group 3 - Diri Medical's shareholder plans to reduce its stake by up to 3%, totaling 814.83 thousand shares, due to funding needs [4] - Kangtai Medical's controlling shareholder plans to reduce its stake by up to 2.99%, equating to 12 million shares [5] Group 4 - Iwu Bio's controlling shareholder plans to transfer up to 450 thousand shares through block trading, representing 0.86% of the total share capital [7] - Guokai Hengtai's four shareholders plan to collectively reduce their stake by up to 4.7%, totaling 22.94 million shares [9] Group 5 - *ST Zhongcheng submitted a hearing application to the Shenzhen Stock Exchange in response to a delisting notice [10] - Donghua Software's actual controller and associated parties plan to reduce their stake by up to 1%, totaling 32.05 million shares [12] Group 6 - Shandong Molong's shareholder reduced its H-share holdings by 107 million shares, representing 13.39% of the total share capital [12] - Yinbang Co.'s shareholder plans to reduce its stake by up to 1%, totaling 821.92 thousand shares [13] Group 7 - Jinxinnong reported April sales of 10.65 million pigs, generating sales revenue of 139 million yuan, with an average selling price of 15.05 yuan per kilogram [14] - Dongfang Jiasheng purchased 9.54 million shares of Zhonggu Logistics for approximately 99.72 million yuan, representing 4.18% of the company's net assets [15] Group 8 - Linglong Tire's controlling shareholder received a financing commitment of up to 270 million yuan for stock repurchase [16] - Wuchan Jinlun's shareholder plans to reduce its stake by up to 3%, totaling 619.77 thousand shares [18] Group 9 - Pengyao Environmental's directors and executives plan to collectively reduce their stake by up to 0.07% [19] - Ruihu Mould's controlling shareholder plans to reduce its stake by up to 1.92%, totaling 401.89 thousand shares [20] Group 10 - Electric Alloy's shareholder plans to reduce its stake by up to 0.63%, totaling 210.88 thousand shares [22] - Shanghai Xinyang's controlling shareholder plans to reduce its stake by up to 0.64%, totaling 200 thousand shares [24] Group 11 - Sujiao Ke's controlling shareholder plans to acquire up to 2% of the company's shares from a fund [26] - Heyuan Bio's shareholders plan to reduce their stake by up to 1%, totaling 649.04 thousand shares [27]
IVD行业一季度承压持续,企业各寻出路
Sou Hu Cai Jing· 2025-05-09 04:17
Core Viewpoint - The IVD industry is experiencing a significant downturn in revenue and profits, with over 70% of companies reporting a year-on-year decline in revenue and more than half facing losses or drastically reduced profits [2][5]. Revenue and Profit Trends - In Q1 2025, major IVD companies such as Mindray Medical, Dian Diagnostics, and RunDa Medical reported substantial declines in both revenue and net profit, with Mindray's revenue at 8.237 billion yuan (down 12.12%) and net profit at 2.629 billion yuan (down 16.81%) [2][4]. - Among 60 IVD companies analyzed, 16 reported revenue growth, with 8 achieving both revenue and net profit growth [2]. Market Challenges - The IVD sector is facing multiple challenges, including a slowdown in the conventional medical testing market, stricter cost control policies in healthcare, and the impact of centralized procurement policies [5][6]. - The anticipated centralized procurement in 28 provinces is expected to further pressure IVD companies, particularly in the high-volume chemical luminescence market [6]. Company Strategies and Innovations - Some companies are adapting by focusing on niche markets and innovative product offerings, such as New Industry and Sansure Bio, which reported revenue growth of 10.12% and 21.62% respectively in Q1 2025 [9]. - Companies are also exploring international markets, with Mindray's overseas revenue reaching 16.43 billion yuan in 2024, accounting for 44.75% of total revenue [9][10]. Technological Advancements - The IVD industry is witnessing a shift towards digitalization and AI integration, with partnerships like that of BGI and Dian Diagnostics aiming to enhance diagnostic efficiency and precision [10][11]. - The emergence of AI technologies is reshaping the IVD landscape, although challenges remain in data integration and commercialization [11].
QIAGEN(QGEN) - 2025 Q1 - Earnings Call Transcript
2025-05-08 14:02
Qiagen (QGEN) Q1 2025 Earnings Call May 08, 2025 09:00 AM ET Company Participants John Gilardi - Vice President & Head of Corporate CommunicationsThierry Bernard - CEO, MD & Member of Management BoardRoland Sackers - CFO, MD & Member of Management BoardDoug Schenkel - Managing DirectorTycho Peterson - Managing DirectorMichael Ryskin - Managing DirectorJan Koch - VP - Equity ResearchDaniel Brennan - Managing DirectorCasey Woodring - Vice President - Equity Research Conference Call Participants Dan Leonard - ...