<p>, /PRNewswire/ -- 沛嘉医疗 (9996.HK)，一家在快速增长的经导管瓣膜治疗和神经血管介入市场中领先的中国本土公司，宣布其 TaurusTrio 经导管主动脉瓣 (TAV) 系统于 2025 年 12 月 11 日获得中国国家药品监督管理局 (NMPA) 的批准。</p>
<p>TaurusTrio TAV 系统由沛嘉医疗开发和制造，基于 JenaValve Technology, Inc. (JenaValve) 的独家许可，用于其 Trilogy 经导管心脏瓣膜 (THV) 系统。该系统旨在通过股动脉途径治疗具有原发性症状性重度主动脉返流 (AR) 的患者。与主动脉狭窄患者不同，AR 患者通常没有钙化供 TAV 锚定，导致 AR 患者的治疗选择有限。TaurusTrio 系统结合了 JenaValve 的专有定位技术，即使在缺乏钙化的情况下，也能通过与原发性主动脉瓣膜的接触实现稳定锚定，同时确保瓣膜对接的对齐。</p>
<p>TaurusTrio ALTER-AR 研究的一年临床结果显示，技术成功率为 99.1%，30 天内全因死亡率为 0%，一年内仅为 2.6%。患者的心脏功能显著改善，91.7% 的患者在六个月内恢复到 NYHA I/II 级。中度或更严重的瓣周漏发生率在一年内为 0%，左心室舒张末期容积 (LVEDV) 和左心室质量 (LVM) 等指标显示出显著的逆重塑，验证了该设备的长期安全性和有效性。</p>
<p>沛嘉医疗董事长兼首席执行官张毅博士表示：“历史上，许多重度纯 AR 且不适合手术的患者缺乏理想的介入治疗，造成了显著的临床需求未得到满足。通过积极引入 JenaValve 独特的定位技术，我们直接解决了 ‘不稳定锚定’ 的核心挑战。这为医生提供了一个重要的新工具，并最终为患者提供了一个专门的、期待已久的解决方案，将 AR 治疗果断推向一个新阶段。此次批准也体现了我们商业化前沿技术和建立本地创新生态系统的战略，反映了全球专业知识与中国执行力的深度融合。”</p>
<p>JenaValve 首席执行官 John Kilcoyne 评论道：“见证 TaurusTrio 获得 NMPA 批准是一件非常高兴的事情，这验证了多年来为将该系统引入中国所投入的非凡努力。作为 AR 领域领先的经导管瓣膜，TaurusTrio 为数百万之前几乎没有可行选择的患者带来了新的希望。这一成就重申了我们与沛嘉医疗的共同目标：确保 AR 患者这一长期被忽视的群体，最终获得他们所需和应得的治疗。代表整个 JenaValve 团队，我想对沛嘉中国团队表示诚挚的感谢。让我们共同继续推进改善患者生活的共同使命。”</p>
<p>JenaValve 的 Trilogy THV 系统于 2021 年 5 月获得 CE 标志批准，并已在超过 1000 个商业程序中使用。来自 ALIGN-AR 关键试验的 700 名高风险症状性重度 AR 患者的扩展队列结果已在《柳叶刀》上发表，并于上个月在 PCR London Valves 会议上展示。</p>
<p>TaurusTrio 的批准是沛嘉医疗的重要里程碑，反映了其对结构性心脏病创新的承诺、对知识产权的尊重以及解决临床需求的决心。这一成就也标志着中国介入治疗领域的关键技术突破。作为专门针对 AR 的设备，TaurusTrio 为患者提供了更长生存期和更好生活质量的前景。随着其更广泛的临床应用，中国的 AR 护理将进入精准、微创治疗的新时代——加强患者保护，体现国内医疗器械创新的协作模式。</p>
<p>关于公司</p>
<p>沛嘉医疗 (9996.HK) 成立于 2012 年，总部位于中国苏州。沛嘉医疗专注于中国快速增长的介入程序医疗器械市场，旨在成为全球知名的医疗器械平台，提供结构性心脏病和神经血管疾病的综合治疗解决方案。公司目前在中国注册了四个 TAVR 系统和近二十个神经介入设备，并有多个创新产品候选者处于不同开发阶段。有关沛嘉的更多信息，请访问 peijiamedical.com/about。</p>
<p>来源：沛嘉医疗</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjEyJk5ld3NJdGVtSWQ9Q040NTM3NyZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTIwNzMwUFJfTkVXU19VU1BSX19fX19DTjQ1Mzc3?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjEyJk5ld3NJdGVtSWQ9Q040NTM3NyZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTIwNzMwUFJfTkVXU19VU1BSX19fX19DTjQ1Mzc3"/></p>

沛嘉医疗-B

<p>沛嘉医疗已获得国家药品监督管理局（NMPA）批准，其 TaurusTrio 经导管主动脉瓣系统旨在治疗中国的重度主动脉返流。该系统采用 JenaValve 的定位技术，实现无钙稳定锚定。临床结果显示成功率高，心脏功能改善。此次批准标志着中国介入治疗领域的技术突破，为选择有限的患者带来了新的希望</p>

<p>, /PRNewswire/ -- Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its TaurusTrio Transcatheter Aortic Valve (TAV) system received approval from the National Medical Products Administration (NMPA) of China on December 11, 2025.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- 沛嘉医疗 (9996.HK)，一家在快速增长的经导管瓣膜治疗和神经血管介入市场中领先的中国本土公司，宣布其 TaurusTrio 经导管主动脉瓣 (TAV) 系统于 2025 年 12 月 11 日获得中国国家药品监督管理局 (NMPA) 的批准。</p>
</div><p>The TaurusTrio TAV system is developed and manufactured by Peijia Medical under an exclusive license from JenaValve Technology, Inc. (JenaValve) for its Trilogy Transcatheter Heart Valve (THV) System. It is designed to treat patients with native symptomatic severe aortic regurgitation (AR) via transfemoral access. Unlike in patients with aortic stenosis, in patients with AR, there is often no calcification for the TAV to anchor onto, leaving AR patients with limited treatment options. The TaurusTrio system incorporates JenaValve's proprietary locator technology, which enables stable anchoring by engaging the native aortic leaflets even in the absence of calcium, while ensuring commissural alignment.</p>
<div class="lb-trans"><p>TaurusTrio TAV 系统由沛嘉医疗开发和制造，基于 JenaValve Technology, Inc. (JenaValve) 的独家许可，用于其 Trilogy 经导管心脏瓣膜 (THV) 系统。该系统旨在通过股动脉途径治疗具有原发性症状性重度主动脉返流 (AR) 的患者。与主动脉狭窄患者不同，AR 患者通常没有钙化供 TAV 锚定，导致 AR 患者的治疗选择有限。TaurusTrio 系统结合了 JenaValve 的专有定位技术，即使在缺乏钙化的情况下，也能通过与原发性主动脉瓣膜的接触实现稳定锚定，同时确保瓣膜对接的对齐。</p>
</div><p>The one-year clinical results from the TaurusTrio ALTER-AR study demonstrated a technical success rate of 99.1%, with 0% all-cause mortality at 30 days and only 2.6% at one year. Patients showed significant cardiac function improvement, with 91.7% recovering to NYHA class I/II at six months. The incidence of moderate or greater paravalvular leak was 0% at one year, and indicators such as LVEDV and LVM showed significant reverse remodeling, validating the device's long-term safety and efficacy.</p>
<div class="lb-trans"><p>TaurusTrio ALTER-AR 研究的一年临床结果显示，技术成功率为 99.1%，30 天内全因死亡率为 0%，一年内仅为 2.6%。患者的心脏功能显著改善，91.7% 的患者在六个月内恢复到 NYHA I/II 级。中度或更严重的瓣周漏发生率在一年内为 0%，左心室舒张末期容积 (LVEDV) 和左心室质量 (LVM) 等指标显示出显著的逆重塑，验证了该设备的长期安全性和有效性。</p>
</div><p>&#34;Historically, many patients with severe, pure AR who are ineligible for surgery have lacked an ideal interventional treatment—leaving a significant unmet clinical need,&#34; said Dr. Yi Zhang, Chairman and CEO of Peijia Medical. &#34;By proactively introducing JenaValve's unique locator technology, we directly tackled the core challenge of 'unstable anchoring'. This gives physicians a vital new tool and finally offers patients a dedicated, long-awaited solution, moving AR treatment decisively into a new phase. The approval also exemplifies our strategy to commercialize cutting-edge technologies and build a local innovation ecosystem, reflecting the deep integration of global expertise and Chinese execution.&#34;</p>
<div class="lb-trans"><p>沛嘉医疗董事长兼首席执行官张毅博士表示：“历史上，许多重度纯 AR 且不适合手术的患者缺乏理想的介入治疗，造成了显著的临床需求未得到满足。通过积极引入 JenaValve 独特的定位技术，我们直接解决了 ‘不稳定锚定’ 的核心挑战。这为医生提供了一个重要的新工具，并最终为患者提供了一个专门的、期待已久的解决方案，将 AR 治疗果断推向一个新阶段。此次批准也体现了我们商业化前沿技术和建立本地创新生态系统的战略，反映了全球专业知识与中国执行力的深度融合。”</p>
</div><p>John Kilcoyne, CEO of JenaValve, commented: &#34;It is a great pleasure to witness the NMPA approval of TaurusTrio, which validates the extraordinary effort invested over the years to introduce this system to China. As the leading transcatheter valve for AR, TaurusTrio provides new hope to millions of patients who previously had few viable options. This achievement reaffirms our shared goal with Peijia Medical: to ensure that patients with AR, a long-underserved community, finally receive the treatment they need and deserve. On behalf of the entire JenaValve team, I would like to extend our sincere appreciation to the Peijia China team. Together, let us continue to advance our shared mission of improving patients' lives.&#34;</p>
<div class="lb-trans"><p>JenaValve 首席执行官 John Kilcoyne 评论道：“见证 TaurusTrio 获得 NMPA 批准是一件非常高兴的事情，这验证了多年来为将该系统引入中国所投入的非凡努力。作为 AR 领域领先的经导管瓣膜，TaurusTrio 为数百万之前几乎没有可行选择的患者带来了新的希望。这一成就重申了我们与沛嘉医疗的共同目标：确保 AR 患者这一长期被忽视的群体，最终获得他们所需和应得的治疗。代表整个 JenaValve 团队，我想对沛嘉中国团队表示诚挚的感谢。让我们共同继续推进改善患者生活的共同使命。”</p>
</div><p>JenaValve's Trilogy THV System received CE Mark approval in May 2021 and has been used in over 1,000 commercial procedures. Results from an expanded cohort of 700 patients from the ALIGN-AR pivotal trial for the Trilogy THV System in high-risk patients with symptomatic, severe AR were published in <em>The Lancet</em> and presented at PCR London Valves last month.</p>
<div class="lb-trans"><p>JenaValve 的 Trilogy THV 系统于 2021 年 5 月获得 CE 标志批准，并已在超过 1000 个商业程序中使用。来自 ALIGN-AR 关键试验的 700 名高风险症状性重度 AR 患者的扩展队列结果已在《柳叶刀》上发表，并于上个月在 PCR London Valves 会议上展示。</p>
</div><p>The approval of TaurusTrio is a major milestone for Peijia Medical, reflecting its dedication to structural heart disease innovation, respect for intellectual property, and commitment to addressing clinical needs. This achievement also signifies a key technological breakthrough in China's interventional treatment landscape. As a dedicated device for AR, TaurusTrio offers patients the prospect of longer survival and a better quality of life. With its wider clinical adoption, AR care in China will enter an era of precision, minimally invasive therapy—strengthening patient protection and exemplifying a collaborative model for domestic medical device innovation.</p>
<div class="lb-trans"><p>TaurusTrio 的批准是沛嘉医疗的重要里程碑，反映了其对结构性心脏病创新的承诺、对知识产权的尊重以及解决临床需求的决心。这一成就也标志着中国介入治疗领域的关键技术突破。作为专门针对 AR 的设备，TaurusTrio 为患者提供了更长生存期和更好生活质量的前景。随着其更广泛的临床应用，中国的 AR 护理将进入精准、微创治疗的新时代——加强患者保护，体现国内医疗器械创新的协作模式。</p>
</div><p>About the Company</p>
<div class="lb-trans"><p>关于公司</p>
</div><p>Peijia Medical (9996.HK) was established in 2012 and is headquartered in Suzhou, China. Peijia Medical focuses on the high-growth interventional procedural medical device market in China and aims to become a world-renowned medical device platform that provides comprehensive treatment solutions for structural heart and neurovascular diseases. The Company now has four TAVR systems and near twenty neurointerventional devices registered in China and various innovative product candidates at different stage of development. For more information about Peijia visit peijiamedical.com/about.</p>
<div class="lb-trans"><p>沛嘉医疗 (9996.HK) 成立于 2012 年，总部位于中国苏州。沛嘉医疗专注于中国快速增长的介入程序医疗器械市场，旨在成为全球知名的医疗器械平台，提供结构性心脏病和神经血管疾病的综合治疗解决方案。公司目前在中国注册了四个 TAVR 系统和近二十个神经介入设备，并有多个创新产品候选者处于不同开发阶段。有关沛嘉的更多信息，请访问 peijiamedical.com/about。</p>
</div><p>SOURCE Peijia Medical</p>
<div class="lb-trans"><p>来源：沛嘉医疗</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjEyJk5ld3NJdGVtSWQ9Q040NTM3NyZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTIwNzMwUFJfTkVXU19VU1BSX19fX19DTjQ1Mzc3" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN45377&amp;Transmission_Id=202512120730PR_NEWS_USPR_____CN45377&amp;DateId=20251212"/></p>

07:30 ET
			
			
				Peijia Medical Receives NMPA Approval for TaurusTrio Transcatheter Aortic Valve System, Pioneering Treatment for Aortic Regurgitation in China

沛嘉医疗-B 的 TaurusTrio 经导管主动脉瓣系统获得 NMPA 批准，成为中国主动脉瓣反流治疗的开创性疗法