Shanghai, China, August 12, 2026
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, a long-acting antiviral drug-Fc conjugate (AFC) candidate being developed for influenza prophylaxis. According to the company, AK0406 is the first influenza AFC drug to enter clinical development in China. The regulatory milestone marks an important step in ArkBio’s clinical development strategy for a next-generation antiviral designed to provide sustained protection against influenza infection.
AK0406 Targets Influenza with Long-Acting AFC Technology
AK0406 is an investigational long-acting antiviral agent discovered and developed by ArkBio using its drug-Fc conjugate technology. The candidate combines a highly potent antiviral small molecule with an antibody Fc fragment, an approach designed to extend drug exposure and provide sustained antiviral activity. ArkBio is developing AK0406 for both pre-exposure and post-exposure prophylaxis, while also evaluating its potential therapeutic benefits against influenza infection. Preclinical data reported by the company indicate that AK0406 demonstrated broad-spectrum activity against influenza A and influenza B viruses, together with prolonged exposure and retained immune effector function. The company says the molecule has been engineered to achieve an optimized profile for both influenza prevention and potential treatment. The development strategy addresses limitations associated with existing seasonal influenza prevention approaches. Current influenza vaccines can face challenges related to antigenic drift, annual strain prediction and strain matching, while protective effectiveness can vary among certain vulnerable populations. ArkBio is therefore pursuing a long-acting antiviral approach intended to provide an additional strategy for influenza prevention, particularly during periods of elevated seasonal transmission.
China IND Approval Expands Clinical Development
The NMPA IND approval enables ArkBio to advance AK0406 into clinical development in China and establishes a second geographic pathway for evaluating the candidate. The company plans to maintain close interactions with the Center for Drug Evaluation (CDE) as it progresses the Chinese clinical program while continuing the ongoing global development work. ArkBio had previously received approval from the Australian Human Research Ethics Committee (HREC) in February 2026 to initiate a Phase 1 clinical trial of AK0406. Enrollment and dosing of healthy adult volunteers across all cohorts in Australia have now been completed, and the study has entered its follow-up phase. The progress of the Australian Phase 1 study provides an important clinical-development foundation as the company moves toward additional evaluation of AK0406 in China. The parallel development strategy is designed to advance AK0406 through clinical development in China and international markets. By pursuing dual-track development, ArkBio aims to generate clinical evidence across multiple regions and accelerate the potential availability of a long-acting antiviral option for influenza prevention.
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ArkBio Builds Respiratory Antiviral Pipeline
The AK0406 program forms part of ArkBio’s broader portfolio of innovative therapeutics targeting respiratory, lung and pediatric diseases. Founded in 2014, the biotechnology company has developed proprietary technology platforms and a pipeline of clinical and preclinical candidates through internal research and strategic collaborations. Its pipeline includes ziresovir (AK0529), a direct-acting antiviral targeting respiratory syncytial virus (RSV), as well as AK3280, an antifibrotic candidate being evaluated in idiopathic pulmonary fibrosis. The company also has AK0901, which has been approved and commercialized in China for ADHD treatment. With AK0406, ArkBio is expanding its antiviral portfolio beyond RSV into influenza prevention, an area with continuing global healthcare needs. The company has established collaborations with multinational pharmaceutical companies, academic institutions and biotechnology organizations to support its research and development activities. The China IND approval represents a significant regulatory milestone for AK0406 and provides a foundation for continued clinical evaluation of its long-acting antiviral drug-Fc conjugate technology. If clinical development confirms the candidate’s safety and efficacy, AK0406 could potentially offer a convenient, longer-acting approach to influenza prophylaxis. For now, the program remains investigational, with further clinical evidence required to establish its therapeutic and preventive benefits.
Source: ArkBio press release
