Taiwanese biotech submits NDA for new antibiotic formulation in China

TaiGen Biotechnology has submitted a new drug application (NDA) for the intravenous formulation of Taigexyn (nemonoxacin) to the China Food and Drug Administration (CFDA).

Taigexyn is a novel non-fluorinated quinolone 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.

The Taiwanese biotech company’s NDA submission is supported by a pivotal Phase III trial comparing intravenous formulations of Taigexyn 500mg to levofloxacin 500mg in 518 patients with moderate to severe community-acquired pneumonia.