TAIPEI, Taiwan, Jan. 08, 2024 – TaiGen Biotechnology announced today that they have received notification from its China partner, Joincare Pharmaceutical Group Industry Co., Ltd., stating the completion of enrollment for the Phase III trial of TG-1000. In the post-pandemic era, there has been a rapid resurgence of influenza outbreaks in mainland China, thereby the enrollment of TG-1000 Phase III clinical trial has been remarkably smooth and swift.

Influenza virus has resurged as one of the primary infectious diseases globally. Since October 2023, mainland China has witnessed a significant rise in influenza outbreaks. Joincare, TaiGen’s partner in mainland China, completed the enrollment for TG-1000 within a few months, halving the originally planned time. The Phase III clinical trial of TG-1000 was designed as a multi-center, randomized, double-blind study amid at evaluating its efficacy and safety compared to a placebo in adults and adolescents with uncomplicated acute influenza virus infection. This trial involved 70 clinical centers with a total enrollment of 752 participants including 675 adults and 77 adolescents.

Kuo-Lung Huang, the chairman and CEO of TaiGen, stated, ”The accelerated enrollment reflects the resurgence of the influenza virus and demonstrates our partner’s dedication to driving the TG-1000 Phase III clinical trial. We’re confident in the subsequent development of TG-1000 in the mainland China market.”

The key difference between the Phase III and Phase II trials of TG-1000 lies in the age group of enrolled patients and the type of viral strains. The Phase III trial included adolescents aged 12 to 18. If the trial results meet the primary endpoint, future drug market inclusion will cover both adult and adolescent populations. Regarding viral strains, the recent influenza outbreaks in mainland China have been predominantly of the Influenza A virus (approximately 75-90%), the primary viral strain among Phase III clinical trial participants. In contrast, the earlier Phase II trials, impacted by the COVID-19 pandemic, experienced a rapid decline in influenza outbreaks, mainly driven by the less responsive Influenza B virus. Given TG-1000's efficacy against the Influenza B virus, both the teams at Joincare and TaiGen are optimistic about its effectiveness against the Influenza A virus.

Concurrent with the Phase III TG-1000 clinical trial are studies focusing on material balance, photo-toxicity, and reproductive toxicity. Presently, no photo-toxic or reproductive toxic effects have been observed, indicating favorable safety profiles. These trial outcomes collectively support the market development of TG-1000 in regions across Europe, America, and Asia.