【重大事项】 MIRXES-B(02629)：GASTROClear™获批中国国家药监局胃癌筛查IVD注册证 京东物流(02618)拟2.7亿美元收购京东集团本地即时配送服务业务 加强"最后一公里"配送能力 汇丰控股(00005)拟将恒生银行(00011)私有化 复宏汉霖(02696)：汉斯状® (斯鲁利单抗注射液)联合化疗用于胃癌新辅助/辅助治疗的3期临床研究达到 主要研究终点 【经营业绩】 宝龙地产(01238)前9个月合约销售总额约54.31亿元，同比减少43.64% 迅销(06288)发布年度业绩，股东应占溢利4330.09亿日圆 同比增长16.4% 10月10日复牌 景瑞控股(01862)前9个月合约签约销售额7.40亿元 同比减少49.52% 东风集团股份(00489)前9个月累计汽车销量为131.68万辆 同比下降约3.6% 药师帮(09885)第三季度厂牌首推业务交易总额约6.584亿元，同比增长163% 药明巨诺-B(02126)：国家药监局正式受理倍诺达®使用国产病毒载体的上市后补充申请 舜宇光学 (02382)拟约19.03亿元转让上海奥来并入股歌尔光学 携手歌尔布局 AI/AR 光学业 ...

2025年10月9日星期四 ➢ 美联储会议纪要；加沙和平协议。 A股国庆假期休市。港股调整，恒 生指数收盘跌0.48%报26829.46点， 恒生科技指数下跌0.55%，恒生中 国企业指数跌0.52%。人工智能概 念股、消费股表现疲软，黄金股、 核电股逆市上涨。大市成交额 1738.03亿港元。外盘方面，欧洲 三大股指收盘全线上涨。美国三 大股指多数收涨，道指持平，标 普500指数涨0.58%，纳指涨1.12%。 美联储会议纪要显示通胀之忧令 官员谨慎看待降息步伐，交易员 加大对冲年内央行决策出现意外 两极的风险。特朗普称以色列和 哈马斯就第一阶段和平计划达成 协议。 | 26829.46 | -0.48 | 33.52 | | --- | --- | --- | | 9523.87 | -0.52 | 30.82 | | 6514.19 | -0.55 | 45.84 | | 117.14 | 0.38 | -18.12 | | 3882.78 | 0.52 | 15.84 | | 13526.51 | 0.35 | 29.88 | | 4640.69 | 0.45 | 17.94 | | 46601.78 ...

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。 ...

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) ...

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 ...

Core Viewpoint - The mid-term performance of Mirxes Holding Company Limited demonstrates its commercial capabilities in the field of early cancer screening [1] Financial Performance - For the first half of 2025, Mirxes achieved revenue of $10.5 million, a 9.4% increase compared to the same period in 2024, driven by a 50% growth in the early detection and precision multi-omics segment, which now accounts for 100% of the company's revenue [4] - The gross profit for this segment reached $7.1 million, reflecting a 102.9% year-on-year increase [4] - The gross margin improved from 49.0% to 67.6%, with gross profit increasing by 51.1% [5][6] - The company reported a significant reduction in losses, down 36.3% to $28.23 million, aided by effective cost management [6] Market Expansion and Strategic Partnerships - Mirxes has engaged in strategic partnerships to enhance its market presence, including a nationwide early screening project in Japan and a memorandum of understanding with PT DIASTIKA BIOTEKINDO in Indonesia [4] - The company’s flagship product, GASTROClear™, has received regulatory approval in Singapore and Thailand, and has been recognized as a "breakthrough medical device" by the FDA in the U.S. [6] Product Development and Future Outlook - The company is advancing its product pipeline, with plans for the CRC-1 colorectal cancer detection product to complete prototype design in the second half of this year and initiate clinical trials in Singapore and China in 2026 [7] - The CEO emphasized the company's commitment to accelerating the global registration process for core products and expanding its product pipeline through a multi-omics technology platform [7]

Group 1 - MIRXES-B (02629) has shown strong performance in the Hong Kong biotech sector, reaching a historical high of 44.98 HKD, representing a cumulative increase of over 93% since its IPO price of 23.3 HKD [1][32] - The stock has a market capitalization of 12.22 billion HKD and a trading volume of 1.16 million shares as of August 15 [1] - The stock is expected to be included in the Hong Kong Stock Connect, which has historically led to significant price increases for newly listed companies [3][4] Group 2 - MIRXES-B has a fully circulated structure, which differentiates it from traditional stocks that face lock-up periods and potential selling pressure after listing [6][7] - The company has a strong market position with its GASTROClear™ product, the only approved molecular diagnostic IVD product for gastric cancer screening globally [24][30] - The market for cancer screening in selected regions is projected to grow from 50.4 billion USD in 2023 to 82.8 billion USD by 2033, with a compound annual growth rate of 11.3% [25] Group 3 - The company has established significant technical barriers, including a sensitivity of 87% for miRNA detection, which is superior to traditional tumor markers [24][31] - The penetration rate for gastric cancer screening in high-risk populations in China has increased from 21.6% in 2019 to 27.8% in 2023, with expectations to reach 67.0% by 2033 [28] - Despite current financial performance needing improvement, the rapid development of precision medicine and the company's technical advantages suggest significant long-term potential [32]

Group 1: Industry Overview - The global cancer early screening market has surpassed $50 billion and is growing at an annual rate of 18% [1] - Despite advanced technology, over 80% of domestic early screening products in China remain confined to the local market due to stringent regulations and high approval barriers in international markets [1] - The European IVDR regulations and the U.S. FDA's classification of early screening products as high-risk Class III devices contribute to the challenges faced by Chinese companies in entering international markets [1] Group 2: Company Profile - Mirxes - Mirxes, established in 2014 and headquartered in Singapore, specializes in RNA technology and aims to provide disease screening solutions globally [3] - Its core product, GASTROClear™, is the first and only approved molecular diagnostic IVD product for gastric cancer screening, having received various international certifications including EU CE and U.S. FDA breakthrough device designation [3][6] - The company plans to leverage its successful IPO on the Hong Kong Stock Exchange to enhance its technology development, market expansion, and international collaborations [5] Group 3: Strategic Initiatives - Post-IPO, Mirxes aims to invest in research for new cancer screening technologies and explore multi-cancer screening products to improve accuracy and detection range [5][6] - The company intends to attract top global research talent and deepen collaborations with international medical institutions to advance its miRNA technology in liquid biopsy applications [6] - Mirxes' strategy includes forming partnerships with renowned pharmaceutical companies and research institutions to enhance its technical capabilities and market competitiveness [6]

Core Viewpoint - Mirxes Holding Company Limited (referred to as "Mirxes") has successfully listed on the Hong Kong Stock Exchange, with its share price rising significantly on the first day of trading, reflecting strong market interest in its innovative cancer screening technology [1][2]. Company Overview - Mirxes, founded in 2014 and headquartered in Singapore, specializes in RNA technology, focusing on non-invasive blood-based microRNA (miRNA) diagnostic kits for early disease detection, particularly cancer [1][5]. - The company has launched its first product, GASTROClear™, which is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening [5]. IPO Details - The IPO involved a global offering of 46.62 million shares, representing 16.87% of the total shares post-IPO, with a pricing of HKD 23.30 per share, raising approximately HKD 1.086 billion [1]. - The public offering was oversubscribed by 25.51 times, while the international offering saw a subscription rate of 0.98 times [2]. Product Pipeline - As of May 2025, Mirxes has one core product (GASTROClear™), two other commercialized products (LUNGClear™ and Fortitude™), and six candidates in preclinical stages [3]. - GASTROClear™ has received CE certification in 2017 and FDA breakthrough device designation in 2023, with clinical trials in China showing promising results [5][10]. Financial Performance - The company reported revenues of USD 17.76 million, USD 24.19 million, and USD 20.28 million for the years 2022, 2023, and 2024, respectively, while incurring net losses of USD 56.20 million, USD 69.57 million, and USD 92.21 million during the same period [7][8]. - Despite increasing revenues, the company has faced continuous losses, indicating challenges in achieving profitability [7]. Market Valuation - As of the closing on May 23, the market capitalization of Mirxes was approximately HKD 82.90 billion, translating to a price-to-sales (P/S) ratio of about 52 times based on projected 2024 revenues [9]. - The valuation is heavily reliant on future revenue expectations, particularly from GASTROClear™ and other products in the pipeline [9][10]. Future Outlook - The company's future valuation will depend on the commercialization speed of GASTROClear™ and the potential of its multi-cancer pipeline [12]. - Approval from China's National Medical Products Administration (NMPA) for GASTROClear™ is anticipated in the first half of 2025, which could significantly impact the company's market position [10][12].

Core Insights - The Hong Kong stock market welcomed two pharmaceutical companies, Heng Rui Pharmaceutical and MIRXES-B, on May 23, with both stocks experiencing significant price increases on their debut [2] - MIRXES, despite being less well-known, saw its stock price rise over 30% by the time of reporting, achieving a market capitalization exceeding HKD 8 billion [2] - MIRXES successfully raised HKD 880.5 million through the issuance of 46.62 million shares at HKD 23.30 each, with a subscription rate of 25.51 times for the public offering [2][3] Company Overview - MIRXES, founded in 2014 and headquartered in Singapore, specializes in microRNA (miRNA) technology, focusing on disease screening and diagnostic solutions in key Asian markets, including Singapore and China [3] - The company has one core product, GASTROClear™, and two other commercialized products, LUNGClear™ and Fortitude™, along with six candidates in preclinical stages [3][4] Product Details - GASTROClear™ is a blood-based miRNA diagnostic test for gastric cancer screening, consisting of 12 miRNA biomarkers. It was the first and only molecular diagnostic IVD product approved for gastric cancer screening globally [4] - The product received a breakthrough medical device designation from the FDA in May 2023, marking a significant achievement for MIRXES in the miRNA diagnostic field [4] Financial Performance - MIRXES reported revenues of USD 17.76 million, USD 24.19 million, and USD 20.28 million for the years 2022, 2023, and 2024, respectively, with gross profits of USD 9.33 million, USD 13.58 million, and USD 8.89 million [4] - The company is projected to incur losses of USD 56.20 million, USD 69.57 million, and USD 92.21 million over the same period [4] Fund Utilization - The funds raised from the global offering will be allocated to the research and development of GASTROClear™, regulatory filings, production, commercialization, and enhancing the company's end-to-end capabilities, as well as general operational expenses [5]