TaiGen Biotechnology submits NDA for Taigexyn Intravenous Formulation to CFDA

TaiGen Biotechnology has submitted a New Drug Application (NDA) for Taigexyn (Nemonoxacin)intravenous formulation to China Food and Drug Administration (CFDA).

Taigexyn is a novel non-fluorinated quinolone antibiotic. The NDA submission is supported by a pivotal Phase 3 trial comparing intravenous formulations of Taigexyn 500 mg to levofloxacin 500 mg in 518 patients with moderate to severe community-acquired pneumonia. The clinical success rates were 91.8% for Taigexyn vs. 85.7% for levofloxacin and Taigexyn was shown to be non-inferior to levofloxacin meeting the primary endpoint of the pivotal trial.

Taigexyn is a novel broad spectrum antibiotic with excellent efficacy against drug-resistant bacteria available in both oral and intravenous formulations. The oral formulation is already approved for marketing and launched in Taiwan and mainland China.