Core Viewpoint - MIRXES-B has completed the enrollment process for the CADENCE CRC study, a large-scale prospective clinical trial aimed at validating the effectiveness of its blood test for colorectal cancer screening in average and high-risk adult populations [1][4]. Group 1: Study Overview - CADENCE CRC is the largest registration study in Southeast Asia to evaluate blood-based colorectal cancer screening tests, recruiting over 6,000 participants from diverse ethnic backgrounds [1][2]. - The study is designed as a prospective validation research to support regulatory approval and clinical adoption of the blood test, with participants undergoing standard colonoscopy as a reference method [1][2]. - Enrollment began in 2023, with a target of 6,000 participants to be reached by early 2026, marking a key milestone for the company [1]. Group 2: Blood Test Technology - The blood test evaluated in CADENCE CRC is driven by the company's proprietary miRNA-centered multi-omics platform, integrating tumor-derived signals, non-tumor host response signals, and AI-driven machine learning algorithms [2]. - Previous studies have shown that the test has a sensitivity of over 80% and a specificity of approximately 90% for detecting early-stage colorectal cancer [2]. Group 3: Market Potential - The proposed laboratory-developed test (LDT) will leverage the company's existing laboratory infrastructure and clinical network in Southeast Asia, aiming for early market access while pursuing broader regulatory approvals [3]. - Colorectal cancer remains a leading cause of cancer-related deaths in Asia, with an estimated 140 to 170 million adults aged 45 to 74 in Southeast Asia recommended for screening [3]. - Despite the large high-risk population, screening participation rates remain low, presenting significant medical opportunities, with the potential market for screening tests in Southeast Asia estimated to reach billions annually [3]. Group 4: Strategic Importance - The completion of the CADENCE CRC enrollment process marks an important step for the company in advancing early detection of the five most common and deadly cancers in Asia [4]. - The study reflects the company's commitment to providing rigorous clinical evidence for blood-based colorectal cancer screening 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，並明確表示不會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。 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 完成CADENCE CRC的入組程序 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。 完成CADENCE CRC的入組程序 本 公 司 董 事（「董 事」）會（「董事會」）宣 佈，本 公 司 已 完 成CADENCE (CAncer Detected Early caN be CurEd) CRC的入組程序，CADENCE CRC是一項大型前瞻性 臨床研究，旨在驗證其血液檢測於平均風險及高風險成人群體中篩查結直腸 癌（「結直腸癌」）的有效性。 – 1 – CADENCE CRC中評估的血液檢測由本公司專 ...