Core Viewpoint - MIRXES-B (02629.HK) 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] Product Approval - 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 was previously approved in Singapore in 2019 and received "breakthrough device" designation from the FDA in 2023 [1] Significance of Approval - The approval in China represents a significant milestone for the company, indicating a successful transition from research and development to commercialization [1] - This achievement reflects the company's long-term commitment and investment in technological innovation and large-scale clinical trials [1]
MIRXES-B(02629.HK)：GASTROClear™获批中国国家药监局胃癌筛查IVD注册证