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]
方正证券:首予MIRXES-B“推荐”评级 GASTROClear获批上市