China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) announced that the US Food and Drug Administration (FDA) has approved its generic version of Bracco’s ProHance (gadoteridol), making it the first and currently only ProHance generic available in the US. The approved strengths include 1.3965 g/5 mL, 2.793 g/10 mL, 4.1895 g/15 mL, and 5.586 g/20 mL.
Drug Profile
ProHance, registered in the US, Japan, Europe, and China (approved in 2014), is used for magnetic resonance imaging (MRI) of the brain, spine, and surrounding tissues. Hainan Poly’s generic offers a cost-effective alternative for enhanced MRI scans.
Strategic Outlook
The FDA approval positions Hainan Poly to capture market share in the US MRI contrast agent segment. Meanwhile, Kelun Pharma secured the first marketing approval for a ProHance generic in China in May 2022, highlighting growing competition in the global generics space.-Fineline Info & Tech
