TaiGen Biotechnology has submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA).
Nemonoxacin is the first pharmaceutical product to be included in Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs of the Economic Cooperation Framework Agreement (ECFA) between Taiwan and mainland China.
Nemonoxacin is new chemical entities (NCE), broad spectrum antibiotic with excellent efficacy and safety profile.
The NDA submission for nemonoxacin is supported by a pivotal Phase 3 trial with 532 patients in community-acquired pneumonia (CAP).
The trial, which was conducted in both Taiwan and mainland China, met all primary and secondary endpoints including non-inferiority to the comparator, levofloxacin.
In the clinical trials nemonoxacin has demonstrated excellent activity against drug-resistant bacteria such as methicillin resistant Staphylococcus aureus (MRSA), quinolone-resistant MRSA and quinolone-resistant Streptococcus pneumoniae.
TaiGen president and CEO Ming-Chu Hsu said that the submission of the NDA for nemonoxacin is the culmination of efforts by the company's experienced management team and all the staff.
"I am very pleased with the groundbreaking achievement of using one NDA dossier for submissions to TFDA and CFDA," Hsu added.
