Gadopiclenol

As a commonly used macrocyclic gadolinium-based contrast agent, gadopiclenol is an extracellular fluid non-specific magnetic resonance contrast agent. Its mechanism of action is to significantly improve the contrast and clarity of magnetic resonance imaging by shortening the relaxation time of protons in tissues, so as to facilitate the accurate clinical identification of tiny lesions. This drug is mainly used for enhanced magnetic resonance examination of multiple parts such as the central nervous system, abdomen and chest, and can also be used as an adjuvant for magnetic resonance angiography. The applicable population covers adults and pediatric patients over 2 years old who need enhanced magnetic resonance examination, and the medication safety for people with normal renal function is good.

At present, the global market size of gadolinium-based contrast agents has exceeded 1.6 billion US dollars, with a compound annual growth rate maintained at around 4.2%. Among them, macrocyclic contrast agents with high relaxation rate and low nephrotoxicity account for an increasing market share year by year, and have replaced linear products as the mainstream in the market. In terms of the domestic market, with the advancement of hierarchical diagnosis and treatment and the growth of demand for imaging examinations, gadopiclenol, as a macrocyclic contrast agent with high clinical recognition, maintains a market growth rate of more than 6%. At present, more than 8 enterprises have applied for generic drugs, and the overall medication accessibility has been greatly improved after centralized procurement, but there is still a certain gap in the supply of high-quality active pharmaceutical ingredients.

The original research enterprise of gadopiclenol is Bayer HealthCare, and the original brand name is Magnevist. The core compound patent of the original drug will expire in China in 2026. The main dosage form of the original marketed product is injection, and the common specifications include 10ml:4.69g, 15ml:7.04g and 20ml:9.38g. The original preparation has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. Up to now, 3 domestic enterprises have obtained CDE registration for gadopiclenol active pharmaceutical ingredients with the status of A, and another 11 enterprises have obtained approval for the marketing of generic preparations. (Data as of October 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of gadopiclenol impurity reference standards, all of which meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA. Most impurities are in stock, and in-stock products ordered before 16:00 can be shipped on the same day, which can fully meet various reference standard needs in the process of active pharmaceutical ingredient research and development, quality research and consistency evaluation.