Levosimendan

In response to the clinical treatment needs of acute decompensated heart failure, calcium-sensitizing positive inotropic drugs, with the advantages of simultaneously strengthening cardiac function, dilating blood vessels and not increasing myocardial oxygen consumption, have gradually become an important treatment option in the field of severe heart failure. As the first marketed calcium sensitizer, levosimendan improves the sensitivity of myocardial contractile proteins to calcium ions by binding to cardiac troponin C, and at the same time opens ATP-sensitive potassium channels on vascular smooth muscle to dilate peripheral blood vessels. It is clinically mainly used for the short-term treatment of acute decompensated heart failure with poor efficacy of traditional diuretics and angiotensin-converting enzyme inhibitors. It can rapidly improve the hemodynamic indexes of patients and reduce the short-term rehospitalization risk of severe patients, especially suitable for the heart failure population with concomitant coronary heart disease and renal insufficiency.

The global market size of levosimendan was approximately USD 320 million in 2023, with a compound annual growth rate of 7.8% from 2019 to 2023. The main driving factors for its growth are the continuous rise in the global prevalence of heart failure and the improvement of safety requirements for positive inotropic drugs in the field of critical care medicine. In terms of the domestic market, only the original research drug and 3 local enterprises have obtained the marketing authorization for this API at present. The sales of levosimendan at the terminal of domestic public medical institutions exceeded RMB 1.2 billion in 2023. The core patent of this drug expired in 2021, and the substitution space for generic drugs is gradually expanding.

CATO can provide a full set of impurity reference standards for levosimendan API. All products meet the quality control requirements under multiple regulatory systems such as Chinese Pharmacopoeia and FDA, with sufficient spot stock. It can quickly respond to the full-process needs of pharmaceutical enterprises in generic drug research and development, consistency evaluation and daily quality testing, and effectively shorten the marketing cycle of customers' products.