SHANGHAI

上海

,

，

Aug. 14, 2026

2026年8月14日

/PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ('ArkBio') today announced that the U.S. Food and Drug Administration (FDA)

/美通社/ -- 上海阿科生物科技有限公司（“ArkBio”）今日宣布，美国食品药品监督管理局（FDA）

has approved

已批准

ziresovir (AK0529) for a phase II clinical trial in the severely ill RSV infected infant patients, including the ones in pediatric intensive care unit (PICU).

齐雷索韦（AK0529）用于重症呼吸道合胞病毒（RSV）感染婴儿患者（包括儿科重症监护室 [PICU] 患者）的II期临床试验。

Severe RSV Infection: An Urgent Unmet Need in PICU

严重呼吸道合胞病毒感染：儿科重症监护室中亟待满足的迫切需求

RSV is the leading pathogen of lower respiratory tract infections (LRTIs) in infants and young children globally, causing approximately 33 million LRTI cases, 3.6 million hospitalizations, and more than 100,000 deaths annually. Severely ill RSV infected infants often require admission to the PICU for intensive care such as respiratory support, with rapid disease progression, high risk and a heavy medical burden.

呼吸道合胞病毒（RSV）是全球婴幼儿下呼吸道感染（LRTIs）的首要病原体，每年导致约3,300万例下呼吸道感染病例、360万例住院以及超过10万例死亡。重症RSV感染婴儿往往需要入住儿科重症监护室（PICU）接受呼吸支持等强化治疗，其病情进展迅速、风险高，且医疗负担沉重。

There is currently no approved RSV-specific antiviral therapy worldwide; clinical management remains limited to symptomatic and supportive care, such as oxygenation, leaving an urgent unmet need for effective antiviral treatment in hospitalized RSV infected patients with severe diseases..

目前全球范围内尚无获批的呼吸道合胞病毒（RSV）特异性抗病毒疗法；临床管理仍仅限于氧疗等对症和支持治疗，因此住院的重症RSV感染患者对有效抗病毒治疗存在迫切的未满足需求。

Ziresovir Advances to Treat Severely Infected Infant Patients

齐雷索韦在救治重症感染婴儿患者方面取得进展

Ziresovir is the first direct RSV antiviral drug to successfully complete a phase III clinical trial with positive results. The clinical study in 1-24 months age patients conducted in China demonstrated that ziresovir can significantly reduce viral load, accelerate the resolution of respiratory symptoms, and significantly lower the risk of recurrent wheezing and asthma over 24-month follow-up period, with a favorable safety profile.

Ziresovir 是首个在 III 期临床试验中取得阳性结果并成功完成的直接抗呼吸道合胞病毒（RSV）药物。在中国开展的针对 1-24 个月龄患者的临床研究显示，Ziresovir 能显著降低病毒载量，加速呼吸道症状的缓解，并在 24 个月的随访期内显著降低复发性喘息和哮喘的风险，且安全性良好。

Key findings from the clinical study have been published in .

该临床研究的主要发现已发表于。

The New England Journal of Medicine

《新英格兰医学杂志》

and

和

The Lancet Child & Adolescent Health

《柳叶刀·儿童与青少年健康》

. In 2025, ziresovir was included as the only therapeutic drug in the WHO's Paediatric Drug Optimization for Respiratory Syncytial Virus publication. The newly approved phase II clinical trial marks the extension of ziresovir's clinical development into the most critically ill RSV patients, representing a key milestone in the clinical development of ziresovir globally..

2025年，齐雷索韦（ziresovir）作为唯一的治疗药物被纳入世界卫生组织发布的《呼吸道合胞病毒儿科药物优化》出版物中。新获批的II期临床试验标志着齐雷索韦的临床开发扩展至病情最危重的RSV患者群体，这代表了齐雷索韦在全球临床开发进程中的一个关键里程碑。

FDA Approved Phase II Clinical Trial

FDA批准的II期临床试验

The approved multicenter, randomized, double-blind, placebo-controlled phase II clinical trial will focus on severely ill RSV infected infants requiring hospitalization in PICU, one of the most critical RSV patient populations with the most urgent clinical treatment needs. This clinical trial is designed to evaluate clinical efficacy of ziresovir, especially the length of oxygen treatment and sustained recovery time, providing the clinical basis for the future registrational trials..

这项已获批准的多中心、随机、双盲、安慰剂对照的II期临床试验将聚焦于需要入住儿科重症监护室（PICU）的重症呼吸道合胞病毒（RSV）感染婴儿，这是RSV患者中病情最危重、临床治疗需求最迫切的人群之一。该临床试验旨在评估泽雷索韦（ziresovir）的临床疗效，特别是吸氧治疗时长和持续恢复时间，为未来的注册性临床试验提供临床依据。

About ArkBio

关于 ArkBio

ArkBio is a commercial-stage biotechnology company focused on the discovery and development of innovative therapeutics for respiratory/lung and pediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated R&D pipeline through internal innovation and strategic collaborations..

ArkBio 是一家处于商业化阶段的生物技术公司，专注于发现和开发用于呼吸系统/肺部疾病及儿科疾病的创新疗法。公司成立于 2014 年，通过内部创新和战略合作，建立了专有技术平台和差异化的研发管线。

Key pipeline assets include: ziresovir (AK0529), the first direct-acting antiviral for RSV with positive phase 3 results; AK3280, a potentially best-in-class anti-fibrotic agent with positive phase 2 results in idiopathic pulmonary fibrosis, currently in phase 3 registrational trials; AK0901, approved and commercialized in China for ADHD treatment.

关键管线资产包括：ziresovir（AK0529），首款针对呼吸道合胞病毒（RSV）的直接作用抗病毒药物，其III期临床试验结果积极；AK3280，一种潜在的同类别最佳抗纤维化药物，在特发性肺纤维化治疗中II期临床试验结果积极，目前正处于III期注册性临床试验阶段；AK0901，已在中国获批上市并商业化，用于治疗注意力缺陷多动障碍（ADHD）。

The company also has multiple first-in-class or best-in-class innovative drug candidates in clinical or preclinical development..

该公司还拥有多个处于临床或临床前开发阶段的同类首创或同类最佳创新药候选药物。

ArkBio has established strategic partnerships with multinational pharmaceutical companies including Roche and Genentech, leading academic institutions including The Scripps Research Institute and the Institute of Microbiology of the Chinese Academy of Sciences, Qilu Pharmaceutical, as well as other domestic and international biotech companies and CROs..

ArkBio已与罗氏和基因泰克等跨国制药公司，斯克里普斯研究所和中国科学院微生物研究所等领先学术机构，齐鲁制药，以及其他国内外生物科技公司和合同研究组织（CRO）建立了战略合作伙伴关系。

For more information, please visit:

如需更多信息，请访问：

www.arkbiosciences.com

www.arkbiosciences.com

Investor Inquiries:

投资者咨询：

[email protected]

[email protected]

SOURCE Shanghai Ark Biopharmaceutical Co., Ltd.

来源：上海阿科生物制药有限公司

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