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 ...

Group 1: Financial Performance - In the first half of 2025, the company achieved revenue of $10.47 million, representing a year-on-year growth of 9.4% [1] - The gross profit for the same period was $7.1 million, up from $4.7 million in the previous year, marking a 51.1% increase [1] - The loss attributable to equity shareholders narrowed to $28.35 million from $44.45 million in 2024, indicating improved operational efficiency and cost control [1] Group 2: Business Segments - The growth in revenue was primarily driven by the early detection and precision multi-omics business, which saw a 50% increase in revenue to $10.47 million [1] - The gross profit for the early detection and precision multi-omics segment reached $7.1 million, reflecting a 102.9% year-on-year growth [1] - The sales gross margin improved from 49% to 67.6% due to high-margin product sales and effective cost management [1] Group 3: Product Development and Market Expansion - The company, founded in 2014, focuses on miRNA technology for disease screening solutions in key Asian markets, including Singapore and China [2] - The core product, GASTROClear, is a blood-based miRNA test for gastric cancer screening, which received regulatory approval in Singapore in May 2019 [2] - GASTROClear has been approved for sale in Singapore and Thailand, with LDT services launched in Japan, and a clinical trial registration completed in China [2] Group 4: Market Recognition - Mirxes was listed on the Hong Kong Stock Exchange on May 23, 2023, and was included in the Hang Seng Composite Index as of August 22, 2023 [3] - The inclusion in the index, just three months after its listing, reflects strong market recognition of the company's potential in early cancer detection technology [3]

Core Viewpoint - MIRXES-B (02629) has seen a significant increase in stock price, reaching a new high of 47.8 HKD, driven by a strategic partnership with PT DIASTIKA BIOTEKINDO for cancer diagnostics in Indonesia [1][2] Group 1: Partnership and Market Expansion - The company has signed a memorandum of understanding with PT DIASTIKA BIOTEKINDO to collaborate on molecular diagnostic testing and related instruments for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1][2] - This partnership allows the company to leverage PT DIASTIKA BIOTEKINDO's existing channels to enter the Indonesian market with blood-based microRNA or multi-omics cancer detection devices [2] - The collaboration aims to utilize local policies in Indonesia, such as tax incentives for local content, and regulatory flexibility under ASEAN medical device frameworks to facilitate market entry [2] Group 2: Regional and Global Strategy - Indonesia is positioned as a pilot region for the company's operations, with plans to replicate the business model in Southeast Asia, the Middle East, North Africa, and other regions that share similar cancer profiles and healthcare structures [2]

Core Viewpoint - MIRXES-B has seen a significant increase in stock price, reaching a new high following the announcement of a collaboration with PT DIASTIKA BIOTEKINDO for cancer diagnostics in Indonesia [1][2] Group 1: Company Developments - On August 15, MIRXES-B announced a memorandum of understanding with PT DIASTIKA BIOTEKINDO to collaborate on molecular diagnostic testing and related instruments for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1] - The memorandum is valid for 12 months from the date of signing [1] Group 2: Market Expansion Strategy - Through the partnership with PT DIASTIKA BIOTEKINDO, the company aims to enter the Indonesian market by deploying blood-based microRNA or multi-omics cancer detection devices for prevalent cancers such as gastric and lung cancer [2] - The collaboration will leverage local policies in Indonesia, such as tax incentives for local content, and regulatory flexibility under ASEAN-centered medical device frameworks [2] - Indonesia is viewed as a pilot region for expanding operations to Southeast Asia, the Middle East, North Africa, and other areas with similar cancer profiles and healthcare structures [2]

Group 1 - The company MiRXES-B (02629) has signed a memorandum of understanding with PT DIASTIKA BIOTEKINDO for collaboration in molecular diagnostic testing and related instruments for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1] - The memorandum is valid for 12 months from the date of signing [1] - The collaboration allows the company to leverage PT DIASTIKA BIOTEKINDO's existing channels to enter the Indonesian market with blood-based microRNA or multi-omics testing devices for high-incidence cancers such as gastric and lung cancer [1] Group 2 - The partnership enables the company to benefit from local policies in Indonesia, such as tax incentives for localization rates of 40% [1] - The collaboration aims to achieve regulatory flexibility under the ASEAN-centered medical device framework [1] - Indonesia is positioned as a pilot region for the company to replicate its business model in Southeast Asia, the Middle East, North Africa, and other regions with similar cancer profiles and healthcare structures [1]

Core Viewpoint - Company MiRXES-B has signed a memorandum of understanding with PT DIASTIKA BIOTEKINDO to collaborate on the registration and commercialization of molecular diagnostic tests for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1][2] Group 1: Collaboration Details - The memorandum is valid for 12 months and includes activities such as sales and distribution of new blood-based microRNA and multi-omics cancer early detection products in Indonesia [1] - The collaboration will involve joint development and clinical validation of projects for the registration of diagnostic devices, as well as training activities for Indonesian scientists and laboratory users [1] - The partnership will explore local manufacturing opportunities [1] Group 2: Market Potential and Strategy - PT DIASTIKA BIOTEKINDO operates a network of over 300 hospitals in Indonesia, providing immediate scale benefits for medical services, with 70% of these hospitals located in Java, serving 57% of the Indonesian population [2] - The collaboration allows the company to leverage existing distribution channels to enter the Indonesian market with blood-based cancer detection devices [2] - The partnership aims to utilize Indonesia's localization policies for tax incentives and regulatory flexibility, with plans to replicate the business model in Southeast Asia, the Middle East, North Africa, and other regions with similar cancer profiles and healthcare structures [2]

Core Viewpoint - MIRXES-B (02629) has seen a significant increase in stock price, reaching a new high of 40.66 HKD, which is over 70% higher than its IPO price of 23.3 HKD [1] Company Overview - Mirxes is a Singapore-based RNA biotechnology company focused on developing and commercializing precise, non-invasive, and affordable blood miRNA tests for early cancer and disease screening [1] - The flagship product, GASTROClear™/觅小卫™, is a blood miRNA-based molecular diagnostic kit for gastric cancer screening, approved in multiple countries including Singapore and the EU, and has received breakthrough medical device certification from the US FDA [1] - GASTROClear™ has completed a prospective clinical trial with a sample size of 9,472 in China and is currently in the registration application process [1] Market Position - The company is recognized as a global leader in the field of early cancer detection based on miRNA, possessing significant technological, product, and market advantages [1] - The global cancer screening market is noted to have vast potential with high entry barriers [1] - GASTROClear™ is the only approved molecular diagnostic IVD product for gastric cancer screening in the global market, holding the largest market share of 66.3% in the Southeast Asian miRNA-based liquid biopsy gastric cancer screening market as of 2023 [1]

Core Viewpoint - Mirxes-B (02629) has seen a significant increase in stock price, reaching a new high of 40.66 HKD, which is over 70% higher than its IPO price of 23.3 HKD [1] Company Overview - Mirxes is a Singapore-based RNA biotechnology company focused on developing and commercializing precise, non-invasive, and affordable blood miRNA tests for early cancer and disease screening [1] - The flagship product, GASTROClear, is a blood miRNA-based molecular diagnostic kit for gastric cancer screening, approved in multiple countries including Singapore and the EU, and has received breakthrough medical device certification from the FDA in the US [1] - GASTROClear has completed a prospective clinical trial with a sample size of 9,472 in China and is currently in the registration application process [1] Market Position - Guoyuan International believes that the company has significant technological, product, and market advantages in the field of miRNA-based early cancer detection, positioning it as one of the global leaders in this sector [1] - Everbright Securities International previously noted the vast market potential for global cancer screening, highlighting high industry entry barriers [1] - GASTROClear is the only approved molecular diagnostic IVD product for gastric cancer screening in the global market, holding the largest market share (66.3%) in the Southeast Asian miRNA-based liquid biopsy gastric cancer screening market as of 2023 [1]