Mavacamten

Hypertrophic cardiomyopathy, as a common hereditary cardiovascular disease, has long lacked targeted treatment methods. Conventional drugs can only relieve symptoms but cannot intervene in the pathological progression of the disease. Mavacamten is a cardiac myosin allosteric modulator and the world's first targeted drug targeting the etiology of hypertrophic cardiomyopathy. It selectively binds to the ATPase binding site of cardiac myosin, reduces the binding probability between the myosin head and actin, inhibits excessive myocardial contractility, and improves myocardial energy metabolism at the same time. At present, this drug has been approved for the treatment of adult patients with symptomatic obstructive hypertrophic cardiomyopathy. It can significantly reduce the left ventricular outflow tract pressure gradient of patients, improve exercise tolerance and quality of life, and provide a brand-new intervention方案 for such patients who had limited treatment options in the past.

The global patient base of hypertrophic cardiomyopathy exceeds 15 million. Since its launch, the market size of mavacamten has expanded rapidly. In 2023, its global sales exceeded 1.3 billion US dollars, with an annual growth rate of more than 120%. At present, the global market of this drug is still dominated by the original manufacturer. With the expiration of patents one after another, generic drug enterprises in many countries have started R&D and declaration. In terms of the domestic market, as of 2024, more than 10 pharmaceutical companies have submitted clinical applications for mavacamten generics, and the research on varieties related to centralized procurement has also been launched simultaneously. After the generics are launched in the next 3-5 years, the accessibility of the drug will be further improved, driving the rapid growth of demand for API.

The original research enterprise of mavacamten is Bristol-Myers Squibb, and the original brand name is Camzyos. Its core compound patent in the United States will expire in 2039, and the compound patent in China will expire in 2038. The main dosage form approved by the original research is capsule, with specifications including 2.5mg, 5mg, 10mg and 15mg. It has been included in the FDA Reference Listed Drug Catalog, but has not been included in the *Catalog of Chemical Drugs* in China for the time being. There is currently no approved marketing registration number for mavacamten API in China. The original preparation was approved for import and marketing by the National Medical Products Administration in December 2023. Domestic generics are all in the clinical research stage, and no generic preparation has been approved. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of mavacamten impurity reference standards, covering all types of impurities such as starting material impurities, intermediate impurities and degradation impurities that may be generated during the synthesis process. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA. Most impurities can be supplied from stock. Stock orders placed before 16:00 can be shipped on the same day, which can provide stable and reliable reference standard support for pharmaceutical enterprises in links such as API R&D, quality research and consistency evaluation.