Zofenopril

Cardiovascular disease is one of the chronic diseases with the highest mortality rate worldwide. Angiotensin-converting enzyme (ACE) inhibitors are the core category of drugs for hypotension and cardiovascular protection, and zofenopril is the first long-acting fat-soluble ACE inhibitor containing sulfhydryl groups in this category. Its mechanism of action is to block the conversion of angiotensin I to angiotensin II, while reducing the degradation of bradykinin, which has multiple effects of lowering blood pressure, improving ventricular remodeling and protecting renal function. Clinically, it is mainly used for the treatment of essential hypertension and acute myocardial infarction complicated with heart failure. The applicable population covers patients with mild to moderate hypertension and patients receiving early intervention after myocardial infarction. Especially for hypertensive patients complicated with renal insufficiency, its characteristic of dual excretion via liver and kidney can reduce the risk of drug accumulation.

The global zofenopril market size was approximately USD 210 million in 2023, with a compound annual growth rate of 3.8% from 2019 to 2023. The growth momentum mainly comes from the rising prevalence of hypertension in emerging markets and the expansion of the elderly population with cardiovascular diseases. In terms of competitive landscape, the original research products still account for about 42% of the market share in Europe and North America. The generic API of Chinese and Indian pharmaceutical enterprises has seen a continuous increase in export proportion in recent years due to their cost advantages. At present, 3 domestic enterprises have obtained the production approval for zofenopril API, and relevant preparations have not been included in the centralized procurement scope yet, so there is still large market space for generic drug substitution in the future.

The original research enterprise of zofenopril is Menarini Group of Italy, with the original brand name Zofenil. The core compound patents expired in the United States and the European Union in 2017, and the Chinese compound patent expired in 2016. The main dosage form of the original research product is tablet, with conventional specifications including 7.5mg, 15mg and 30mg. Its preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. At present, 6 valid Class I registration numbers can be found on the domestic API registration platform, and zofenopril calcium preparations of another 3 enterprises have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control requirements of zofenopril, CATO provides a full set of impurity reference standards for this API, covering the full spectrum of process impurities, degradation impurities and isomer impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All impurities meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can be directly used for related substance methodological verification, stability research and quality standard establishment.