Taigexyn, a biological antibiotic, was approved by Taiwan

Taiwan's Taigen biotechnology company announced on March 13 that taigexyn (nemonoxacin) oral formula (500mg) new drug application (NDA) was approved by Taiwan's food and Drug Administration (TFDA) for the treatment of community-acquired bacterial pneumonia (CAP) Taiwan is the first region to be approved for listing by taigenxyn Taigexyn NDA, previously submitted to China's State Food and Drug Administration (CFDA) in April 2013, is currently under review Clinical trials of taigexyn for community acquired bacterial pneumonia (CAP) are being carried out in Taiwan and Mainland China In June 2012, Taigen granted Zhejiang Pharmaceutical Co., Ltd taigexyn the exclusive agency right in mainland China Taigexyn, a new molecular entity (NCE), is a broad-spectrum, non fluoroquinolones antibiotic, which can be administered orally and intravenously at the same time Taigen has completed several multi-national and multi center clinical trials to confirm the efficacy and safety of taigexyn In clinical trials, the drug has shown antimicrobial activity against resistant bacteria such as methicillin resistant Staphylococcus aureus (MRSA), quinolone resistant Staphylococcus aureus and quinolone resistant Streptococcus pneumoniae In addition, the FDA granted taigexyn qualified infectious disease product (qidp) qualification and fast track status in December 2013 for the treatment of community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structural infection (absssi) Original English: Taipei, March 13, 2014 / PRNewswire / -- Taigen biotechnology company, Limited ("TaiGen") today announced that the Taiwan Food and Drug Administration (TFDA) has approved the new drug application (NDA) of Taigexyn? (nemonoxacin) oral formulation (500 mg) for the treatment of community-acquired bacterial pneumonia (CAP) With this NDA approval, Taiwan is the first region to grant marketing approval to Taigexyn? An NDA for Taigexyn?  was also submitted to China FDA (CFDA) in April 2013 and is currently under review 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." In June 2012, TaiGen out-licensed the exclusive rights of Taigexyn? in mainland China to Zhejiang Medicine Co and in January 2014, TaiGen out-licensed the exclusive rights in Russian Federation, Commonwealth Independent States, and Turkey to R-Pharm of Russia.  Discussions of Taigexyn? partnerships in other territories are ongoing About TaiGen Biotechnology TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China In addition to Taigexyn?, TaiGen has two other in-house discovered NCEs in clinical development under IND with US FDA: TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, in Phase 2 Both TG-0054 and TG-2349 are currently in clinical trials in patients in the US