China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received marketing approval from the US FDA for its generic version of German giant Bayer’s (ETR: BAYN) Gadovist (gadobutrol injection). The drug is approved for use in contrast-enhanced magnetic resonance imaging (CE-MRI) examination of lesions in various parts of the body, including the brain and spinal cord, and contrast-enhanced magnetic resonance angiography (CE-MRA) examination of various body parts.
Background and Market Entry
Gadovist is a contrast agent used to support magnetic resonance imaging (MRI) scans. It was first approved for marketing in Switzerland in 1998. Hainan Poly Pharm has also filed for market approval for the product in China, expanding its reach in the global market.
Market Context and Competition
Jiangsu Hengrui Medicine Co., Ltd’s (600276.SH) generic version of Gadovist became the first of its kind to receive FDA approval in the US in November last year. This approval for Hainan Poly Pharm further diversifies the options available for healthcare providers and patients in the US market.-Fineline Info & Tech
