<ul>
<li>Elanco 在预计价值 13 亿美元的美国犬类皮肤病市场中，在不到 18 个月内获得的第二个皮肤病产品批准</li>
<li>Befrena 已被证明对任何年龄的狗治疗犬类特应性皮炎和过敏性皮炎有效，治疗时间为 6 到 8 周，视需要而定</li>
<li>USDA 对 Befrena 的批准进一步强化了 Elanco 在每个关键治疗领域提供差异化、高质量产品的承诺，巩固了其在犬类皮肤病和单克隆抗体（mAbs）领域的领导地位</li>
<li>犬类过敏性和特应性皮炎是兽医普遍关注的问题，数据显示近 98% 的兽医表示他们经常治疗犬类特应性皮炎，而瘙痒的狗占他们患者群体的近 20%。</li>
</ul>
<p>, /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) 今天宣布其在快速增长的犬类皮肤病领域的最新进展，获得美国农业部（USDA）对 Befrena™（tirnovetmab）的批准，这是一种针对犬类过敏性和特应性皮炎的新型抗 IL31 单克隆抗体（mAb）注射剂。重要的是，Befrena 建议在治疗后每 6 到 8 周给药一次，这与当前市场竞争对手 lokivetmab 的 4 到 8 周给药间隔形成对比。</p>
<p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2309278/Elanco_Logo.jpg?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://mma.prnewswire.com/media/2309278/Elanco_Logo.jpg"/></p>
<p>USDA 对 Befrena 的批准进一步证明了 Elanco 在每个关键治疗领域提供差异化、高质量产品的承诺，特别是巩固了其在犬类皮肤病和单克隆抗体领域的领导地位。Elanco 预计将在 2026 年上半年推出 Befrena。</p>
<p>Befrena 的批准标志着 Elanco 在不到 18 个月内获得的第二个皮肤病产品批准，它与 Zenrelia™（ilunocitinib 片）一起，后者是一种有效、方便且安全的每日一次口服 JAK 抑制剂，用于控制至少 12 个月大犬只的皮肤过敏引起的瘙痒和炎症。今年 9 月，Elanco 宣布对美国 Zenrelia 标签进行了改进，食品药品监督管理局（FDA）得出结论称 “所有证据支持从标签中移除由改良活病毒疫苗引起的致命疫苗诱导疾病的风险”。</p>
<p>标签中的盒装警告继续建议在接种疫苗前至少 28 天至 3 个月停止使用 Zenrelia，并在接种疫苗后至少 28 天内暂停使用 Zenrelia。</p>
<p>&#34;动物健康领域越来越关注基于抗体的疗法，今天的批准是向前迈出的重要一步，旨在提供高影响力的创新，提升宠物的生活质量，&#34; Elanco 研发执行副总裁 Ellen de Brabander 博士表示。&#34;我们很高兴能为兽医和宠物主人提供 Befrena，它能为患有过敏性瘙痒的狗提供持久的缓解。&#34;</p>
<p>今年早些时候，Elanco 推出了《美国瘙痒狗报告》，这是首个强调瘙痒对狗、其主人和兽医影响的报告。该报告包括来自多项宠物主人和兽医的调查结果，揭示了全国各地的狗有多么渴望获得缓解和经济有效、持久的解决方案。根据报告，90% 的美国狗被其主人认为是 “瘙痒狗”，在一年中的某个时候经历过瘙痒症状。宠物主人通常在寻求兽医护理之前尝试多种家庭解决方案。宠物主人平均在非处方药物上花费约 400 美元，并在带宠物去看兽医之前等待六周。兽医表示，瘙痒狗的主人往往等待太久才带狗去看病，导致皮肤发炎和感染，同时也让希望狗能迅速得到缓解的主人感到烦恼。研究显示，近 70% 的兽医愿意储备另一种皮肤病产品，以帮助更多的狗找到瘙痒缓解。</p>
<p>&#34;兽医需要更多的瘙痒缓解选择，以便能够提供针对性疗法，专注于作用机制，以满足个体患者的独特需求，提供快速、有效和有价值的瘙痒缓解，&#34; 兽医皮肤科医生 Griffin 博士表示。&#34;USDA 对 Befrena 的批准使兽医更接近拥有另一种有益且安全的治疗选择。我很高兴能与 Elanco 合作，并计划在该产品上市时在我的诊所提供。&#34;</p>
<p>您可以在 www.befrenaforvets.com 了解更多关于 Befrena 的信息，并注册未来的新闻和网络研讨会。</p>
<p><strong>关于 ELANCO</strong> Elanco Animal Health Incorporated (NYSE: ELAN) 是一家全球领先的动物健康公司，致力于创新和提供产品与服务，以预防和治疗农场动物和宠物的疾病，为农民、宠物主人、兽医、利益相关者和整个社会创造价值。凭借 70 年的动物健康传统，我们致力于打破界限，超越自我，帮助客户改善他们所照顾动物的健康，同时对我们当地和全球社区产生积极影响。在 Elanco，我们的愿景是 “食物与陪伴丰富生活”，我们的使命是——为动物、客户、社会和我们的员工超越自我。了解更多信息，请访问 www.elanco.com。</p>
<p><strong>适应症</strong> Zenrelia 是一种处方药，用于控制 12 个月以上犬只的皮肤过敏引起的瘙痒和炎症。</p>
<p><strong>重要安全信息</strong></p>
<p><strong>在使用此药物之前，请阅读包装说明，包括盒装警告。</strong> 有关完整的处方信息，请咨询您的兽医，拨打 1 888 545 5973 或访问 <strong>www.elancolabels.com/us/zenrelia</strong>。</p>
<p><strong>警告：对疫苗的免疫反应不足。根据疫苗反应研究的结果，接受 Zenrelia 的狗面临疫苗免疫反应不足的风险。在接种疫苗前至少停用 Zenrelia 28 天至 3 个月，并在接种疫苗后至少停用 Zenrelia 28 天。</strong> 狗在开始使用 Zenrelia 前应确保疫苗接种是最新的。不得用于小于 12 个月的狗或有严重感染的狗。应监测狗的感染情况，因为 Zenrelia 可能增加感染的风险。在临床研究中观察到肿瘤性疾病（良性和恶性）。最常见的副作用包括呕吐、腹泻和疲劳。Zenrelia 尚未在用于繁殖的狗、怀孕或哺乳的狗中进行测试，也未与糖皮质激素、环孢素或其他免疫抑制药物联合评估。</p>
<p>Befrena、Zenrelia、Elanco 及对角线条标志是 Elanco 或其附属公司的商标。© 2025 Elanco 或其附属公司</p>
<p>i Elanco Animal Health。档案数据。</p>
<p>ii Zenrelia 补充 FOI 摘要</p>
<p>iii Elanco Animal Health。档案数据。</p>
<p>iv Elanco Animal Health。档案数据。</p>
<p>v AVMA 宠物拥有与人口统计资料手册 2022 和 Elanco Animal Health。档案数据。</p>
<p>投资者联系：Tiffany Kanaga (765) 740-0314 tiffany.kanaga@elancoah.com</p>
<p>媒体联系：Season Solorio (765) 316-0233 season.solorio@elancoah.com</p>
<p>来源 Elanco Animal Health</p>

ELAN

<p>Elanco Animal Health 已获得美国农业部（USDA）对 Befrena™（tirnovetmab）的批准，这是一种针对犬类过敏性和特应性皮炎的新型抗 IL31 单克隆抗体注射剂。这标志着 Elanco 在不到 18 个月的时间内获得的第二个皮肤科产品批准，进一步巩固了其在 13 亿美元的美国犬类皮肤科市场中的领导地位。Befrena 为任何年龄段的狗提供有效治疗，给药间隔为 6 到 8 周。Elanco 计划在 2026 年上半年推出 Befrena，旨在为兽医提供更多治疗瘙痒狗狗的选择</p>

<ul>
<li>Elanco's second dermatology product approval in less than 18 months in the estimated $1.3 billion U.S. canine dermatology market</li>
<li>Befrena has been shown to be effective for treatment of dogs of any age against canine atopic dermatitis and allergic dermatitis for 6 to 8 weeks of treatment, as needed</li>
<li>USDA approval of Befrena reinforces Elanco's commitment to going beyond to deliver differentiated, high-quality products in every key therapeutic area, bolstering its leadership in canine dermatology and monoclonal antibodies (mAbs)</li>
<li>Canine allergic and atopic dermatitis is a widespread concern amongst veterinarians, with data revealing that nearly 98% of vets say they routinely treat dogs for atopic dermatitis and that itchy dogs make up nearly 20% of their patient populationi</li>
</ul>
<div class="lb-trans"><ul>
<li>Elanco 在预计价值 13 亿美元的美国犬类皮肤病市场中，在不到 18 个月内获得的第二个皮肤病产品批准</li>
<li>Befrena 已被证明对任何年龄的狗治疗犬类特应性皮炎和过敏性皮炎有效，治疗时间为 6 到 8 周，视需要而定</li>
<li>USDA 对 Befrena 的批准进一步强化了 Elanco 在每个关键治疗领域提供差异化、高质量产品的承诺，巩固了其在犬类皮肤病和单克隆抗体（mAbs）领域的领导地位</li>
<li>犬类过敏性和特应性皮炎是兽医普遍关注的问题，数据显示近 98% 的兽医表示他们经常治疗犬类特应性皮炎，而瘙痒的狗占他们患者群体的近 20%。</li>
</ul>
</div><p>, /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced its latest entry into the rapidly growing canine dermatology space with the U.S. Department of Agriculture (USDA) approval of Befrena™ (tirnovetmab), a new anti-IL31 monoclonal antibody (mAb) injection targeting canine allergic and atopic dermatitis. Importantly, Befrena is recommended at a dosing interval of 6 to 8 weeks post-treatment, which stands in contrast to the 4 to 8 weeks of the current market competitor, lokivetmab.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) 今天宣布其在快速增长的犬类皮肤病领域的最新进展，获得美国农业部（USDA）对 Befrena™（tirnovetmab）的批准，这是一种针对犬类过敏性和特应性皮炎的新型抗 IL31 单克隆抗体（mAb）注射剂。重要的是，Befrena 建议在治疗后每 6 到 8 周给药一次，这与当前市场竞争对手 lokivetmab 的 4 到 8 周给药间隔形成对比。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2309278/Elanco_Logo.jpg" alt="" original-src="https://mma.prnewswire.com/media/2309278/Elanco_Logo.jpg"/></p>
<p>USDA approval of Befrena further demonstrates Elanco's commitment to going beyond to deliver differentiated, high-quality products in every key therapeutic area, specifically bolstering its leadership in canine dermatology and monoclonal antibodies. Elanco continues to expect to launch Befrena in the first half of 2026.</p>
<div class="lb-trans"><p>USDA 对 Befrena 的批准进一步证明了 Elanco 在每个关键治疗领域提供差异化、高质量产品的承诺，特别是巩固了其在犬类皮肤病和单克隆抗体领域的领导地位。Elanco 预计将在 2026 年上半年推出 Befrena。</p>
</div><p>The approval of Befrena marks Elanco's second dermatology product approved in less than 18 months, as it joins Zenrelia™ (ilunocitinib tablets), an effective, convenient, and safe once-daily oral JAK inhibitor for control of itching and inflammation associated with skin allergies in dogs at least 12 months of age. In September, Elanco announced improvements to the U.S. Zenrelia label with the Food and Drug Administration (FDA) concluding &#34;the totality of evidence supports removal of the risk of fatal vaccine-induced disease from modified live virus vaccines from the labelingii.&#34;</p>
<div class="lb-trans"><p>Befrena 的批准标志着 Elanco 在不到 18 个月内获得的第二个皮肤病产品批准，它与 Zenrelia™（ilunocitinib 片）一起，后者是一种有效、方便且安全的每日一次口服 JAK 抑制剂，用于控制至少 12 个月大犬只的皮肤过敏引起的瘙痒和炎症。今年 9 月，Elanco 宣布对美国 Zenrelia 标签进行了改进，食品药品监督管理局（FDA）得出结论称 “所有证据支持从标签中移除由改良活病毒疫苗引起的致命疫苗诱导疾病的风险”。</p>
</div><p>The label Boxed Warning continues to advise discontinuation of Zenrelia for at least 28 days to 3 months prior to vaccination and withholding Zenrelia for at least 28 days after vaccination.</p>
<div class="lb-trans"><p>标签中的盒装警告继续建议在接种疫苗前至少 28 天至 3 个月停止使用 Zenrelia，并在接种疫苗后至少 28 天内暂停使用 Zenrelia。</p>
</div><p>&#34;The animal health sector is increasingly focused on antibody-based therapies, and today's approval is an important step forward in delivering high-impact innovation that enhances the quality of life for pets,&#34; said Dr. Ellen de Brabander, Executive Vice President of Research &amp; Development at Elanco. &#34;We are pleased to offer veterinarians and pet owners Befrena, which delivers long lasting relief to treat dogs with allergic itch.&#34;</p>
<div class="lb-trans"><p>&#34;动物健康领域越来越关注基于抗体的疗法，今天的批准是向前迈出的重要一步，旨在提供高影响力的创新，提升宠物的生活质量，&#34; Elanco 研发执行副总裁 Ellen de Brabander 博士表示。&#34;我们很高兴能为兽医和宠物主人提供 Befrena，它能为患有过敏性瘙痒的狗提供持久的缓解。&#34;</p>
</div><p>Earlier this year Elanco launched the America's Itchy Dogs Report, a first-of-its-kind report highlighting the impact itch has on dogs, their owners, and veterinarians. The report includes findings from multiple surveys of pet owners, as well as veterinarians, and reveals startling details on how badly dogs around the country are itching for relief and cost-effective, long-lasting solutions. According to the report, 9 in 10 dogs in the U.S. are &#34;itchy dogs&#34; according to their pet owners, having experienced symptoms of itchiness at some point in the year.iii Pet owners typically try many at-home solutions before finally seeking veterinary care. On average, pet owners spend about $400 on over-the-counter remedies and wait six weeks before taking their pet to the veterinarian. Veterinarians say that itchy dog owners wait too long before bringing their dog, resulting in raw and infected skin and also an irritated dog owner who wants their dog to experience relief quickly.iv Research shows that nearly 70% of veterinarians would be willing to stock another dermatology product in an effort to help more dogs find itch relief.v</p>
<div class="lb-trans"><p>今年早些时候，Elanco 推出了《美国瘙痒狗报告》，这是首个强调瘙痒对狗、其主人和兽医影响的报告。该报告包括来自多项宠物主人和兽医的调查结果，揭示了全国各地的狗有多么渴望获得缓解和经济有效、持久的解决方案。根据报告，90% 的美国狗被其主人认为是 “瘙痒狗”，在一年中的某个时候经历过瘙痒症状。宠物主人通常在寻求兽医护理之前尝试多种家庭解决方案。宠物主人平均在非处方药物上花费约 400 美元，并在带宠物去看兽医之前等待六周。兽医表示，瘙痒狗的主人往往等待太久才带狗去看病，导致皮肤发炎和感染，同时也让希望狗能迅速得到缓解的主人感到烦恼。研究显示，近 70% 的兽医愿意储备另一种皮肤病产品，以帮助更多的狗找到瘙痒缓解。</p>
</div><p>&#34;Veterinarians need more options for itch relief so they can offer targeted therapy that focuses on mode of action to meet the unique needs of the individual patient to deliver fast, effective and valuable itch relief,&#34; said Dr. Griffin, veterinary dermatologist. &#34;USDA approval of Befrena brings veterinarians a step closer to having another beneficial and safe treatment option. I'm excited to collaborate with Elanco and plan to offer this product in my practice when it becomes available.&#34;</p>
<div class="lb-trans"><p>&#34;兽医需要更多的瘙痒缓解选择，以便能够提供针对性疗法，专注于作用机制，以满足个体患者的独特需求，提供快速、有效和有价值的瘙痒缓解，&#34; 兽医皮肤科医生 Griffin 博士表示。&#34;USDA 对 Befrena 的批准使兽医更接近拥有另一种有益且安全的治疗选择。我很高兴能与 Elanco 合作，并计划在该产品上市时在我的诊所提供。&#34;</p>
</div><p>You can learn more about Befrena and sign up for future news and webinars at www.befrenaforvets.com.</p>
<div class="lb-trans"><p>您可以在 www.befrenaforvets.com 了解更多关于 Befrena 的信息，并注册未来的新闻和网络研讨会。</p>
</div><p><strong>ABOUT ELANCO</strong> Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. Learn more at www.elanco.com.</p>
<div class="lb-trans"><p><strong>关于 ELANCO</strong> Elanco Animal Health Incorporated (NYSE: ELAN) 是一家全球领先的动物健康公司，致力于创新和提供产品与服务，以预防和治疗农场动物和宠物的疾病，为农民、宠物主人、兽医、利益相关者和整个社会创造价值。凭借 70 年的动物健康传统，我们致力于打破界限，超越自我，帮助客户改善他们所照顾动物的健康，同时对我们当地和全球社区产生积极影响。在 Elanco，我们的愿景是 “食物与陪伴丰富生活”，我们的使命是——为动物、客户、社会和我们的员工超越自我。了解更多信息，请访问 www.elanco.com。</p>
</div><p><strong>INDICATIONS</strong> Zenrelia is a prescription medication used to control itching and inflammation associated with skin allergies for dogs over 12 months of age.</p>
<div class="lb-trans"><p><strong>适应症</strong> Zenrelia 是一种处方药，用于控制 12 个月以上犬只的皮肤过敏引起的瘙痒和炎症。</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><strong>Read the package insert, including the Boxed Warning, before using this drug.</strong> For full prescribing information speak with your veterinarian, call 1 888 545 5973 or visit <strong>www.elancolabels.com/us/zenrelia</strong>.</p>
<div class="lb-trans"><p><strong>在使用此药物之前，请阅读包装说明，包括盒装警告。</strong> 有关完整的处方信息，请咨询您的兽医，拨打 1 888 545 5973 或访问 <strong>www.elancolabels.com/us/zenrelia</strong>。</p>
</div><p><strong>WARNING: INADEQUATE IMMUNE RESPONSE TO VACCINES. Based on results of the vaccine response study, dogs receiving Zenrelia are at risk of an inadequate immune response to vaccines. Discontinue Zenrelia for at least 28 days to 3 months prior to vaccination and withhold Zenrelia for at least 28 days after vaccination.</strong> Dogs should be up to date on vaccinations prior to starting Zenrelia. Do not use in dogs less than 12 months old or dogs with a serious infection. Dogs should be monitored for infections because Zenrelia may increase the chances of developing an infection. Neoplastic conditions (benign and malignant) were observed during clinical studies. The most common side effects were vomiting, diarrhea and tiredness. Zenrelia has not been tested in dogs used for breeding, pregnant, or lactating dogs and has not been evaluated in combination with glucocorticoids, cyclosporine, or other immune suppressive drugs.</p>
<div class="lb-trans"><p><strong>警告：对疫苗的免疫反应不足。根据疫苗反应研究的结果，接受 Zenrelia 的狗面临疫苗免疫反应不足的风险。在接种疫苗前至少停用 Zenrelia 28 天至 3 个月，并在接种疫苗后至少停用 Zenrelia 28 天。</strong> 狗在开始使用 Zenrelia 前应确保疫苗接种是最新的。不得用于小于 12 个月的狗或有严重感染的狗。应监测狗的感染情况，因为 Zenrelia 可能增加感染的风险。在临床研究中观察到肿瘤性疾病（良性和恶性）。最常见的副作用包括呕吐、腹泻和疲劳。Zenrelia 尚未在用于繁殖的狗、怀孕或哺乳的狗中进行测试，也未与糖皮质激素、环孢素或其他免疫抑制药物联合评估。</p>
</div><p>Befrena, Zenrelia, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2025 Elanco or its affiliates</p>
<div class="lb-trans"><p>Befrena、Zenrelia、Elanco 及对角线条标志是 Elanco 或其附属公司的商标。© 2025 Elanco 或其附属公司</p>
</div><p>i Elanco Animal Health. Data on File.</p>
<div class="lb-trans"><p>i Elanco Animal Health。档案数据。</p>
</div><p>ii Zenrelia Supplemental FOI Summary</p>
<div class="lb-trans"><p>ii Zenrelia 补充 FOI 摘要</p>
</div><p>iii Elanco Animal Health. Data on File.</p>
<div class="lb-trans"><p>iii Elanco Animal Health。档案数据。</p>
</div><p>iv Elanco Animal Health. Data on File.</p>
<div class="lb-trans"><p>iv Elanco Animal Health。档案数据。</p>
</div><p>v AVMA Pet Ownership and Demographic Sourcebook 2022 and Elanco Animal Health. Data on File.</p>
<div class="lb-trans"><p>v AVMA 宠物拥有与人口统计资料手册 2022 和 Elanco Animal Health。档案数据。</p>
</div><p>Investor Contact: Tiffany Kanaga (765) 740-0314 tiffany.kanaga@elancoah.com</p>
<div class="lb-trans"><p>投资者联系：Tiffany Kanaga (765) 740-0314 tiffany.kanaga@elancoah.com</p>
</div><p>Media Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com</p>
<div class="lb-trans"><p>媒体联系：Season Solorio (765) 316-0233 season.solorio@elancoah.com</p>
</div><p>SOURCE Elanco Animal Health</p>
<div class="lb-trans"><p>来源 Elanco Animal Health</p>
</div>

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