Beraprost

Symptoms such as intermittent claudication, rest pain, and ulcers caused by chronic arterial occlusive diseases have long been difficult points in the treatment of peripheral vascular diseases, and there is an urgent clinical demand for drugs with both anti-platelet aggregation and vasodilatory effects. Beraprost is an orally active drug of the prostacyclin class. It acts on prostacyclin receptors on platelets and vascular smooth muscle to increase the intracellular cAMP level, and simultaneously inhibits the production of thromboxane A2, with definite effects in anti-platelet aggregation, dilating peripheral blood vessels and improving microcirculation. It is mainly used clinically to improve related symptoms caused by chronic arterial occlusive diseases, and can also be used for adjuvant treatment of pulmonary arterial hypertension. The applicable population covers patients with peripheral vascular diseases and some patients with pulmonary arterial hypertension.

According to public data, the domestic market size of beraprost preparations was approximately 1.8 billion yuan in 2023, and the compound growth rate in the past three years has remained at around 12%. The growth is mainly driven by the increase in the prevalence of peripheral vascular diseases and the rise in the penetration rate of clinical medication. In terms of the competitive landscape, the original research product accounts for approximately 65% of the market share. In recent years, the market share of domestic generic drugs has gradually increased after passing the consistency evaluation. At present, generic drugs from 3 domestic enterprises have been approved for marketing. The promotion of the volume-based procurement policy has further promoted the improvement of drug accessibility.

The original research enterprise of beraprost is Astellas Pharma Inc. of Japan, and the original research brand name is "Dorna". The expiration time of its core compound patent in major markets such as Japan and the United States is 2012, and the expiration time of the compound patent in China is 2013. The main dosage form approved for the original research product is tablet, with specifications of 20μg and 40μg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also listed in the FDA Reference Preparations Catalogue. In terms of domestic API registration, 4 enterprises have obtained CDE registration numbers for beraprost APIs at present, among which 3 are in A status. A number of preparation varieties including the original research product and generic drugs have been approved for marketing in China. (Data as of July 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for beraprost API. Most products are available from stock. Spot orders paid before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the various reference standard needs of pharmaceutical enterprises in the stages of API R&D, quality research and registration application.