SSY Group’s Blonanserin and Paracetamol Approved by China’s NMPA

China-based SSY Group Limited (HKG: 2005) has announced receiving market approvals from the National Medical Products Administration (NMPA) for its generic versions of blonanserin, paracetamol, mannitol, and levofloxacin. Notably, the generic versions of blonanserin and paracetamol are the first of their kind to be approved in China.

Drug Details and Approvals
Blonanserin, developed by Sumitomo Pharmaceuticals Co Ltd, is a highly selective Dopamine D2 and 5-HT2A receptor antagonist. It demonstrates significant binding affinity to D2 receptors, 20 times greater than haloperidol and 94 times greater than risperidone. It also binds to adrenergic α1, 2, and β receptors, histamine H1 receptors, and cholinergic M1 receptors with lower affinity. This profile allows blonanserin to effectively improve both positive and negative symptoms of schizophrenia while potentially reducing the risk of adverse reactions. First approved in Japan in April 2008, blonanserin received marketing approval in China in February 2017.

Paracetamol and mannitol are approved for relieving fever in adults, while levofloxacin is indicated for treating or preventing infections caused by sensitive bacteria.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry