Next-Generation RSV Antibody Advances in China

Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) today announced that it had received IND approval from the National Medical Products Administration in China for a novel monoclonal antibody AK0610 that was bioengineered based on a respiratory syncytial virus (RSV) infection.

AK0610 specifically targets the RSV pre-F protein.

It demonstrated potent neutralizing effects against RSV both in vitro and in vivo. With a prolonged half-life, it holds promise as a next-generation long-acting antibody for RSV prevention.  

Dr. Jim Wu, chairman and CEO of ArkBio, commented in a press release on November 23, 2023, "We are excited with the IND approval of AK0610 and its great potential in the field of RSV prevention."

"...We will strive to provide very needed RSV high-risk population and patients with efficacious prevention and treatment solutions." 

The discovery and pre-clinical characterization have been published in hLife jointly by Professor George Fu Gao and his team from the Institute of Microbiology, Professor Zhengde Xie and his team from Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China, and ArkBio R&D team.

China has one of the highest rates of lower respiratory tract infection in children caused by RSV, accounting for 18-27% of all hospitalizations in children under five years old due to RSV infections.

ArkBio licensed AK0610 intellectual properties from the Institute of Microbiology, Chinese Academy of Sciences and Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China, followed by further engineering and optimization at ArkBio.

Currently, there is no approved drug for preventing RSV infection in China. 

In the United States, RSV antibody passive immunization products have been U.S. FDA-approved since 1998.

Recently, AstraZeneca and Sanofi co-developed Beyfortus™ monoclonal antibody, which was approved by the FDA to protect infants through their first and second RSV season.