Fosun Pharmaceutical (02196) FXR0906, an innovative small nucleic acid drug, was approved for the treatment of hypertriglyceridemia in the “30-day Fast Track” clinical trial

The Zhitong Finance App learned that on July 15, 2026, Fosun Pharmaceutical (stock code: 600196.SH; 02196) announced that the holding subsidiary Fosun Pharmaceutical Industry Development (Shenzhen) Co., Ltd. (hereinafter referred to as “Fosun Pharmaceutical (Shenzhen)”) has received approval from the State Drug Administration to conduct clinical trials for FXR0906 injection (hereinafter referred to as “FXR0906”) for the treatment of hypertriglyceridemia (HTG).

FXR0906 is an innovative liver-targeted siRNA-interfering nucleic acid drug. Through RNA interference technology, APOC3 gene expression is silenced to reduce serum triglyceride levels, thereby achieving treatment of hypertriglyceridemia. FXR0906 was introduced with permission from Fosun Pharmaceutical Group, and enjoys exclusive research, development, registration, production and commercialization rights for this drug in China, Hong Kong and Macau regions.

As of the announcement date, no minor interfering nucleic acid drugs for the treatment of hypertriglyceridemia have been approved for marketing in China. According to reports, on July 15, 2026, FXR0906 was approved by the Drug Evaluation Center for the 30th Fast Track for Clinical Trials of Innovative Drugs. FXR0906 will conduct registered clinical studies in China, including phase I bridging studies and follow-up clinical studies to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of the drug in Chinese patients with hypertriglyceridemia (HTG).

Hypertriglyceridemia (HTG) is a common dyslipidemia. According to statistics, the prevalence of HTG with Tg≥2.3 mmol/L (about 200 mg/dL) in China is about 15%, and there are about 10 million patients with SHTG (severe hypertriglyceridemia) with Tg≥5.7 mmol/L (about 500 mg/dL). At the same time, HTG is a risk factor for atherosclerotic cardiovascular disease (ASCVD) and acute pancreatitis. Existing TG-lowering drugs (fibrates, omega-3 fatty acids, niacin, etc.) have limited efficacy or safety issues, and clinical needs are far from being met.

On September 12, 2025, the State Drug Administration issued the “Notice of the State Drug Administration on Matters Relating to Optimizing Clinical Trial Evaluation and Approval of Innovative Drugs” (No. 86 of 2025). In order to further support clinical value-oriented innovative drug research and development and improve the quality and efficiency of clinical research and development, clinical trial applications for innovative drugs that meet the requirements were completed within 30 working days after acceptance.

FXR0906 passed the fast-track clinical trial approval, which is not only the evaluation center's initial affirmation of its clinical value and development potential, but also a key milestone in Fosun Pharmaceutical's deepening development in the field of innovative small nucleic acid drugs. Fosun Pharmaceutical will accelerate the clinical development process of this innovative therapy, with a view to providing Chinese HTG patients with more innovative, more effective, and more convenient new treatment options as soon as possible.