| 代码 | 名称 | | 涨跌幅 √ | 最新价 | 总市值 | 年初至今涨跌 | | --- | --- | --- | --- | --- | --- | --- | | 02617 | 药捷安康-B | (0) | 31.25% | 218.000 | 865.24亿 | 1557.79% | | 09966 | 康宁杰瑞制药-B | | 7.15% | 14.680 | 142.45亿 | 319.43% | | 00928 | 帝王国际投资 | | 5.50% | 0.115 | 2.13亿 | 155.56% | | 09606 | 映恩生物-B | | 5.00% | 336.000 | 295.8亿 | 255.18% | | 02616 | 基石药业-B | | 4.66% | 7.190 | 106.12亿 | 212.61% | | 02197 | 三叶草生物-B | | 4.39% | 2.140 | 27.76亿 | 787.97% | | 02315 | 百奥塞图-B | | 3.86% | 24.220 | 96.73亿 | 184.94% | | 02105 | 来凯医药-B ...

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]

Core Insights - MIRXES-B's core product GASTROClear™ has received approval from the National Medical Products Administration of China for Class III medical device registration, 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 approval allows GASTROClear™ to be used for screening high-risk adults aged 45-74, potentially covering over 500 million people in China [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]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或依 賴該等內容而引致的任何損失承擔任何責任。 本公告乃由Mirxes Holding Company Limited（「本公司」，連同其附屬公司統稱「本 集團」）自願刊發，旨在知會本公司股東及潛在投資者有關本集團最新業務發展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，其核心產品GASTROClear™已獲 得中國國家藥品監督管理局（「國家藥監局」）批准第三類醫療器械注冊證，作 為體外診斷（「IVD」）產品在中國用於非侵入性胃癌篩查。該款產品為首款獲國 家藥監局批准用於胃癌篩查的血液檢測。 GASTROClear™為全球首個獲批用於胃癌早期檢測的微小核酸(miRNA)血液檢 測方法，通過檢測12種胃癌相關miRNA標誌物評估胃癌風險。此前，該產品已 於2019年在新加坡獲批，並於2023年獲美國食品藥物管理局（「FDA」）「突破性 器械」認定。此次在中國獲國家藥監局批准，標誌著本公司完成了從研發到商 業化的重要跨越，也體現了其在技術創新、大規模臨 ...

FF301 公司名稱: Mirxes Holding Company Limited (於開曼群島註冊成立的有限責任公司) 呈交日期: 2025年10月8日 I. 法定/註冊股本變動 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 致：香港交易及結算所有限公司 FF301 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02629 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 10,000,000,000 | USD | | 0.00001 | USD | | 100,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 10,000,00 ...

Major Events - Huiying Holdings (00821) plans to establish a joint venture to provide training, professional consulting services, and high-end conference business in the RWA category [1] - MIRXES-B (02629) intends to set up a joint venture for research, development, and commercialization of early cancer detection and other nucleic acid-based tests in Malaysia [1] - Kintor Pharmaceutical-B (02171) will present updates on the research results of CT0596 at the 2025 ASH annual meeting [1] - Energy & Energy Global (01142) has had its mining license revoked by a Russian subsidiary and plans to appeal further [1] Operating Performance - C&D International Group (01908) reported a cumulative contract sales amount of approximately 71.03 billion yuan for the first nine months, representing a year-on-year increase of about 7.5% [1] - Sa Sa International (00178) recorded a total revenue of 1.031 billion HKD for the second quarter, an annual increase of 8.4% [1] Buybacks/Reductions - Hang Seng Bank (00011) repurchased 200,000 shares for 23.9836 million HKD on October 6 [1] - Tencent Holdings (00700) repurchased 815,000 shares for 550.3 million HKD on October 6 [1] - Mengniu Dairy (02319) repurchased 1 million shares for 14.4099 million HKD on October 6 [1] - HSBC Holdings (00005) repurchased 1.49 million shares for 163 million HKD on October 3 [1]

MIRXES-B(02629)发布公告，于2025年10月6日，公司全资附属公司Mirxes International Holding Limited 与Xeraya Opportunities Fund PCC Limited(Xeraya)订立合营协议，以成立一家合营企业公司MYRNA DIAGNOSTICS SDN.BHD.。 合营企业由Mirxes International Holding Limited及Xeraya分别持有40%及60%股权。公司与Xeraya同意按 其各自的股权比例，分别以现金向合营企业的注册资本注资约200万美元及300万美元。成立合营企业的 目的为在马来西亚就癌症早期检测及其他核酸基础检测进行研究、开发、商业化及取得监管批准。 马来西亚作为人口达3500万以上的中高收入多元经济体，正面对日益严峻的癌症负担。2022年，当地录 得约51,650例新增癌症病例及31,633例癌症死亡(Global Cancer Observatory,2022)。值得注意的是，在马 来西亚，超过60%的癌症病例均在晚期(第III期或第IV期)方被诊断出来，严重限制患者的存活结果，并 对国家的 ...

Core Insights - MIRXES-B has entered into a joint venture agreement with Xeraya Opportunities Fund to establish MYRNA DIAGNOSTICS SDN. BHD., focusing on cancer early detection and nucleic acid-based testing in Malaysia [1] Company Summary - The joint venture will be owned 40% by Mirxes International Holding Limited and 60% by Xeraya, with a total capital injection of approximately $5 million [1] - The establishment of the joint venture aligns with the company's mission to make early disease detection solutions accessible globally, starting with addressing critical healthcare gaps in Malaysia [4] Industry Summary - Malaysia faces a significant cancer burden, with over 51,650 new cases and 31,633 deaths reported in 2022, and more than 60% of cases diagnosed at advanced stages [2] - The cancer incidence rate in Malaysia is projected to increase by over 70% by 2050, highlighting the urgent need for early detection, particularly for prevalent cancers such as lung, colorectal, breast, liver, and stomach cancers [2] - The joint venture aims to leverage Malaysia's strong life sciences and healthcare expertise to establish a leading cancer omics platform and enhance localized testing services [3] - The initiative will also integrate R&D and clinical operations across Singapore, China, and Malaysia to expedite regulatory approvals and innovation in diagnostic testing [3]