华东医药股份有限公司关于全资子公司收到药品注册证书的公告

Core Viewpoint - The announcement highlights that Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., has received approval from the National Medical Products Administration (NMPA) for the marketing authorization of Relmapirazin Injection, a new drug aimed at assessing kidney function in patients [1][2][3]. Drug Information - The drug is named Relmapirazin Injection, with a specification of 7ml:130.2mg, classified as a Class 1 chemical drug [1][3]. - It is designed to be used in conjunction with MediBeacon Inc.'s transdermal glomerular filtration rate measurement device (TGFR) to evaluate patients' glomerular filtration rate (GFR) [1][3]. Development and Registration Status - Relmapirazin Injection is a non-radioactive, non-iodinated fluorescent GFR tracer, developed in collaboration with MediBeacon Inc. [3][4]. - The drug's international multi-center Phase III clinical trial application was approved by NMPA in May 2021, and a key clinical trial in China was approved in December 2022 [5]. - As of September 30, 2025, the company has invested approximately 273 million yuan in the development of Relmapirazin Injection and TGFR [5]. Market Impact and Future Prospects - Chronic kidney disease (CKD) is a significant global health burden, with a median prevalence of 9.5% worldwide and 8.2% to 13.8% in China [6]. - The approval of Relmapirazin Injection is a milestone in the development of MediBeacon?TGFR, which has already received FDA approval in the U.S. [7]. - The company anticipates stable supply and market penetration for the product, with plans to produce and sell Relmapirazin Injection in China while also supplying the U.S. market [7].