ArkBio Receives China IND Approval for Long-Acting Influenza Drug AK0406
AK0406 Becomes First Influenza AFC Candidate to Enter Clinical Development in China
Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announced that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for AK0406 injection.
AK0406 is being developed as a long-acting antiviral drug-Fc conjugate, also known as an AFC, for influenza prevention.
According to ArkBio, AK0406 is the first influenza AFC drug to enter clinical development in China.
The approval allows ArkBio to move forward with clinical development of the candidate in China and adds another development program to the company's respiratory disease pipeline.
What Is AK0406?
AK0406 is a long-acting antiviral candidate discovered and developed by ArkBio.
The drug combines a highly potent antiviral small molecule with an antibody Fc fragment. The aim is to keep the antiviral drug in the body for a longer period and provide sustained protection against influenza.
ArkBio is developing AK0406 for both pre-exposure and post-exposure prophylaxis. The company is also exploring its potential as a treatment for influenza infection.
The approach is designed to provide protection during periods when influenza infections are more common, particularly during seasonal peaks.
AK0406 Targets Both Influenza A and B
According to preclinical studies, AK0406 has shown broad-spectrum antiviral activity against both influenza A and influenza B viruses.
The candidate has also demonstrated high antiviral potency and prolonged exposure in preclinical testing.
ArkBio said AK0406 is designed to maintain immune effector function while providing extended drug exposure.
The company has engineered the molecule with the goal of supporting both influenza prevention and treatment, rather than focusing on only one use.
Why Long-Acting Influenza Protection Matters
Influenza continues to be a major public health challenge around the world.
Seasonal vaccination remains an important tool for preventing influenza, but it has some limitations.
Influenza viruses can change over time through antigenic drift, making it difficult to predict which strains will circulate each season. The effectiveness of seasonal vaccines can also vary depending on how closely the vaccine strains match the viruses circulating in the community.
Protection can also be lower in some older adults and people with weakened immune systems.
Because of these challenges, researchers continue to look for additional ways to prevent and treat influenza.
AK0406 is being developed as one potential approach.
AK0406 Is Already in Global Clinical Development
The China IND approval follows clinical development work that has already started in Australia.
In February 2026, ArkBio received approval from the Australian Human Research Ethics Committee (HREC) to begin a Phase I clinical trial of AK0406.
The company has completed enrollment and dosing of healthy adult volunteers across all cohorts in Australia.
The Australian Phase I study has now moved into its follow-up stage.
This gives ArkBio an opportunity to continue collecting clinical information while preparing to advance the program in China.
ArkBio Plans a Dual-Track Development Strategy
Following the NMPA approval, ArkBio plans to work closely with China's Center for Drug Evaluation (CDE) as it advances the clinical development of AK0406.
At the same time, the company will continue follow-up activities from the ongoing Phase I study in Australia.
The company is using a parallel development approach in China and international markets.
The goal is to move the clinical program forward in multiple regions and potentially develop a convenient long-acting option for influenza prevention.
How the AFC Approach Works
AK0406 uses an antiviral drug-Fc conjugate design.
In simple terms, the approach connects an antiviral small molecule with an antibody Fc fragment.
The Fc component is intended to help extend the time the drug remains in circulation, while the antiviral component is designed to directly act against influenza viruses.
This combination could allow the medicine to maintain antiviral activity for a longer period than a conventional short-acting antiviral.
The company is studying whether this design can provide sustained protection before or after exposure to influenza and potentially support treatment of infection.
ArkBio's Respiratory Disease Pipeline
AK0406 is one of several programs in ArkBio's pipeline targeting respiratory and other diseases.
The company's pipeline includes ziresovir, also known as AK0529, which is being developed as a direct-acting antiviral for respiratory syncytial virus (RSV).
Ziresovir has reported positive pivotal Phase 3 results.
ArkBio is also developing AK3280, an anti-fibrotic candidate for idiopathic pulmonary fibrosis. The program has reported positive Phase 2 results and is currently being evaluated in Phase 3 registrational trials.
Another ArkBio product, AK0901, has been approved and commercialized in China for the treatment of attention-deficit/hyperactivity disorder (ADHD).
The company also has additional candidates in clinical and preclinical development.
ArkBio Has Global Research Partnerships
ArkBio has built research and development partnerships with pharmaceutical companies, academic institutions and biotechnology organizations.
Its partners include Roche and Genentech, as well as academic institutions such as The Scripps Research Institute and the Institute of Microbiology of the Chinese Academy of Sciences.
The company has also established collaborations with Qilu Pharmaceutical and other domestic and international biotechnology companies and contract research organizations.
These partnerships support ArkBio's efforts to develop innovative medicines across respiratory, lung and pediatric diseases.
What Comes Next for AK0406?
With the Chinese IND now approved, ArkBio can move ahead with the next steps required for clinical development of AK0406 in China.
The company will continue discussions with the CDE while following up on the Phase I study in Australia.
The clinical program will provide additional information on the safety, pharmacokinetics and potential activity of the long-acting influenza candidate as development progresses.
ArkBio is aiming to advance AK0406 through its China and global development pathways as it works toward developing a longer-acting approach to influenza prevention and treatment.
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