Gadoxetate

The early and accurate detection of focal liver lesions is crucial for the screening of high-risk populations for liver cancer, the formulation of clinical diagnosis and treatment plans, and the improvement of prognosis. Gadoxetate disodium is a hepatocyte-specific magnetic resonance contrast agent. Its mechanism of action is that it can be specifically taken up by hepatocytes through the organic anion transporting polypeptide 1B3 (OATP1B3) on the hepatocyte membrane, and then excreted into the biliary tract via the multidrug resistance-associated protein 2 (MRP2). It has the dual advantages of dynamic phase imaging and hepatobiliary specific phase imaging. Compared with traditional non-specific gadolinium contrast agents, it can significantly improve the detection rate of lesions such as small liver cancer less than 1 cm and atypical hyperplastic nodules of liver cirrhosis. Clinically, it is mainly used for the diagnosis and differentiation of liver malignant tumors and benign space-occupying lesions, and the applicable population includes patients with chronic liver disease, liver cirrhosis and high-risk screening populations for liver cancer.

The global market size of gadoxetate disodium preparations has grown steadily in recent years. In 2023, the market size has exceeded 1.2 billion US dollars, and the compound annual growth rate has remained at around 6%. The growth rate of the Chinese market is much higher than the global average. In 2023, the market size was approximately 1.8 billion RMB, with a compound annual growth rate of more than 12%. The core driving forces come from the increased popularity of early liver cancer screening and the sinking of magnetic resonance examinations to primary medical institutions. At present, the domestic preparation market is still dominated by the original research drug. Generic preparations from 3 domestic enterprises have been approved for marketing. Since 2022, inter-provincial alliance centralized procurement in many regions has included this variety in the scope, and the price drop of generic drugs has further broadened clinical accessibility.

The original research enterprise of gadoxetate disodium is Bayer Healthcare, and the original brand name is "Primovist". The expiration date of its core compound patent in China is 2026. The dosage form approved by the original research is injection, with a specification of 10ml:1.814g (calculated as gadoxetate disodium). It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. In terms of API registration, as of now, there are 11 registration entries of gadoxetate disodium API on the CDE platform, of which 6 have been activated with A status. The APIs of the original research enterprise and many domestic enterprises have been approved for associated use in domestic marketing, and the domestic approved preparation varieties have covered 6 enterprises. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for gadoxetate disodium API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They can meet the compliance requirements under multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and fully satisfy the reference standard use needs in different stages such as API R&D, quality research, and consistency evaluation.