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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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Credits to: American Chemical Society
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APBN Editorial Calendar 2015
Trends and Predictions for 2015 Robotics in Healthcare Nutrition Universal Health Coverage
Start-Up Biotech Companies Preventative and Translational Medicine Biofuels ASEAN Economic Community and Asia's Life Sciences Industry
Big Data: Healthcare and Drug Development Antibody Engineering in Japan Christmas Edition
APBN Editorial Calendar 2016
Korea's Biotechnology Industry Nutrition and Allergies: Are we, Too Clean? Medical Devices and Technology: Innovation that leaves an Inspiration Tobacco Smoking: The 'Real' Cost of One Cigarette
Life-Saving Opportunities: A Guide to Regenerative Medicine Occupational Health Water Technology Olympics: Evolution of Sports
Respiratory: Seasonal flu viruses
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