TAIPEI, Taiwan, March 20, 2025－TaiGen Biotechnology Company, Limited (“TaiGen”) announced today that its influenza antiviral, Pixavir marboxil (TG-1000), has been officially submitted for an Investigational New Drug (IND) application for pediatric formulation to the National Medical Products Administration (NMPA) of China by its collaboration partner. If no additional documentation is required, clinical trials are expected to commence in the second half of the year.

Kuo-Lung Huang, Chairman and Chief Executive Officer of TaiGen, pointed out, “Both Taiwan and mainland China's pharmaceutical markets face a shortage of pediatric-specific medications. In mainland China, in comparison to adult medications, pediatric drugs account for only about 2% of all medications, underscoring the urgent need for pediatric formulations.”

The influenza drug market in mainland China has been steadily recovering since the COVID-19 pandemic, with the sales of pediatric formulations significantly outpacing those of adult formulations. According to IQVIA data, between 2021 and 2024, sales of pediatric formulations of the influenza drug Oseltamivir accounted for approximately 60-70% of the total sales in China. In 2024, total sales reached approximately 4.9 billion RMB, with pediatric formulations representing about 70% of that (approximately 3.5 billion RMB).

Pixavir marboxil (TG-1000) is a cap-dependent endonuclease inhibitor that targets the viral replication process by inhibiting the cap-snatching mechanism. Phase III clinical trial data for adults and adolescents aged 12–18 have demonstrated a single dose of the drug effectively shortens the time to flu symptom relief. Its efficacy is particularly notable in the 12-18 age adolescent group. The pediatric formulation IND application aims to confirm the drug’s efficacy and safety in children under the age of 12.

About TaiGen Biotechnology
TaiGen Biotechnology, with a subsidiary in Beijing, China, was founded in 2001 and became publicly listed on the Taiwan OTC Stock Market in 2014. TaiGen is a fully-integrated pharmaceutical company dedicated to developing innovative small molecule drugs (New Chemical Entity, NCE). The company has extensive expertise in research topic selection, drug discovery, drug development, and regulatory approval. It possesses the capability to conduct multi-country, multi-center clinical trials and has a strong track record of international licensing. Its flagship product, non-fluorinated quinolone antibiotic Taigexyn® (Nemonoxacin), has received marketing approvals in Taiwan, mainland China, and Russia. The influenza antiviral Pixavir marboxil (TG-1000) has completed it phase III clinical trial and has been submitted for NDA approval in mainland China.