TaiGen Biotechnology Company, Limited announced that it has filed an Investigational New Drug application with the US FDA for its influenza antiviral TG-1000.
TAIPEI, Taiwan, Oct. 4, 2020 /PRNewswire/ -- TaiGen Biotechnology Company, Limited (“TaiGen”) announced today that it has filed an Investigational New Drug (IND) application with the US FDA for its influenza antiviral TG-1000.
TG-1000 is a novel pan-influenza antiviral, which interrupts viral replication and transmission via a cap-snatching mechanism and is able to do this effectively against influenza-A, influenza-B, avian flu H7N9, and Tamiflu-resistant viruses. The first US patent for TG-1000 was successfully prosecuted and granted by the United States Patent and Trademark Office on Jan 14th, 2020.
A Phase 1 trial for in China was initiated by TaiGen in July 2020 and has successfully completed the first 4 groups in the single ascending dose part. A Phase 2 protocol has also been submitted to the institutional review board (IRB) of China-Japan Friendship Hospital in Beijing last month.
“We are excited about the IND filing in the US for the internally developed TG-1000 which has the potential to be a single dose treatment for influenza,” said Kuo-Lung Huang, the Chairman and CEO of TaiGen, “TG-1000 IND filing demonstrates yet again TaiGen’s capacity and experience in research and development of NCEs.”
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to TG-1000, TaiGen has three other in-house discovered NCEs: Taigexyn®, a novel non-fluorinated quinolone available in both oral and intravenous formulations, TG-3000, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, and Furaprevir, a HCV protease inhibitor for treatment of chronic hepatitis infection. Taigexyn® is already on the market in the mainland China and Taiwan, TG-3000 has completed Phase 2 clinical studies, and Furaprevir is currently in Phase 3 clinical development.
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