Huadong Medicine unit gets approval for kidney device

Huadong Medicine (SZSE:000963) announced that its wholly-owned subsidiary, Sino-American Huadong Pharmaceutical, received a medical device registration certificate from China's National Medical Products Administration (NMPA) for its innovative Class III medical device: percutaneous glomerular filtration rate measurement equipment. The device, used with the company's Lumitrace injection, assesses glomerular filtration rate in patients with impaired kidney function, specifically those with 15ml/min/1.73m2 <GFR<120ml/min/1.73m2. This approval marks a significant step for MediBeacon®TGFR, developed in collaboration with MediBeacon Inc. This device is not for diagnosis, but a tool used with other factors to help diagnose, and is only good for qualified practitioners, as per NMPA requirements. Huadong Medicine holds exclusive commercialization rights for the product in 25 Asian countries/regions. The company plans to launch the device in China after its Lumitrace injection receives approval, as it is still under regulatory review.