Core Viewpoint - MIRXES-B (02629) has been officially included in the Hang Seng Composite Index and Hong Kong Stock Connect as of September 8, 2025, which is expected to attract significant southbound capital attention and allocation, providing additional upward momentum for the company's stock price [1] Group 1: Market Position and Growth Potential - The company is a global pioneer in gastric cancer early screening, possessing first-mover advantages and technological barriers [1] - The core product, GASTROClear, is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening, commercialized in markets such as Singapore and Thailand, and recognized as a "breakthrough medical device" by the US FDA [1] - The company has a strong patent portfolio with over ten years of R&D in miRNA technology, including 27 approved patents and 63 pending applications, positioning it favorably in the non-invasive cancer early screening market, especially in Asia where gastric cancer is prevalent [1] - Revenue projections for 2025-2027 are $0.27 billion, $0.41 billion, and $0.75 billion, reflecting year-on-year growth rates of 30.84%, 55.14%, and 81.32% respectively [1] Group 2: Product Pipeline and Technological Development - The company has established a clear product pipeline leveraging its mature miRNART-qPCR technology platform, with ongoing development of screening products for colorectal cancer (CRC-1), liver cancer (LV-1), and breast cancer (BC-1), as well as a multi-cancer screening project (CADENCE) [2] - LUNGClear (lung cancer) has been commercialized as an LDT service in Southeast Asia and Japan, while CRC-1 is expected to complete prototype design by the second half of 2025 and initiate commercialization in Southeast Asia [2] - The platform's scalability allows for the replication of GASTROClear's success, potentially shortening R&D cycles and continuously launching new products [2] Group 3: Integrated Industry Capabilities - The company has built an integrated platform covering R&D, production, and commercialization, creating high barriers and cost advantages [3] - With two cGMP-compliant production facilities in Singapore and China, the company has an annual testing capacity of approximately 590,000 tests, ensuring product quality and stable supply while effectively controlling costs [3] - The gross margin for the first half of 2025 increased by 18.8 percentage points to 67.8%, providing a solid foundation for future market competition and profit release [3]

FF301 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10月31日 狀態: 新提交 致：香港交易及結算所有限公司 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11月6日 I. 法定/註冊股本變動 | 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 | | | 10,000,000,000 ...

Core Insights - The biotechnology sector in the Hong Kong stock market has shown strong performance, with several stocks experiencing significant gains today, particularly药捷安康-B which surged over 30% [1] Stock Performance Summary - 药捷安康-B: Increased by 31.25%, latest price at 218.000, total market value of 86.524 billion, year-to-date increase of 1557.79% [2] - 康宁杰瑞制药-B: Increased by 7.15%, latest price at 14.680, total market value of 14.245 billion, year-to-date increase of 319.43% [2] - 帝王国际投资: Increased by 5.50%, latest price at 0.115, total market value of 0.0213 billion, year-to-date increase of 155.56% [2] - 映恩生物-B: Increased by 5.00%, latest price at 336.000, total market value of 29.58 billion, year-to-date increase of 255.18% [2] - 基石药业-B: Increased by 4.66%, latest price at 7.190, total market value of 10.612 billion, year-to-date increase of 212.61% [2] - 三叶草生物-B: Increased by 4.39%, latest price at 2.140, total market value of 2.776 billion, year-to-date increase of 787.97% [2] - 百奥塞图-B: Increased by 3.86%, latest price at 24.220, total market value of 9.673 billion, year-to-date increase of 184.94% [2] - 来凯医药-B: Increased by 3.71%, latest price at 14.540, total market value of 6.49217 billion, year-to-date increase of 55.18% [2] - 君实生物: Increased by 3.29%, latest price at 27.600, total market value of 28.337 billion, year-to-date increase of 138.34% [2] - MIRXES-B: Increased by 3.26%, latest price at 72.900, total market value of 20.145 billion, year-to-date increase of 212.88% [2]

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]

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]