China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a glomerular filtration rate (GFR) dynamic monitoring system has been accepted by the National Medical Products Administration (NMPA). The device, co-developed by subsidiaries Hangzhou Zhongmei Huadong Pharmaceutical and MediBeacon Inc., measures GFR non-invasively in patients with normal or impaired renal function.
Device Overview
The system, the world’s first for bedside, real-time, continuous, and dynamic GFR monitoring, tracks fluorescence changes from an exogenous tracer. It holds 31 US patents, with 13 and 15 pending in the US and China. The device received US Breakthrough Device Designation in 2018 and China’s fast-track status in 2021.
Clinical and Regulatory Progress
MB-102 (relmapirazin), a Category I drug used with the system, received NMPA approval for a global Phase III trial in May 2021. The study will launch in China and the US later this year.-Fineline Info & Tech
