Bayer's Gadoquatrane submitted for marketing authorization in China

On September 16, China's Center for Drug Evaluation (CDE) website disclosed that Bayer's Class 1 new drug Gadoquatrane injection has been submitted for marketing approval in China. Based on the drug's clinical development progress, it is speculated that the intended indication is for magnetic resonance imaging (MRI).

Image: CDE website

Gadoquatrane is a clinical-stage extracellular macrocyclic contrast agent developed by Bayer to enhance contrast in MRI. This low-dose gadolinium-based agent features a unique tetrameric structure, offering high stability and high relaxivity.

In June and July of this year, Bayer submitted marketing applications for Gadoquatrane in Japan, the U.S., and the EU for enhanced MRI of the central nervous system (CNS) and other body areas in adults and pediatric patients, including newborns. According to Bayer's press release, if approved, Gadoquatrane will become the lowest-dose macrocyclic GBCA available in the U.S. and EU markets.

The submission is supported by the pivotal Phase III QUANTI study, in which Gadoquatrane was administered at a dose of 0.04 mmol Gd/kg—reducing the gadolinium dose by 60% compared to macrocyclic contrast agents dosed at 0.1 mmol Gd/kg.

The QUANTI program included two large multinational, randomized, prospective, double-blind, crossover Phase III trials—QUANTI CNS and QUANTI OBR—as well as a QUANTI pediatric study. A total of 808 patients from 15 countries (including mainland China) participated.

Results demonstrated that Gadoquatrane met all primary and secondary efficacy endpoints for visualization parameters and lesion detection. The pediatric study also confirmed similar pharmacokinetic profiles between children and adults.

The safety profile observed in both adult and pediatric patients (from birth to under 18 years) was consistent with previous data on Gadoquatrane and other macrocyclic GBCAs. No new safety signals were identified.