By VETTAPHARMA reporter – Derek Roche: Fosun Pharma announced that its investigational FXR0906, a liver-targeted small interfering RNA (siRNA) therapy for hypertriglyceridemia (HTG), has entered clinical development in China after the first participant was dosed in a Phase 1 clinical trial.
FXR0906 is designed to reduce apolipoprotein C-III (APOC3) through messenger RNA silencing, with the aim of lowering serum triglyceride levels in patients with HTG. Fosun Pharma has obtained an exclusive license to research, develop, register, manufacture and commercialize FXR0906 in mainland China, Hong Kong and Macau.
According to Fosun Pharma, no siRNA therapy for hypertriglyceridemia has yet been approved in mainland China. FXR0906 received approval through the 30-day fast-track review pathway for innovative drug clinical trial applications from China’s National Medical Products Administration (NMPA) on July 15, 2026.
The Phase 1 clinical development program in China will include a Phase 1 bridging study followed by subsequent clinical studies. These studies are designed to evaluate the therapy’s safety, tolerability, pharmacokinetics and preliminary efficacy in Chinese patients with hypertriglyceridemia.
Hypertriglyceridemia is a common form of dyslipidemia characterized by elevated blood triglyceride levels. Fosun Pharma estimates that approximately 15% of China’s population has HTG, defined as triglyceride levels of at least 2.3 mmol/L, or approximately 200 mg/dL. The company estimates that approximately 10 million people in China have severe hypertriglyceridemia, defined as triglyceride levels of at least 5.7 mmol/L, or approximately 500 mg/dL.
Elevated triglyceride levels are associated with an increased risk of atherosclerotic cardiovascular disease and acute pancreatitis. Fosun Pharma noted that currently available triglyceride-lowering treatments, including fibrates, omega-3 fatty acids and nicotinic acid, have limitations in efficacy or safety, highlighting an ongoing need for additional treatment approaches.
The company expects APOC3-targeted siRNA therapy to potentially provide a new treatment option for patients with HTG in China, with the potential advantages of a long-acting effect and convenient administration.
The first participant dosing represents a key R&D milestone for Fosun Pharma’s siRNA pipeline and expands its innovative-drug development efforts in the cardiovascular and metabolic disease areas.
Quick FAQs
1. What Is FXR0906?
FXR0906 is an investigational liver-targeted siRNA therapy designed to reduce APOC3 production through mRNA silencing and thereby lower serum triglyceride levels.
2. What Happened?
The first participant was dosed in a Phase 1 clinical trial in China, marking the start of clinical development of FXR0906 in the country.
3. What Is The Drug Designed To Treat?
FXR0906 is being developed for hypertriglyceridemia, including severe hypertriglyceridemia.
4. How Does FXR0906 Work?
The therapy is designed to silence APOC3 mRNA, reducing APOC3 levels and potentially lowering circulating triglyceride levels.
5. What Will The Phase 1 Trial Evaluate?
The Chinese clinical program will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy in Chinese patients with hypertriglyceridemia.
6. Why Is This Important?
Fosun Pharma states that no siRNA treatment for hypertriglyceridemia is currently approved in mainland China. FXR0906 could therefore introduce a new siRNA-based approach for patients with elevated triglyceride levels.
