TAIPEI, Taiwan, August 5, 2024－TaiGen Biotechnology Company, Limited (“TaiGen”) announces today that the business partner, Joincare Pharmaceutical, has submitted the New Drug Application (NDA) for the influenza antiviral Pixavir marboxil (TG-1000) to the National Medical Products Administration (NMPA) in mainland China.

The NDA submission is supported by a phase III trial comparing Pixavir to placebo in 752 adult and adolescent patients with uncomplicated acute influenza infection. The primary endpoint of the study, the median time to alleviation of all influenza symptoms in the Pixavir group was 60.9 hours, compared to 87.9 hours in the placebo group, demonstrating a statistically significant reduction (P<0.0001). Subgroup analyses by virus subtype and age also showed significantly shorter symptom relief times compared to the placebo group, with an even greater difference in median relief time among adolescents, indicating that the drug is more effective for adolescent flu patients.

Regarding the secondary endpoints, the trial results showed that Pixavir accelerated the time to fever resolution and significantly shortened the time to viral inactivation. Additionally, in the resistance detection analysis, data from Phase II and Phase III trials showed no drug-resistance mutations in patients infected with influenza B virus and adolescent subjects, indicating that Pixavir has the potential to overcome the resistance issue that is of significant concern to health care providers.

About Pixavir marboxil (TG-1000)
Pixavir marboxil is a novel influenza antiviral independently developed by TaiGen Biotechnology. It is an endonuclease inhibitor that blocks the replication and transmission of the influenza virus via a cap-snatching mechanism. Pixavir has completed Phase III clinical trials, which confirmed its effectiveness against influenza-A, influenza-B, and Tamiflu-resistant viruses.

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.