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]

Core Viewpoint - The mid-term performance of Mirxes Holding Company Limited demonstrates its commercial capabilities in the field of early cancer screening [1] Financial Performance - For the first half of 2025, Mirxes achieved revenue of $10.5 million, 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, which now accounts for 100% of the company's revenue [4] - The gross profit for this segment reached $7.1 million, reflecting a 102.9% year-on-year increase [4] - The gross margin improved from 49.0% to 67.6%, with gross profit increasing by 51.1% [5][6] - The company reported a significant reduction in losses, down 36.3% to $28.23 million, aided by effective cost management [6] Market Expansion and Strategic Partnerships - Mirxes has engaged in strategic partnerships to enhance its market presence, including a nationwide early screening project in Japan and a memorandum of understanding with PT DIASTIKA BIOTEKINDO in Indonesia [4] - The company’s flagship product, GASTROClear™, has received regulatory approval in Singapore and Thailand, and has been recognized as a "breakthrough medical device" by the FDA in the U.S. [6] Product Development and Future Outlook - The company is advancing its product pipeline, with plans for the CRC-1 colorectal cancer detection product to complete prototype design in the second half of this year and initiate clinical trials in Singapore and China in 2026 [7] - The CEO emphasized the company's commitment to accelerating the global registration process for core products and expanding its product pipeline through a multi-omics technology platform [7]