Li-Wen Chang

Vice President of Clinical Development
TaiGen Biotechnology

​Ms. Chang joined TaiGen in 2003, held the positions of Senior Manager, Associate Director and Senior Director of Clinical Development and now serves as Vice President of Clinical Development Department. 
Ms. Chang has over 20-year working experience in clinical research and development field, with the last 15 years in leading clinical science team for preparing clinical-related documents from IND packages until NDA dossiers. Took on lead medical writer position and successfully received four IND approvals from US FDA (NCEs), seven IND approvals from NMPA (Class 1 New Drug), and two NDA approvals from TFDA and CFDA (Taigexyn®).

Ms. Chang has strong understanding of new drug development and clinical research study, especially in infectious diseases (such as pneumonia, influenza, chronic hepatitis C infection) and hematology & oncology therapeutic areas. She played a key role in maintaining relationship with key opinion leaders on several ongoing and new clinical projects. Since 2008, Ms. Chang led the medical science team to work on the clinical trials of Nemonoxacin, Burixafor, Furaprevir, and Pixavir marboxil in the United States, Mainland China and Taiwan..
Ms. Chang had excellent inter-personal and coordination skills, with demonstrated ability to lead team to achieve company’s milestones; Ability to think critically, solve problems proactively and effectively, and learn quickly. Ms. Chang obtained her master degree in Biochemistry and Molecular Biology from National Cheng-Kung University in Taiwan.
 

Speech title & Synopsis

Influenza Antiviral TG-1000

Every year, influenza affects approximately 1 billion people globally, with severe cases reaching 3 to 5 million and causing 290,000 to 650,000 deaths, as reported by the World Health Organization. Current treatments like Oseltamivir must be administered twice daily for 5 days and have limited efficacy in reducing complications, hospitalizations, and mortality, according to updated clinical data.
In response, TaiGen Biotechnology has developed Pixavir marboxil (TG-1000), an innovative oral antiviral medication targeting the influenza virus. Acting as a cap-dependent endonuclease inhibitor, TG-1000 effectively disrupts virus replication and transmission for influenza A and B strains.
TG-1000 demonstrates positive and promising phase 3 results recently. Taken orally as Only Single-Dose, TG-1000 significantly reduced the time to alleviation of influenza symptoms versus placebo (median time of 60.9 hours versus 87.9 hours; p<0.0001) in treating adult and adolescent patients with acute uncomplicated flu. Additionally, TG-1000 demonstrated rapid reduction in infectious virus load and cessation of viral shedding, together with favorable safety profiles and faster return to pre-influenza health status, TG-1000 represents a promising option for the treatment of influenza.
Key features of TG-1000 include:

Mechanism targeting the essential cap-snatching process in viral replication

Potent activity against both influenza A & B strains

Superior inhibition of influenza B compared to neuraminidase inhibitors like Oseltamivir

Ability to suppress Oseltamivir-resistant viral strains

High potential to overcome drug resistance issues

Convenient single-oral-dose administration throughout the course of influenza

High safety profile
Notably, TG-1000 holds global patent protection until at least 2043, with substance patents granted in key markets including the US, Canada, Australia, NZ, Japan, Korea, Israel, India, Chile, and Greater China. TaiGen Biotechnology plans to expand development partnerships across Europe, the Americas, and Asian countries outside of China. By the 2024 Q3, licensing partner Joincare Pharmaceutical will submit the NDA application for TG-1000 in mainland China.
TG-1000 represents a significant advancement in flu treatment, offering a promising alternative for managing influenza with improved efficacy, convenience use, and safety beyond current standards.