Viwit Pharmaceuticals proudly announces the receipt of the "Drug Supplementary Application Approval Notice" from the National Medical Products Administration (NMPA) for their Gadoterate Meglumine Injection. This approval includes the following strengths: 10 mL containing 3.769 g, 15 mL containing 5.654 g, and 20 mL containing 7.538 g. The corresponding approval numbers are H20243899, H20243900, and H20243901.

This milestone signifies that Gadoterate Meglumine Injection is now approved for the Chinese market and has successfully passed the generic conformity evaluation. Viwit Pharmaceuticals is now the third company in China to obtain this effective approval for the product, demonstrating its commitment to providing high-quality pharmaceutical solutions.

To ensure a consistent supply and maintain the highest standards of product quality, Viwit Pharmaceuticals has independently developed the crucial excipient DOTA. This key ingredient has successfully passed rigorous review and approval processes, achieving an A status with the registration number F20220000276.

Gadoterate Meglumine injection is an intravenous contrast agent for magnetic resonance imaging (MRI) and was first approved for marketing in France in 1989. This product is only used for the diagnosis of diseases and is used for MRI examinations of the following diseases: (1) brain and spinal cord lesions; (2) spine lesions; (3) other systemic pathological examinations (including adult angiography). It is not recommended for systemic use in children under 6 months old.

Contrast agents are products administered via injection or ingestion into humans to enhance imaging observation effects. These agents are indispensable for diagnosis and differential diagnosis in the field of medical imaging. In recent years, the application of medical imaging in clinical diagnosis has become increasingly widespread, with imaging technology evolving from a supplementary examination tool to one of the most critical methods for clinical diagnosis and differential diagnosis in modern medicine. Consequently, the contrast agent market has exhibited a rapid growth trend.

Gadoterate Meglumine injection is a macrocyclic gadolinium contrast agent known for its enhanced stability compared to linear structures. This stability reduces the likelihood of gadolinium ion release and minimizes the risk of deposition in the brain, making it an option in clinical MRI diagnostics. According to the Pharmcodia database, the market sales of Gadoterate Meglumine injection surpassed 600 million Chinese Yuan in 2023, marking a remarkable 31% YOY growth. 

Gadoterate Meglumine injection is Viwit’s first approved and commercialized contrast agent, laying a solid foundation for the development and manufacturing of the company’s contrast agent portfolio. We are committed to expanding the contrast agent industry supply chain and achieving seamless integration and internationalization of APIs and formulations. Our goal is to meet the clinical demand for contrast agents and bring significant benefits to patients undergoing MRI examinations. We are also vigorously advancing the registration process for the raw materials and formulations of Gadoterate Meglumine and Gadobutrol across the Chinese, American, and European markets.