Shanghai Fosun Pharmaceutical (02196) innovative small nucleic acid drug FXR0906 has been approved for clinical trial "30-day fast track" for the treatment of hypertriglyceridemia.

On July 15, 2026, Shanghai Fosun Pharmaceutical (stock code: 600196.SH; 02196) announced that its holding subsidiary Shanghai Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd. (hereinafter referred to as "Shanghai Fosun Pharmaceutical (Shenzhen)") has received approval from the National Medical Products Administration to conduct clinical trials for FXR0906 injection (hereinafter referred to as "FXR0906") for the treatment of Hypertriglyceridemia (HTG). FXR0906 is a liver-targeted siRNA small interfering nucleic acid innovative drug, which silences the expression of the APOC3 gene through RNA interference technology, reducing serum triglyceride levels, thereby treating HTG. FXR0906 is licensed and exclusively researched, developed, registered, produced, and commercialized within China and the Hong Kong and Macau regions by the Shanghai Fosun Pharmaceutical Group. As of the announcement date, there are no siRNA drugs approved for the treatment of HTG in China. It is reported that on July 15, 2026, FXR0906 was approved for fast-track clinical trials by the Drug Evaluation Center for Innovative Drugs. FXR0906 will conduct registered clinical studies in China, including Phase I bridging studies and subsequent clinical studies, aiming to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of the drug in Chinese HTG patients. HTG is a common lipid metabolism disorder. According to statistics, the prevalence of HTG in China with TG2.3mmol/L (approximately 200mg/dL) is about 15%, and sHTG (severe hypertriglyceridemia) patients with TG 5.7mmol/L (approximately 500mg/dL) are about 10 million. HTG is a risk factor for atherosclerotic cardiovascular disease (ASCVD) and acute pancreatitis. Existing TG-lowering drugs (fibrates, -3 fatty acids, niacin, etc.) have limited efficacy or safety issues, and the clinical demand is far from being met. On September 12, 2025, the National Medical Products Administration issued Announcement No. 86 of 2025 on "Optimizing the Evaluation and Approval of Clinical Trials for Innovative Drugs," to further support innovation-oriented drug research and development based on clinical value, improve the quality and efficiency of clinical research and complete the review and approval of clinical trial applications for eligible innovative drugs within 30 working days after acceptance. The approval of FXR0906 through the fast-track clinical trial route is not only a preliminary affirmation of its clinical value and development potential by the evaluation center but also a key milestone for Shanghai Fosun Pharmaceutical's deep cultivation in the field of small nucleic acid innovative drugs. Shanghai Fosun Pharmaceutical will accelerate the clinical development process of this innovative therapy to provide more innovative, effective, and convenient treatment options for Chinese HTG patients as soon as possible.