Joincare Pharmaceutical Group Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has reportedly completed the unblinding of a Phase III trial for TG-1000, an investigational influenza antiviral drug. The trial has shown positive preliminary data, indicating that the company is now preparing to file a New Drug Application (NDA) in China. TG-1000 is developed in collaboration with TaiGen Biotechnology Co., Ltd, a Taiwan, China-based biotechnology company.
TG-1000 is formulated to effectively inhibit influenza viruses A, B, and the avian influenza virus H7N9 with a single dose, offering efficacy up to 72 hours after the onset of the first symptoms. The Phase III study demonstrated that TG-1000 significantly accelerated the alleviation of all influenza symptoms compared to the placebo group, with no concerning safety signals. The primary endpoint of the study revealed a median time to alleviation of all influenza symptoms of 60.9 hours in the TG-1000 group, significantly shorter than the 87.9 hours observed in the placebo group (P<0.0001). The multi-center trial involved 752 adolescent or adult patients with uncomplicated acute influenza infection.
According to TaiGen’s press release, in addition to seeking approval in China, the company will also use the data to pursue licensing agreements for TG-1000 in Europe, the US, and other Asian markets.- Flcube.com
