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EYE ON CHINA
TaiGen Biotechnology receives marketing approval from the Taiwan Food and Drug Administration for Taigexyn® in Taiwan

The Taiwan Food and Drug Administration (TFDA) has approved the new drug application of Taigexyn® (nemonoxacin) oral formulation (500 mg) by TaiGen Biotechnology for the treatment of community-acquired bacterial pneumonia (CAP). With this NDA approval, Taiwan is the first region to grant marketing approval to Taigexyn®.

Taigexyn® is a new chemical entity (NCE), broad spectrum, non-fluorinated quinolone antibiotic available in both oral and intravenous formulations. TaiGen have completed multi-national and multi-center clinical trials of Taigexyn® in over 1280 subjects with demonstrated efficacy and safety. In the clinical trials conducted to this point, Taigexyn® have shown activity against drug-resistant bacteria such as methicillin resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumoniae. TaiGen owns the worldwide patent portfolio of Taigexyn® that protects composition, use, and processes until 2029. The clinical development of the intravenous formulation in CAP is ongoing in Taiwan and mainland China.

Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen said, "This is the first drug approval for TaiGen and we hope there are more to come. It proves that an NCE drug can be developed by a company in Taiwan and approved by the Taiwan regulatory authorities ahead of the rest of the world. This is a very important milestone for the TFDA and the entire Taiwan pharmaceutical industry, especially for the future development of NCE drugs in Taiwan."

Source: PR Newswire

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PR NEWSWIRE  
Asia Pacific Biotech News
EDITORS' CHOICE  
COLUMNS  
APBN Editorial Calendar 2016
January:
Guest Editorial - Biotechnology In Korea
February:
Guest Editorial - Biomedical Research Governance
March:
Guest Editorial - Life-Saving Opportunities: A Guide to Regenerative Medicine
April:
Leading-Edge ONCOLOGY
May:
Healthcare Systems & Policies in Asia
June:
Medical Devices and Digital Health Technology
July:
Water Technology
August:
Guest Editorial - Antibody Informatics In Japan
September:
Infectious Diseases
October:
Medical Tourism
November:
Biomedical Imaging Technology
December:
Food Technology
Editorial calendar is subjected to changes.
– Editor: Carmen, Jia Wen Loh
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