台湾太景（TaiGen）生物科技公司3月13日宣布，Taigexyn（nemonoxacin，奈诺沙星）口服配方（500mg）新药申请（NDA）获台湾食品药物管理局（TFDA）批准，用于社区获得性细菌性肺炎（CAP）的治疗。台湾是获得Taigenxyn上市批准的首个地区。此前于2013年4月提交至中国国家食品药品监督管理总局（CFDA）的Taigexyn NDA目前正在审查中。Taigexyn静脉制剂用于社区获得性细菌性肺炎（CAP）的相关临床试验在正在台湾和中国大陆开展。2012年6月，Taigen授予浙江医药股份有限公司Taigexyn在中国大陆的独家代理权。
Taigexyn是一种新分子实体（NCE），是一种广谱、非氟化喹诺酮类抗生素，可同时口服和静脉给药。Taigen已完成了数个多国多中心临床试验，证实了Taigexyn的疗效和安全性。在临床试验中，该药已表现出对耐药细菌如耐甲氧西林金黄色葡萄球菌（MRSA）、耐喹诺酮类金黄色葡萄球菌、耐喹诺酮类肺炎链球菌的抗菌活性。
此外，FDA于2013年12月授予Taigexyn合格传染病产品（QIDP）资格认定和快速通道地位，用于治疗社区获得性细菌性肺炎（CAP）和急性细菌性皮肤及皮肤结构感染（ABSSSI）的治疗。
英文原文：
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.
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