Ark Biopharmaceutical Receives IND Approval from NMPA for AK0610, a Respiratory Syncytial Virus Neutralizing Antibody

SHANGHAI, Nov. 23, 2023 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announces that it had received IND approval from National Medical Products Administration (NMPA) for a novel antibody drug AK0610. This antibody drug is bioengineered based on a neutralizing antibody originally isolated from a recovered child from respiratory syncytial virus (RSV) infection. It is anticipated to protect infants throughout an entire RSV season. ArkBio licensed the drug's intellectual properties 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, followed by further engineering and optimization at ArkBio. 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 ^[1].  

RSV is a highly prevalent and infectious RNA virus. Populations at high risk of severe RSV infection include children, the elderly, and individuals with compromised immune systems. RSV is the primary viral pathogen responsible for acute lower respiratory tract infection (ALRTI) in infants worldwide, and a major cause of bronchiolitis and pneumonia. According to Lancet, there were 33 million cases of RSV-ALRTI in children under 5 years of age worldwide in 2019, resulting in approximately 3.6 million hospitalizations and 100,000 deaths. China has one of the highest rates 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. On average, 2,500 children in China are hospitalized daily due to RSV infection ^[2]. At present, there is no approved drug for the prevention of RSV infection in China. 

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 drug for RSV prevention.  

Dr. Jim Wu, chairman and CEO of ArkBio, said, "We are excited with the IND approval of AK0610 and its great potential in the field of RSV prevention. We sincerely thank Professor George Fu Gao, a member (academician) of CAS and his team from the Institute of Microbiology, and Professor Zhengde Xie and his team from Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China, for their professional collaboration and scientific spirits. ArkBio specializes in drug discovery and development in the RSV field with a pipeline in both RSV treatment and prevention. We will strive to provide very needed RSV high-risk population and patients with efficacious prevention and treatment solutions." 

Professor George Fu Gao, a member (academician) of CAS and director of the Institute of Microbiology said, "We are delighted with AK0610's IND approval and excellent scientific results, which are the fruits of our collaboration among the expert team of Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China and outstanding scientists at ArkBio. We will expedite the clinical development of AK0610 and make this partnership an exemplary case among biotech industry, academia, and medical community. We will strive to lead scientific research towards improvement of public life and health, to direct scientific discovery to patient care at bedside, and to meet the unmet needs of our public." 

Professor Zhengde Xie of Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, China added, "RSV infection severely impacts children's health and lives. There is a huge unmet medical need for pediatric prophylaxis of RSV infection. We are delighted to see the progress of AK0610 towards clinical development and wish it a great success in upcoming clinical trials that will eventually benefit very needed pediatric population." 

About ArkBio 

ArkBio is a global biotech company focusing on discovery and development of innovative drugs for unmet medical needs, especially in the areas of pediatric and respiratory diseases. Since its inception in 2014, the company has established core technology platforms and built an innovative and highly differentiated R&D pipeline through in-house R&D efforts and external collaborations. One of the core drug products, ziresovir, is the first direct-acting RSV antiviral drug that successfully completed Phase III clinical trial with positive results. Its NDA application has been accepted and granted Priority Review by NMPA. Moreover, ziresovir is the first non-oncology drug that has received a breakthrough designation from NMPA. Another near-commercial drug asset is an attention deficit hyperactivity disorder (ADHD) drug AZSTARYS^® that has been approved by FDA. ArkBio owns the right for its development and commercialization in Greater China. The R&D pipeline program also includes a battery of clinical and pre-clinical stage drug candidates with first- or best-in-class potential for global clinical development. 

ArkBio has established strategic partnerships with several multinational pharmaceutical companies and acedmic institues, including Roche, Genentech, Scripps Research Institute, the Institute of Microbiology, Chinese Academy of Sciences, domestic and international biotechnology companies, CROs as well as venture investment institutions. 

For more information, please visit www.arkbiosciences.com