FXR0906是一款肝靶向的siRNA小干扰核酸创新药，通过RNA干扰技术精准沉默APOC3基因表达，降低血清甘油三酯水平，从而实现对高甘油三酯血症的治疗。FXR0906由复星医药集团许可引进，并享有该药品于中国内地及港澳地区研究、开发、注册、生产及商业化的独占权利。

截至目前，中国境内尚无用于治疗高甘油三酯血症的小干扰核酸药物获批上市。2026年7月15日，FXR0906获国家药品监督管理局创新药临床试验审评审批30日快速通道批准，在中国境内开展注册临床研究，包括I期桥接研究及后续临床研究，旨在评估该药物在中国HTG患者中的安全性、耐受性、药代动力学及初步疗效。本次首例参与者给药的完成，标志着这一创新疗法中国临床开发的正式启航。

高甘油三酯血症（HTG）是常见的血脂异常疾病。据统计，中国TG≥2.3mmol/L（约200mg/dL）的HTG患病率约15%，TG≥5.7mmol/L（约500mg/dL）的sHTG（严重高甘油三酯血症）患者约1,000万人。同时，HTG是动脉粥样硬化性心血管疾病（ASCVD）及急性胰腺炎的风险因素，现有降TG药物（贝特类、ω-3脂肪酸、烟酸类等）疗效有限或存在安全性问题，临床需求远未得到满足。以APOC3为靶点的siRNA疗法有望凭借长效、便利、安全等优势，为中国广大HTG患者带来治疗新选择。

FXR0906首例参与者给药是复星医药小核酸领域的关键研发里程碑，也是践行公司创新引领战略的又一实质性进展，将进一步夯实公司心血管及代谢领域的创新管线，加速为中国患者提供更可及、更有效的治疗选择。

Fosun Pharma's siRNA Innovative Drug FXR0906 for Hypertriglyceridemia Completes First Participant Dosing in Phase 1 Clinical Trial in China

On 20 August 2026, Fosun Pharma (Stock Codes: 600196.SH; 02196.HK) announced that FXR0906 (the “Drug”), a liver-targeted small interfering RNA (siRNA) drug for the treatment of hypertriglyceridemia (HTG), has recently completed the first participant dosing in its Phase 1 clinical trial in Chinese mainland.

FXR0906 is a liver-targeted small interfering RNA (siRNA) drug, which can precisely reduce the level of APOC3 through an mRNA silencing strategy, thereby lowering serum triglyceride level in patients with hypertriglyceridemia. FXR0906 is licensed in by the Group, which is granted an exclusive license to research, develop, register, manufacture and commercialize the drug in Chinese mainland, Hong Kong SAR and Macau SAR.

To date, no small interfering RNA drug for the treatment of hypertriglyceridemia has been approved for marketing in Chinese mainland. On 15 July 2026, FXR0906 received approval through the 30-day fast-track review pathway for innovative drug clinical trial applications by the National Medical Products Administration (.NMPA) Registration clinical studies of FXR0906 will be conducted in Chinese mainland, including a Phase 1 bridging study and subsequent clinical studies, designed to evaluate the Drug's safety, tolerability, pharmacokinetics and preliminary efficacy in Chinese patients with HTG. The completion of the first participant dosing marks the official launch of clinical development of this innovative therapy in China.

HTG is a common dyslipidemia. According to statistics, the prevalence of HTG (TG ≥ 2.3 mmol/L, approximately 200 mg/dL) in China is approximately 15%, and the number of patients with severe hypertriglyceridemia (sHTG, TG ≥ 5.7 mmol/L, approximately 500 mg/dL) is approximately 10 million. HTG is a risk factor for atherosclerotic cardiovascular disease (ASCVD) and acute pancreatitis. Currently available TG-lowering drugs (such as fibrates, omega-3 fatty acids, and nicotinic acid) have limited efficacy or safety concerns, leaving a significant unmet clinical need. The APOC3‑targeted siRNA therapy is expected to bring a new treatment option for the broad HTG patient population in China, leveraging advantages such as long‑acting effect, convenience, and safety.

The first participant dosing of FXR0906 represents a key R&D milestone for Fosun Pharma in the siRNA field, and marks another tangible progress in executing the Company's innovation‑driven strategy. It will further strengthen the Company's innovative pipeline in the cardiovascular and metabolic therapeutic areas, and accelerate the delivery of more accessible and effective treatment options for patients in China.

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