觅瑞通过港交所聆讯：已实现miRNA早筛产品的商业化，具有全球化端对端能力

Core Viewpoint - Mirxes Holding Company Limited, known as "觅瑞," is a pioneer in developing and commercializing blood-based miRNA diagnostic kits for early cancer detection, with its core product GASTROClear™ being the only approved molecular diagnostic IVD product for gastric cancer screening globally [1][5]. Company Overview - Founded in 2014, Mirxes focuses on making disease screening and diagnostic solutions accessible in key Asian markets, including Singapore and China [2]. - The company has a core product, GASTROClear™, along with two other commercialized products (LungClear™ and Fortitude™) and six candidates in preclinical stages [4]. Product Details - GASTROClear™ consists of 12 miRNA biomarkers for gastric cancer screening and was successfully commercialized in Singapore after receiving regulatory approval in May 2019 [4]. - Fortitude™ 2.0 received temporary clinical use authorization in April 2020 and CE-IVD certification in June 2020, leading to its commercialization in Singapore and global markets [4]. - LungClear™ has been commercialized as an LDT service in Southeast Asia since December 2022 and in Japan since January 2023 [4]. Market Position - According to Frost & Sullivan, Mirxes is one of the few companies globally to have received regulatory approval for molecular cancer screening IVD products and is the only one for gastric cancer screening [5]. - The company has established end-to-end capabilities across research, clinical trials, production, and commercialization, with facilities in Southeast Asia, China, Japan, and the U.S. [5]. Team and Expertise - The founding team has significant academic achievements and research experience in miRNA molecular detection, having established Singapore's first RNA diagnostic PCR laboratory in the early 2000s [6]. - They founded a leading miRNA candidate discovery laboratory in Singapore in 2012, which had one of the highest throughput capacities globally [6]. Funding and Financial Strategy - Mirxes has received investments from notable institutions, including Rock Springs Capital and others, and secured $40 million in strategic financing from a fund under 康桥资本 to accelerate GASTROClear™'s market entry in the Asia-Pacific region [6][7]. - The net proceeds from the IPO will primarily fund the R&D, regulatory filings, production, and commercialization of GASTROClear™, as well as support ongoing and planned R&D efforts [7].