On March 13, 2026, Hanhui Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Hisun Pharmaceutical, received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration for a new specification of Hybromide Atorvastatin Calcium Tablets (Hybromide 10mg/Atorvastatin 20mg) . After review, the National Medical Products Administration approved the direct commencement of Phase I and Phase III clinical trials for this product.The development of this new specification represents a further expansion of the company's existing Hybromide-Atorvastatin combination formulation (10mg/10mg and 20mg/10mg specifications) , which is currently under market review. Closely aligned with clinical practice and market demand, it aims to provide patients with hyperlipidemia with a wider range of personalized lipid-lowering treatment options. The approval to directly enter Phase I/III clinical trials demonstrates the high recognition of the product's preliminary research data and clinical value by the national drug regulatory agency, and will significantly shorten the development and market launch process for this specification.

Hybromide and Atorvastatin Calcium Tablets, as an innovative fixed-dose combination drug in the Class 2.3 chemical drug category, have a core advantage in their synergistic innovation of mechanism of action. They combine two mainstream lipid-lowering mechanisms: my country's first independently developed selective cholesterol absorption inhibitor (Hybromide) and a classic statin drug (atorvastatin). Through synergistic enhancement, they directly address the core challenges in the current treatment of hyperlipidemia.

According to data from the "Chinese Guidelines for Lipid Management (2023)," the overall prevalence of dyslipidemia among adults in my country is currently as high as approximately 35%, making it a key risk factor for atherosclerotic cardiovascular disease (ASCVD). Dyslipidemia has become a significant public health issue threatening the cardiovascular health of Chinese residents. However, clinical practice data shows that among ASCVD secondary prevention patients receiving statin monotherapy, the target rate for low-density lipoprotein cholesterol (LDL-C) is only about 33%¹. This means that more than 60% of patients require intensive lipid-lowering therapy or combination therapy to achieve clinical goals, indicating a significant unmet clinical need. The continuous advancement of the Hybromide Atorvastatin Calcium Tablet series of specifications is precisely designed to accurately meet the treatment needs of these patients and improve the clinical lipid-lowering target achievement rate.

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