Shanghai Ark Biopharmaceutical Co., Ltd announced today that China’s National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for AK0406 injection, the company’s first antiviral drug-Fc conjugate (AFC) candidate designed for long-acting influenza prevention. The approval makes AK0406 the first influenza-focused AFC candidate in China to progress into clinical development.

AK0406 is a next-generation, long-acting antiviral candidate discovered and developed by ArkBio. The molecule combines a highly potent antiviral small-molecule agent with an antibody Fc fragment through targeted conjugation, with the aim of delivering sustained protection before and after exposure and potentially offering therapeutic benefits.

This approach is intended to address the continuing need for effective influenza prevention, particularly during periods of high seasonal transmission. Preclinical studies indicate that AK0406 has potent and broad activity against both influenza A and influenza B viruses, while retaining immune effector activity and achieving prolonged systemic exposure. Its molecular design is intended to provide a balanced profile suitable for both influenza prophylaxis and treatment.

ArkBio is also advancing AK0406 through international clinical development. In February 2026, the company received authorization from an Australian Human Research Ethics Committee (HREC) to begin a Phase I study. Recruitment and dosing of healthy adult participants across all planned cohorts in Australia have been completed, and the study has subsequently moved into the follow-up stage.

Influenza continues to represent a substantial global public health burden. Existing prevention strategies rely heavily on seasonal vaccination, but these approaches have inherent challenges. These include the difficulty of accurately anticipating and matching circulating viral strains each year, the effects of ongoing antigenic drift, and lower levels of vaccine protection in certain vulnerable groups, including older adults and people with compromised immune systems. Consequently, significant unmet needs remain in influenza prevention.

ArkBio plans to work closely with China’s Center for Drug Evaluation (CDE) to support the continued clinical development of AK0406 in China while completing follow-up activities associated with the Phase I study in Australia. Through a coordinated development strategy spanning China and international markets, the company intends to advance the program efficiently and ultimately develop a safe, effective, and convenient option for influenza prevention worldwide.

Harbour BioMed, a global biopharmaceutical company focused on advancing innovative antibody-based therapies in immunology and immune-oncology, has announced the online publication of results from the first-in-human Phase I clinical trial (NCT05790694/CTR20221961) of HBM9378 (also referred to as SKB378 or WIN378).

The study, led by Dr. Min Xu, a respiratory medicine specialist at Chengdu Fifth People’s Hospital, appears in the peer-reviewed journal Drug Design, Development and Therapy. Findings from the trial highlight a strong safety profile and a prolonged half-life, supporting continued investigation of HBM9378 in patients with serious immune-related conditions.

HBM9378 is a fully human monoclonal antibody with an extended half-life that targets thymic stromal lymphopoietin (TSLP). It is being co-developed by Harbour BioMed and Kelun-Biotech. The randomized, double-blind, placebo-controlled, single-ascending-dose (SAD) study enrolled 50 healthy adults to assess safety, tolerability, pharmacokinetics (PK), and immunogenicity. Participants were divided into five dose groups—20 mg, 60 mg, 200 mg, 600 mg, and 900 mg—with each cohort consisting of ten individuals, eight receiving HBM9378 and two receiving a placebo.

Results showed that treatment-emergent adverse events (TEAEs) occurred at similar rates across both the treatment and placebo groups, with no evidence of increased safety concerns at higher doses. The median time to reach peak concentration (Tmax) ranged between 4.05 and 14.1 days, while the average half-life (T1/2) was between 55.0 and 65.8 days. Drug exposure, measured by Cmax and AUC, rose proportionally with increasing doses from 20 mg to 900 mg. Anti-drug antibodies (ADA) were detected in 5% of participants (2 out of 40), with no observed clinical effects or impact on drug exposure. Notably, no injection site reactions were reported in any group.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, described the Phase I results as an important step forward in developing new treatments for immune-related diseases. He emphasized that the favorable safety profile and extended half-life strengthen confidence in the drug’s potential to address unmet needs in conditions such as severe asthma and chronic obstructive pulmonary disease (COPD).

Dr. Min Xu, Principal Investigator of the study, noted that HBM9378 was well-tolerated and demonstrated a promising pharmacokinetic profile in healthy volunteers. He added that its long half-life could allow for less frequent dosing, which may improve patient adherence and overall treatment outcomes. The findings pave the way for further clinical trials to evaluate the drug’s effectiveness in individuals with severe immunological disorders.