SHANGHAI

上海

,

，

Oct. 12, 2026

2026年10月12日

/PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ('ArkBio') today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK0406, a long-acting antiviral drug-Fc conjugate (AFC), enabling the company to initiate a phase II clinical trial for influenza prevention in general population in the United States..

/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）已批准其长效抗病毒药物-Fc偶联物（AFC）AK0406的新药临床试验（IND）申请，使该公司能够在美国启动针对普通人群的流感预防II期临床试验。

Addressing Gaps in Influenza Prevention

弥补流感预防方面的不足

Seasonal vaccination remains central to influenza prevention. However, changes in circulating influenza viruses and variability in individual immune response can limit vaccine protection, particularly among older adults and people who are immunocompromised. Additional preventive approaches could help address these unmet needs..

季节性疫苗接种仍然是预防流感的核心措施。然而，流行流感病毒株的变化以及个体免疫反应的差异可能会削弱疫苗的保护效果，尤其是在老年人和免疫功能受损人群中。额外的预防措施有助于满足这些尚未被充分解决的需求。

According to the U.S. Centers for Disease Control and Prevention (CDC), despite the availability of influenza vaccines, the 2025–2026 influenza season resulted in at least 32 million illnesses, 380,000 hospitalizations and 24,000 deaths in the United States.

根据美国疾病控制与预防中心（CDC）的数据，尽管有流感疫苗可用，2025–2026年流感季节在美国仍导致至少3200万例感染、38万例住院和2.4万例死亡。

About AK0406

关于 AK0406

AK0406 is a novel AFC drug discovered and developed by ArkBio. By precisely conjugating multiple potent small-molecular antivirals to an antibody Fc domain, AK0406 is designed to combine direct antiviral activity with Fc-mediated immune clearance to prevent influenza, with potential therapeutic applications..

AK0406 是由 ArkBio 发现并开发的一种新型抗体偶联小分子抗病毒药物（AFC）。通过将多种强效小分子抗病毒药物精确偶联至抗体 Fc 结构域，AK0406 旨在结合直接抗病毒活性与 Fc 介导的免疫清除作用，用于预防流感，并具有潜在的治疗应用价值。

In preclinical studies, AK0406 demonstrated broad-spectrum and highly potent antiviral activity against both influenza A and B strains. It has also been optimized for its pharmacokinetics (PK) properties and GMP manufacturing process.

在临床前研究中，AK0406 对甲型和乙型流感病毒株均显示出广谱且强效的抗病毒活性。此外，其药代动力学（PK）特性和 GMP 生产工艺也已得到优化。

Global Clinical Development

全球临床开发

In February 2026, AK0406 received approval from a Human Research Ethics Committee (HREC) in Australia to initiate a phase I clinical trial. In July 2026, ArkBio announced that enrollment and dosing of healthy adult participants had been completed across all cohorts and that the study had entered the follow-up phase..

2026年2月，AK0406获得澳大利亚人类研究伦理委员会（HREC）的批准，启动一项I期临床试验。2026年7月，ArkBio宣布已完成所有队列中健康成年受试者的入组和给药，研究已进入随访阶段。

In August 2026, National Medical Products Administration (NMPA) of China cleared the IND application for AK0406 for influenza prevention. The FDA clearance marks a further milestone in the global clinical development of AK0406.

2026年8月，中国国家药品监督管理局（NMPA）批准了AK0406用于流感预防的临床试验申请（IND）。这一获批标志着AK0406在全球临床开发进程中又迈出了重要一步。

Planned U.S. Phase II Trial

计划中的美国II期临床试验

The U.S. phase II clinical trial will be a multicenter, randomized, double-blind, placebo-controlled study in adults during an influenza season. Its primary objective is to evaluate AK0406 for influenza prevention. The study will also assess safety, tolerability, PK and immunogenicity. The resulting data will inform AK0406's future global development strategy..

美国的II期临床试验将是一项在流感季节针对成人开展的多中心、随机、双盲、安慰剂对照研究。其主要目的是评估AK0406在预防流感方面的效果。该研究还将评估安全性、耐受性、药代动力学（PK）和免疫原性。所得数据将为AK0406未来的全球开发策略提供依据。

ArkBio plans to continue discussions with the FDA and the Center for Drug Evaluation (CDE) of China's NMPA to advance phase II development in the United States and China. Through parallel development pathways, the company aims to accelerate the AK0406 program as an additional option for influenza prevention, addressing challenges posed by viral evolution and limited vaccine protection, including in populations at high-risk of severe disease..

ArkBio 计划继续与美国食品药品监督管理局（FDA）及中国国家药品监督管理局（NMPA）药品审评中心（CDE）开展讨论，以推动 AK0406 在美国和中国的 II 期临床开发。通过并行开发路径，公司旨在加速 AK0406 项目的进展，使其成为流感预防的补充选择，从而应对病毒进化以及疫苗保护力有限所带来的挑战，包括在重症高风险人群中的保护不足问题。

About ArkBio

关于 ArkBio

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

ArkBio是一家处于商业化阶段的生物制药公司，专注于发现和开发用于治疗呼吸系统/肺部疾病及儿科疾病的创新疗法。该公司成立于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创新研发管线。

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

核心研发管线资产包括：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；AK3280，一种潜在的同类最佳抗纤维化药物，在治疗特发性肺纤维化方面II期临床试验结果积极，目前正处于III期临床试验阶段；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 under 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 and domestic pharmaceutical companies including Roche, Genentech, and Qilu Pharmaceutical; leading academic institutions including The Scripps Research Institute and the Institute of Microbiology, Chinese Academy of Sciences; and other domestic and international biotech companies and CROs..

ArkBio已与罗氏、基因泰克和齐鲁制药等跨国及国内制药企业；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；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:

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 Arkbio

来源 Arkbio

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