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]

华东医药（000963）(000963.SZ)公告，公司全资子公司杭州中美华东制药有限公司(简称"中美华东")收 到国家药品监督管理局(NMPA)核准签发的《药品注册证书》，由中美华东申报的瑞玛比嗪注射液的上 市许可申请获得批准。该药品是一种注射用外源性荧光示踪剂，需与MediBeacon Inc生产的经皮肾小球 滤过率测量设备(TGFR)配合使用，评估患者的肾小球滤过率(GFR)。 ...

证券代码：000963 证券简称：华东医药 公告编号：2025-093 华东医药股份有限公司 剂型：注射剂 规格：7ml:130.2mg 申请事项：药品注册（境内生产） 注册分类：化学药品1类 关于全资子公司收到药品注册证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 近日，华东医药股份有限公司（以下简称"公司"）全资子公司杭 州中美华东制药有限公司（以下简称"中美华东"）收到国家药品监督 管理局（NMPA）核准签发的《药品注册证书》，由中美华东申报的 瑞玛比嗪注射液（英文名称：Relmapirazin Injection；研发代码：MB-102） 的上市许可申请获得批准。现将有关详情公告如下： 一、该药物基本信息内容 药品通用名称：瑞玛比嗪注射液 英文名：Relmapirazin Injection 受理号：CXHS2400001 证书编号：2025S03136 药品批准文号：国药准字H20250060 适应症：本品是一种注射用外源性荧光示踪剂，需与MediBeacon Inc生产的经皮肾小球滤过率测量设备（TGFR）配合使用，评估患者 的肾小球滤 ...

Core Viewpoint - The approval of the registration certificate for Remabizine injection by the National Medical Products Administration is a significant development for the company, indicating progress in its pharmaceutical offerings and potential future revenue growth [1] Company Summary - The company's wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received the registration certificate for Remabizine injection, which is an exogenous fluorescent tracer used in conjunction with MediBeacon Inc's equipment to assess patients' glomerular filtration rate [1] - The total direct investment in the development of Remabizine injection and the TGFR project amounts to approximately 273 million yuan [1] - The approval is not expected to have a major impact on the company's current financial status and operating results, but it is anticipated to have a positive effect on future performance [1]

Group 1 - The core point of the article is that Huadong Medicine's application for the marketing approval of Maihua Tini tablets is still under review and is expected to be approved by the end of the year [1] - The specific timing of the new drug review and approval process remains uncertain, and the final outcome will depend on the announcements from the National Medical Products Administration (NMPA) and the company [1]

Core Viewpoint - The article emphasizes the rising importance of biomanufacturing as a strategic and innovative field that disrupts traditional production methods, presenting it as a new growth point for optimizing industrial structures and transforming economic models. The release of the "2025 China Synthetic Biomanufacturing Industry Development White Paper" highlights the current state, trends, and challenges of the biomanufacturing industry in China [1]. Group 1: Current State and Trends - The white paper outlines the development status and trends of biomanufacturing, analyzing the global landscape and key platform facilities [5]. - It compares the biomanufacturing sectors of China and the United States, identifying competitive advantages and areas for improvement [5]. - Future development trends in biomanufacturing are discussed, indicating a shift towards more integrated and innovative approaches [5]. Group 2: Policy Landscape - The report reviews major policies affecting biomanufacturing both domestically and internationally, providing insights into regulatory frameworks that shape the industry [5]. - It categorizes foreign and domestic policies, highlighting their implications for the growth of the biomanufacturing sector [5]. Group 3: Industry Map and Applications - A comprehensive map of the Chinese biomanufacturing industry is presented, detailing key players and their roles [5]. - The report identifies critical application areas for biomanufacturing, including pharmaceuticals, food, personal care, agriculture, chemicals, materials, and energy [5]. Group 4: Key Enterprises and Investment Landscape - The white paper lists the top 10 leading enterprises in China's biomanufacturing sector, showcasing their contributions and market positions [6]. - It also summarizes the strategic directions of 15 publicly listed companies in synthetic biology, along with their investment and development strategies [6]. Group 5: Challenges and Recommendations - The report discusses the challenges faced by the biomanufacturing industry in China, including technological, regulatory, and market-related issues [6]. - Targeted policy recommendations are provided to address these challenges and promote sustainable growth in the biomanufacturing sector [6].