TaiGen Biotech of Taiwan submitted a New Drug Application in China for the IV formulation of Taigexyn®, an antibiotic for drug-resistant infections. TaiGen already has CFDA approval for the oral form of the drug, a novel non-fluorinated quinolone antibiotic. The IV formulation of Taigexyn proved non-inferiority to levofloxacin in a Phase III trial among patients with moderate to severe community-acquired pneumonia. Taigexyn’s clinical success rate was 92% vs. 86% for levofloxacin.
