• 25 Nov 2023
• Admin
• News Article

Ark Biopharmaceutical's AK0610 Receives IND Approval for RSV Antibody

Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) has officially announced the approval of its Investigational New Drug (IND) application by the National Medical Products Administration (NMPA) for the innovative antibody drug AK0610. This revolutionary antibody drug is a result of bioengineering, originating from a neutralizing antibody found in a child who had previously recovered from respiratory syncytial virus (RSV) infection. Its primary goal is to protect infants throughout the entire RSV season.

ArkBio acquired the intellectual property rights for the drug through licensing from the Institute of Microbiology, Chinese Academy of Sciences (CAS), and Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China. Following the licensing, ArkBio conducted further engineering and optimization processes. The discovery and pre-clinical characterization of AK0610 were collaboratively published in hLife 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 the ArkBio R&D team.

RSV, a highly prevalent and infectious RNA virus, poses a significant risk to populations, especially children, the elderly, and individuals with compromised immune systems. It is a leading cause of acute lower respiratory tract infection (ALRTI) in infants globally, resulting in bronchiolitis and pneumonia. In 2019, there were 33 million reported cases of RSV-ALRTI in children under 5 years of age worldwide, with approximately 3.6 million hospitalizations and 100,000 deaths, according to Lancet. China, in particular, has a high incidence of lower respiratory tract infection (LRTI) in children caused by RSV, accounting for 18-27% of all hospitalizations in children under 5 years old due to RSV-ALRTI, with an average of 2,500 children hospitalized daily.

AK0610 targets the RSV pre-F protein and has shown potent neutralizing effects against RSV in both in vitro and in vivo settings. With its extended half-life, it holds promise as a next-generation, long-acting antibody drug for RSV prevention.

Dr. Jim Wu, Chairman and CEO of ArkBio, expressed excitement over the IND approval of AK0610 and highlighted its potential in the field of RSV prevention. He expressed gratitude to the collaborating professionals, including Professor George Fu Gao and Professor Zhengde Xie, emphasizing ArkBio's dedication to providing effective prevention and treatment solutions for the high-risk RSV population.

Professor George Fu Gao, a member (academician) of CAS and Director of the Institute of Microbiology, expressed delight at AK0610's IND approval, attributing the success to the collaboration between Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China, and the exceptional scientists at ArkBio. He emphasized the commitment to expediting the clinical development of AK0610 and making the partnership an exemplary case in the biotech industry, academia, and the medical community.

Professor Zhengde Xie of Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China, added that RSV infection significantly impacts children's health and lives. He expressed joy at AK0610's progress toward clinical development and wished for its success in upcoming trials, foreseeing its potential to benefit the much-needed pediatric population.