[Good News] Beilu Pharma's Gadobutrol API Approved

Recently, Beilu Pharma received the Notice of Approval for Marketing Application of Chemical API for Gadobutrol, issued by the National Medical Products Administration (NMPA).

Gadobutrol API can be used to manufacture Gadobutrol Injection. This injection is indicated for adults and children of all ages (including full-term neonates) for contrast-enhanced magnetic resonance imaging (MRI) of lesions in all parts of the body, including the brain and spinal cord. It is particularly advantageous for dynamic contrast-enhanced magnetic resonance angiography (DCE-MRA) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the whole body. Currently, Gadobutrol Injection has been included in Category B of the National Reimbursement Drug List (NRDL).

The approval of the Gadobutrol API indicates that it has met the relevant national technical evaluation standards. Upon compliance with Good Manufacturing Practice (GMP) requirements, it can be manufactured and sold in the domestic market, and utilized in the production of related gadolinium-based contrast media. This milestone will consolidate the company's "API + Formulation" business model, further enrich its product pipeline, and enhance the market competitiveness of the contrast media portfolio.