TaiGen Biotechnology Company has announced that it 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.
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. In addition, Taigexyn is also partnered in Russia, Commonwealth Independent States, Turkey, Mexico, Brazil and the Latin American territory for a total 32 countries worldwide.
TaiGen Biotechnology, a public listed company in Taipei Exchange (4157.TWO), is a leading research-based biotechnology company in Taiwan. In addition to Taigexyn, TaiGen has two other in-house discovered NCEs in clinical development: TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, and TG-0054, a chemokine receptor antagonist for hematopoietic stem cell transplantation and chemosensitization.