Core Viewpoint - Mirxes has signed a memorandum of understanding with Watson Bio to collaborate in molecular diagnostics and vaccine development, aiming to expand into ASEAN and global markets [1] Group 1: Company Developments - Mirxes' stock rose nearly 8% in early trading, currently up 2.48% at HKD 53.8, with a trading volume of HKD 18.2942 million [1] - The partnership with Watson Bio signifies a strategic collaboration between a leading precision diagnostics company and a top vaccine developer, establishing a solid foundation for an RNA-based preventive and precision medical platform [1] Group 2: Product Approval and Market Impact - In October, Mirxes' core product GASTROClear received approval from the National Medical Products Administration (NMPA) in China, becoming the world's first and only approved molecular diagnostic IVD product for gastric cancer screening [1] - This milestone represents a commercial breakthrough for the company, transitioning from "0 to 1," and is expected to lead to a revaluation of the company's worth [1] - The approval allows Mirxes to enter the vast gastric cancer screening market in China, serving as a significant catalyst for short-term performance [1]

智通财经APP获悉，MIRXES-B(02629)早盘涨近8%，截至发稿，涨2.48%，报53.8港元，成交额1829.42 万港元。 消息面上，11月18日，Mirxes觅瑞宣布与沃森生物(300142.SZ)正式签署谅解备忘录，双方将围绕分子诊 断与疫苗研发领域开展深度合作，携手拓展东盟及全球市场。此次合作标志着精准诊断领军企业与顶尖 疫苗研发企业实现战略协同，为构建以RNA为核心的预防及精准医疗平台奠定坚实基础。 值得注意的是，今年10月，核心产品GASTROClear经中国国家药品监督管理局（NMPA）批准上市，成 为全球首款也是目前唯一获批用于胃癌筛查的分子诊断IVD产品。方正证券发布研报称，这一里程碑事 件不仅实现了公司"从0到1"的商业化突破，也为其带来价值重估新逻辑。此次获批意味着公司正式进入 中国庞大的胃癌筛查市场，成为短期内最重要的业绩催化剂。 ...

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-B's core product GASTROClear has received approval from the National Medical Products Administration of China for use as a non-invasive gastric cancer screening IVD product, marking a significant milestone in the company's journey from research and development to commercialization [1] - GASTROClear is the first blood test approved for gastric cancer screening in China, utilizing a microRNA-based method to assess gastric cancer risk by detecting 12 gastric cancer-related miRNA biomarkers [1] Group 1 - GASTROClear is designated for screening high-risk adults aged 45-74 as defined by the "Guidelines for Screening and Early Diagnosis and Treatment of Gastric Cancer in China (2024 Edition)," potentially covering over 500 million individuals [2] - The product will be implemented in both public and private medical institutions in China as an IVD testing project, significantly expanding the company's business space in the gastric cancer screening market [2] Group 2 - The company plans to continue increasing its commercialization efforts in China, including expanding the sales team and upgrading local production capabilities [2] - There will be a focus on strengthening business development and collaboration in mainland China to promote broader adoption of the product [2]

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]