Ripasudil

Pulmonary arterial hypertension is a rare cardiovascular disease characterized by progressive increase in pulmonary vascular resistance, with poor prognosis and high mortality, and there has been a long-term lack of highly specific therapeutic drugs in clinical practice. Riociguat is an anti-pulmonary arterial hypertension drug belonging to the Rho kinase inhibitor class. It selectively inhibits the Rho/ROCK signaling pathway, reduces the contraction and proliferation levels of pulmonary vascular smooth muscle cells, effectively dilates pulmonary vessels and reverses vascular remodeling, while having less impact on systemic circulation with better safety. At present, this drug is mainly used for the treatment of adult pulmonary arterial hypertension, which can significantly improve the exercise tolerance of patients, delay disease progression, and provide a new treatment option for the long-term management of patients with pulmonary arterial hypertension.

The current global market size of pulmonary arterial hypertension drugs has exceeded 8 billion US dollars, with a compound annual growth rate maintained at around 7%. Among them, Rho kinase inhibitor drugs, relying on their precise targeting advantages, have seen their market share increase year by year. The number of patients with pulmonary arterial hypertension in China exceeds 5 million. In the past, clinical medication was dominated by imported original research drugs, bringing heavy economic burden to patients. With the implementation of medical insurance policies for rare diseases and the advancement of domestic generic drug research and development, the clinical demand for cost-effective riociguat is being released rapidly. At present, the original research product of riociguat has not been commercialized in China, and local pharmaceutical companies are leading in the layout progress, leaving a large market substitution space in the future.

The original research enterprise of riociguat is Asahi Kasei Pharma Corporation of Japan, with the original brand name "Gran". The expiration time of its core compound patent in Japan is 2028, and the expiration time of the compound patent in China is 2026. The main dosage form approved for the original research product is injection, with a specification of 30mg per vial, which has been included in the Japanese Reference Listed Drug Catalog. Up to now, the import of the original research riociguat preparation has not been approved in China, and there is no publicly available A-status registration number for its active pharmaceutical ingredient (API). A number of local enterprises have submitted clinical declaration applications for relevant APIs and preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for riociguat, and most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the requirements of multiple national regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of pharmaceutical enterprises for quality research and compliance verification in the process of research and development and production, helping enterprises accelerate the declaration and launch progress of relevant products.