TAIPEI, Taiwan, April 18, 2024－TaiGen Biotechnology Company, Limited (“TaiGen”) announces today that the business partner, Joincare Pharmaceutical, has completed the unblinding of influenza antiviral TG-1000 phase III study. Preliminary data shows that the median time to alleviation of all influenza symptoms after treatment with TG-1000 was significantly shorter compared to the placebo group. Furthermore, TG-1000 demonstrated a favorable safety profile, with no clinically significant safety concerns observed. Following these encouraging results, TaiGen will proceed with cooperation and development negotiations in Europe, the U.S., and other Asian countries. Joincare Pharmaceutical is expected to file a new drug application for TG-1000 in mainland China in the second half of the year.

 

The primary endpoint of the study, the median time to alleviation of all influenza symptoms in the TG-1000 group was 60.9 hours, compared to 87.9 hours in the placebo group, demonstrating a statistically significant reduction (P<0.0001).

 

The 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 effect (AE) of TG-1000 group is similar to that of placebo group. TG-1000 treatment group possesses favorable safety profile with no death or serious adverse reaction occurred.

 

The phase III trial of TG-1000 is a multi-center, randomized and double-blinded study involving 752 participants. It aimed to evaluate the efficacy and safety of TG-1000 compared to placebo in adult and adolescent patients with uncomplicated acute influenza infection. Consistent with China influenza surveillance data, the majority of patients admitted to the Phase III trial are influenza virus A infected.

 

Kuo-Lung Huang, Chairman and CEO of TaiGen commented on the trial results, stating that “The surge in influenza cases from 2023 to 2024 indicates the trend of coexistence between influenza viruses and humans. The positive outcome of TG-1000 Phase III trial represents another opportunity for an innovative drug to enter clinical use. TaiGen holds a cautiously optimistic attitude.” He mentioned that the sales of influenza medication in mainland China exceeded RMB 6 billion in 2023, returning to the market size before the COVID-19 epidemic. The potential market size for innovative flu medication in the future can be expected.

 

TaiGen Biotechnology, with a subsidiary in Beijing, China, was founded in 2001 and became listed on the Taiwan OTC Stock Market in 2014. TaiGen is a fully-integrated pharmaceutical company dedicated to the development of innovative small molecule drugs with a focus on anti-infective drug research. Its flagship product, non-fluorinated quinolone antibiotic Taigexyn® (Nemonoxacin), has obtained marketing approvals in Taiwan, mainland China, and Russia. The influenza antiviral TG-1000 has completed the phase III clinical trial.