Core 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].

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Sino-American Huadong Pharmaceutical Co., has received approval from the National Medical Products Administration (NMPA) for the marketing authorization of Relmapirazin Injection, a new Class 1 chemical drug aimed at assessing kidney function through non-invasive monitoring [1] Group 1 - The approved product, Relmapirazin Injection, is a non-radioactive, non-iodinated fluorescent GFR tracer [1] - Relmapirazin Injection is designed to be used in conjunction with MediBeacon Inc.'s transdermal glomerular filtration rate measurement device (TGFR) [1] - The combination of Relmapirazin Injection and TGFR aims to evaluate the glomerular filtration rate (GFR) in patients with impaired or normal kidney function through the monitoring of the fluorescence of the exogenous tracer over time [1]

Core Viewpoint - Huadong Medicine (000963.SZ) has received approval from the National Medical Products Administration (NMPA) for the marketing authorization of Relmapirazin Injection, a new Class 1 chemical drug developed by its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [1] Group 1: Product Details - Relmapirazin Injection is a non-radioactive, non-iodinated fluorescent GFR tracer that requires the use of MediBeacon Inc.'s transdermal glomerular filtration rate measurement device (TGFR) [1] - The product aims to non-invasively monitor the fluorescence of an exogenous tracer over time to assess the glomerular filtration rate (GFR) in patients with impaired or normal kidney function [1]

Core Viewpoint - Huadong Medicine (000963) is actively communicating with its partner regarding the supply timeline for the product "Yanduo" [1] Group 1: Product Details - MediBeacon TGFR consists of a transcutaneous glomerular filtration rate measurement device and Lumitrace (Remabizine) injection, managed as a medical device and a drug in China respectively [1] - The transcutaneous glomerular filtration rate measurement device was approved in February 2025, and the company has completed inventory preparations with its partner in advance [1] - The drug portion will be produced independently by the company, ensuring a stable supply with sufficient buffer periods and multiple safeguard mechanisms [1]