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远大医药(00512)aXess展现全球领先革命性潜力 全球创新布局加速“Go Global”战略推进
智通财经网· 2025-10-11 08:24
Core Insights - Recent clinical achievements in the innovative pipeline of YuanDa Pharmaceutical (00512) enhance its competitive edge in the nuclear medicine oncology diagnosis and treatment sector, particularly with the completion of patient enrollment for the GPN00289 temperature-sensitive embolization agent [1] - The aXess product, a groundbreaking artificial blood vessel, has shown unprecedented safety and efficacy in key clinical trials, indicating a potential shift in treatment paradigms for end-stage renal disease (ESRD) patients [1][10] Group 1: Clinical Developments - The aXess product has successfully completed pivotal clinical trials in Europe, demonstrating superior patency rates and lower re-intervention rates compared to existing arteriovenous fistula (AVF) methods [9] - The clinical trial involved 120 patients, with only one case of infection-related removal of the artificial vessel, highlighting its high anti-infection performance [9] - aXess utilizes unique endogenous tissue repair technology, allowing for rapid integration with the patient's own tissue, which may significantly reduce complications associated with traditional dialysis access methods [10] Group 2: Market Context - Chronic kidney disease (CKD) poses a significant global health challenge, with approximately 850 million affected individuals, and ESRD cases expected to rise to nearly 14.61 million by 2030, reflecting a compound annual growth rate of about 4.5% [2] - In China, ESRD patients account for over 30% of the global total, with projections indicating that numbers will exceed 6.2 million by 2030 [2] Group 3: Product Synergy and Strategic Positioning - The aXess product is part of a broader strategy in YuanDa's cardiovascular precision intervention platform, which includes over 30 high-end medical device products, with 22 already approved for market in China [11][14] - The company aims to leverage the synergy between aXess and another innovative device, APERTO® OTW, to enhance dialysis access for patients [11] - YuanDa's commitment to innovation is reflected in its ongoing development of multiple products, with a focus on meeting clinical needs and expanding its international presence through strategic partnerships [15]