<ul>
<li><em>心脏病</em> <em>在狗的生命周期中影响约 10% 的狗 1</em></li>
<li><em>来自勃林格殷格翰的 VETMEDIN® (匹莫贝恩) 是唯一被批准用于治疗狗的前临床二尖瓣疾病的药物</em></li>
<li><em>FDA 的授权扩大了 VETMEDIN®在患有心脏病的狗中的使用范围，这是对条件批准的扩展</em></li>
</ul>
<p>, /PRNewswire/ -- 勃林格殷格翰，全球动物健康领域的领导者，今天宣布美国食品药品监督管理局（FDA）已批准 VETMEDIN (匹莫贝恩) 咀嚼片和 VETMEDIN 溶液（匹莫贝恩口服溶液），用于延缓患有 B2 期前临床粘液性二尖瓣疾病（MMVD）狗的充血性心力衰竭（CHF）发作。VETMEDIN 是唯一被批准用于治疗狗的前临床心脏病并延长其无症状生活的药物。</p>
<p>心脏病在狗中很常见，约有 10% 的狗在其生命周期中受到影响。1 受到粘液性二尖瓣疾病（MMVD）或扩张型心肌病（DCM）影响的狗可能会进展为 CHF，心脏无法有效地将血液泵送到全身。</p>
<p>“心脏病在狗身上通常在症状可见之前就已存在，因此能够在疾病进展到 CHF 之前，早期用 VETMEDIN 治疗狗是极其重要的，这将有助于提高狗的生存时间和生活质量，” 勃林格殷格翰美国宠物部门负责人 Daniel Watkins 解释道。“VETMEDIN 已经帮助狗治疗心脏病超过 25 年，我们很高兴这一全面的额外批准将使我们能够改善更多狗的生活。”</p>
<p>该批准是对 2022 年 FDA 条件批准的扩展，标志着首次 FDA 对最初条件批准的动物药物适应症的全面批准。全面批准基于两项多中心研究。在 EPIC 研究中，VETMEDIN 使 B2 期前临床 MMVD 狗的 CHF 或心脏相关死亡的发作延迟了 15.6 个月，相较于对照组。2 在第二项研究中，79% 的 B2 期前临床 MMVD 狗在一年内成功接受 VETMEDIN 治疗而未发展为 CHF。</p>
<p>该批准为 VETMEDIN 标签中已包含的适应症增加了额外的适应症——管理因临床 MMVD 或 DCM 导致的轻度、中度或重度充血性心力衰竭的症状，适用于与充血性心力衰竭的联合治疗（例如，呋塞米等），具体情况具体分析。研究表明，VETMEDIN 可以帮助改善因 MMVD 或 DCM 导致的 CHF 狗的生存时间和生活质量。3-5</p>
<p>VETMEDIN 是勃林格殷格翰 Vetmedica GmbH 的注册商标，使用时需获得许可。</p>
<p><strong>重要安全信息：</strong></p>
<p>尚未确定 VETMEDIN® (匹莫贝恩) 咀嚼片和 VETMEDIN® 溶液（匹莫贝恩口服溶液）在因 MMVD 以外的病因引起的无症状心脏病狗或因 MMVD 或 DCM 以外的病因引起的 CHF 中的安全性。在现场研究中报告的最常见非心脏不良反应包括食欲不振、嗜睡、腹泻、呼吸困难、呕吐、肌肉骨骼疼痛和共济失调。有关完整的处方信息，请参见包装说明或访问 www.VETMEDINclinic.com。</p>
<p><strong>关于勃林格殷格翰 – 动物健康业务</strong></p>
<p>勃林格殷格翰为预防和治疗动物疾病提供创新。该公司为兽医、动物主人、农民和政府提供广泛的疫苗、寄生虫控制产品和宠物、马匹及牲畜的药物。作为动物健康领域的领导者，勃林格殷格翰重视人类和动物健康的深度联系，并努力为人类、动物和社会带来改变。了解更多信息，请访问 www.boehringer-ingelheim.com/animal-health。</p>
<p><strong>关于勃林格殷格翰</strong></p>
<p>勃林格殷格翰是一家活跃于人类和动物健康领域的生物制药公司。作为行业内在研发方面的顶级投资者之一，该公司专注于开发能够改善和延长高未满足医疗需求领域生命的创新疗法。自 1885 年成立以来，勃林格始终保持独立，采取长期视角，将可持续性融入整个价值链。我们约 54,500 名员工为 130 多个市场服务，以建设一个更健康、更可持续的未来。了解更多信息，请访问 www.boehringer-ingelheim.com。</p>
<p><strong>参考文献：</strong></p>
<p>1 Keene, Bruce W 等人。“ACVIM 共识指南：狗的粘液性二尖瓣疾病的诊断和治疗。” <em>兽医内科学杂志</em> 第 33 卷，第 3 期（2019）：1127-1140。doi:10.1111/jvim.15488。</p>
<p>2 Boswood A, Häggström J, Gordon SG 等。匹莫贝恩对患有前临床粘液性二尖瓣疾病和心脏扩大狗的影响：EPIC 研究 - 一项随机临床试验。J Vet Intern Med. 2016 年 11 月；30(6):1765-1779。doi: 10.1111/jvim.14586。Epub2016 年 9 月 28 日。</p>
<p>3 Haggstrom J 等，匹莫贝恩或贝那普利对因自然发生的粘液性二尖瓣疾病导致的充血性心力衰竭狗的生存时间的影响：QUEST 研究，J Vet Intern Med. 2008；22(5): 1124-1135。</p>
<p>4 Lombard, Christophe W 等。“匹莫贝恩与贝那普利治疗狗获得性房室瓣疾病的临床疗效。” <em>美国动物医院协会杂志</em> 第 42 卷，第 4 期（2006）：249-261。doi:10.5326/0420249。</p>
<p>5 Luis Fuentes V 等，匹莫贝恩在扩张型心肌病狗中的双盲、随机、安慰剂对照研究。J Vet Intern Med. 2002；16: 255-261。</p>
<p>来源：勃林格殷格翰动物健康美国公司。</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMTE5Jk5ld3NJdGVtSWQ9Q0w2NjI2MCZUcmFuc21pc3Npb25fSWQ9MjAyNjAxMTkxNjEwUFJfTkVXU19VU1BSX19fX19DTDY2MjYw?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-RGF0ZUlkPTIwMjYwMTE5Jk5ld3NJdGVtSWQ9Q0w2NjI2MCZUcmFuc21pc3Npb25fSWQ9MjAyNjAxMTkxNjEwUFJfTkVXU19VU1BSX19fX19DTDY2MjYw"/></p>

纳斯达克生物科技指数 ETF - iShares Nasdaq

动态生物技术与基因组 ETF - Invesco

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<p>博瑞医药宣布，FDA 已批准 VETMEDIN（匹莫贝恩）用于延缓患有 B2 期前临床黏液性二尖瓣病的犬只充血性心力衰竭的发生。此次批准是在 2022 年条件性批准的基础上扩展而来，基于研究表明 VETMEDIN 可以显著延长受影响犬只的无症状生活时间。该药物已使用超过 25 年，旨在改善心脏病犬只的生活质量。安全信息显示可能存在不良反应，该药物尚未确立用于其他心脏病原因</p>

<ul>
<li><em>Heart disease</em> <em>affects approximately 10 percent of dogs in their lifetime1</em></li>
<li><em>VETMEDIN® (pimobendan) from Boehringer Ingelheim is the only medication approved to treat preclinical mitral valve disease in dogs</em></li>
<li><em>An expansion of a conditional approval, the FDA authorization broadens the use of VETMEDIN® in dogs with heart disease</em></li>
</ul>
<div class="lb-trans"><ul>
<li><em>心脏病</em> <em>在狗的生命周期中影响约 10% 的狗 1</em></li>
<li><em>来自勃林格殷格翰的 VETMEDIN® (匹莫贝恩) 是唯一被批准用于治疗狗的前临床二尖瓣疾病的药物</em></li>
<li><em>FDA 的授权扩大了 VETMEDIN®在患有心脏病的狗中的使用范围，这是对条件批准的扩展</em></li>
</ul>
</div><p>, /PRNewswire/ -- Boehringer Ingelheim, a global leader in animal health, today announced that the U.S. Food and Drug Administration (FDA) has approved VETMEDIN (pimobendan) Chewable Tablets and VETMEDIN Solution (pimobendan oral solution), for the delay of onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). VETMEDIN is the only medication approved to treat preclinical heart disease in dogs and extend their symptom-free life.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- 勃林格殷格翰，全球动物健康领域的领导者，今天宣布美国食品药品监督管理局（FDA）已批准 VETMEDIN (匹莫贝恩) 咀嚼片和 VETMEDIN 溶液（匹莫贝恩口服溶液），用于延缓患有 B2 期前临床粘液性二尖瓣疾病（MMVD）狗的充血性心力衰竭（CHF）发作。VETMEDIN 是唯一被批准用于治疗狗的前临床心脏病并延长其无症状生活的药物。</p>
</div><p>Heart disease is common in dogs, affecting approximately 10 percent of dogs in their lifetime.1 Dogs that are affected by myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM) may progress to CHF, with the heart unable to effectively pump blood throughout the body.</p>
<div class="lb-trans"><p>心脏病在狗中很常见，约有 10% 的狗在其生命周期中受到影响。1 受到粘液性二尖瓣疾病（MMVD）或扩张型心肌病（DCM）影响的狗可能会进展为 CHF，心脏无法有效地将血液泵送到全身。</p>
</div><p>&#34;Heart disease is most often present in dogs long before symptoms are visible, so the ability to treat dogs with VETMEDIN early, before the disease progresses to CHF, is incredibly significant and will help increase the survival time and quality of life in dogs,&#34; explained Daniel Watkins, Head of U.S. Pet at Boehringer Ingelheim. &#34;VETMEDIN has been helping dogs with heart disease for more than 25 years, and we are thrilled that this full additional approval will allow us to improve the lives of more dogs.&#34;</p>
<div class="lb-trans"><p>“心脏病在狗身上通常在症状可见之前就已存在，因此能够在疾病进展到 CHF 之前，早期用 VETMEDIN 治疗狗是极其重要的，这将有助于提高狗的生存时间和生活质量，” 勃林格殷格翰美国宠物部门负责人 Daniel Watkins 解释道。“VETMEDIN 已经帮助狗治疗心脏病超过 25 年，我们很高兴这一全面的额外批准将使我们能够改善更多狗的生活。”</p>
</div><p>The approval is an expansion of an FDA conditional approval in 2022 for this indication and marks the first FDA full approval of an animal drug indication that was initially conditionally approved. The full approval was based on two multi-site studies. In the EPIC study, VETMEDIN delayed the onset of CHF or cardiac-related death by 15.6 months in dogs with Stage B2 preclinical MMVD, compared to the control arm.2 In a second study, 79% of dogs with Stage B2 preclinical MMVD were successfully treated with VETMEDIN for one year without developing CHF.</p>
<div class="lb-trans"><p>该批准是对 2022 年 FDA 条件批准的扩展，标志着首次 FDA 对最初条件批准的动物药物适应症的全面批准。全面批准基于两项多中心研究。在 EPIC 研究中，VETMEDIN 使 B2 期前临床 MMVD 狗的 CHF 或心脏相关死亡的发作延迟了 15.6 个月，相较于对照组。2 在第二项研究中，79% 的 B2 期前临床 MMVD 狗在一年内成功接受 VETMEDIN 治疗而未发展为 CHF。</p>
</div><p>The approval adds an additional indication to those already included in the VETMEDIN label – the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical MMVD or DCM, for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. Studies have shown that VETMEDIN can help improve the survival time and quality of life for dogs with CHF due to MMVD or DCM.3-5</p>
<div class="lb-trans"><p>该批准为 VETMEDIN 标签中已包含的适应症增加了额外的适应症——管理因临床 MMVD 或 DCM 导致的轻度、中度或重度充血性心力衰竭的症状，适用于与充血性心力衰竭的联合治疗（例如，呋塞米等），具体情况具体分析。研究表明，VETMEDIN 可以帮助改善因 MMVD 或 DCM 导致的 CHF 狗的生存时间和生活质量。3-5</p>
</div><p>VETMEDIN is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.</p>
<div class="lb-trans"><p>VETMEDIN 是勃林格殷格翰 Vetmedica GmbH 的注册商标，使用时需获得许可。</p>
</div><p><strong>IMPORTANT SAFETY INFORMATION:</strong></p>
<div class="lb-trans"><p><strong>重要安全信息：</strong></p>
</div><p>The safety of VETMEDIN® (pimobendan) Chewable Tablets and VETMEDIN® Solution (pimobendan oral solution) has not been established in dogs with asymptomatic heart disease caused by etiologies other than MMVD or in CHF caused by etiologies other than MMVD or DCM. The most common non-cardiac adverse reactions reported in field studies, were poor appetite, lethargy, diarrhea, dyspnea, vomiting, musculoskeletal pain, and ataxia. For full prescribing information see package insert or visit www.VETMEDINclinic.com.</p>
<div class="lb-trans"><p>尚未确定 VETMEDIN® (匹莫贝恩) 咀嚼片和 VETMEDIN® 溶液（匹莫贝恩口服溶液）在因 MMVD 以外的病因引起的无症状心脏病狗或因 MMVD 或 DCM 以外的病因引起的 CHF 中的安全性。在现场研究中报告的最常见非心脏不良反应包括食欲不振、嗜睡、腹泻、呼吸困难、呕吐、肌肉骨骼疼痛和共济失调。有关完整的处方信息，请参见包装说明或访问 www.VETMEDINclinic.com。</p>
</div><p><strong>About Boehringer Ingelheim – Animal Health business</strong></p>
<div class="lb-trans"><p><strong>关于勃林格殷格翰 – 动物健康业务</strong></p>
</div><p>Boehringer Ingelheim provides innovation for preventing and treating diseases in animals. The company offers a wide range of vaccines, parasite-control products, and medicines for pets, horses, and livestock to veterinarians, animal owners, farmers, and governments. As a leader in animal health, Boehringer Ingelheim values that the health of humans and animals is deeply connected and strives to make a difference for people, animals, and society. Learn more at www.boehringer-ingelheim.com/animal-health.</p>
<div class="lb-trans"><p>勃林格殷格翰为预防和治疗动物疾病提供创新。该公司为兽医、动物主人、农民和政府提供广泛的疫苗、寄生虫控制产品和宠物、马匹及牲畜的药物。作为动物健康领域的领导者，勃林格殷格翰重视人类和动物健康的深度联系，并努力为人类、动物和社会带来改变。了解更多信息，请访问 www.boehringer-ingelheim.com/animal-health。</p>
</div><p><strong>About Boehringer Ingelheim</strong></p>
<div class="lb-trans"><p><strong>关于勃林格殷格翰</strong></p>
</div><p>Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.</p>
<div class="lb-trans"><p>勃林格殷格翰是一家活跃于人类和动物健康领域的生物制药公司。作为行业内在研发方面的顶级投资者之一，该公司专注于开发能够改善和延长高未满足医疗需求领域生命的创新疗法。自 1885 年成立以来，勃林格始终保持独立，采取长期视角，将可持续性融入整个价值链。我们约 54,500 名员工为 130 多个市场服务，以建设一个更健康、更可持续的未来。了解更多信息，请访问 www.boehringer-ingelheim.com。</p>
</div><p><strong>References:</strong></p>
<div class="lb-trans"><p><strong>参考文献：</strong></p>
</div><p>1  Keene, Bruce W et al. &#34;ACVIM consensus guidelines for the diagnosis and treatment of myxomatous mitral valve disease in dogs.&#34; <em>Journal of Veterinary Internal Medicine</em> vol. 33,3 (2019): 1127-1140. doi:10.1111/jvim.15488.</p>
<div class="lb-trans"><p>1 Keene, Bruce W 等人。“ACVIM 共识指南：狗的粘液性二尖瓣疾病的诊断和治疗。” <em>兽医内科学杂志</em> 第 33 卷，第 3 期（2019）：1127-1140。doi:10.1111/jvim.15488。</p>
</div><p>2 Boswood A, Häggström J, Gordon SG, et al. Effect of Pimobendan in Dogs with Preclinical Myxomatous Mitral Valve Disease and Cardiomegaly: The EPIC Study-A Randomized Clinical Trial. J Vet Intern Med. 2016 Nov;30(6):1765-1779. doi: 10.1111/jvim.14586. Epub 2016 Sep 28.</p>
<div class="lb-trans"><p>2 Boswood A, Häggström J, Gordon SG 等。匹莫贝恩对患有前临床粘液性二尖瓣疾病和心脏扩大狗的影响：EPIC 研究 - 一项随机临床试验。J Vet Intern Med. 2016 年 11 月；30(6):1765-1779。doi: 10.1111/jvim.14586。Epub2016 年 9 月 28 日。</p>
</div><p>3 Haggstrom J et al , Effect of pimobendan or benazepril hydrochloride on survival times in dogs with congestive heart failure caused by naturally occurring myxomatous mitral valve disease: the QUEST Study, J Vet Intern Med. 2008; 22(5): 1124-1135.</p>
<div class="lb-trans"><p>3 Haggstrom J 等，匹莫贝恩或贝那普利对因自然发生的粘液性二尖瓣疾病导致的充血性心力衰竭狗的生存时间的影响：QUEST 研究，J Vet Intern Med. 2008；22(5): 1124-1135。</p>
</div><p>4 Lombard, Christophe W et al. &#34;Clinical efficacy of pimobendan versus benazepril for the treatment of acquired atrioventricular valvular disease in dogs.&#34; <em>Journal of the American Animal Hospital Association</em> vol. 42,4 (2006): 249-61. doi:10.5326/0420249.</p>
<div class="lb-trans"><p>4 Lombard, Christophe W 等。“匹莫贝恩与贝那普利治疗狗获得性房室瓣疾病的临床疗效。” <em>美国动物医院协会杂志</em> 第 42 卷，第 4 期（2006）：249-261。doi:10.5326/0420249。</p>
</div><p>5 Luis Fuentes V et al, A Double-blind, Randomized, Placebo-Controlled Study of Pimobendan in Dogs with Dilated Cardiomyopathy J Vet Intern Med. 2002;16: 255-261.</p>
<div class="lb-trans"><p>5 Luis Fuentes V 等，匹莫贝恩在扩张型心肌病狗中的双盲、随机、安慰剂对照研究。J Vet Intern Med. 2002；16: 255-261。</p>
</div><p>SOURCE Boehringer Ingelheim Animal Health USA Inc.</p>
<div class="lb-trans"><p>来源：勃林格殷格翰动物健康美国公司。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMTE5Jk5ld3NJdGVtSWQ9Q0w2NjI2MCZUcmFuc21pc3Npb25fSWQ9MjAyNjAxMTkxNjEwUFJfTkVXU19VU1BSX19fX19DTDY2MjYw" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CL66260&amp;Transmission_Id=202601191610PR_NEWS_USPR_____CL66260&amp;DateId=20260119"/></p>

FDA 批准了首个用于延缓犬充血性心力衰竭发作的药物