Fasudil

As a classic drug in the field of Rho kinase inhibitors, fasudil inhibits the activity of Rho kinase, reduces vascular smooth muscle contraction, improves microcirculation and alleviates inflammatory response, making it an important clinical option for the management of cerebrovascular diseases. Its indications cover cerebral ischemic symptoms caused by cerebral vasospasm after subarachnoid hemorrhage, and it can also be used to improve microcirculation disorders in ischemic cerebrovascular diseases. It is especially suitable for neurological function protection in patients with acute cerebrovascular events, and can effectively reduce the risk of postoperative complications and improve the long-term prognosis of patients.

The global market size of fasudil has maintained steady growth in recent years. The market size in 2023 was approximately USD 180 million, with China accounting for more than 60% of the market share, making it the core consumption region for this product. The domestic competition landscape is dominated by generic drugs. More than 20 enterprises have obtained preparation approvals. After the implementation of centralized procurement, the price has dropped by more than 75%, which has greatly promoted clinical accessibility. The localization rate of upstream API has exceeded 90%, and only a small number of high-end preparations use imported APIs.

The original developer of fasudil is Asahi Kasei Pharma of Japan, with the trade name "Eril". Its core compound patents expired in 2010 in major markets such as Japan and the United States, and the compound patent in China also expired in 2010. The mainstream dosage form of the original product is injection, with the specification of 2ml:30mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and listed as a reference preparation by the FDA. Up to now, there are 17 fasudil API registration numbers on the API registration platform of China CDE, among which 12 are in status "A" (can be used in marketed preparations). There are a total of 38 domestic approved fasudil injection approvals, covering all mainstream specifications. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for fasudil, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with multiple regulatory requirements such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for pharmaceutical enterprises in API R&D, quality research and compliance declaration.

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