<p>，/PRNewswire/ -- 全球制药领导者 Lupin Limited（Lupin）（BSE：500257）（NSE：LUPIN）（路透社：LUPIN.BO）（彭博社：LPCIN）今天宣布，已获得美国食品和药物管理局（U.S. FDA）对其 Revefenacin 吸入溶液 175 mcg/3 mL 单剂量小瓶的简略新药申请的初步批准。</p>
<p>Lupin 的 Revefenacin 吸入溶液 175 mcg/3 mL 与 Mylan 的 Yupelri®吸入溶液生物等效，适用于慢性阻塞性肺病（COPD）患者的维持治疗。</p>
<p>Revefenacin 吸入溶液（RLD Yupelri®）在美国的年销售额估计为 2.607 亿美元（IQVIA MAT 2026 年 3 月）。</p>
<p><strong>关于 Lupin</strong></p>
<p>Lupin Limited 是一家全球制药领导者，总部位于印度孟买，产品分销至 100 多个市场。Lupin 专注于制药产品，包括品牌和仿制药制剂、复杂仿制药、生物技术产品和活性药物成分。该公司在全球范围内受到医疗专业人士和消费者的信任，在印度和美国的多个治疗领域（包括呼吸、心血管、抗糖尿病、抗感染、胃肠道、中枢神经系统和女性健康）享有强大的市场地位。Lupin 在全球拥有 15 个先进的制造基地和 7 个研究中心，员工超过 24,000 名专业人士。Lupin 致力于通过其子公司——Lupin Diagnostics、Lupin Digital Health 和 Lupin Manufacturing Solutions，改善患者的健康结果。</p>
<p>欲了解更多信息，请访问 www.lupin.com 或关注我们的 LinkedIn https://www.linkedin.com/company/lupin</p>
<p><em>* 安全港声明</em></p>
<p>Yupelri®是 Viatris Specialty LLC 的注册商标</p>
<p>Logo - https://mma.prnewswire.com/media/2461104/5975844/Lupin_Logo.jpg</p>
<p>来源：Lupin Pharmaceuticals, Inc.</p>
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<p>Lupin Limited 已获得美国 FDA 对其 Revefenacin 吸入溶液的初步批准，该药物用于慢性阻塞性肺病（COPD）的维持治疗。该产品与 Mylan 的 Yupelri® 生物等效，预计在美国的年销售额为 2.607 亿美元。Lupin 是一家总部位于印度的全球制药领导者，专注于多个治疗领域</p>

<p>, /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials.</p>
<div class="lb-trans"><p>，/PRNewswire/ -- 全球制药领导者 Lupin Limited（Lupin）（BSE：500257）（NSE：LUPIN）（路透社：LUPIN.BO）（彭博社：LPCIN）今天宣布，已获得美国食品和药物管理局（U.S. FDA）对其 Revefenacin 吸入溶液 175 mcg/3 mL 单剂量小瓶的简略新药申请的初步批准。</p>
</div><p>Lupin's Revefenacin Inhalation Solution, 175 mcg/3 mL is bioequivalent to Mylan's Yupelri® Inhalation Solution and indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).</p>
<div class="lb-trans"><p>Lupin 的 Revefenacin 吸入溶液 175 mcg/3 mL 与 Mylan 的 Yupelri®吸入溶液生物等效，适用于慢性阻塞性肺病（COPD）患者的维持治疗。</p>
</div><p>Revefenacin Inhalation Solution (RLD Yupelri®) had estimated annual sales of USD 260.7 million in the U.S. (IQVIA MAT March 2026).</p>
<div class="lb-trans"><p>Revefenacin 吸入溶液（RLD Yupelri®）在美国的年销售额估计为 2.607 亿美元（IQVIA MAT 2026 年 3 月）。</p>
</div><p><strong>About Lupin</strong></p>
<div class="lb-trans"><p><strong>关于 Lupin</strong></p>
</div><p>Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.</p>
<div class="lb-trans"><p>Lupin Limited 是一家全球制药领导者，总部位于印度孟买，产品分销至 100 多个市场。Lupin 专注于制药产品，包括品牌和仿制药制剂、复杂仿制药、生物技术产品和活性药物成分。该公司在全球范围内受到医疗专业人士和消费者的信任，在印度和美国的多个治疗领域（包括呼吸、心血管、抗糖尿病、抗感染、胃肠道、中枢神经系统和女性健康）享有强大的市场地位。Lupin 在全球拥有 15 个先进的制造基地和 7 个研究中心，员工超过 24,000 名专业人士。Lupin 致力于通过其子公司——Lupin Diagnostics、Lupin Digital Health 和 Lupin Manufacturing Solutions，改善患者的健康结果。</p>
</div><p>To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin</p>
<div class="lb-trans"><p>欲了解更多信息，请访问 www.lupin.com 或关注我们的 LinkedIn https://www.linkedin.com/company/lupin</p>
</div><p><em>*Safe Harbor Statement</em></p>
<div class="lb-trans"><p><em>* 安全港声明</em></p>
</div><p>Yupelri® is a registered trademark of Viatris Specialty LLC</p>
<div class="lb-trans"><p>Yupelri®是 Viatris Specialty LLC 的注册商标</p>
</div><p>Logo - https://mma.prnewswire.com/media/2461104/5975844/Lupin_Logo.jpg</p>
<div class="lb-trans"><p>Logo - https://mma.prnewswire.com/media/2461104/5975844/Lupin_Logo.jpg</p>
</div><p>SOURCE Lupin Pharmaceuticals, Inc.</p>
<div class="lb-trans"><p>来源：Lupin Pharmaceuticals, Inc.</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTE4Jk5ld3NJdGVtSWQ9SU82MjEwMSZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MTgxNDA1UFJfTkVXU19VU1BSX19fX19JTzYyMTAx" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=IO62101&amp;Transmission_Id=202605181405PR_NEWS_USPR_____IO62101&amp;DateId=20260518"/></p>

Lupin 公司获得美国 FDA 对 Revefenacin 吸入溶液的暂时批准