According to Kexing Biopharm, the FDA has approved the company’s IND for GB05 human interferon alpha-1b inhalation solution, which the company’s subsidiary Shenzhen Kexing plans to advance into clinical development for the treatment of lung infections caused by respiratory syncytial virus in children. In April 2024, Kexing announced the initiation of a Phase 3 trial of GB05 in children with pneumonia or bronchiolitis associated with RSV in China.
The company says, “GB05, Human Interferon α1b Inhalation Solution, is specifically formulated for pediatric use: it incorporates a mutation to increase stability, is formulated with low human albumin content for increased safety and lower cost, and in inhaled regimen, the active ingredient can be delivered directly to the infection site for better efficacy and reduced side effects. In addition, inhalation delivery enhances pediatric patients’ compliance compared to subcutaneous injection.”
Read the Kexing Biopharm press release
