R&D Progress: Enrollment of Subjects in Phase III Clinical Trial for Inhaled Aerosol Drug in Children by Kexing Biopharm

SHENZHEN, China, April 10, 2024 /PRNewswire/ -- Recently, Kexing Biopharm (688136.SH) announced that the Phase III clinical trial of Human Interferon α1b Inhalation Solution developed by its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., had completed the enrollment of first patient and dosing. This drug is indicated for respiratory syncytial virus-associated lower respiratory infections (pneumonia, bronchiolitis) in children. It is designed specifically for children by using a nebulizer, which can directly deliver the active ingredients to the lesion site, resulting in a rapid onset of therapeutic effect, improved pediatric patient compliance and  safety.

As mentioned by relevant R&D directors of Kexing Biopharm, the Phase I clinical dose-escalation and bronchoalveolar lavage studies of Kexing Biopharm's Human Interferon α1b Inhalation Solution were completed in October 2023. In these studies, the drug safety, tolerability and concentration in the lungs were systematically and comprehensively validated. The results showed high local drug concentration in the lungs and low systemic exposure, indicating that the drug can be delivered directly to the lesion site (lung) using a nebulizer, shows low plasma concentration, and excellent safety profile.

Respiratory syncytial virus (RSV) is one of the most common viral pathogens that cause acute respiratory infections in infants. In recent years, due to the persistently high incidence of various respiratory diseases, inhalation preparations have seen a growing market demand, especially when used in treating RSV-associated lower respiratory infections in children, thus aerosol inhalation has become a more ideal route of administration.

However, due to various challenges such as specific requirements for the physicochemical and pharmacological properties of inhaled aerosol drugs, the uncertainty of therapeutic effects by depositing atomized drug particles in airways and lungs, as well as strict approval procedures for pediatric medication, inhaled protein therapeutics for children have yet to be marketed in China. Human Interferon α1b Inhalation Solution, another significant breakthrough in the antiviral field achieved by Kexing Biopharm, is expected to fill this market void.