FDA Clears ArkBio to Begin Phase II Trial of AK0406 for Influenza Prevention

SHANGHAI, Oct. 12, 2026 /CourierPR/ -- Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) has taken a significant step forward in its efforts to address gaps in influenza prevention with the announcement that the U.S. Food and Drug Administration (FDA) has granted clearance for its investigational new drug (IND) application for AK0406, a long-acting antiviral drug-Fc conjugate (AFC). This clearance allows ArkBio to proceed with a Phase II clinical trial aimed at evaluating AK0406 for influenza prevention in the general population in the United States.

Influenza remains a significant public health challenge, with the 2025-2026 season alone resulting in at least 32 million illnesses, 380,000 hospitalizations, and 24,000 deaths in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC). Despite the availability of influenza vaccines, these figures underscore the need for additional preventive approaches, particularly for older adults and immunocompromised individuals.

AK0406 is a novel AFC drug developed by ArkBio, designed to combine direct antiviral activity with Fc-mediated immune clearance to prevent influenza. Preclinical studies have demonstrated broad-spectrum and highly potent antiviral activity against both influenza A and B strains. The drug has also been optimized for its pharmacokinetics (PK) properties and GMP manufacturing process.

In February 2026, ArkBio received approval from a Human Research Ethics Committee (HREC) in Australia to initiate a Phase I clinical trial for AK0406. Enrollment and dosing of healthy adult participants were completed across all cohorts, and the study has since entered the follow-up phase. In August 2026, the 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.

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

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.

Founded in 2014, ArkBio is a commercial-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of respiratory/lung and pediatric diseases. The company's key R&D pipeline assets include ziresovir (AK0529), the first direct-acting antiviral for respiratory syncytial virus (RSV) with positive phase III results; AK3280, a potentially best-in-class anti-fibrotic agent with positive phase II results for the treatment of idiopathic pulmonary fibrosis, currently in a phase III trial; and AK0901, approved and commercialized in China for the treatment of attention deficit hyperactivity disorder (ADHD).

Through strategic partnerships with multinational and domestic pharmaceutical companies, leading academic institutions, and other biotech companies, ArkBio aims to continue advancing its innovative drug candidates.