Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, received approval from the National Medical Products Administration (NMPA) for the new drug, Remabizine Injection, which is a non-radioactive, non-iodinated fluorescent GFR tracer used in conjunction with MediBeacon Inc.'s TGFR device for assessing kidney function [1][2]. Group 1: Product Approval and Development - Remabizine Injection is classified as a Class 1 chemical drug and is designed to evaluate glomerular filtration rate (GFR) in patients with normal or impaired kidney function [1]. - The TGFR device, developed in collaboration with MediBeacon Inc., has been approved by the FDA in the U.S. for the same purpose as of January 17, 2025 [1]. - Both Remabizine Injection and the TGFR device must be submitted separately for drug and medical device approvals according to Chinese registration regulations [2]. Group 2: Commercialization and Market Strategy - Huadong Medicine has established exclusive commercialization rights for the product in 25 Asian countries or regions [1]. - The company has reported significant growth in its innovative product business, achieving sales and agency service revenue of 1.084 billion yuan, a year-on-year increase of 59% [2]. - The company is actively planning to transfer the production of TGFR to domestic facilities and has received procurement orders from distributors and medical institutions for research and clinical use [3]. Group 3: Pipeline and R&D Focus - Huadong Medicine is focusing on three core therapeutic areas: endocrinology, autoimmune diseases, and oncology, with a dual approach of "independent development + external introduction" [2]. - The company is advancing over 80 projects in its innovative drug R&D center, indicating a rich pipeline of differentiated innovative drugs [2].

Core Viewpoint - The report by Zhiyan Consulting highlights the growth trends in China's chemical pharmaceutical industry, projecting a production increase in raw chemical drugs by 3.4% year-on-year in April 2025, with a cumulative growth of 3.9% from January to April 2025 [1] Industry Summary - In April 2025, China's production of raw chemical drugs reached 332,000 tons, marking a year-on-year increase of 3.4% [1] - The cumulative production of raw chemical drugs from January to April 2025 totaled 1,257,000 tons, reflecting a cumulative growth of 3.9% [1] - The report provides insights into the supply and demand dynamics of the chemical pharmaceutical industry in China from 2025 to 2031 [1] Company Summary - Listed companies in the report include Heng Rui Medicine, East China Pharmaceutical, Lijun Group, Baiyunshan, North China Pharmaceutical, Haizheng Pharmaceutical, Fosun Pharmaceutical, Kelun Pharmaceutical, Enhua Pharmaceutical, and Xianju Pharmaceutical [1] - Zhiyan Consulting is recognized as a leading industry consulting firm in China, specializing in in-depth industry research and providing comprehensive consulting services for investment decisions [1]

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].

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 Points - Huadong Medicine announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the drug registration certificate from the National Medical Products Administration (NMPA) for Relmapirazin Injection [2] Group 1 - The approval of Relmapirazin Injection marks a significant milestone for Huadong Medicine, enhancing its product portfolio in the pharmaceutical market [2] - The drug is identified by its research code MB-102, indicating its development stage and potential therapeutic applications [2]

Core Insights - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, received approval from the NMPA for the innovative drug Relmapirazin Injection, marking a significant milestone in the company's product portfolio [1] - The drug is designed to be used in conjunction with MediBeacon's TGFR device to assess patients' glomerular filtration rate (GFR), addressing a critical clinical need in chronic kidney disease (CKD) management [1][2] - The approval of Relmapirazin Injection and the TGFR device signifies a successful collaboration between Huadong Medicine and MediBeacon, enhancing the company's position in the renal health market [2][3] Product and Market Potential - The TGFR device, which has already received FDA approval in the U.S., is expected to improve the efficiency of clinical assessments of kidney function, addressing the high prevalence of CKD globally [2][3] - Chronic kidney disease poses a significant public health challenge, with a global median prevalence of 9.5% and a mortality rate of 2.4%, highlighting the urgent need for effective screening and intervention [2] - Huadong Medicine plans to leverage its commercialization strengths to ensure rapid market penetration of the TGFR device and Relmapirazin Injection in China, aiming to benefit a large patient population [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 - The company has received approval for the marketing license of Remabizine Injection, a drug that requires specific equipment for assessing kidney function [1] Company Summary - East China Pharmaceutical (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd. (referred to as "Sino-American East China"), has received the drug registration certificate issued by the National Medical Products Administration (NMPA) [1] - The approved drug, Remabizine Injection, is an exogenous fluorescent tracer used in conjunction with MediBeacon Inc's transcutaneous glomerular filtration rate measurement device (TGFR) to evaluate patients' glomerular filtration rate (GFR) [1]

Core Viewpoint - Huadong Medicine (000963) announced the approval of its subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., for the marketing authorization of Remabizine Injection by the National Medical Products Administration [1] Group 1: Company Developments - The approved drug, Remabizine Injection, is an exogenous fluorescent tracer used in conjunction with MediBeacon Inc.'s transcutaneous glomerular filtration rate measurement device [1] - The purpose of the drug is to evaluate patients' glomerular filtration rate (GFR) [1]