FDA受理长效流感预防药 AK0406 二期临床申请：抗病毒药-Fc偶联物将在美国开展流感预防试验
上海10月13日——据 PRNewswire 10月13日发布的企业通报，上海 ArkBio（昂瑞生物）宣布，美国食品药品监督管理局（FDA）已受理其长效抗病毒药物-Fc 偶联物（AFC）AK0406 的新药临床试验（IND）申请，准许该公司在美国启动针对普通人群流感预防的二期临床试验。
AK0406 将多个强效小分子抗病毒药精准偶联到抗体 Fc 结构域上，设计上兼具直接抗病毒活性与 Fc 介导的免疫清除作用。临床前研究显示，该药对甲型与乙型流感毒株均呈广谱强效抗病毒活性，其药代动力学与生产工艺已经优化。
开发进程：AK0406 于2026年2月获澳大利亚人类研究伦理委员会批准开展一期试验，同年7月健康成人全部队列入组与给药完成、进入随访阶段。通报援引 CDC 数据指出，尽管有季节性流感疫苗，2025-26流感季美国仍至少有3,200万例流感、38万例住院与2.4万例死亡；通报同时称，病毒变异与个体免疫反应差异会限制疫苗保护效果，老年人与免疫功能受损者尤其需要额外的预防手段。
来源：ArkBio 企业通报（PRNewswire，2026年10月13日）。
FDA Clears Phase II Trial of Long-Acting Influenza Prevention Drug AK0406 in the United States
SHANGHAI, Oct. 13 — Shanghai Ark Biopharmaceutical (ArkBio) announced that the U.S. Food and Drug Administration has cleared its investigational new drug application for AK0406, a long-acting antiviral drug-Fc conjugate, enabling the company to initiate a Phase II clinical trial for influenza prevention in the general population in the United States, according to a company release via PRNewswire.
AK0406 conjugates multiple potent small-molecule antivirals to an antibody Fc domain, designed to combine direct antiviral activity with Fc-mediated immune clearance. In preclinical studies, the drug demonstrated broad-spectrum, potent activity against both influenza A and B strains, with optimized pharmacokinetics and manufacturing process.
The program previously received ethics approval in Australia in February 2026 to begin a Phase I trial; enrollment and dosing of healthy adults across all cohorts were completed in July and the study entered follow-up. Citing CDC figures, the company noted that despite seasonal vaccination, the 2025-26 U.S. influenza season resulted in at least 32 million illnesses, 380,000 hospitalizations and 24,000 deaths, and that viral variation and individual immune responses can limit vaccine protection, particularly among older adults and immunocompromised people.
Source: ArkBio release via PRNewswire, October 13, 2026.
图片来源：禽流感病毒彩色透射电子显微图（CDC 资料图），Public domain（Wikimedia Commons，摄影/作者：Photo Credit: Cynthia Goldsmith Content Providers: CDC/ Courtes）
