Lysine

In clinical scenarios such as children's growth retardation, postoperative hypoproteinemia, and nutritional exhaustion caused by chronic digestive system diseases, amino acid supplementation is one of the core intervention links. As a type of essential amino acid, lysine cannot be synthesized independently by the human body and needs to be supplemented through exogenous intake. It participates in multiple physiological processes of the human body, including protein synthesis, muscle growth and repair, immunoglobulin production, and calcium absorption. In clinical practice, it is often used as the core component of enteral nutrition preparations and compound amino acid injections, and can also be used for the preparation of pediatric nutritional supplements. The applicable population covers children in the growth and development stage, patients in the postoperative recovery period, elderly people with malnutrition, and patients with chronic consumptive diseases.

As one of the most used amino acid API, the global annual production capacity of lysine exceeds 3 million tons, of which feed grade and food grade account for more than 90%, and medicinal grade accounts for about 2%. In 2023, the global medicinal lysine market size was about 1.2 billion yuan, with a compound annual growth rate maintained at around 4.3%. The global production capacity is highly concentrated in China and the United States, and Chinese enterprises account for 62% of the global medicinal lysine supply. With the advancement of domestic consistency evaluation, the annual growth rate of demand for medicinal grade lysine in oral preparations and injections reaches 7%. At present, there are 11 medicinal lysine production enterprises with GMP qualification in China, the market competition is sufficient, and there is no oligopoly pattern.

Lysine is a basic amino acid product, and there is no clear single original research enterprise. Medicinal grade preparations were first developed and marketed simultaneously by multiple pharmaceutical companies. At present, there are 27 types of lysine-related preparations already marketed in China, including lysine hydrochloride injection and pediatric lysine granules. There are 19 lysine-related registration numbers on the CDE API registration platform, of which 12 have been registered in A status and can be used for associated review. Lysine hydrochloride oral solution and lysine hydrochloride injection have been included in the *China Listed Drug Catalog*, and most of the reference preparations are products of domestic first generic enterprises. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of lysine impurity reference standards, which meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in stock. Orders placed before 16:00 can be shipped on the same day, which can fully meet the various needs of API enterprises for quality research, consistency evaluation and daily inspection.