本报讯(记者张敏)1月29日，港股生物医药上市企业MirxesHoldingCompanyLimited(以下简称"Mirxes觅 瑞")发布公告宣布完成新股配售。本次配售募集资金约7.11亿港元，配售定价每股32.5港元，较2025年5 月上市发行价23.30港元/股溢价约40%。 此外，Mirxes觅瑞上市时募集资金达10.86亿港元，而此次配售募集资金约7.11亿港元，距离觅瑞登陆港 交所主板仅八个月。这种上市短时间内即完成溢价配售的情况，在港股生物科技板块并不多见，折射出 投资者对觅瑞技术路径和商业前景的信心。这也标志着，Mirxes觅瑞作为癌症早筛企业正从技术验证阶 段，加速迈向市场规模化扩张的新阶段。 持续夯实产品管线 Mirxes觅瑞此次募集资金的用途体现了未来的战略重点。根据公告，约30%的募集资金将用作投资及并 购活动；约25%将用作研究及开发，包括现有管线的临床研究以及开发新管线；约20%将用作扩展新兴 市场，例如印度；约25%将用作一般营运资金用途。 在中国市场，Mirxes觅瑞通过与顶尖医院和体检机构以及国内知名企业的合作，加速产品在专业场景的 落地。 值得一提的是，微小核糖核酸(mi ...

Core Insights - The company has established a strategic partnership with N Health and Bangkok Dusit Medical Services to introduce advanced microRNA cancer screening solutions in Thailand, marking a significant step forward in early cancer detection and patient outcomes in the region [1][2] Group 1: Strategic Partnership and Market Growth - The partnership aims to penetrate the rapidly growing health check market in Thailand, which is expected to reach approximately $500 million by 2030, with a compound annual growth rate (CAGR) of 9.2% starting from 2025 [1] - The specialized health check segment is the fastest-growing part of the market, indicating strong demand for advanced and targeted screening solutions [1] Group 2: Cancer Screening Solutions - The partnership will leverage the company's cutting-edge miRNA technology and innovative screening solutions, such as GASTROClear for gastric cancer and LUNGClear for lung cancer, to improve cancer treatment standards in the region [2] - Nearly 60 hospitals within the N Health network will adopt the cancer screening tests, supporting broader access to early disease detection services across Thailand and Southeast Asia [2] Group 3: Home Testing Kits Launch - The company announced the launch of new home screening test kits, HELICORapid for H. pylori detection and FITRapid for fecal occult blood detection, in Thailand, following approvals from the Thai FDA [3] - These home test kits are the first of their kind in the Thai market, designed to integrate sample collection and testing into a single, user-friendly device, significantly reducing contamination and user error risks [3][4] Group 4: Accessibility and Consumer Engagement - The home test kits will be distributed through modern trade channels and pharmacies across Thailand, catering to evolving consumer healthcare behaviors and the increasing demand for preventive, self-diagnostic solutions [4] - The launch emphasizes the company's mission to democratize early detection, empowering individuals with practical tools to manage their health and support the healthcare system through early intervention and increased disease awareness [4]

Core Viewpoint - MIRXES-B (02629) has been officially included in the Hang Seng Composite Index and Hong Kong Stock Connect as of September 8, 2025, which is expected to attract significant southbound capital attention and allocation, providing additional upward momentum for the company's stock price [1] Group 1: Market Position and Product Advantage - The company is a global pioneer in gastric cancer early screening, possessing first-mover advantages and technological barriers [1] - The core product GASTROClear is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening, having achieved commercialization in markets such as Singapore and Thailand, and received "breakthrough medical device" designation from the US FDA [1] - The company has over ten years of R&D accumulation in miRNA technology and a strong patent portfolio, including 27 approved patents and 63 pending patent applications, positioning it favorably in the non-invasive cancer early screening market, particularly in Asia where gastric cancer is prevalent [1] Group 2: Revenue Growth and Financial Performance - The company expects revenues for 2025, 2026, and 2027 to be $0.27 billion, $0.41 billion, and $0.75 billion, respectively, with year-on-year growth rates of 30.84%, 55.14%, and 81.32% [1] - In the first half of 2025, the revenue from the "early detection and precision multi-omics" division increased by 50% year-on-year to $10.5 million, driven primarily by GASTROClear and LUNGClear [1] Group 3: Product Pipeline and Future Growth - The company has a clear product pipeline supported by its mature miRNART-qPCR technology platform, with ongoing development of screening products for colorectal cancer (CRC-1), liver cancer (LV-1), and breast cancer (BC-1), as well as a multi-cancer screening project (CADENCE) [2] - LUNGClear has been commercialized as an LDT service in Southeast Asia and Japan, while CRC-1 is expected to complete prototype design and initiate commercialization in Southeast Asia by the second half of 2025 [2] - The pipeline for liver cancer (LV-1) and breast cancer (BC-1) is in early development stages, and the CADENCE project has initiated large-scale clinical research, providing long-term growth potential for the company [2] Group 4: Integrated Industry Capability - The company has established an integrated platform covering R&D, production, and commercialization, creating high barriers and cost advantages [3] - With two cGMP-compliant production facilities in Singapore and China, the company has an annual total capacity of approximately 590,000 tests, ensuring product quality and stable supply while effectively controlling costs [3] - The gross margin for the first half of 2025 increased by 18.8 percentage points to 67.8%, laying a solid foundation for future market competition and profit release [3]

Core Viewpoint - MIRXES-B (02629) has been officially included in the Hang Seng Composite Index and Hong Kong Stock Connect as of September 8, 2025, which is expected to attract significant southbound capital attention and allocation, providing additional upward momentum for the company's stock price [1] Group 1: Market Position and Growth Potential - The company is a global pioneer in gastric cancer early screening, possessing first-mover advantages and technological barriers [1] - The core product, GASTROClear, is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening, commercialized in markets such as Singapore and Thailand, and recognized as a "breakthrough medical device" by the US FDA [1] - The company has a strong patent portfolio with over ten years of R&D in miRNA technology, including 27 approved patents and 63 pending applications, positioning it favorably in the non-invasive cancer early screening market, especially in Asia where gastric cancer is prevalent [1] - Revenue projections for 2025-2027 are $0.27 billion, $0.41 billion, and $0.75 billion, reflecting year-on-year growth rates of 30.84%, 55.14%, and 81.32% respectively [1] Group 2: Product Pipeline and Technological Development - The company has established a clear product pipeline leveraging its mature miRNART-qPCR technology platform, with ongoing development of screening products for colorectal cancer (CRC-1), liver cancer (LV-1), and breast cancer (BC-1), as well as a multi-cancer screening project (CADENCE) [2] - LUNGClear (lung cancer) has been commercialized as an LDT service in Southeast Asia and Japan, while CRC-1 is expected to complete prototype design by the second half of 2025 and initiate commercialization in Southeast Asia [2] - The platform's scalability allows for the replication of GASTROClear's success, potentially shortening R&D cycles and continuously launching new products [2] Group 3: Integrated Industry Capabilities - The company has built an integrated platform covering R&D, production, and commercialization, creating high barriers and cost advantages [3] - With two cGMP-compliant production facilities in Singapore and China, the company has an annual testing capacity of approximately 590,000 tests, ensuring product quality and stable supply while effectively controlling costs [3] - The gross margin for the first half of 2025 increased by 18.8 percentage points to 67.8%, providing a solid foundation for future market competition and profit release [3]

Core Insights - Mirxes Holding Company Limited (Mirxes) has demonstrated significant achievements in its core product commercialization, financial optimization, and R&D pipeline advancement as of June 30, 2025 [1] Financial Performance - Mirxes reported a revenue of $10.5 million for the first half of 2025, marking a 9.4% increase compared to the same period in 2024, driven by a 50% growth in the early detection and precision multi-omics segment [2] - The gross profit reached $7.1 million, a 102.9% increase year-on-year, with the gross margin improving from 49.0% to 67.6% [2] - The company reduced its losses by 36.3% to $28.23 million, aided by effective cost management and non-operating factors [2] - Cash and cash equivalents rose to $108 million following a global offering, significantly improving the company's financial structure with a debt-to-asset ratio reduced from 377.8% to 29.8% [2] Market Expansion - Mirxes is expanding its global market presence, with significant sales growth in China (revenue of $3.21 million, up 18.1%) and Southeast Asia (revenue of $7.26 million, with a 71.2% increase in early detection and precision multi-omics business) [3] - The company has initiated a nationwide early screening project in Japan and signed a memorandum of understanding with PT DIASTIKA BIOTEKINDO in Indonesia to advance cancer screening and molecular diagnostics [3] Product Pipeline and Competitive Advantage - Mirxes' GASTROClear, the world's first approved molecular diagnostic product for gastric cancer screening, is leading the market and has received regulatory approvals in Singapore and Thailand, as well as FDA breakthrough device designation [4] - The LUNGClear product is also performing well, contributing to revenue growth in Southeast Asia and Japan [4] - The company is advancing its R&D pipeline, with plans for the CRC-1 colorectal cancer detection product to complete prototype design in the second half of 2025 and initiate clinical trials in Singapore and China in 2026 [4] Industry Position - Mirxes holds 19 family patents and 63 pending applications, with GASTROClear included in Singapore's industry standards [5] - The company benefits from government support in Singapore, including R&D grants and tax incentives, ensuring continued innovation [6] - Mirxes was recently included in the Hang Seng Composite Index, enhancing its market influence and capital attention [6]

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]

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].