获批上市！全球首款椎动脉药物涂层球囊

Core Viewpoint - The approval of AcoArt Verbena® marks a significant breakthrough in the treatment of vertebral artery stenosis, ushering in a new era of "intervention without implantation" [2][4]. Group 1: "Intervention Without Implantation" Concept - The "intervention without implantation" concept aims to restore the health of blood vessels while avoiding the long-term issues associated with permanent implants, such as in-stent restenosis and chronic inflammation [4]. - This approach addresses the limitations of traditional metal stents, which can lead to complications over time [4]. Group 2: AcoArt Verbena® Overview - AcoArt Verbena® is the world's first drug-coated balloon (DCB) specifically designed for vertebral artery origin stenosis (VAOS), suitable for patients with ≥70% stenosis and ineffective drug therapy [9][10]. - The product utilizes advanced drug coating technology with magnesium stearate as a carrier for paclitaxel, enhancing drug stability and delivery efficiency [10]. Group 3: Clinical Trial Results - AcoArt Verbena® demonstrated a significant reduction in target lesion restenosis rates, with the trial group showing a 12-month restenosis rate of 13.04% compared to 37.31% in the control group, a decrease of 67% [16][13]. - The product avoids serious adverse events related to devices, mitigating risks associated with long-term metal stent implantation [16]. Group 4: Market Landscape and Competitive Position - The global peripheral DCB market was valued at 4.91 billion yuan in 2023, with a projected compound annual growth rate (CAGR) of 14.1%, reaching 12.28 billion yuan by 2030 [15]. - Xianruida holds an 86.9% market share in China's peripheral DCB market, indicating a strong competitive position [15]. - The collaboration with Boston Scientific is expected to enhance market penetration and revenue growth, with potential sales exceeding 1.2 billion yuan in the next three years [18][19]. Group 5: Company Background - Xianruida, founded in 2008 and listed on the Hong Kong Stock Exchange in 2021, focuses on innovative medical technologies in vascular intervention [20][21]. - The company has developed a diverse product pipeline, including several DCB products and other interventional devices, addressing unmet clinical needs across various medical fields [21].