Recently, JiuDian Pharmaceutical's Choline Fenofibrate Sustained-release Capsules have received marketing approval from  the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug is recognized as passing the consistency evaluation for generic drugs in terms of quality and efficacy. As a newly added Class B drug in the latest National Reimbursement Drug List (NRDL), this medication, with its next-generation sustained-release technology, offers significant clinical advantages such as high bioavailability, no need for hepatic metabolism, and safer combination therapy, providing a superior treatment option for patients with hypertriglyceridemia and mixed dyslipidemia.

Hypertriglyceridemia has a prevalence rate of up to 15% in China and is a major risk factor for atherosclerotic cardiovascular disease. It is also closely associated with health issues such as acute pancreatitis, obesity, diabetes, fatty liver, and chronic kidney disease. Effective control of blood lipids, particularly triglyceride levels, is crucial for preventing severe complications.

According to data from Menet, the domestic hospital market size for triglyceride-lowering drugs reached 740 million yuan in the first half of 2024. Among the three major drug classes—fibrates, omega-3 fatty acids, and niacin—fibrates dominate the market (with a share exceeding 90%) due to robust evidence-based medical support, with fenofibrate being the most widely used. As an optimized next-generation product in this category, Choline Fenofibrate Sustained-release Capsules, now included in the NRDL, will accelerate its clinical adoption and benefit more hyperlipidemia patients.

Fenofibrate, as a prodrug, requires hepatic esterification into fenofibric acid to become active. Due to its low solubility in water, it has limited bioavailability and must be taken with meals, posing inconveniences for patients. Additionally, safety concerns regarding its combination with statins have been highlighted in the drug's labeling. In contrast, Choline Fenofibrate Sustained-release Capsules, as the active metabolite of fenofibrate, demonstrate significant advantages in efficacy stability, safety, and convenience.

Designed specifically for lipid regulation, Choline Fenofibrate Sustained-release Capsules feature sustained-release technology that ensures gradual release in the body, maintaining stable blood concentration. Compared to traditional drugs, it offers clinical benefits such as higher bioavailability, no need for hepatic metabolism, and safer combination therapy, making it a superior choice for patients with hypertriglyceridemia and mixed dyslipidemia.

The drug's labeling explicitly states that it can be safely combined with statins without dose adjustment, alleviating patient concerns and improving treatment adherence and efficacy. With a convenient dosing regimen—one capsule (135 mg) per day, taken without regard to meals—it provides flexible treatment options and enhances overall convenience.

This approval marks another milestone in JiuDian Pharmaceutical's ongoing innovation and commitment to the field of cardiovascular and cerebrovascular disease treatment. Moving forward, the company will continue to uphold its philosophy of "Integrating Tradition and Innovation, Delivering Health" to contribute to the advancement of the "Healthy China" initiative.