Taiwan's TaiGen Biotech receives domestic marketing approval for Taigexyn

Taiwan-based drug developer TaiGen Biotechnology says that the Taiwan Food and Drug Administration (TFDA) has approved the New Drug Application of Taigexyn(nemonoxacin) oral formulation (500mg) for the treatment of community-acquired bacterial pneumonia (CAP).

With this NDA approval, Taiwan is the first region to grant marketing approval to Taigexyn. An NDA for the product was also submitted to China FDA (CFDA) in April 2013 and is currently under review.

Taigexynis a new chemical entity, broad spectrum, non-fluorinated quinolone antibiotic available in both oral and intravenous formulations. TaiGen have completed multi-national and multicenter clinical trials of Taigexynin over 1,280 subjects with demonstrated efficacy and safety. In the clinical trials conducted to this point, Taigexyn have shown activity against drug-resistant bacteria such as methicillin-­resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumoniae. TaiGen owns the worldwide patent portfolio of Taigexyn that protects composition, use, and processes until 2029. The clinical development of the intravenous formulation in CAP is ongoing in Taiwan and mainland China.