Chinese biopharmaceutical company Kexing Biopharm Co Ltd (SHA:688136) announced on Friday that the Investigational New Drug Application (IND) for GB05, Human Interferon alpha 1b Inhalation Solution, developed by its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co Ltd, has been approved by the US Food and Drug Administration (FDA).
This approval enables Shenzhen Kexing to initiate its planned clinical trials in the United States.
The proposed indications are paediatric lower respiratory tract infections caused by respiratory syncytial virus (RSV), such as pneumonia and bronchiolitis. RSV is one of the most causative viruses for acute respiratory infections in infants.
Phase III clinical trials for GB05 are currently being conducted in China.
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