Thursday, April 18, 2024
TaiGen Biotechnology Company, Limited ("TaiGen") has announced today that its business partner, Joincare Pharmaceutical, has concluded the unblinding process for the phase III study of the influenza antiviral TG-1000. Initial findings indicate that TG-1000 significantly reduced the median time for alleviation of all influenza symptoms compared to the placebo group. Additionally, TG-1000 demonstrated a favorable safety profile with no notable safety concerns observed. Encouraged by these results, TaiGen plans to initiate negotiations for cooperation and development in Europe, the U.S., and other Asian countries. Joincare Pharmaceutical intends to submit a new drug application for TG-1000 in mainland China in the latter half of this year.
The primary endpoint of the study, the median time to alleviate all influenza symptoms in the TG-1000 group, was notably shorter compared to the placebo group, demonstrating a statistically significant reduction (P<0.0001).
Secondary endpoints of the study, including antiviral efficacy, clinical symptom alleviation, and influenza-related complications, are currently undergoing testing and statistical analysis.
The incidence rate of adverse effects (AEs) in the TG-1000 group is similar to that of the placebo group. The TG-1000 treatment group demonstrates a favorable safety profile, with no instances of death or serious adverse reactions reported.
The phase III trial of TG-1000 is a multi-center, randomized, and double-blinded study involving 752 participants. Its objective is to evaluate the efficacy and safety of TG-1000 compared to placebo in adult and adolescent patients with uncomplicated acute influenza infection. Consistent with Chinese influenza surveillance data, the majority of patients enrolled in the Phase III trial are infected with influenza virus A.
Kuo-Lung Huang, Chairman, and CEO of TaiGen, commented on the trial results, stating, "The rise in influenza cases from 2023 to 2024 highlights the coexistence trend between influenza viruses and humans. The positive outcome of the TG-1000 Phase III trial represents another opportunity for an innovative drug to enter clinical use. TaiGen maintains a cautiously optimistic stance." He noted that influenza medication sales in mainland China surpassed RMB 6 billion in 2023, returning to pre-COVID-19 epidemic market sizes. The potential market size for innovative flu medication in the future is promising.
Source: taigenbiotech.com
