Huadong Medicine's subsidiary secures key drug registration for renal function assessment tool

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine, has received a drug registration certificate from the National Medical Products Administration (NMPA) for Relmapirazin Injection (MB-102). This injection is a non-radioactive, non-iodinated fluorescent GFR tracer designed to be used with MediBeacon Inc.'s transdermal glomerular filtration rate (TGFR) measurement device to assess patients' glomerular filtration rate (GFR). This marks the approval of a Class 1 chemical new drug.

The Relmapirazin Injection, produced by Zhongmei Huadong, received NMPA approval for its marketing application in January 2024 and was recently granted a registration certificate. It is the first globally approved bedside product for renal function assessment in normal and impaired patients, developed in collaboration with MediBeacon Inc. Zhongmei Huadong holds exclusive commercialization rights in 25 Asian countries or regions.

The company's total direct R&D investment in the Relmapirazin Injection and TGFR project amounted to approximately CNY 273 million as of September 30, 2025. This approval is expected to positively impact the company's future performance, addressing a critical need in early screening and diagnosis of chronic kidney disease.