TaiGen Biotech gains approval from China's FDA for Taigexyn

Taiwanese drug developer TaiGen Biotechnology has received approval from the China Food and Drug Administration (CFDA) to market the oral formulation of its novel antibiotic, Taigexyn (nemonoxacin), in mainland China.

Taigexyn is the first Class 1.1 new drug developed by a Taiwanese company to receive market approval in mainland China. It is also the first new drug approval after the CFDA announced the requirement of self-inspection of drug clinical trial data in July 2015.

Dr Ming-Chu Hsu, chairman and chief executive of TaiGen, said: "This is the second market approval for Taigexynand will further expand its commercial opportunity. Mainland China is the largest antibiotic market in the world with annual sales exceeding $12 billion. Taigexyn’s excellent activity against drug-resistant bacteria and low propensity to resistance development is a valuable tool in fighting the problem of increasing antimicrobial resistance."