RSV is the most significant viral pathogen globally causing acute lower respiratory tract infections in children under 5 years old. It is also the primary cause of hospitalization for infant virus-related respiratory infections. In recent years, mounting research has demonstrated that RSV also plays a pivotal role in severe lung diseases in adults, primarily the elderly. It is estimated that in 2019, there were approximately 33 million cases of RSV-ALRTI (RSV viral infection with symptoms of acute lower respiratory tract infection) in children under 5 years old worldwide, which resulted in approximately 3.6 million hospitalizations and 100,000 deaths. Currently, there are no effective treatments specifically for RSV.
AK0529 is the first anti-RSV drug that has successfully completed a phase 3 pivotal clinical study globally. Its NDA has been accepted and granted Priority Review by NMPA