CFDA approves Taiwan Taijing new antibiotic product Taigexyn June 23, 2016 Source: Bio Valley The State Food and Drug Administration (CFDA) recently approved Taigexyn (nemonoxacin) capsules, a new antibiotic product developed by Taiwan's TaiGen Biotech Co., Ltd., which was approved by Taiwanese companies for research and development in the mainland. The first new class 1.1 drug sold, and the first new drug approved by the CFDA since the July 2015 release of the most stringent new drug clinical data self-inspection order. According to a cooperation agreement reached in June 2012, Zhejiang Pharmaceutical Co., Ltd. will be solely responsible for the production and sales of Taigexyn in mainland China. The company has plans to bring its products to the market in the second half of 2016. Previously, Taigexyn 250mg capsules were approved by the Taiwan Food and Drug Administration (TFDA) for community-acquired bacterial pneumonia (CAP) treatment in March 2014. The CFDA approval also marks the second market approval of Taigexyn, which will further expand the commercial prospects of the product. In addition to oral preparations, Taijing intends to submit a marketing application for 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 exceeding $12 billion. Taigexyn's excellent performance against resistant bacteria and its low propensity to develop resistance have made it a very valuable tool for combating resistant bacteria. Taigexyn is a new molecular entity (NCE), a broad-spectrum, non-fluorinated quinolone antibiotic that can be administered both orally and intravenously. Taigen has completed several multi-country multi-center clinical trials confirming the efficacy and safety of Taigexyn. In clinical trials, the drug has demonstrated antibacterial activity against resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), quinolone-resistant Staphylococcus aureus, and quinolone-resistant Streptococcus pneumoniae. In the United States, the FDA granted Taigexyn in December 2013 for the treatment of community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infection (ABSSSI) qualified infectious disease products (QIDP) qualification and fast-track status. In addition to Taigexyn, Taijing has two in-house developed new chemical entities (NCEs) in clinical development: (1) TG-0054 is a chemokine receptor antagonist for stem cell transplantation and chemotherapy sensitization; (2) TG-2349 is a chronic hepatitis C (HCV) protease inhibitor for the treatment of chronic hepatitis infection. One-stop solution, one machine multi-test
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CFDA approves Taiwan Taijing new antibiotic product Taigexyn