Taigexyn, a new antibiotic product approved by CFDA, is the first class 1.1 new drug developed by Taiwan enterprises and approved for sale in mainland China

June 20, 2016 --The State Food and Drug Administration (CFDA) recently approved taigexyn (nemonoxacin) capsule, a new antibiotic product developed by Taiwan's Taigen biotechnology company, to be sold in the mainland The drug is the first 1.1 new drug approved by Taiwan enterprises to be sold in the mainland It is also the most stringent self-examination order for clinical data of new drugs issued by CFDA since July 2015 To get the first new drug approved According to a cooperation agreement reached in June 2012, Zhejiang Pharmaceutical Co., Ltd will be fully responsible for taigexyn's production and sales in mainland China, and the company has planned to market its products in the second half of 2016 Previously, taigexyn 250mg capsule was approved by Taiwan food and Drug Administration (TFDA) for the treatment of community-acquired bacterial pneumonia (CAP) in March 2014 The CFDA approval also marks taigexyn's second market approval, which will further expand the product's business prospects In addition to oral preparations, Taijing plans to submit the listing application of intravenous preparations to CFDA in the second half of 2016 Dr Xu Mingzhu, chairman and CEO of Taijing, said that mainland China is the world's largest antibiotic market, with annual sales of more than 12 billion US dollars Taigexyn is a valuable tool to fight against drug-resistant bacteria because of its excellent performance and low tendency to produce drug-resistant resistance Taigexyn is a new molecular entity (NCE), which is a broad-spectrum, non fluoroquinolones antibiotic that 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 the United States, in December 2013, FDA awarded taigexyn the qualification and fast track status of qualified infectious disease product (qidp) for the treatment of community acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structural infection (absssi) In addition to taigexyn, Taijing has two new chemical entities (NCE) in clinical development: (1) tg-0054 is a chemokine receptor antagonist used for stem cell transplantation and chemotherapy sensitization; (2) tg-2349 is a protease inhibitor of chronic hepatitis C (HCV) for the treatment of chronic hepatitis C infection Original source: China FDA approved Taigen biotech pneumonia focused taigexyn antibiatic