Major Events - MIRXES-B (02629) received approval from the National Medical Products Administration of China for the GASTROClear™ IVD registration certificate for gastric cancer screening [1] - JD Logistics (02618) plans to acquire JD Group's local instant delivery service business for $270 million to enhance "last mile" delivery capabilities [1] - HSBC Holdings (00005) intends to privatize Hang Seng Bank (00011) [1] - Fuhong Hanlin (02696) reported that the phase III clinical study of Hansu® (sulizumab injection) in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer achieved its primary endpoint [1] - WuXi AppTec (02126) announced that the National Medical Products Administration officially accepted the supplementary application for the post-marketing use of Benodda® with a domestic viral vector [1] - Sunny Optical (02382) plans to transfer approximately 1.903 billion yuan to Shanghai Aolai and invest in GoerTek to jointly develop AI/AR optical business [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval for SYH2070 injection (double-stranded small interfering RNA drug) in the United States [1] - Yanda Pharmaceutical (00512) completed patient enrollment for the registration clinical study of a globally innovative temperature-sensitive embolic agent in China [1] - CloudWalk Technology (09678) successfully won bids for multiple intelligent agent projects, including the AI capability platform for Beijing Friendship Hospital [1] - Huakang Biomedical (08622) received a cash offer from Anselme Limited to acquire 27.71% of its shares at a discount of approximately 68.10%, with resumption of trading on October 10 [1] Operating Performance - Baolong Properties (01238) reported a total contracted sales of approximately 5.431 billion yuan in the first nine months, a year-on-year decrease of 43.64% [2] - Fast Retailing (06288) released its annual performance, with a net profit attributable to shareholders of 433.009 billion yen, a year-on-year increase of 16.4%, with trading resuming on October 10 [2] - Jingrui Holdings (01862) reported a contracted sales amount of 740 million yuan in the first nine months, a year-on-year decrease of 49.52% [2] - Dongfeng Motor Group (00489) recorded cumulative automobile sales of 1.3168 million units in the first nine months, a year-on-year decline of approximately 3.6% [2] - Yaoshi Bang (09885) reported a total transaction volume of approximately 658.4 million yuan for its brand promotion business in the third quarter, a year-on-year increase of 163% [2]

Market Performance - The Hang Seng Index closed down 0.48% at 26,829.46 points, with the Hang Seng Tech Index down 0.55% and the Hang Seng China Enterprises Index down 0.52%[1] - The total market turnover was HKD 173.8 billion[1] - In contrast, European indices closed higher, and the S&P 500 rose by 0.58% while the Nasdaq increased by 1.12%[1] Federal Reserve Insights - The Federal Reserve's meeting minutes indicated a cautious approach to interest rate cuts due to inflation concerns, with a majority of officials suggesting further easing may be appropriate this year[12] - The Federal Funds rate was lowered by 25 basis points to a range of 4% to 4.25%, marking the first cut of the year[12] Currency Movements - The Japanese yen reached an eight-month low against the US dollar, nearing the critical psychological level of 155[12] - Observers are considering the risk of intervention by Japanese authorities if the yen continues to weaken[12] Geopolitical Developments - Former President Trump announced that Israel and Hamas reached an agreement on the first phase of a peace plan, which includes the release of hostages and the withdrawal of Israeli troops[12] Corporate Actions - HSBC's CEO stated that a 30% premium for privatizing Hang Seng Bank is an attractive offer, emphasizing the potential for growth in Hong Kong[14] - Zijin Mining International exercised its over-allotment option, raising approximately RMB 3.747 billion through the issuance of additional shares[14]

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 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 ...

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]