ZhiliDa (Rosuvastatin/Ezetimibe Fixed-Dose Combination) Approved in China, Offering a 'One-Tablet Solution' to Achieve Dual LDL-C Targets in Lipid Management

ShanghaiDecember 27, 2023PR Newswire -- December 27, 2023, Sanofi announced its Rosuvastatin Ezetimibe Tablets (I) (Zhilida).^®) has been approved by the China National Medical Products Administration (NMPA) for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) patients.ForChina's FirstApprovedThe marketed Rosuvastatin Ezetimibe single-pill combination preparation, Zhi Li Da^®A New Era of Powerful Compound Lipid-Lowering; One Tablet Can Achieve Low-Density Lipoprotein Cholesterol (LDL-C)Decrease greater than50%，Potently and continuously reduce LDL-C to target goals, support "double achievement" in lipid management, and offer a new choice of potent and sustained lipid-lowering drugs for patients with dyslipidemia.

Prof. Ge Junbo, Academician of Fudan University Zhongshan HospitalSaid: "In the face of the increasingly severe burden of cardiovascular diseases, it is very important to manage and control risk factors. Only by controlling LDL-C to an ideal level as early as possible can we reduce the incidence of adverse events and improve patient prognosis. The latest edition of the 'Chinese Lipid Management Guidelines' points out that the combined use of lipid-lowering drugs is a basic trend in the intervention strategy for dyslipidemia. Relevant studies have also shown that the combination of ezetimibe and moderate-intensity statins can easily achieve the goal of reducing LDL-C by more than 50% without increasing the adverse reactions of statins. Currently, Rosuvastatin Ezetimibe Tablets (I) (Zhi Li Da^®) The approval in China provides a lipid-lowering solution more suitable for the Chinese population and can reduce the pill burden on patients, enhancing medication convenience. It is believed that with subsequent clinical implementation, it will further improve the current state of lipid management in China, increase the rate of achieving lipid targets, and bring improvements to the prognosis of more patients."

Wang Shi, President of Sanofi Greater ChinaSaid: "Sanofi is accelerating to provide accessible innovative drugs and vaccines for the Chinese public, and we are very pleased with the progress made."^®Approved in China, providing Chinese patients with a more effective and sustained lipid management solution, allowing patients to enjoy the clinical benefits and improved quality of life from long-term lipid control. This is also the 11th innovative drug, vaccine, and indication approved in China this year, setting a new record for the highest number of approvals in the company’s history. With over 70 years of expertise in the cardiovascular field, Sanofi continues to advance the availability of innovative drugs and enrich its cardiovascular pipeline to benefit more patients with a more comprehensive product portfolio and higher-quality services. Moving forward, we will remain focused on unmet patient needs, continuously improving the accessibility of pharmaceuticals and healthcare for patients in China, contributing to the strategic goal of Healthy China.

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

Cardiovascular disease is the leading cause of death among urban and rural residents in China.^[1], and dyslipidemia is an important risk factor for cardiovascular disease. Due to the lack of obvious symptoms in the early stages and insufficient public awareness of management, the达标率of LDL-C in patients with dyslipidemia is only 6.8%.^[2], therefore, hyperlipidemia is also known as the "king of chronic diseases."

According to the "China Lipid Management Guidelines (2023)", patients should achieve corresponding LDL-C target values based on different risk stratifications, and ASCVD patients mustAchieving the target and reduction greater than50%Double Achievement^[3]Among which, an LDL-C reduction of more than 50% is considered the beginning of plaque reversal.^[4], which is also the key to further clinical benefits. Although statins are the cornerstone treatment for dyslipidemia, they are limited by the "6% effect," making it difficult to achieve the desired reduction target with monotherapy.^[5]，Combined therapy becomes the prevailing trend.

"Yipin Lida" Helps AchieveLDL-C""Double Achievement"Zhilida^®Brings a Powerful New Choice for Compound Lipid-Lowering

"The Chinese Lipid Management Guideline (2023)" indicates that when LDL-C has not reached the target after statin therapy, a combination of cholesterol absorption inhibitors and/or PCSK9 inhibitors should be considered.^[6]Ezetimibe in combination with statins targets both "synthesis" and "absorption" of cholesterol, and is considered one of the best strategies for combination therapy.^[7]。

Zhilida^®AsChina's FirstRuiThe single-pill combination of Rosuvastatin and Ezetimibe, with the most potent statin Rosuvastatin paired with the widely recognized "ideal statin partner" Ezetimibe, achieves highly efficient synergistic inhibitory effects. Data shows that Zhi Li Da...^®The lipid-lowering effect is significant, and it can further reduce LDL-C by 27% on the basis of 10mg of Rosuvastatin.^[8]，A single dose of Lida is greater than50%^[9]The LDL-C reduction target.

In addition, the single-pill combination resolves the issue of poor compliance that may result from single-drug combinations. Real-world data shows that Rosuvastatin Ezetimibe tablets achieve better compliance compared to single-drug combinations.ReduceMACERisk of Major Adverse Cardiovascular Events42%^[10]. At the same time, in terms of technology, Zhilida^®The "double-layer tablet pressing" technology, along with innovative processes such as non-alkaline excipients, ensures drug stability while reducing the potential risk of gastric mucosal damage.

About Sanofi China

Sanofi is a global leading innovative pharmaceuticals and healthcare company with the mission of "Chasing Scientific Miracles, Revitalizing Life's Radiance." As one of the first multinational companies to enter China after the reform and opening up, Sanofi established its office in China in 1982. Currently, it operates 12 offices with diverse business models, 3 production bases, 4 major R&D centers, and 1 digital innovation hub. Its diversified businesses cover pharmaceuticals, human vaccines, and consumer healthcare. In alignment with China’s development goals, Sanofi is committed to accelerating the introduction of innovative medicines and vaccines into China, continuously transforming medical practices, benefiting more Chinese people, and creating a better life for its partners, communities, and employees.

For more information, please visitwww.sanofi.cn, or follow the "Sanofi China" WeChat Official Account.

About Sanofi

Sanofi is a global leading innovative pharmaceuticals and healthcare company. Our mission is to pursue scientific miracles and revitalize the brilliance of life. Sanofi's presence spans over 100 countries worldwide, dedicated to transforming medical practices and turning the impossible into possible. We provide people around the world with potentially life-changing healthcare solutions and vaccines that prevent life-threatening diseases, while placing sustainability and social responsibility at the core of our ambitious strategy.

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[1] National Center for Cardiovascular Diseases. Report on Cardiovascular Health and Diseases in China 2021 [M]. Beijing: Science Press, 2022.

[2] Zhang M, Deng Q, Wang L, et al. Prevalence of dyslipidemia andachievement of low-density lipoprotein cholesterol targets in Chinese adults: a nationally representative survey of 163 641 adults[J]. Int JCardiol, 2018, 260: 196-203. DOI:10.1016/j.ijcard.2017.12.069.

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

[4] JAMA 2004;291:1071-1080.

[5] Atherosclerosis and Coronary Heart Disease Group of the Chinese Society of Cardiology, Editorial Board of Chinese Journal of Cardiology. Chinese Expert Consensus on Lipid Management for Patients with Extremely High-Risk Atherosclerotic Cardiovascular Disease [J]. Chinese Journal of Cardiology, 2020, 48(4): 280-286.

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

[7] H. Drexel et al., An expert opinion paper on statin adherence and implementation of new lipid-lowering medications by the ESCWorking Group on Cardiovascular Pharmacotherapy: Barriers to be overcome. European Heart Journal - Cardiovascular Pharmacotherapy (2020) 6, 115–121.

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

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

[10] 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].