TAIPEI, Taiwan, May 27, 2020 – TaiGen Biotechnology Company, Limited (“TaiGen”) announced today that they received a clinical trial authorization (CTA) for influenza antiviral TG-1000 from China NMPA (National Medical Products Administration). TaiGen is expecting to launch the phase I clinical trial in June 2020, said the Chairman and CEO of TaiGen, Kuo-Lung Huang.
 
As a highly competent R&D team, TaiGen got a waiver of notice for pre-IND meeting from China CDE (Center for Drug Evaluation). Huang said that CDE has never request for additional documents during the IND process. TaiGen has also well prepared for the phase I trial with clinical trial site, CRO, SMO, patient recruitment agency and logistic company in order to activate the trial on schedule.
 
TG-1000 is an influenza antiviral, acts on cap-snatching mechanism and blocks flu virus replication and transmission. It inhibits influenza virusus A, B and avian influenza virus H7N9 effectively. TaiGen also granted first US patent for TG-1000 from the United States Patent and Trademark Office on Jan 14, 2020.