China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its human interferon α1b inhalation solution, GB05. The drug is designed to treat pediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as pneumonia and bronchiolitis.
Drug Details
GB05 is an innovative antiviral drug specifically designed for children. It increases stability by introducing mutations and uses a low human albumin content formula to enhance safety and reduce costs. The inhalation administration of GB05 allows the active ingredient to be directly delivered to the site of infection, improving efficacy and compliance while minimizing side effects.
Clinical Development
A Phase III clinical study for GB05 is currently underway in China, further evaluating its safety and efficacy in pediatric patients. The FDA approval marks a significant milestone in the global development of GB05, paving the way for potential future applications in the treatment of RSV-related infections in children.-Fineline Info & Tech
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