ZhiLiDa® (Rosuvastatin/Ezetimibe Fixed-Dose Combination) Launches in China to Address Unmet Needs in Lipid Management

ShanghaiMarch 1, 2024PR Newswire -- Sanofi announced today the launch of Rosuvastatin Ezetimibe Tablets (I) (registered trademark: Zhilida®) in China, achieving rapid accessibility across multiple provinces and cities in China through innovative channels. Zhilida® is indicated for the treatment of primary hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH), filling the gap in the field of hyperlipidemia in China for single-pill combination lipid-lowering therapy. This single-pill combination formulation helps achieve target levels of low-density lipoprotein cholesterol (LDL-C), with a reduction greater than 50%.^[1], bringing a new option of "one-pill solution" for lipid management to patients with dyslipidemia.

Ge Junbo, an academician of Fudan University Affiliated Zhongshan Hospital, stated:"In the face of the increasingly severe burden of cardiovascular diseases, it is crucial to manage and control risk factors effectively. Achieving an ideal level of low-density lipoprotein cholesterol as early as possible can reduce the incidence of major adverse cardiovascular events and improve patient prognosis. The latest edition of the 'Chinese Guidelines for Lipid Management' points out that the combined use of lipid-lowering drugs is a fundamental trend in lipid abnormality intervention strategies. We believe that the introduction and clinical application of the Rosuvastatin Ezetimibe compound preparation in China will provide a more suitable treatment option for Chinese patients, reduce their medication burden, enhance medication convenience, further improve the current state of lipid management in China, increase the rate of achieving lipid targets, and bring benefits to the prognosis of more patients."

Sanofi Greater China President Wang Shi said"The successful launch of Zhi Li Da® in China provides Chinese patients with a new treatment option, ushering in a new era of single-pill combination lipid-lowering therapy. With over four decades of presence in China, Sanofi, leveraging its extensive experience in chronic disease management, continuously enriches its product portfolio in cardiovascular and other chronic disease areas through a diverse range of innovative products, meeting the significant demand for 'three highs' management among Chinese patients. We will continue to accelerate the introduction of innovative drugs, expand multi-dimensional new channels for broad coverage, and collaborate with ecosystem partners to address the challenges of chronic disease management in China, enhance the full life-cycle management of chronic diseases, and contribute to achieving the goal of Healthy China."

Dyslipidemia Becomes a "Silent Killer," Achievement Rate of the Core Indicator "LDL Cholesterol" Insufficient7%

Cardiovascular diseases are the leading cause of death among urban and rural residents in China.^[2]Dyslipidemia is an important risk factor for cardiovascular diseases. Long-term dyslipidemia can lead to lipid deposition on the vascular endothelium, forming atherosclerosis, which in turn causes stroke, myocardial infarction, heart failure and other diseases. Therefore, dyslipidemia is known as a "silent killer."

Abnormal blood lipids are positively correlated with low-density lipoprotein cholesterol. According to the "China Lipid Management Guidelines (2023)," in recent years, the prevalence of abnormal blood lipids in the Chinese population has been on the rise, with an overall prevalence rate of 35.6% in adults.^[3], only 6.8% of patients with dyslipidemia achieve the target level of low-density lipoprotein cholesterol.^[4]。

Currently, achieving the target level of low-density lipoprotein cholesterol is the core goal of clinical lipid management. Controlling its level within the ideal range helps delay the formation of vascular atherosclerotic plaques and reduces the risk of major adverse cardiovascular events.

Statins Have Limitations, Chinese Patients Urgently Need New Lipid-Lowering Solutions

"The Chinese Guidelines for Lipid Management (2023)" points out that patients with dyslipidemia should achieve corresponding low-density lipoprotein cholesterol target management based on different risk level stratifications. Among them, ultra-high-risk and very high-risk patients with atherosclerotic cardiovascular disease (ASCVD) need to achieve "double targets," which means reducing low-density lipoprotein cholesterol to 1.4 mmol/L and 1.8 mmol/L, with a simultaneous reduction of 50%.^[5]。

Relevant studies show that the combination of ezetimibe and moderate-intensity statins can achieve a reduction of more than 50% in low-density lipoprotein cholesterol without increasing the adverse reactions of statins.

"Yi Pian Li Da" Combination Lipid-Lowering, Multi-Channel Rapid Accessibility

The launch of Zhilida® fills the gap in China's lipid disorder field regarding single-pill combination lipid-lowering therapy. On one hand, rosuvastatin reduces cholesterol synthesis in the liver; simultaneously, ezetimibe inhibits cholesterol absorption in the intestines and bile ducts. The combination of these dual mechanisms achieves highly efficient synergy. Clinical data shows that this single-pill combination can further reduce low-density lipoprotein cholesterol by 27% based on 10mg of rosuvastatin.^[6]`, and a single dose reduction can exceed 50%.`^[7], contributing to "double achievement." Meanwhile, real-world data shows that compared with free combination therapy of single drugs, the use of Rosuvastatin Ezetimibe single-pill combination can reduce the risk of major adverse cardiovascular events by 42%.^[8], further reducing the treatment costs incurred as a result, and benefiting patients in their medium- to long-term lives.

In addition, the single-pill combination formulation addresses the issue of poor compliance caused by the combination of single drugs, providing a "cost-effective" new option for lipid management. Real-world data shows that patients with dyslipidemia take an average of 4.1 pills per day.^[9]Patients may experience situations such as drug discontinuation or missed doses, and the medication burden is heavy. The single-tablet combination of Rosuvastatin and Ezetimibe improves patient medication adherence by 2 times compared to the combination of two separate drugs. The "double-layer tablet" innovative technology ensures drug stability while also reducing the risk of adverse events such as potential gastric mucosal injury.

Currently, the healthcare industry is actively collaborating to explore chronic disease health management covering the "in-hospital + out-of-hospital" full life cycle. By closely integrating medical institutions with service terminals, efforts are being made to promote the integration of chronic disease management and enhance public access to and convenience of medication. Through the joint efforts of multiple parties, Zhi Li Da® has achieved multi-channel connectivity across medical institutions, retail pharmacies, and internet hospitals at the time of its launch, collectively helping patients overcome the "last mile" in lipid management.

[1] Joint Expert Committee for the Revision of China's Lipid Management Guidelines. Chinese Circulation Journal. 2023,38(3):237-271.

[2] Writing Group of China Cardiovascular Health and Disease Report. Summary of "China Cardiovascular Health and Disease Report 2022"[J]. Chinese Journal of Interventional Cardiology, 2023.

[3] Joint Expert Committee for the Revision of China's Lipid Management Guidelines. Chinese Journal of Cardiology. 2023,51(3):221-255.

[4] Zhang M, Deng Q, Wang L, et al. Prevalence of dyslipidemia and achievement of low–density lipoprotein cholesterol targets in Chinese adults: A nationally representative survey of 163, 641 adults[J]. Int J Cardiol, 2018, 260:196–203. DOI: 10.1016/j.ijcard.2017.12.069.

[5] Joint Expert Committee for the Revision of China's Lipid Management Guidelines. Chinese Journal of Cardiology. 2023, 51(3): 221-255.

[6] Catapano AL, et al. J Cardiovasc Pharmacol Ther. 2022;27:10742484221138284.

[7] Joint Expert Committee for the Revision of China's Lipid Management Guidelines. Chinese Circulation Journal. 2023,38(3):237-271.

[8] Luke Schmerold I K P P. Persistence, Adherence, and Low-Density Lipoprotein Cholesterol Goal Achievement in a Population Receiving Fixed-Dose Combination of Rosuvastatin 10mg / Ezetimibe 10mg: The 17th Qianjiang International Cardiovascular Conference, Hangzhou, 2023[C].

[9] Umeda T, et alCirc J. 2019 Jul 25;83(8):1689-1697.