Olprinone

Heart failure is an acute and severe cardiovascular disease with high incidence globally. For patients who have poor response to conventional diuretics and vasodilator therapy, positive inotropic drugs are a critical option for clinical rescue. Olprinone belongs to selective phosphodiesterase Ⅲ (PDE Ⅲ) inhibitors. By inhibiting the activity of PDE Ⅲ in myocardial and vascular smooth muscle, it reduces the degradation of cyclic adenosine monophosphate (cAMP), and has the dual effects of enhancing myocardial contractility and dilating peripheral vessels, with little impact on heart rate and blood pressure. It is mainly used for the short-term treatment of acute heart failure and acute exacerbation of chronic heart failure, especially suitable for heart failure patients with pulmonary hypertension. It can rapidly improve hemodynamic indexes and reduce the risk of in-hospital death.

The clinical application of olprinone is relatively mature in East Asian countries such as Japan and South Korea. In 2022, the market size of olprinone in China's sample hospitals was approximately 190 million yuan, with a compound annual growth rate of more than 35% in the recent 3 years, making it one of the fast-growing varieties in the field of acute heart failure medication. At present, the domestic preparation market is dominated by generic drugs, and 5 enterprises have been approved to produce olprinone for injection. The localization rate of the API supply side continues to increase. With the rise in the prevalence of heart failure and the standardization of emergency diagnosis and treatment pathways in recent years, the market still has great expansion potential.

The original developer of olprinone is Japan's Tanabe Mitsubishi Pharma Corporation, with the brand name Coretec®. It was first approved for marketing in Japan in 1996. The expiration dates of the compound patent in different countries are concentrated between 2008 and 2010. The original dosage form is injection, with a specification of 5ml:5mg. The original product of this variety has not entered the Chinese market. The domestic reference preparation takes the original dosage form marketed in Japan as the control, and has been included in the *Catalogue of Reference Preparations for Generic Chemical Drugs* issued by the National Medical Products Administration. As of now, there are 7 registration records of olprinone API on China's CDE API registration platform, among which 5 are in status A, which can be used in association with domestic preparation declaration or marketing. A total of 6 olprinone for injection preparation varieties have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for olprinone API, and most of the products are available from stock. Stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of the entire process of API R&D, quality research and declaration.