Qidu Pharmaceutical’s Yiruiqing® - Rosuvastatin Calcium and Ezetimibe Tablets (I) Approved for Marketing

On June 23, Qidu Pharmaceutical’s Rosuvastatin Calcium and Ezetimibe Tablets (I) (trademark: Yiruiqing®) received approval from the National Medical Products Administration (NMPA). The product is available in a strength of 10 mg rosuvastatin calcium (as C22H28FN3O6S) and 10 mg ezetimibe per tablet. Filed under Chemical Drug Category 4, it is deemed to have passed the generic drug quality and efficacy consistency evaluation.

China has a vast patient population with dyslipidemia, which surpassed 400 million by the end of 2025, with an adult prevalence rate exceeding 40%. However, disease awareness, treatment rates, and lipid target attainment remain generally low, posing significant risks for cardiovascular and cerebrovascular events. Lipid-lowering agents fall into two categories: monotherapy and combination therapy. Monotherapy contains a single lipid-lowering active ingredient acting on a single target—rosuvastatin and pitavastatin monotherapies are examples. Combination therapy comprises two active ingredients with complementary mechanisms in a fixed-dose ratio, enabling synergistic multi-target lipid reduction while reducing pill burden and improving treatment adherence. The newly approved Rosuvastatin Calcium and Ezetimibe Tablets (I) is a classic combination lipid-lowering agent, indicated for patients with primary hypercholesterolemia and mixed dyslipidemia who are inadequately controlled on monotherapy. Through the dual-target synergistic mechanism, rosuvastatin inhibiting hepatic cholesterol synthesis and ezetimibe blocking intestinal cholesterol absorption, the product achieves a “1+1>2” potent lipid-lowering effect. The Chinese Guidelines for Lipid Management (2024) explicitly recommends statin plus ezetimibe as a core intensified treatment strategy for high-risk and very-high-risk patients. The 2026 Guideline on the Management of Dyslipidemia lists this formulation as a recommended dual-therapy option, and it is included in the National Medical Insurance Catalog (Category B). The product’s sales exceeded RMB 3 million in 2024, surged to RMB 175 million in 2025, and reached RMB 773 million in the first quarter of 2026 alone.

Compared with similar products, Rosuvastatin Calcium and Ezetimibe Tablets (I) offers three core advantages:

1. Synergistic and Potent Lipid Lowering. A single dose can reduce low-density lipoprotein cholesterol (LDL-C) by more than 50%, significantly outperforming either agent alone. This effectively improves patients’ LDL-C goal attainment, delays the progression of atherosclerosis at its source, and reduces the risk of major adverse cardiovascular events.

2. Improved Safety and Tolerability. By employing a moderate-dose statin to achieve potent lipid reduction, the product helps to lower the risk of adverse reactions associated with high-dose statins, such as myopathy and abnormal liver enzymes. Rosuvastatin is a hydrophilic statin that enters hepatocytes via liver-specific transport proteins, offering high hepatic selectivity, minimal extrahepatic distribution, and a lower risk of muscle toxicity. Moreover, it is less dependent on hepatic enzyme metabolism, resulting in a lower risk of drug-drug interactions—making it especially suitable for patients on multiple medications. Patients with mild-to-moderate hepatic or renal impairment may use it with dose adjustment under medical guidance, covering a wider range of clinical scenarios.

3. Enhanced Convenience and Adherence. The fixed-dose combination design allows for convenient once-daily administration, independent of food intake. A retrospective analysis of the Belgian and French THIN databases showed that patient adherence to this combination formulation can be up to three times higher than to the two monotherapies taken separately, facilitating better long-term lipid management.

Qidu Pharmaceutical has long been dedicated to the cardiovascular and cerebrovascular therapeutic area. With the approval of Yiruiqing®, the company now offers a complementary portfolio together with its third-generation statin, Pitavastatin Calcium Tablets (trademark: Yiqing®, available in 1 mg, 2 mg, and 4 mg strengths), forming a “monotherapy plus combination therapy” model that enhances clinical accessibility and reduces the long-term medication burden on patients. Furthermore, the lipid-lowering and antihypertensive pipelines work in synergy. Yiruiqing® and Yiqing® join forces with antihypertensive products such as Luoping® (Felodipine Tablets), Huoping® (Telmisartan Capsules), Qi'antan® (Telmisartan and Amlodipine Tablets), and Qiluo'an® (Bisoprolol Fumarate and Amlodipine Besilate Tablets) to balance individualized therapy with simplified regimens, further strengthening the prevention and control of cardiovascular and cerebrovascular diseases.