HUADONG MEDICINE(SZ:000963) Zheng Quan Shi Bao Wang·2025-10-17 15:09Core Viewpoint - Huadong Medicine's innovative drug Relmapirazin Injection has received approval from the National Medical Products Administration (NMPA) in China, marking a significant advancement in kidney disease diagnosis and treatment [1][2]. Group 1: Product Overview - Relmapirazin Injection is a non-radioactive, non-iodinated fluorescent GFR tracer that requires the MediBeacon TGFR device for use, aimed at assessing glomerular filtration rate (GFR) in patients with normal or impaired kidney function [2][4]. - MediBeacon TGFR is the first bedside product approved globally for GFR assessment in both normal and impaired kidney function patients, developed in collaboration with MediBeacon Inc. [2][4]. Group 2: Market Context - Chronic kidney disease (CKD) has become a global public health crisis, with the median prevalence rate at 9.5% and a median mortality rate of 2.4% according to the International Society of Nephrology [2]. - In China, the prevalence of CKD ranges from 8.2% to 13.8%, with approximately 1.18 million patients undergoing dialysis or kidney transplantation in 2023 [3]. Group 3: Clinical Significance - The MediBeacon TGFR device allows for real-time, non-invasive monitoring of GFR, addressing current clinical challenges related to GFR testing processes and spatial limitations [4]. - The approval of MediBeacon TGFR signifies a major breakthrough in the field of diagnostic innovation for kidney function assessment, enhancing clinical efficiency and convenience [4]. Group 4: Company Strategy - Huadong Medicine has developed a diverse pipeline of over 80 projects through a dual approach of "independent development + external introduction," focusing on endocrine, autoimmune, and oncology treatment areas [4]. - The successful approval of MediBeacon TGFR reflects the company's strong innovative capabilities and strategic vision in advancing clinical value-driven development [4].