Kexing Biopharm Starts Phase III Pediatric Inhaled Drug Trial

Kexing Biopharm made an announcement regarding its Human Interferon α1b Inhalation Solution, specifically developed by its subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd. The company has successfully enrolled and dosed the first participant in its Phase III clinical trial. This medication is intended for the treatment of lower respiratory infections (such as pneumonia and bronchiolitis) in children caused by respiratory syncytial virus (RSV). This pediatric drug, administered via a nebulizer, is designed to deliver the active ingredients directly to the affected area, ensuring quick therapeutic action, enhanced patient compliance, and safety.

Kexing Biopharm's R&D leaders highlighted that the Phase I clinical dose-escalation and bronchoalveolar lavage studies for the Human Interferon α1b Inhalation Solution were completed in October 2023. These studies thoroughly validated the drug's safety, tolerability, and lung concentration. Results indicated a high local drug concentration in the lungs with minimal systemic exposure, showcasing that the medication can be effectively delivered to the target area (the lungs) using a nebulizer, which maintains low plasma levels and a strong safety profile.

RSV is a prevalent viral pathogen leading to acute respiratory infections in infants. Due to the rising incidence of respiratory diseases, the demand for inhalation therapies has increased, particularly for treating RSV-related lower respiratory infections in children. Hence, aerosol inhalation has emerged as a preferred method of administration.

Nonetheless, the development of inhaled aerosol drugs faces numerous challenges. These include stringent requirements for the physicochemical and pharmacological properties of such medications, the uncertainty of therapeutic outcomes due to the deposition of atomized drug particles in the airways and lungs, and rigorous approval procedures for pediatric medications. Consequently, inhaled protein therapeutics for children are not yet commercially available in China. Kexing Biopharm's Human Interferon α1b Inhalation Solution represents a notable advancement in the antiviral sector and is anticipated to meet this critical market need.