SHANGHAI

上海

,

，

April 9, 2026

2026年4月9日

/PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ('ArkBio') today announced that the first cohort of healthy volunteers has been dosed in a phase I clinical trial of AK0406, a novel long-acting antiviral drug-Fc conjugate (ADFC) drug for influenza infection, following approval by the Human Research Ethics Committee (HREC) in Australia.

/PREnews/ -- 上海阿尔克生物医药有限公司（“阿尔克生物”）今日宣布，在澳大利亚人类研究伦理委员会（HREC）批准后，其用于治疗流感感染的新型长效抗病毒药物-Fc结合物（ADFC）药物AK0406的第一批健康志愿者已在I期临床试验中接受给药。

This milestone marks the first-in-human (FIH) evaluation of AK0406 and an important step in the global clinical development of ArkBio's influenza pipeline..

这一里程碑标志着AK0406的首次人体（FIH）评估，也是ArkBio流感产品线全球临床开发的重要一步。

AK0406 is a next-generation, long-acting ADFC candidate discovered and developed by ArkBio. By conjugating a potent small-molecule antiviral to the antibody Fc domain, AK0406 is designed to combine the direct antiviral effect of the payload with Fc-mediated immune clearance and an extended half-life.

AK0406 是由 ArkBio 发现并开发的一种下一代长效 ADFC 候选药物。通过将一种强效的小分子抗病毒药物与抗体 Fc 结构域结合，AK0406 旨在将有效载荷的直接抗病毒作用与 Fc 介导的免疫清除和延长的半衰期相结合。

Preclinical data show that AK0406 exerts broad-spectrum, high-potency activity against both influenza A and B viruses, maintains immune effector function, and provides prolonged exposure. Compared with first-generation ADFC molecules, AK0406 is engineered to offer an optimized profile for both prophylaxis and treatment of influenza infection..

临床前数据显示，AK0406对甲型和乙型流感病毒均具有广谱、高效的活性，能够维持免疫效应功能，并提供持久的暴露时间。与第一代ADFC分子相比，AK0406经过工程优化，在流感感染的预防和治疗方面展现出更优的特性。

The phase I trial is a single-center, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of AK0406 in healthy adult participants in Australia. Data from this FIH study will inform subsequent dose selection and future proof-of-concept trials in populations at risk for influenza infection..

I 期试验是一项单中心、随机、双盲、安慰剂对照的研究，旨在评估 AK0406 在澳大利亚健康成年参与者中的安全性、耐受性和药代动力学 (PK) 特征。这项首次人体试验的数据将为后续剂量选择及针对流感感染高风险人群的概念验证试验提供依据。

Influenza remains a significant global public health burden, causing substantial morbidity and mortality each year and posing an ongoing pandemic threat. Current preventive measures, including seasonal vaccination, are challenged by antigenic drift, strain-selection uncertainty, and reduced effectiveness in the general population, especially in vulnerable groups such as older adults and immunocompromised individuals.

流感仍然是全球公共卫生的重大负担，每年导致大量的发病和死亡，并持续构成大流行威胁。目前的预防措施，包括季节性疫苗接种，受到抗原漂移、毒株选择不确定性的挑战，并且在普通人群中的有效性降低，尤其是在老年人和免疫功能低下者等脆弱群体中。

With its long-acting, broad-spectrum ADFC design, AK0406 has the potential to address key limitations of existing therapies and offer improved options for both prevention and treatment of seasonal influenza and potential pandemic outbreaks. ArkBio will continue to accelerate the clinical development of AK0406 and work with global partners to advance better prevention and treatment options for patients worldwide..

凭借其长效、广谱的ADFC设计，AK0406有潜力解决现有疗法的关键局限性，并为季节性流感和潜在的大流行爆发提供改进的预防和治疗选择。ArkBio将继续加速AK0406的临床开发，并与全球合作伙伴携手，为全世界患者推进更优的预防和治疗方案。

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，专注于发现和开发针对呼吸系统/肺部和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协作，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 pivotal phase 3 results; AK3280, a potentially best-in-class anti-fibrotic agent with positive phase 2 results in idiopathic pulmonary fibrosis and is advancing into Phase 3 registrational trials; AK0901, approved and commercialized in China for the treatment of ADHD.

关键的管道资产包括：ziresovir（AK0529），首个针对RSV的直接作用抗病毒药物，具有积极的关键性3期结果；AK3280，一种潜在的最佳抗纤维化药物，在特发性肺纤维化中取得了积极的2期结果，并正在进入3期注册试验；AK0901，已在中国获批并商业化，用于治疗ADHD。

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

公司还有多个处于临床或临床前开发阶段的首创或同类最佳创新候选药物。

ArkBio has established strategic partnerships with multinational pharmaceutical companies including Roche and Genentech, leading academic institutions such as 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与罗氏、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知名学术机构、齐鲁制药及其他国内外生物技术公司和CRO建立了战略合作伙伴关系。

For more information, please visit:

有关更多信息，请访问：

www.arkbiosciences.com

www.arkbiosciences.com

Investor Inquiries:

投资者查询：

[email protected]

[email protected]

SOURCE Arkbio

来源：Arkbio

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