Sanofi's (SNY.US) antihistamine "fexofenadine" has filed for market approval in China for a new indication.

On February 25, the latest public announcement on the website of the National Medical Products Administration's Drug Review Center (CDE) showed that Sanofi (SNY.US) had received a new indication application for its oral suspension of clemastine fumarate. Clemastine fumarate tablets have already been approved in China for the treatment of allergic rhinitis and chronic idiopathic urticaria. The application for the oral suspension is a new dosage form, and it is also the second application for the oral suspension in China. According to Sanofi's previous press release, the US FDA has approved clemastine fumarate oral suspension for the treatment of seasonal allergic symptoms in children aged 2-11 and chronic idiopathic urticaria in children aged 6 months-11. It is speculated that the indications for the two applications in China may also be seasonal allergic symptoms in children and chronic idiopathic urticaria. Compared with the tablet dosage form, the oral suspension has a good taste and is easy to swallow, which may provide more convenient treatment options for children. According to Sanofi's public information, clemastine fumarate is a second-generation antihistamine with both antihistamine and anti-inflammatory effects, with the characteristics of rapid onset, 24-hour long-lasting, and no sedation, and low occupancy of brain receptors. Its high affinity for H1 receptors indicates good cardiac safety. From the mechanism of action, H1 receptors are mainly distributed in vascular endothelial cells, airway smooth muscle cells, etc., and are closely related to allergic reactions. Antihistamines targeting H1 receptors can reduce the receptors activated by histamine to the unactivated state, reduce allergic inflammation, reduce the expression of pro-inflammatory cytokines and cell adhesion molecules, and weaken the chemotactic effect of eosinophils and other cells, thereby exerting biological effects.