GASTROClear™为全球首个获批用于胃癌早期检测的微小核酸(miRNA)血液检测方法，通过检测12种胃 癌相关miRNA标志物评估胃癌风险。此前，该产品已于2019年在新加坡获批，并于2023年获美国食品 药物管理局("FDA")"突破性器械"认定。此次在中国获国家药监局批准，标志着本公司完成了从研发到 商业化的重要跨越，也体现了其在技术创新、大规模临床试验的成果，这奠基于其在创新与市场准入方 面的长期坚持与投入。 格隆汇10月9日丨MIRXES-B(02629.HK)宣布，其核心产品GASTROClear™已获得中国国家药品监督管 理局("国家药监局")批准第三类医疗器械注册证，作为体外诊断("IVD")产品在中国用于非侵入性胃癌筛 查。该款产品为首款获国家药监局批准用于胃癌筛查的血液检测。 ...

（原标题：MIRXES-B(02629)：GASTROClear?获批中国国家药监局胃癌筛查IVD注册证） 智通财经APP讯，MIRXES-B(02629)发布公告，其核心产品GASTROClear已获得中国国家药品监督管理 局批准第三类医疗器械注册证，作为体外诊断(IVD)产品在中国用于非侵入性胃癌筛查。该款产品为首 款获国家药监局批准用于胃癌筛查的血液检测。 未来，公司将持续扩大在中国的商业化投入，包括将销售团队规模扩大，并升级本土生产能力。同时， 公司也将进一步加强在中国大陆的业务发展与合作(BD)布局，推动产品更广泛落地。 GASTROClear为全球首个获批用于胃癌早期检测的微小核酸(miRNA)血液检测方法，通过检测12种胃癌 相关miRNA标志物评估胃癌风险。此前，该产品已于2019年在新加坡获批，并于2023年获美国食品药 物管理局(FDA)"突破性器械"认定。此次在中国获国家药监局批准，标志着公司完成了从研发到商业化 的重要跨越，也体现了其在技术创新、大规模临床试验的成果，这奠基于其在创新与市场准入方面的长 期坚持与投入。 根据批准预定用途，GASTROClear可用于《中国胃癌筛查与早诊早 ...

Core Insights - MIRXES-B (02629) 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] - 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 is expected to cover a potential population of over 500 million high-risk adults aged 45-74, as defined by the "Guidelines for Gastric Cancer Screening and Early Diagnosis and Treatment (2024 Edition)" [1] Company Strategy - The company plans to continue expanding its commercialization efforts in China, including increasing the size of its sales team and upgrading local production capabilities [2] - The company aims to strengthen its business development and collaboration efforts in mainland China to promote wider adoption of its products [2]

根据批准预定用途，GASTROClear™可用于《中国胃癌筛查与早诊早治指南(2024 版)》定义的45–74岁 胃癌高风险成人筛查，潜在覆盖人群超过5亿。该产品将在中国公立及私立医疗机构作为IVD检测项目 投入使用，显著拓展公司在中国胃癌筛查市场的业务空间。 未来，公司将持续扩大在中国的商业化投入，包括将销售团队规模扩大，并升级本土生产能力。同时， 公司也将进一步加强在中国大陆的业务发展与合作(BD)布局，推动产品更广泛落地。 GASTROClear™为全球首个获批用于胃癌早期检测的微小核酸(miRNA)血液检测方法，通过检测12种胃 癌相关miRNA标志物评估胃癌风险。此前，该产品已于2019年在新加坡获批，并于2023年获美国食品 药物管理局(FDA)"突破性器械"认定。此次在中国获国家药监局批准，标志着公司完成了从研发到商业 化的重要跨越，也体现了其在技术创新、大规模临床试验的成果，这奠基于其在创新与市场准入方面的 长期坚持与投入。 智通财经APP讯，MIRXES-B(02629)发布公告，其核心产品GASTROClear™已获得中国国家药品监督管 理局批准第三类医疗器械注册证，作为体外诊断(IVD) ...

Core Insights - Gastric cancer is often diagnosed at an advanced stage, with early symptoms resembling common stomach ailments, leading to a significant drop in the five-year survival rate to 30% [1] - Early diagnosis is challenging due to the discomfort associated with gastroscopy, which is often perceived as a daunting procedure, and long waiting times discourage many individuals from pursuing screening [1] Industry Challenges - The difficulty in early detection of gastric cancer is primarily attributed to the similarity of early symptoms to less severe stomach issues, resulting in delayed diagnosis [1] - The perception of gastroscopy as a "sword-swallowing" level challenge contributes to the reluctance of individuals to undergo necessary screening [1] - Long waiting times for screening procedures further exacerbate the issue, leading to a high rate of abandonment among potential patients [1]

Core Viewpoint - The introduction of the world's first AI model for gastric cancer screening, DAMO GRAPE, represents a significant advancement in early detection and intervention, potentially increasing the five-year survival rate from 35% to over 90% if cancer is detected early [3][5]. Group 1: AI Model Development and Application - The DAMO GRAPE model utilizes plain CT imaging to identify early gastric cancer lesions and has undergone large-scale clinical research involving nearly 100,000 individuals across 20 centers [3]. - The model's initial screening significantly reduces the high-risk population for gastric cancer, achieving detection rates of 24.5% and 17.7% in two regional hospitals, with approximately 40% of detected cases being asymptomatic [4]. - The AI model demonstrates a sensitivity of 85.1% and specificity of 96.8%, surpassing radiologist diagnoses by 21.8% and 14.0%, respectively, making early detection of gastric cancer via plain CT feasible [4]. Group 2: Clinical Impact and Future Plans - The AI model has shown the ability to detect gastric cancer 2 to 10 months earlier than traditional methods, as evidenced by a case where a patient was diagnosed with advanced gastric cancer that could have been identified earlier with AI monitoring [4]. - The model is being deployed in high-incidence areas for gastric cancer across the country, with plans for large-scale promotion both domestically and internationally [5].