Sanofi announced that its rosuvastatin and ezetimibe tablets (I) (Yipian Lida®) have been approved by the National Medical Products Administration (NMPA) of China for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) patients. As the first approved and marketed combination formulation of rosuvastatin and ezetimibe in China, Yipian Lida® marks the beginning of a new era in potent combination lipid-lowering therapy. A single dose achieves a greater than 50% reduction in low-density lipoprotein cholesterol (LDL-C), effectively and continuously lowering LDL-C to target levels, supporting 'Dual Standards' in lipid management, and providing a new and powerful option for patients with lipid abnormalities.

Academician Ge Junbo from Zhongshan Hospital, affiliated with Fudan University, stated, "In the face of the increasingly serious burden of cardiovascular diseases, effective control and management of risk factors are crucial. Only by controlling LDL-C to ideal levels early can we reduce the incidence of adverse events and improve patient prognosis. The latest version of the 'Chinese Guidelines for Blood Lipid Management' points out that the combined use of lipid-lowering drugs is the basic trend in interventions for lipid abnormalities. Relevant studies also show that the combination of ezetimibe and moderate-intensity statins can easily achieve a target LDL-C reduction of more than 50%, without increasing adverse reactions to statins. The approval of rosuvastatin and ezetimibe tablets (I) (Yipian Lida®) in China provides a more suitable lipid-lowering solution for the Chinese population, reducing the burden of medication for patients and improving medication convenience. With the subsequent clinical application, it is believed that it can further improve the current status of lipid management in our country, increase the rate of achieving lipid targets, and improve the prognosis for more patients."

Swan Shih, President of Sanofi Greater China, stated, "Sanofi is accelerating the provision of accessible innovative drugs and vaccines for the Chinese public. We are pleased with the approval of Yipian Lida® in China, bringing a more potent and sustained lipid management solution for Chinese patients, allowing them 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 by our company in China this year, setting a new record for the number of approvals in the company's history. With over 70 years of professional accumulation in the cardiovascular field, Sanofi continues to drive the landing of innovative drugs, enrich the cardiovascular pipeline layout, and provide more patients with a more complete product system and better-quality services. In the future, we will continue to focus on unmet patient needs, continuously improve the accessibility of medical care for Chinese patients, and contribute to the goal of a healthy China."

Limitations Exist in Statin Therapy, and Chinese Patients Urgently Need New Lipid-Lowering Strategies

Cardiovascular diseases are the leading cause of death for both urban and rural residents in China, and lipid abnormalities are an important risk factor for cardiovascular diseases. Due to the lack of obvious symptoms in the early stage and issues such as insufficient public awareness, the rate of achieving LDL-C targets among patients with lipid abnormalities is only 6.8%. Therefore, high lipids are also known as the 'king of chronic diseases.'

According to the 'Chinese Guidelines for Blood Lipid Management (2023),' patients should achieve corresponding LDL-C target values based on different risk stratifications, and ASCVD patients should achieve the 'Dual Standards' of both target goals and a reduction of more than 50%. Among them, an LDL-C reduction of more than 50% is considered the beginning of plaque reversal and a key factor for further clinical benefits. Although statin drugs are cornerstone treatments for lipid abnormalities, limited by the '6% effect,' monotherapy struggles to achieve target reductions, and combination therapy has become the trend."

Note: The translation may have some variations in interpretation based on specific medical terminology and phrasing.

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