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TaiGen Biotechnology Announces Submission of New Drug Application for Taigexyn® Intravenous Formulation to the China Food and Drug Administration

2017-05-30 13:15
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TAIPEI, Taiwan, May 30, 2017 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that it has submitted a New Drug Application (NDA) for the intravenous formulation of Taigexyn® (Nemonoxacin) to the China Food and Drug Administration (CFDA). Taigexyn® is a novel non-fluorinated quinolone antibiotic. The NDA submission is supported by a pivotal Phase 3 trial comparing intravenous formulations of Taigexyn® 500 mg to levofloxacin 500 mg in 518 patients with moderate to severe community-acquired pneumonia. The clinical success rates were 91.8% for Taigexyn® vs. 85.7% for levofloxacin and Taigexyn® was shown to be non-inferior to levofloxacin meeting the primary endpoint of the pivotal trial.

About Taigexyn®
Taigexyn® is a novel broad spectrum antibiotic with excellent efficacy against drug-resistant bacteria available in both oral and intravenous formulations. The oral formulation is already approved for marketing and launched in Taiwan and mainland China. In addition, Taigexyn® is also partnered in Russia, Commonwealth Independent States, Turkey, Mexico, Brazil and the Latin American territory for a total 32 countries worldwide.

About TaiGen Biotechnology
TaiGen Biotechnology, a public listed company in Taipei Exchange (4157.TWO), is a leading research-based biotechnology company in Taiwan. In addition to Taigexyn®, TaiGen has two other in-house discovered NCEs in clinical development: TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, and TG-0054, a chemokine receptor antagonist for hematopoietic stem cell transplantation and chemosensitization.

For more information please contact:
Peter W. Tsao, PhD, Sr. Vice President Business Development
Tel: +886-2-8177-7072
ptsao@taigenbiotech.com

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/taigen-biotechnology-announces-submission-of-new-drug-application-for-taigexyn-intravenous-formulation-to-the-china-food-and-drug-administration-300465183.html

Source: TaiGen

Related stocks: Gretai:4157

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