Shanghai Ark Biopharmaceutical (ArkBio), a commercial-stage biotechnology company focused on respiratory, lung and paediatric diseases, has received approval from China’s National Medical Products Administration (NMPA) for the Investigational New Drug (IND) application of AK0406 injection, its long-acting Antiviral Fc Conjugate (AFC) candidate for influenza prophylaxis.

According to the company, AK0406 is the first influenza AFC drug to enter clinical development in China. The candidate is designed by conjugating a potent antiviral small molecule with an antibody Fc fragment to provide prolonged drug exposure and sustained protection before and after influenza exposure, while also offering potential therapeutic benefits.

Preclinical studies have shown that AK0406 has broad-spectrum antiviral activity against both influenza A and B viruses. The candidate is also designed to maintain immune effector function and provide extended exposure, with ArkBio developing it for both influenza prevention and treatment.

The company is also advancing the global clinical development of AK0406. In February 2026, ArkBio received approval from the Australian Human Research Ethics Committee to initiate a Phase I clinical trial. Enrolment and dosing of healthy adult volunteers across all cohorts have been completed in Australia, and the study has entered its follow-up phase.

ArkBio plans to continue working with China’s Centre for Drug Evaluation to advance AK0406’s clinical development in China while completing follow-up activities from the Australian Phase I study. The company is pursuing parallel development in China and international markets to accelerate the programme.

Influenza continues to present significant public health challenges, while existing seasonal vaccines face limitations associated with annual strain prediction, antigenic changes and reduced protection in certain vulnerable populations. ArkBio is developing AK0406 as a potential long-acting option to address some of these unmet needs in influenza prevention.

Founded in 2014, ArkBio has established proprietary technology platforms and an R&D pipeline focused on innovative therapies for respiratory, lung and paediatric diseases through internal research and strategic collaborations.