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]
方正证券:首予MIRXES-B(02629)“推荐”评级 GASTROClear获批上市