TAIPEI, Taiwan, June 13, 2016 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") announced today that the Company has received approval from the China Food and Drug Administration (CFDA) to market the oral formulation of its novel antibiotic, Taigexyn® (nemonoxacin), in mainland China. It is the first Class 1.1 new drug developed by a Taiwanese company to receive market approval in mainland China. It is also the first new drug approval after the CFDA announced the requirement of self-inspection of drug clinical trial data in July 2015.
Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen said, "This is the second market approval for Taigexyn® and will further expand its commercial opportunity. Mainland China is the largest antibiotic market in the world with annual sales exceeding US$12 billion. Taigexyn®'s excellent activity against drug-resistant bacteria and low propensity to resistance development is a valuable tool in fighting the problem of increasing antimicrobial resistance."
Taigexyn® will be marketed in mainland China by Zhejiang Medicine Co. through an exclusive marketing and manufacturing licensing agreement. TaiGen also partnered the exclusive rights in the Russian Federation, the Commonwealth of Independent States, and Turkey to R-Pharm of Russia.
Taigexyn® is a new chemical entity (NCE), non-fluorinated quinolone, broad spectrum antibiotic available in both oral and intravenous formulations. TaiGen have completed multi-national and multi-center clinical trials in community-acquired pneumonia (CAP) with demonstrated efficacy and safety. In particular, Taigexyn® has clinical activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumonia (PRSP). Taigexyn®, 250 mg capsules, has received marketing approval from Taiwan Food and Drug Administration and launched in the Taiwan market. In addition to the oral formulation, TaiGen is planning to file for market approval of the intravenous formulation in China in the second half of 2016. TaiGen owns the worldwide patent portfolio of Taigexyn® that protects composition, use, and processes.
Taigexyn® is granted both Qualified Infectious Disease Product (QIDP) and fast track designations by the US Food and Drug Administration for CAP and acute bacterial skin and skin structure infections (ABSSSI). These two designations will provide an additional five year extension to the NCE market exclusivity and priority review when applying for market approval in the US to TaiGen and/or its partners.
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, and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection. Both TG-0054 and TG-2349 are currently in Phase 2 clinical development.
Peter W. Tsao, PhD, Vice President Corporate Development
 Class 1.1 means a NCE that has not been marketed anywhere in the world at the time of application for market approval in China
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