Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced positive results from the YUPELRI® (revefenacin) Phase III placebo-controlled clinical trial conducted in China assessing the efficacy and safety of YUPELRI, a once-daily nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of patients with COPD.

全球医疗保健公司Viatris Inc.（纳斯达克股票代码：VTRS）和Theravance Biopharma，Inc.（纳斯达克股票代码：TBPH）今天公布了在中国进行的YUPELRI®（revefenacin）III期安慰剂对照临床试验的积极结果，YUPELRI是一种每日一次雾化长效毒蕈碱拮抗剂（LAMA），用于维持治疗COPD患者。

Top-line results showed that YUPELRI met its primary efficacy endpoint demonstrating a statistically significant increase in trough FEV1 (forced expiratory volume in one second) versus placebo. The results are comparable to those from studies of the same design used for U.S. registration and provide support for a regulatory filing in China anticipated to occur in mid-2024.Top Line Results Highlights:Viatris President Rajiv Malik said, 'We are pleased with the positive top-line results of our Phase III clinical results for YUPELRI in China.

一线结果显示，YUPELRI达到其主要疗效终点，表明与安慰剂相比，谷值FEV1（一秒钟用力呼气量）显着增加。结果与用于美国注册的相同设计的研究结果相当，并为预计在2024年中期发生的中国监管申请提供支持。在线结果亮点：Viatris总裁Rajiv Malik说：“我们对我们在中国的YUPELRI III期临床结果的积极顶线结果感到满意。

The strength of the data and the primary endpoint analysis, which is consistent with our U.S. clinical data, firmly supports a comparable efficacy and safety profile of YUPELRI. With this data, we look forward to progressing our regulatory application in China and continue to believe, when approved, a once-daily nebulized revefenacin product will be an important therapeutic option for the millions of patients in the region with COPD.''Given its novel profile, we and Viatris share a commitment to make YUPELRI available for as many COPD patients as possible, particularly those who stand to benefit from nebulized therapy, and we commend VIATRIS on the execution of this study,' said Rick E Winningham, CEO of Theravance Biopharma.

数据强度和主要终点分析与我们的美国临床数据一致，坚定地支持了YUPELRI相当的疗效和安全性。有了这些数据，我们期待着在中国推进监管应用，并继续相信，一旦获得批准，每日一次的雾化revefenacin产品将成为该地区数百万COPD患者的重要治疗选择鉴于其新颖性，我们和Viatris共同承诺使YUPELRI尽可能多地用于COPD患者，特别是那些能够从雾化治疗中受益的患者，我们赞扬Viatris执行这项研究，“Rick E Winningham说，Theravance Biopharma首席执行官。

'The consistent lung function improvement demonstrated in this study supports the use of LAMA therapy as foundational in a.

'本研究中证实的一致的肺功能改善支持使用LAMA治疗作为基础。