OSAKA, Japan, and TOKYO, Japan. October 24, 2024 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') and UBE Corporation (Head Office: Minato-ku, Tokyo; President & Representative Director: Masato Izumihara.; hereafter 'UBE') announced that the U.S.

日本大阪和日本东京。2024年10月24日-Shionogi&Co.，Ltd.（总部：日本大阪；首席执行官：Isao Teshirogi，Ph.D.；以下简称“Shionogi”）和UBE Corporation（总部：东京Minato ku；总裁兼代表董事：Masato Izumihara.；以下简称“UBE”）宣布。

Food and Drug Administration (FDA) has granted Fast Track designation for S-337395, our novel anti-respiratory syncytial virus (RSV) drug candidate (hereafter “S-337395”)..

美国食品和药物管理局（FDA）已批准我们的新型抗呼吸道合胞病毒（RSV）候选药物S-337395（以下简称“S-337395”）的快速通道名称。。

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that may treat serious conditions and fulfill an unmet medical need. Respiratory infections caused by RSV are diseases that most children contract at least once by the age of two and many children continue to experience recurrent infections throughout their lives.1 In particular, RSV often causes inflammation of the lower respiratory tract and severe respiratory symptoms in newborns, infants, and the elderly, making early treatment critically important.2 However, effective antiviral treatment options for RSV remain limited, and there continues to be a significant unmet medical need in this area.3.

FDA的快速通道设计旨在促进开发并加速审查可能治疗严重疾病并满足未满足医疗需求的潜在新疗法。由RSV引起的呼吸道感染是大多数儿童在两岁时至少感染一次的疾病，许多儿童在其一生中继续经历反复感染。特别是，RSV通常会导致新生儿，婴儿和老年人的下呼吸道炎症和严重的呼吸道症状，使早期治疗至关重要。2然而，RSV的有效抗病毒治疗选择仍然有限，并且在这方面仍然存在大量未满足的医疗需求。

S-337395 is an oral, novel anti-RSV investigational drug that targets the protein, essential for RSV replication, thereby inhibiting its proliferation. A dose-dependent reduction of RSV in the lungs was confirmed in non-clinical trials, and currently, a Phase 2 trial is underway to assess the efficacy and safety of S-337395.

S-337395是一种口服新型抗RSV研究药物，靶向RSV复制所必需的蛋白质，从而抑制其增殖。在非临床试验中证实了肺部RSV的剂量依赖性降低，目前正在进行2期试验以评估S-337395的疗效和安全性。

With the recent Fast Track designation, we expect more frequent consultations with the FDA and the ability to submit application materials in stages, potentially accelerating the development and review process..

随着最近的快速通道指定，我们期望与FDA进行更频繁的咨询，并能够分阶段提交申请材料，从而可能加速开发和审查过程。。

Shionogi and UBE entered a strategic research collaboration for novel anti-RSV drug candidates in 2018.4 In 2022, Shionogi and UBE reported they would be progressing S-337395 based on the results of non-clinical studies.5 We will continue to advance the development of S-337395, combining our respective strengths and seeking to provide this compound to patients as soon as possible..

Shionogi和UBE于2018年为新型抗RSV候选药物进行了战略研究合作。4 2022年，Shionogi和UBE报告说，他们将根据非临床研究结果开发S-337395。5我们将继续推进S-337395的开发，结合我们各自的优势，寻求尽快为患者提供这种化合物。。

【About Shionogi & Co., Ltd.】

【关于Shionogi&Co.，Ltd.】

Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as our key focus. We are not only conducting research and development of novel therapeutics, but we are also working towards total care, through building awareness, epidemiologic monitoring, prevention, diagnosis, and addressing exacerbations, as well as treating the infection itself..

Shionogi致力于“保护全世界人民免受传染病的威胁”，这是我们的重点。我们不仅在进行新疗法的研究和开发，而且还通过提高认识、流行病学监测、预防、诊断和应对恶化以及治疗感染本身，努力实现全面护理。。

【About UBE Corporation】

【关于UBE公司】

UBE Corporation encompasses a group of specialty chemicals businesses, of which the pharmaceuticals business comprises the core of its life sciences portfolio, progressing beyond its track record of discoveries in small molecule therapeutics into high added-value products such as ADCs (antibody-drug conjugates).

UBE公司包括一组特种化学品业务，其中制药业务是其生命科学投资组合的核心，超越了其在小分子治疗中发现的跟踪记录，发展成为高附加值产品，如ADC（抗体-药物偶联物）。

Alongside is a CDMO (contract development and manufacturing organization) business, which is strengthening its existing small molecule production capacity while also acquiring capabilities in novel modalities such as oligonucleotide therapeutics. UBE's life science businesses will continue to offer solutions that enhance and protect human life and health  https://www.ube.com/ube/en/.

此外还有一家CDMO（合同开发和制造组织）业务，该业务正在加强其现有的小分子生产能力，同时还获得了寡核苷酸治疗等新型方式的能力。UBE的生命科学业务将继续提供增强和保护人类生命和健康的解决方案https://www.ube.com/ube/en/.