Iloprost

Pulmonary arterial hypertension (PAH) is a rare cardiovascular disease with rapid progression and poor prognosis. In the past, clinical treatment options were very limited, and the 5-year survival rate of patients was only 20% to 35%. Iloprost is a synthetic prostacyclin analog. It exerts the effects of dilating pulmonary blood vessels, inhibiting platelet aggregation and improving vascular endothelial function by activating prostacyclin receptors on platelets and vascular smooth muscle. It is currently one of the core drugs for targeted therapy of pulmonary arterial hypertension. It is mainly used for the treatment of adult patients with NYHA class Ⅲ-Ⅳ primary pulmonary arterial hypertension and scleroderma-associated pulmonary arterial hypertension, and can also be used for patients with chronic thromboembolic pulmonary arterial hypertension who are inoperable. It can significantly improve the exercise tolerance of patients and reduce the risk of disease progression.

The global market size related to iloprost was approximately USD 420 million in 2023, and it is expected to grow steadily at a compound annual growth rate of 3.7% from 2024 to 2030. The growth drivers mainly come from the improvement of the diagnosis and treatment coverage of rare diseases and the popularization of combination therapy regimens. The domestic market is still dominated by imported original research drugs at present. After this variety was included in the National Medical Insurance Catalog in 2021, the payment threshold for patients was greatly reduced, and the domestic market size increased by 28.9% year-on-year in 2023. There are less than 5 generic drug application enterprises, the market competition pattern is relatively loose, and there is sufficient space for domestic substitution in the future.

The original research enterprise of iloprost is Bayer Healthcare, and the original research trade name is "Ventavis". Its core compound patent expired in the EU region in 2019, the core patent in the US market expired in 2021, and the compound patent in China expired in 2020. The main dosage form of the original research drug launched globally is inhalation solution, with the specification of 2ml:20μg. This dosage form has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalogue of Reference Preparations for Chemical Drugs (11th Batch)* of China. In terms of domestic API registration, as of now, there is no approved domestic iloprost API registration number on the CDE platform, only the original research imported preparation has been approved for marketing, and domestic preparations have not been approved yet. (Data as of October 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of iloprost impurity reference standards, covering all types of process impurities and degradation impurities. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA. Most impurities are available in stock. Stock orders paid before 16:00 can be shipped on the same day, which can fully meet the diversified needs of pharmaceutical enterprises in the stages of generic drug research and development and quality research.