TAIPEI, Taiwan, October 7, 2020－TaiGen Biotechnology Company, Limited (“TaiGen”) announced today that Taiwan Food and Drug Administration (TFDA) has approved the new drug application (NDA) for Taigexyn® (Nemonoxacin) IV formulation (500 mg/250 ml) for the treatment of community-acquired bacterial pneumonia (CAP). With this NDA approval, Taiwan is the first country to grant marketing approval to Taigexyn IV formulation. With this approval, TaiGen has accumulated a total of 3 marketing authorization approvals.
Kuo-Lung Huang, Chairman and Chief Executive Officer of Licensor, said, “This NDA approval will provide hospitalized patients with moderate to severe CAP a further option of access to Taigexyn and expand the market reach of the product for TaiGen.”
Taigexyn® is a novel, safe, and effective antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria. Furthermore, Nemonoxacin, the active ingredient in Taigexyn, is one of the few antibiotics available in both oral and intravenous formulations, thus providing primary care physicians and their patients a wide option of choice.
Taigexyn® is a novel non-fluorinated quinolone available in both oral and intravenous formulations. TaiGen has completed multi-national and multi-center trials of Taigexyn® in oral and intravenous forms. The oral formulation of Taigexyn® have received market approval in Taiwan and mainland China shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. Taigexyn® is marketed in mainland China by Zhejiang Medicine Co. through an exclusive marketing and manufacturing licensing agreement. TaiGen also partnered the exclusive rights in the Russian Federation, the Commonwealth of Independent States, and Turkey to R-Pharm of Russia; in the Latin American to Productos Científicos S.A. de C.V.; in Canada, New Zealand and Australia to Luminarie.