S-腺苷-L-蛋氨酸

As an important active methyl donor in cells, S-adenosyl-L-methionine belongs to the adjuvant medication for the hepatobiliary system. By participating in the three core metabolic pathways of transmethylation, transsulfuration and transaminopropylation, it stabilizes the structure of liver cell membranes and promotes liver cell regeneration. Meanwhile, it can regulate the synthesis and transmission of central neurotransmitters and improve emotional regulation function. Clinically, it is mainly used for the treatment of intrahepatic cholestasis caused by pre-cirrhosis and cirrhosis stages, and also has definite therapeutic value for intrahepatic cholestasis of pregnancy. It can also be used as an adjuvant therapeutic agent for depression, and the applicable population covers patients with chronic liver diseases, women in special pregnancy stages and people receiving adjuvant therapy for affective disorders.

The global market size of S-adenosyl-L-methionine had exceeded 780 million US dollars by 2023, with a compound annual growth rate remaining at around 6.2%. The growth momentum mainly comes from the rising prevalence of chronic liver diseases and the expansion of demand in the field of adjuvant antidepressant therapy. In the domestic market, generic drugs occupy a dominant position, and the market share of original research products is less than 15%. At present, more than 20 enterprises have obtained preparation approvals. On the API supply side, the production capacity of domestic enterprises accounts for more than 60% of the total global production capacity, making China the core exporter of this variety.

The original research enterprise of this variety is Abbott Italy (formerly Knoll Pharmaceuticals), with the original brand name "Transmetil". Its core compound patent expired in Europe and the United States in 2003, and the relevant Chinese patent expired in 2005. The approved dosage forms of the original drug include injection (0.5g) and enteric-coated tablet (0.5g), which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and listed as reference preparations by the FDA. At present, more than 30 S-adenosyl-L-methionine APIs have been approved for registration (status A) in China, and a number of domestic preparations of dosage forms such as enteric-coated tablets and injections have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for S-adenosyl-L-methionine, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the reference substance needs in the whole process of API R&D, quality research and registration declaration.