（原标题：MIRXES-B(02629)：GASTROClear?获批中国国家药监局胃癌筛查IVD注册证） 智通财经APP讯，MIRXES-B(02629)发布公告，其核心产品GASTROClear已获得中国国家药品监督管理 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。 未来，公司将持续扩大在中国的商业化投入，包括将销售团队规模扩大，并升级本土生产能力。同时， 公司也将进一步加强在中国大陆的业务发展与合作(BD)布局，推动产品更广泛落地。 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。 根据批准预定用途，GASTROClear可用于《中国胃癌筛查与早诊早 ...

Core Insights - MIRXES-B (02629) has received approval from the National Medical Products Administration of China for its core product GASTROClear, marking it as the first blood test approved for non-invasive gastric cancer screening in China [1] - GASTROClear is the world's first microRNA blood test approved for early detection of gastric cancer, assessing cancer risk by detecting 12 gastric cancer-related miRNA biomarkers [1] - The product is expected to cover a potential population of over 500 million high-risk adults aged 45-74, as defined by the "Guidelines for Gastric Cancer Screening and Early Diagnosis and Treatment (2024 Edition)" [1] Company Strategy - The company plans to continue expanding its commercialization efforts in China, including increasing the size of its sales team and upgrading local production capabilities [2] - The company aims to strengthen its business development and collaboration efforts in mainland China to promote wider adoption of its products [2]

Group 1: Financial Performance - In the first half of 2025, the company achieved revenue of $10.47 million, representing a year-on-year growth of 9.4% [1] - The gross profit for the same period was $7.1 million, up from $4.7 million in the previous year, marking a 51.1% increase [1] - The loss attributable to equity shareholders narrowed to $28.35 million from $44.45 million in 2024, indicating improved operational efficiency and cost control [1] Group 2: Business Segments - The growth in revenue was primarily driven by the early detection and precision multi-omics business, which saw a 50% increase in revenue to $10.47 million [1] - The gross profit for the early detection and precision multi-omics segment reached $7.1 million, reflecting a 102.9% year-on-year growth [1] - The sales gross margin improved from 49% to 67.6% due to high-margin product sales and effective cost management [1] Group 3: Product Development and Market Expansion - The company, founded in 2014, focuses on miRNA technology for disease screening solutions in key Asian markets, including Singapore and China [2] - The core product, GASTROClear, is a blood-based miRNA test for gastric cancer screening, which received regulatory approval in Singapore in May 2019 [2] - GASTROClear has been approved for sale in Singapore and Thailand, with LDT services launched in Japan, and a clinical trial registration completed in China [2] Group 4: Market Recognition - Mirxes was listed on the Hong Kong Stock Exchange on May 23, 2023, and was included in the Hang Seng Composite Index as of August 22, 2023 [3] - The inclusion in the index, just three months after its listing, reflects strong market recognition of the company's potential in early cancer detection technology [3]

Core Insights - MIRXES-B reported mid-term results for 2025, with revenues of $10.5 million, representing a year-on-year increase of 9.4% [2] - The company's loss attributable to equity shareholders was approximately $28.35 million, narrowing by 36.22% year-on-year, with a loss per share of $0.185 [2] - The revenue growth was primarily driven by increased earnings from GASTROClear and LUNGClear [2]

Core Insights - MIRXES-B (02629) reported a mid-year revenue of $10.5 million for 2025, reflecting a year-on-year increase of 9.4% [1] - The company recorded a loss attributable to equity shareholders of approximately $28.35 million, which represents a 36.22% reduction compared to the previous year; the loss per share was $0.185 [1] - The increase in revenue is primarily attributed to the growth in earnings from the early detection and precision multi-omics divisions, specifically from GASTROClear and LUNGClear, which offset a $2.6 million revenue decline in the infectious disease division due to the termination of Fortitude product sales [1]

Group 1 - MIRXES-B was listed on the Hong Kong Stock Exchange with an issue price of HKD 23.3 per share, raising approximately HKD 881 million from the issuance of 46.62 million shares [1] - The stock price increased by 27.90% to HKD 29.80, resulting in a market capitalization exceeding HKD 8.235 billion [1] - The company plans to apply for a dual listing on the Singapore Stock Exchange after its global offering, aiming to enhance its reach in Southeast Asia and mainland China [1][2] Group 2 - MIRXES was founded in 2014 and is headquartered in Singapore, specializing in microRNA technology [2] - The company's core product, GASTROClear, is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening [2] - The CEO mentioned that the company is in the early stages of commercialization and is effectively controlling costs through automation [2]

Core Viewpoint - The article discusses the challenges faced by Mirxes Holding Company Limited (referred to as "Mirxes Group") in commercializing its blood-based cancer screening product GASTROClear, highlighting issues related to technology maturity, market education, and financial sustainability [3][4][24]. Group 1: Product Technology and Market Challenges - Mirxes Group's core technology is based on the detection of microRNA (miRNA), which plays a crucial role in gene regulation and is linked to various diseases, including cancer [5]. - GASTROClear, designed for early gastric cancer screening, claims a sensitivity of 87.5% for stage I gastric cancer, requiring only 5ml of blood for testing [5][6]. - Despite the promising technology, GASTROClear has not yet been commercialized in China, leading to a 16.14% decline in revenue to $2.028 million and a 32.55% increase in losses to $92.2147 million in 2024 [6][24]. Group 2: Pricing and Market Acceptance - GASTROClear is priced between $150 and $250, which is higher than traditional gastroscopy priced at $80 to $200, raising concerns about its competitiveness in the market [8]. - The specificity of GASTROClear is only 68.4%, meaning a significant number of false positives could lead to consumer skepticism and reluctance to adopt the product [9][10]. Group 3: Financial Needs and Investment Landscape - The company has relied heavily on external funding, with significant investments from various entities, including a $87 million C round financing in 2021 [15][16]. - As of March 31, 2025, Mirxes Group had only $2.6125 million in cash and cash equivalents, indicating a pressing need for capital to sustain operations [18]. - The company has not demonstrated the ability to generate revenue independently, with R&D expenses accounting for 94.19% of revenue in 2024, leading to a cumulative loss of $218 million since 2022 [20][23]. Group 4: Regulatory and Market Entry Barriers - Even if GASTROClear receives regulatory approval, the lack of a comprehensive cancer screening system in China poses significant challenges for market penetration [22]. - The Chinese healthcare system is primarily government-driven, and without support from public insurance, widespread adoption of cancer screening products like GASTROClear is unlikely [22].

Core Viewpoint - Mirxes Holding Company Limited, known for its "blood test for cancer," is nearing the end of its IPO process after four rounds of applications, with plans to list on the Hong Kong Stock Exchange on May 23, 2023, aiming to raise a net amount of HKD 888 million through the issuance of 46.62 million shares at HKD 23.30 each [1]. Group 1: IPO Details - The company has secured cornerstone investors, including Beijing Xunrui and Evergreen Gate, who have collectively subscribed to USD 57.92 million, accounting for 41.37% of the global offering shares and 6.98% of the total share capital post-IPO [2]. - Beijing Xunrui, a significant investor, is indirectly controlled by the Jiujiang State-owned Assets Supervision and Administration Commission, while Evergreen Gate is a wholly-owned subsidiary of Fosun International, indicating a strategic interest in the biotech sector [2][3]. Group 2: Financial Background - Mirxes has raised a total of USD 167.2 million across three financing rounds (B, C, D), attracting notable institutions such as China Chengtong, Jiancheng Kaiyuan, and Nohow Venture Capital [5]. - Despite substantial fundraising, the company faces cash flow pressures, with cash and cash equivalents dropping from USD 102 million at the end of 2021 to USD 261.24 million by Q1 2025, alongside increasing annual losses projected at USD 56.2 million, USD 69.6 million, and USD 92.2 million for 2022-2024 [6]. Group 3: Product Development - The core product, GASTROClear, is a gastric cancer early screening tool that requires only 5 milliliters of blood to detect 12 miRNA biomarkers, having received regulatory approval in Singapore in 2019 and breakthrough device designation from the FDA in 2023 [6][7]. - GASTROClear has not yet launched in China, but a Class III registration application was submitted in 2023, with expectations for a market introduction in the first half of the year [7]. - The company is also developing additional products, including LungClear for lung cancer screening and a COVID-19 testing kit, with six more candidates in the pipeline [7].

一周IPO动态，覆盖港股、美股、A股。 本文为IPO早知道原创 作者｜C叔 微信公众号｜ipozaozhidao 希迪智驾 港股｜递交招股书 据IPO早知道消息，希迪智驾(湖南)股份有限公司（以下简称"希迪智驾"）于2024年11月7日正式向 港交所递交招股说明书，拟主板挂牌上市，中金公司、中信建投国际和中国平安资本（香港）担任联 席保荐人。 成立于2017年的希迪智驾作为一家商用车自动驾驶技术供应商，专注于自动驾驶矿卡及物流车、 V2X技术及高性能感知解决方案的研发，并提供以专有技术为基础的尖端产品和解决方案。 截至2021年、2022 年、2023年12月31日以及2024年6月30日，希迪智驾分别服务31名、44名、 85名以及100名客户。截至2024年9月30日，希迪智驾的积压订单总价值达约5亿元。 截至2024年9月30日，希迪智驾向客户交付了123辆自动驾驶矿卡，并收到320辆自动驾驶矿卡和 206套独立自动驾驶卡车系统的指示性订单。自部署起至2024年11月1日，自动驾驶矿卡运输煤及矿 石超过1200万吨，累计行驶里程超过120万公里，累计不间断运作至多700天。 自2023年开始，希迪智驾还 ...

根据弗若斯特沙利文的资料， 觅瑞 是开发及商业化用于癌症及其他疾病早期检测 的、精准的、无 创的、可负担的、基于血液的miRNA检测试剂盒的先驱者与领导者 ； 根据弗若斯特沙利文的资料， 觅瑞 是全球为数不多的已获得分子癌症筛查行业IVD产品监管批准的公司之一，同时也是全球范围 内首家且唯一一家获得分子胃癌筛查IVD产品监管批准的公司。 今年上半年，核心产品GASTROClear的毛利率超80%。 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"）于11月4日更新招股 书，继续推进港交所主板上市进程，中金公司和建银国际担任联席保荐人。 成立于2014年的觅瑞作为一家起源于新加坡的微小核糖核酸("miRNA")技术公司，专注于在全球范 围内普及疾病筛查诊断解决方案。 截至2024年10月31日，觅瑞拥有一种核心产品(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，觅瑞的核心产品GASTROC ...