SSY GROUP (02005.HK): Gadobutrol API Approved for Registration by NMPA, a New-Generation Macrocyclic MRI Contrast Agent
NewTimeSpace News: SSY GROUP (02005.HK) announced that its gadobutrol active pharmaceutical ingredient (API) has obtained registration approval from the National Medical Products Administration (NMPA) for use in marketed finished pharmaceutical products. As an MRI contrast agent, gadobutrol is indicated for adults and paediatric patients of all ages, applied in contrast-enhanced MRI and MR angiography examinations for lesions across all body parts.
NewTimeSpace News: On 21 July 2026, SSY GROUP (02005.HK) issued a voluntary announcement. The Group’s gadobutrol has been granted registration approval by the National Medical Products Administration of China as an active pharmaceutical ingredient eligible for formulation into marketed finished drugs.
Gadobutrol is a magnetic resonance imaging (MRI) contrast agent suitable for adults and paediatric patients of all ages including full-term newborns. It is primarily used for contrast-enhanced magnetic resonance imaging (CE-MRI) of lesions in all body regions covering the brain and spinal cord, as well as contrast-enhanced magnetic resonance angiography (CE-MRA) across the whole body.
A new-generation macrocyclic MRI contrast agent, gadobutrol features superior structural stability and safety compared with linear gadopentetate dimeglumine, conferring prominent clinical substitution advantages. Gadolinium is a rare earth metal element, and the Group is actively building an integrated industrial chain covering gadolinium-based APIs and injectable formulations.
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