Vericiguat

As the world's first approved soluble guanylate cyclase (sGC) activator for the treatment of heart failure, vericiguat provides a brand-new treatment path for patients with heart failure with reduced ejection fraction (HFrEF). It directly stimulates sGC while enhancing the sensitivity of sGC to nitric oxide, activating the impaired NO-sGC-cGMP pathway through a dual mechanism, improving myocardial energy metabolism and vascular function, and reducing myocardial fibrosis and ventricular remodeling. Clinically, it is mainly used for the treatment of adult patients with chronic heart failure who have obvious symptoms and an ejection fraction lower than 45%. It can reduce the risks of cardiovascular death and heart failure hospitalization, and is especially suitable for patients whose condition is still poorly controlled after standard treatment, filling the long-existing pathway gap in the field of heart failure treatment.

In recent years, the global prevalence of chronic heart failure has continued to rise, with the total number of patients exceeding 60 million. The number of heart failure patients in China is approximately 13.7 million, with more than one million new cases every year, which directly drives the rapid expansion of the market size of vericiguat. In 2023, the global sales of this drug exceeded 1.7 billion US dollars, a year-on-year increase of 62%, making it one of the core varieties with the fastest growth rate in the field of heart failure. After its launch in the Chinese market in 2022, its sales exceeded 100 million RMB in the same year, and the year-on-year growth rate in 2023 exceeded 200%. At present, the original research product occupies the major market share in the world, and nearly 10 pharmaceutical companies in China have started the research and development of generic drugs. Its compound patent will expire in 2026. After the patent cliff, market competition will be significantly intensified, and the price drop will further improve the accessibility of the drug.

The original research enterprise of vericiguat is Bayer HealthCare Co., Ltd., and the original research trade name is "Verquvo". The expiration date of its compound patent in China is September 2026. At present, the main approved dosage form is tablet, with specifications including 2.5mg, 5mg and 10mg. The original research preparation has been included in the *Catalogue of Chemical Reference Preparations (54th Batch)* of China, and is also included in the FDA Reference Preparation Catalogue. Up to now, there is no registration and publicity of vericiguat API from domestic enterprises on the platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China. Only the preparation of the original research enterprise has obtained the marketing approval in China, and the relevant declaration of domestic generic drugs is still in the clinical research stage. (Data as of June 2025, please refer to the official website of CDE for the latest information)

For the impurity research requirements in the process of generic drug research and development and quality control of vericiguat, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and orders for in-stock products placed before 16:00 can be shipped on the same day. All impurity reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can directly support methodological validation, stability research and submission of declaration materials, helping R&D enterprises to efficiently advance the project process.