Shandong Xinhua (00719) obtained the "Drug Supplementary Application Approval Letter" for Levosalbutamol Hydrochloride Inhalation Solution.
20/01/2025
GMT Eight
Shandong Xinhua (00719) announced that the company recently received the approval and issuance of a supplementary drug application approval notice for the albuterol sulfate inhalation solution by the National Medical Products Administration. The transfer of the marketing authorization holder for this product has been approved.
The albuterol sulfate inhalation solution is used to treat or prevent bronchospasm caused by reversible airway obstructive diseases in adults and children aged 6 and above. Albuterol is a beta-adrenergic agonist that is the levorotatory form of salbutamol, which can relax bronchial smooth muscles. According to relevant data, sales of albuterol inhalation preparations have been rapidly increasing in recent years, with sales in 2023 reaching RMB 804 million in China's public medical institutions.
The albuterol sulfate inhalation solution was approved by the National Medical Products Administration in January 2025, and Shandong Xinhua Pharmaceutical became the marketing authorization holder for this product. The launch of this product will help enrich the company's respiratory system drug product line and enhance the company's overall competitive advantage.