Taigexyn nemonoxacin regulatory update

The China FDA approved TaiGen’s oral Taigexyn nemonoxacin, a non-fluorinated quinolone antibiotic topoisomerase inhibitor. Taigexyn is approved in Taiwan to treat community-acquired bacterial pneumonia (CABP). Zhejiang Medicine Co. Ltd. (Shanghai:600216, Zhejiang, China) has exclusive rights from TaiGen to commercialize and manufacture nemonoxacin in mainland China (see BioCentury, Dec. 19, 2011 & July 2, 2012).

The company said Taigexyn is CFDA’s first new drug approval since the agency announced self-inspection requirements for clinical data. TaiGen also said the antibiotic is the first Class 1.1 “new drug” -- a product that was not yet marketed anywhere else in the world at the time of submission -- from a Taiwanese company to receive CFDA approval. ...