ARTICLE | Clinical News

TaiGen prepping NDA in China for antibiotic

December 4, 2015 2:47 AM UTC

TaiGen Biopharmaceuticals Holdings Ltd. (TPEx:4157) said IV nemonoxacin met the primary endpoint of clinical success rate in a Phase III study to treat community-acquired bacterial pneumonia (CABP). The company said it plans to submit an NDA to China FDA in 2016.

IV nemonoxacin produced a clinical success rate of 92.8% in the 525-patient study's evaluable modified intent-to-treat (mITT) population, compared to 87.0% for levofloxacin, and showed statistical non-inferiority to levofloxacin (p<0.05). ...