Cinepazide

Cardiovascular and cerebrovascular diseases have become the category of chronic diseases with the highest fatality rate globally. Improving microcirculation and protecting nerve cells are among the core directions for the clinical treatment of such diseases. Cinepazide is a cardiovascular and cerebrovascular drug belonging to the calcium channel blocker class. It blocks the transmembrane entry of calcium ions into vascular smooth muscle cells, relaxes vascular smooth muscle, and dilates cerebral blood vessels, coronary vessels and peripheral vessels. Meanwhile, it can improve the flexibility and deformability of red blood cells, reduce blood viscosity and improve microcirculation. It is clinically mostly used for cerebral arteriosclerosis, transient ischemic attack, cerebral thrombosis, cerebral embolism, angina pectoris due to coronary heart disease, as well as peripheral vascular diseases such as atherosclerosis and thromboangiitis obliterans, etc. Its applicable population covers middle-aged and elderly patients with cardiovascular and cerebrovascular diseases in the attack stage and recovery stage.

At present, the market size of cardiovascular and cerebrovascular drugs in China has exceeded 300 billion yuan, among which the annual growth rate of microcirculation-improving drugs maintains at around 8%. With its multi-target action characteristics, the prescription volume of cinepazide in primary medical institutions and secondary hospitals has been rising steadily, and its current domestic market size is about 1.2 billion yuan. The competitive landscape is dominated by generic drugs. As of 2024, more than 20 enterprises have obtained the production approval for cinepazide preparations, and 11 domestic enterprises have completed the CDE registration of cinepazide APIs on the API supply side, with relatively sufficient overall competition. The promotion of centralized procurement has further promoted the improvement of the clinical accessibility of the product.

The original research enterprise of cinepazide is Sanofi, France, and the original trade name is "Kelinao". Its core compound patent expired globally in 2011. The main dosage form of the original marketed product is cinepazide maleate injection, with specifications of 2ml:80mg and 10ml:320mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* published by the NMPA. In terms of domestic API registration, as of the retrieval time, there have been 11 registration numbers of cinepazide maleate APIs, among which 8 are in Status A and can be legally supplied for preparation production. On the preparation side, multiple dosage forms such as cinepazide maleate injection and cinepazide tablets have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for cinepazide, which can directly match the full-process demands of domestic API and preparation enterprises in R&D, registration and quality control. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and help enterprises efficiently promote product declaration and quality control work.