Core Insights - MIRXES-B's core product GASTROClear has received approval from the National Medical Products Administration of China for use as a non-invasive gastric cancer screening IVD product, marking a significant milestone in the company's journey from research and development to commercialization [1] - GASTROClear is the first blood test approved for gastric cancer screening in China, utilizing a microRNA-based method to assess gastric cancer risk by detecting 12 gastric cancer-related miRNA biomarkers [1] Group 1 - GASTROClear is designated for screening high-risk adults aged 45-74 as defined by the "Guidelines for Screening and Early Diagnosis and Treatment of Gastric Cancer in China (2024 Edition)," potentially covering over 500 million individuals [2] - The product will be implemented in both public and private medical institutions in China as an IVD testing project, significantly expanding the company's business space in the gastric cancer screening market [2] Group 2 - The company plans to continue increasing its commercialization efforts in China, including expanding the sales team and upgrading local production capabilities [2] - There will be a focus on strengthening business development and collaboration in mainland China to promote broader adoption of the product [2]

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]

Core Insights - MIRXES-B (02629) has entered into a joint venture agreement with Xeraya Opportunities Fund PCC Limited to establish MYRNA DIAGNOSTICS SDN.BHD, with Mirxes holding 40% and Xeraya 60% of the equity [1] - The joint venture aims to address the urgent need for early cancer detection and other nucleic acid-based testing in Malaysia, a country facing a significant cancer burden [1][2] Company Strategy - The joint venture will leverage Xeraya's regional expertise in life sciences and healthcare to create a leading cancer omics platform in Malaysia, focusing on advanced miRNA-based multi-omics technology and validated blood cancer early detection [3] - The company plans to establish a localized omics testing business to enhance turnaround time and cost-effectiveness for existing clinical operations, while expanding into new market segments, including public healthcare institutions [3] - The strategy includes utilizing Malaysia's thriving biotech ecosystem to accelerate the development of clinical pipelines for colorectal, breast, liver, and multi-cancer types [3] - The joint venture aims to integrate R&D and clinical operations across Singapore, China, and Malaysia to expedite regulatory approvals for in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs) [3] - The company envisions establishing a scalable regional platform in Malaysia as a springboard for expansion into neighboring ASEAN countries and other Asian markets with similar epidemiological characteristics and unmet screening needs [3] Industry Context - Malaysia, with a population exceeding 35 million, is facing a rising cancer burden, with over 51,650 new cancer cases and 31,633 cancer deaths reported in 2022 [2] - More than 60% of cancer cases in Malaysia are diagnosed at advanced stages (Stage III or IV), which severely limits patient survival outcomes and places a heavy burden on the healthcare system [2] - The cancer incidence rate in Malaysia is projected to increase by over 70% by 2050, highlighting the critical unmet need for early detection, particularly for high-incidence cancers such as lung, colorectal, breast, liver, and stomach cancers, which together account for nearly 50% of total cases [2]

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]

Mirxes Holding Company Limited （ 於 開 曼 群 島 註 冊 成 立 的 有 限 責 任 公 司 ） （股份代號：2629） 自願性公告 成立合營企業 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的最新業務 發展。 成立合營企業 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因 依賴該等內容而引致的任何損失承擔任何責任。 – 2 – (i) 建立馬來西亞領先的癌症組學平台，以本公司先進且以miRNA為中心的多 組學技術平台及經驗證的血液癌症早期檢測為基礎，解決馬來西亞在癌 症早期檢測及精準醫學方面未被滿足的關鍵臨床需求； (ii) 在馬來西亞建立強大且具在地化的專業組學檢測業務， a. 透過在地化檢測服務擴展現有臨床業務的規模，為現有客戶改善週 轉時間及成本效益； b. 加速拓展業務合作並涉足包括公立醫療機構等新市場領域； (iii) 善用馬來西 ...

Mirxes Holding Company Limited 股份代號 : 2629 （於開曼群島註冊成立的有限責任公司） C M Y CM MY CY CMY K Mirxes Holding Company Limited (Incorporated in the Cayman Islands with limited liability) Stock Code : 2629 「CRC-1」 指 CRC-1為一種我們正在開發的用於結直腸癌篩查的基於miRNA 的檢測試劑盒 2025年中期報告 Mirxes Holding Company Limited 2 「無症狀」 指 並無產生或顯示症狀 「審核委員會」 指 董事會審核委員會 「BC-1」 指 BC-1為一種根據我們專有RT-qPCR技術用於乳腺癌篩查的基於 miRNA的檢測 「董事會」 指 本公司董事會 「乳腺癌」 指 自乳房發展而來的癌症 「癌症篩查」 指 對並無明顯癌症症狀的個體進行檢查或檢測，以確定此類疾病 的任何潛在跡象或早期階段 「CE-IVD證」 指 表明符合歐盟體外診斷醫療器械法規(IVDR 2017/746)的認證標 誌，其概述有關I ...