Huadong Medicine (000963.SZ): Medical device MediBeacon TGFR for evaluating kidney function approved by the U.S. FDA.

Huadong Medicine (000963.SZ) announced recently that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (referred to as "Zhongmei Huadong"), and its American partner MediBeacon Inc. have announced that their medical device, the MediBeacon Transdermal GFR System (TGFR), for assessing kidney function, has been approved by the U.S. Food and Drug Administration (FDA). The MediBeacon TGFR consists of a monitoring device, sensor, and Lumitrace (Relmapirazin, research code: MB-102) injection (a non-radioactive, non-iodinated fluorescent GFR tracer), which aims to evaluate the glomerular filtration rate (GFR) of adult patients with impaired or normal kidney function by monitoring the fluorescence value of an exogenous tracer over time. Its effectiveness has been validated in patients with stable kidney function. The system evaluates kidney function by measuring the clearance rate of the fluorescent tracer in the body, calculating real-time changes in the transcutaneous measurement of Lumitrace fluorescence intensity relative to time using sensors placed on the skin. The monitoring method used is not influenced by age, weight, gender, or race. The sensors in the system can record 2.5 fluorescence values per second, and the TGFR monitor can provide the average GFR for hospitalized or outpatient patients for a specific time period. The design of TGFR, validated through clinical trials, can be used for bedside assessment of patients with stable kidney function without the need for blood or urine analysis. The current clinical methods for measuring GFR require multiple blood draws, urine samples, complex clinical laboratory analyses, and are unable to provide bedside assessments. The MediBeacon TGFR, developed through collaboration between Zhongmei Huadong and MediBeacon, is the world's first bedside product approved for evaluating kidney function in patients with normal or impaired kidney function. Zhongmei Huadong has the exclusive commercialization rights for this product in 25 Asian countries or regions including mainland China, Hong Kong, Taiwan, Singapore, and Malaysia. In July 2023, the product's Premarket Approval (PMA) application was accepted by the U.S. FDA. On January 17, 2025 (U.S. time), MediBeacon announced that the product had received FDA approval for evaluating kidney function in patients with normal or impaired kidney function.