TaiGen announced on the evening of the 17th that its subsidiary received notification from its cooperation partner, Health Elements Pharmaceuticals, that the third-phase clinical trial results of the anti-influenza virus new drug TG-1000 met the endpoints. Health Elements Pharmaceuticals will apply for TG-1000's new drug inspection and registration in mainland China.
TaiGen stated that the indication claim of TG-1000 capsules is for patients aged 12 and above with uncomplicated acute infections of influenza A and B viruses. The median time to symptom relief for the TG-1000 group and the placebo group was 60.9 hours and 87.9 hours, respectively, demonstrating achievement of the primary efficacy endpoint with statistical significance (P<0.0001).
Regarding the statistical results of secondary endpoints, antiviral efficacy is currently undergoing examination and statistical analysis, while clinical symptom resolution and influenza-related complications are under statistical analysis. In terms of safety, the incidence rate of adverse events (AEs) in the TG-1000 trial group was similar to that in the placebo group. The TG-1000 trial group demonstrated good safety, with no deaths or drug-related serious adverse reactions reported.
TaiGen pointed out that the surge in influenza cases from 2023 to 2024 indicates a trend of coexistence between influenza viruses and humans. The positive results of the TG-1000 Phase III clinical trial represent another opportunity for an innovative drug to enter clinical use. TaiGen maintains a cautiously optimistic attitude. The sales of influenza drugs in mainland China in 2023 reached RMB 5.5 billion, surpassing RMB 6 billion including other generic drugs, returning to the market size before the COVID-19 pandemic. The potential for innovative influenza drugs to enter the market in the future is promising.
Resource (Mandarin):
