CFDA approves TaiGen antibiotic

TaiGen Biopharmaceuticals Holdings Ltd. (TPEx:4157) said China FDA approved Taigexyn nemonoxacin, a non-fluorinated quinolone antibiotic topoisomerase inhibitor. The company said it is CFDA's first new drug approval since the agency announced self-inspection requirements for clinical data (see BioCentury Extra, July 29, 2015).

Taigexyn is approved in Taiwan to treat community-acquired bacterial pneumonia (CABP), and has Qualified Infectious Disease Product (QIDP) designation in the U.S. for CABP and acute bacterial skin and skin structure infections (ABSSSIs). ...