TAIPEI, April 17,
2024 /PRNewswire/ -- 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 TG-1000
treatment was shorter than that of the placebo group, with a
statistically significant difference. TG-1000 also possesses great
safety profile, and there was no clinically significant safety
concerns observed. Furthermore, TaiGen will advance cooperation and
development negotiation in Europe,
the U.S., and other Asian countries. It is expected that in the
second half of the year, Joincare Pharmaceutical will file a new
drug application for TG-1000 in mainland China.
The primary endpoint of the study, the median time to
alleviation of all influence symptoms of TG-1000 group (60.9
hours), was shorter than that of the placebo group (87.9 hours). It
shows that TG-1000 effectively shortens the time for influenza
symptom alleviation, which is statistically significant
(P<0.0001).
The secondary endpoints of the study include antiviral efficacy,
clinical symptom alleviation, and influenza related complications.
Those indicators are still 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. The purpose is to evaluate the efficacy and
safety of TG-1000 compared with placebo in adult and adolescent
patients with uncomplicated acute influenza infection. 752
participants are randomly allocated to TG-1000 treatment group and
placebo control group. 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.
About TaiGen Biotechnology
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.
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SOURCE TaiGen