Aosaikang’s Marketing Approval Filing for Delafloxacin Accepted by China’s NMPA

Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the National Medical Product Administration (NMPA) in China has accepted for review its marketing approval filing for the Category III chemical injectable drug delafloxacin.

Delafloxacin is a new generation broad-spectrum fluoroquinolone antibiotic indicated for the treatment of acute bacterial skin and skin structural infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The originator drug was approved for marketing in the US in 2017 and in Europe in 2019 but has not yet made its way to the Chinese market. Aosaikang challenged three preparation patents held by the originator company, Melinta Therapeutics, Inc., in China. These patents were declared invalid by the China National Intellectual Property Administration (CNIPA) in October 2021.- Flcube.com

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