Gadoteridol

Improved accuracy of central nervous system imaging cannot be achieved without the technological iteration of specific magnetic resonance contrast agents. Gadoteridol is a macrocyclic gadolinium-based non-ionic magnetic resonance imaging (MRI) contrast agent. It enhances imaging contrast by shortening the relaxation time of protons in tissues, and has higher thermodynamic stability and lower risk of gadolinium ion dissociation. It is mainly used clinically for MRI examination of the brain, spine and systemic soft tissues, and is especially suitable for populations with high requirements for the safety of gadolinium agents such as patients with renal insufficiency. It can effectively identify tiny lesions and define tumor boundaries, providing clear imaging basis for disease staging and surgical plan formulation.

At present, the global market size of gadolinium-based contrast agents is growing steadily, among which macrocyclic products account for more than 60%, with a compound annual growth rate maintained at around 6%. Driven by the promotion of hierarchical diagnosis and treatment and the expansion of imaging examination demand in the domestic market, the annual sales of gadoteridol-related preparations have exceeded 800 million yuan, with a compound growth rate of 9.2% from 2020 to 2023. In terms of competitive landscape, original research products still account for nearly 50% of the market share, and 3 domestic enterprises have been approved for generic preparations. With the expansion of the coverage of centralized procurement, the substitution space for generic drugs continues to be released.

The original research enterprise of gadoteridol is Bracco S.p.A. of Italy, with the original brand name of "ProHance". The core compound patent of gadoteridol will expire in 2026 in the United States and Europe, and the Chinese compound patent expired in 2023. The main dosage form approved by the original research is injection, with specifications including 10ml:2.793g, 15ml:4.1895g, and 20ml:5.586g. It has been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, 3 enterprises have passed the CDE evaluation and publicity (A status) for their gadoteridol APIs, and another 2 are under evaluation. There are 4 gadoteridol injection varieties approved for marketing in China. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of gadoteridol impurity reference standards, covering process impurities, degradation impurities and isotopic labels. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for API and preparation enterprises in quality research, stability study and registration declaration.