Core Insights - The company has established a strategic partnership with N Health and Bangkok Dusit Medical Services (BDMS) to introduce advanced microRNA cancer screening solutions in Thailand, marking a significant step forward in early cancer detection and patient outcomes in the region [1][2] Market Overview - The Thai health check market is experiencing substantial growth, projected to reach approximately $500 million by 2030, with a compound annual growth rate (CAGR) of 9.2% starting from 2025. The specialty health check segment is the fastest-growing part, indicating strong demand for advanced and targeted screening solutions [1] Strategic Partnership - The partnership will leverage the company's cutting-edge miRNA technology and innovative screening solutions, such as GASTROClear™ for gastric cancer and LUNGClear™ for lung cancer, to enhance early disease detection services across nearly 60 hospitals within the N Health network [2] Product Launch - The company plans to launch new home screening test kits, HELICORapid for H. pylori detection and FITRapid for fecal occult blood detection, in Thailand starting January 9, 2026, following approvals from the Thai FDA [3] Innovation in Testing - The new home test kits are the first of their kind in the Thai market, featuring an innovative single-device design that integrates sample collection and testing into one component, significantly reducing contamination and user error risks [3][4] Accessibility and Consumer Focus - The company aims to distribute these test kits through modern trade channels and pharmacies across Thailand, aligning with evolving consumer healthcare behaviors and the increasing demand for preventive, self-diagnostic solutions [4]

Core Viewpoint - The strategic partnership between MIRXES-B and N Health aims to introduce advanced microRNA cancer screening solutions in Thailand, marking a significant step forward in early cancer detection and improving patient outcomes in the region [1][2]. Group 1: Strategic Partnership - The partnership is established to leverage MIRXES-B's cutting-edge miRNA technology and innovative screening solutions, such as GASTROClear™ for gastric cancer and LUNGClear™ for lung cancer [2]. - The collaboration will introduce cancer screening tests across nearly 60 hospitals within the N Health network, supporting broader access to early disease detection services in Thailand and Southeast Asia [2]. - N Health aims to enhance its role in providing end-to-end healthcare solutions and expand the accessibility of advanced cancer screening nationwide, integrating cancer risk assessments into preventive care [2]. Group 2: Market Potential - Thailand's health check-up market is projected to reach approximately $500 million by 2030, with a compound annual growth rate (CAGR) of 9.2% starting from 2025, indicating strong demand for advanced and targeted screening solutions [1]. - The increasing awareness of preventive healthcare and rising chronic disease prevalence create an ideal environment for adopting innovative diagnostic technologies like MIRXES-B's miRNA tests [1]. Group 3: New Product Launch - The company plans to launch new home screening test kits, HELICORapid for H. pylori detection and FITRapid for fecal occult blood detection, in Thailand starting January 9, 2026, following approvals from the Thai FDA [3]. - These home test kits are designed to complement the core miRNA cancer screening solutions and are the first of their kind in the Thai market, featuring an innovative single-device design that minimizes processing steps and reduces contamination risks [3][4]. - The distribution of these test kits will be through modern trade and pharmacy channels across Thailand, aligning with evolving consumer healthcare behaviors and increasing demand for preventive, self-diagnostic solutions [4].

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。 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 於泰國的近期業務發展進程 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。 與N HEALTH建立戰略夥伴關係 本公司董事（「董事」）會（「董事會」）宣佈，本公司已於2025年12月15日與N Health （「N Health」，為 一 家 醫 療 保 健 解 決 方 案 供 應 商 及 泰 國 最 大 醫 療 保 健 供 應 商 Bangkok Dusit Medical Services (BDMS) Group的成員公司）建立戰略夥伴關係（「戰 略夥伴關係」）。戰略夥伴關係旨在將先進的microRN ...

Core Insights - Mirxes Holding Limited, a leading cancer early screening company based in Singapore, was listed on the Hong Kong Stock Exchange on May 23, 2025, and quickly gained recognition by being included in the Hang Seng Composite Index and the Hong Kong Stock Connect program within four months [1][2] Company Performance - Since its listing, Mirxes has shown impressive market performance, becoming the first unicorn in Southeast Asia's biotechnology sector with a market capitalization exceeding $1 billion on its listing day [2] - For the first half of 2025, the company reported revenues of $10.5 million, a 9.4% increase compared to the same period in 2024, with gross profit rising to $7.1 million, reflecting a 51.1% year-on-year growth and an increase in gross margin from 49.0% to 67.6% [2] - The company's losses decreased by 36.3% year-on-year to $28.23 million, and cash and cash equivalents rose to $108 million, providing a solid financial foundation for future R&D and commercialization efforts [2] Product and Technology - Mirxes continues to lead the industry with its core competencies, including the world's first approved molecular diagnostic product for gastric cancer screening, GASTROClear™, which has received regulatory approval in Singapore and Thailand, as well as "Breakthrough Medical Device" designation from the FDA in the U.S. [3] - The lung cancer detection product, LUNGClear™, has also performed well, contributing significantly to revenue growth in Southeast Asia and Japan due to its non-invasive and cost-effective nature [3] - The company's miRNA technology has been recognized in China, being included in expert consensus guidelines for early screening and diagnosis of common malignant tumors [3] Market Impact - The inclusion of Mirxes in the Hong Kong Stock Connect program not only broadens its investor base but also serves as a new model for the international development of Asian biotechnology companies [3] - This development highlights Hong Kong's role as a crucial bridge connecting China and the global market, allowing mainland investors to easily participate in the growth of high-quality biotechnology firms [3]

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]

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]

Core Viewpoint - Mirxes Holding Company Limited, known as "Mirxes," is the first and only company globally to receive regulatory approval for molecular gastric cancer screening IVD products, marking a significant milestone in the field of early cancer detection [2][3]. Company Overview - Mirxes was officially listed on the Hong Kong Stock Exchange on May 23, 2025, under the stock code "2629," raising approximately HKD 1.086 billion through the issuance of 46,620,000 shares at an issue price of HKD 23.30 per share [2]. - The IPO saw a subscription rate of 25.51 times for the public offering portion, with cornerstone investors including Jiujiang State-owned Assets and Fosun International, collectively subscribing for USD 57.92 million (approximately HKD 449 million) [2]. Product Portfolio - The core product, GASTROClear™, is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening, consisting of a blood-based miRNA detection kit with 12 miRNA biomarkers [5]. - GASTROClear™ received its C-class IVD certificate from HSA in May 2019 and was commercialized in Singapore, having also obtained CE-IVD certification in November 2017 [5]. - The product has been recognized as a breakthrough medical device by the FDA in May 2023, establishing Mirxes as a leader in the miRNA diagnostic field [5]. Market Expansion Goals - Over 50% of the net proceeds from the IPO will be allocated to the research, regulatory filing, production, and commercialization of GASTROClear™, with a strategic focus on entering the Japanese and U.S. markets [6]. - The strategy includes providing LDT services to private health check centers and public hospitals to build brand recognition and demand before gradually selling IVD test kits [6]. Research and Development Capabilities - Mirxes has established a global end-to-end capability across research, clinical trials, production, and commercialization, with operational facilities in Southeast Asia, China, Japan, and the U.S. [9]. - The company operates two R&D laboratories, a clinical diagnostic laboratory, and two production facilities, ensuring efficient product delivery to customers worldwide [9]. - The R&D team consists of 94 members, with over 54% holding a master's degree or higher, demonstrating strong academic and research credentials in the miRNA detection field [10]. Investment and Support - Mirxes has received investments from notable institutions, including Gao Rong Capital, which has supported the company for seven years, witnessing its transition from laboratory to industrialization and globalization [11][12]. - The company aims to leverage its technological advancements in miRNA for further product development in cancer screening and diagnostics [13].

Core Viewpoint - Mirxes has successfully listed on the Hong Kong Stock Exchange, achieving a market capitalization of over 8.5 billion HKD, and generates annual revenue of approximately 146 million CNY through its innovative cancer detection technology using a single blood sample [3][11]. Company Overview - Mirxes specializes in miRNA technology and currently has three commercialized products and six candidates in preclinical stages [10]. - The core product, GASTROClear™, allows for early detection of gastric cancer using just 1 milliliter of blood, with an accuracy rate exceeding 87% [7][10]. Financial Performance - The company's revenue fluctuated from 17.76 million USD in 2022 to 24.19 million USD in 2023, before dropping to approximately 20.28 million USD in 2024 [11]. - Mirxes reported a loss that expanded from 56.2 million USD in 2022 to 92.2 million USD in 2024 [11]. Research and Development - Over the past three years, Mirxes has invested more than 60 million USD in R&D, holding 22 granted patents and 68 pending patent applications [12]. - The company has a cash reserve of over 5 million USD as of the end of 2024, bolstered by approximately 888 million HKD raised from its IPO [12]. Investment and Shareholding - The company has attracted significant investment, including a D round financing of 50 million USD, with notable investors such as Sun Tongyu, who holds a 22.03% stake, making him the largest shareholder [17][14]. - Other key shareholders include the founders and various venture capital firms, reflecting strong institutional support [17][14]. Market Position and Future Prospects - Mirxes aims to launch GASTROClear™ in China by the first half of 2025, expanding its market reach [10]. - The company has established a reputation in the miRNA field and is positioned for growth in the Asia-Pacific region [8][10].