Core Viewpoint - The company is actively working on transferring the production of its renal filtration system and related drugs to domestic markets, with ongoing orders and preparations in place for both medical devices and pharmaceuticals [1] Group 1: Medical Devices - The company has received procurement orders for the transcutaneous glomerular filtration rate measurement device (TGFR) from various distributors and medical institutions for research and clinical use [1] - The company has completed inventory preparations with partners in advance for the TGFR device and is planning to transfer production to domestic facilities [1] Group 2: Pharmaceuticals - The company's wholly-owned subsidiary, China-US East, will independently produce and sell the drug Remabizine injection in China [1] - China-US East will also serve as one of the suppliers for MediBeacon in the U.S. market [1]

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its innovative drug, Maleate Mevanertinib Tablets (brand name: Mairuidong), for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 21 (L858R) substitution mutations [1][2] Group 1 - Maleate Mevanertinib Tablets are a new, potent, highly selective, orally active irreversible EGFR/HER2 small molecule inhibitor, representing a novel national class 1 innovative drug with independent intellectual property rights [2] - The drug irreversibly inhibits tyrosine kinase autophosphorylation by covalently binding to the kinase regions of EGFR (ErbB1) and HER2 (ErbB2), leading to downregulation of ErbB signaling and suppression of tumor growth [2] Group 2 - Huadong Medicine aims to actively promote the commercialization of Mairuidong post-approval, providing better clinical benefits to patients and striving to make it accessible to a wider patient population [1] - Mairuidong is the second innovative drug launched by Huadong Medicine within a week, following the approval of Remabizine Injection, which is part of a combination product for renal function assessment [1]

Core Viewpoint - Huadong Medicine's innovative drug, Mevanertinib (brand name: Mairuidong), has received approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR exon 21 (L858R) substitution mutation, marking a significant advancement in lung cancer treatment options [1][4]. Company Developments - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has successfully developed and launched Mevanertinib, which is a first-class innovative drug with independent intellectual property rights [1][5]. - The company has achieved a milestone by obtaining approval for two innovative drugs within a week, showcasing its commitment to advancing its product pipeline [1][4]. - The company is actively preparing for the commercialization of Mevanertinib to provide better clinical benefits to patients [1][4][8]. Industry Context - Lung cancer remains the most prevalent and deadly malignancy globally, with NSCLC accounting for approximately 85% of primary lung cancer cases [2]. - In China, the incidence of lung cancer is particularly high, with over 1.06 million new cases reported in 2024, and the EGFR mutation is present in about 50% of lung adenocarcinoma patients [2]. - The targeted drug market for NSCLC in China is projected to reach 182.87 billion yuan by 2030, with a compound annual growth rate (CAGR) of 13.2% [2]. Clinical Insights - Mevanertinib is a novel, potent, and highly selective irreversible EGFR/HER2 small molecule inhibitor, demonstrating superior safety and tolerability compared to existing third-generation EGFR-TKIs in patients with the L858R mutation [3][4]. - The approval of Mevanertinib is based on a Phase III clinical trial that met predefined efficacy standards, indicating its potential to fulfill unmet clinical needs in the treatment of NSCLC [3][4]. Future Outlook - The approval of Mevanertinib is expected to provide significant market growth opportunities, as it addresses the clinical demand for effective treatments in patients with the EGFR L858R mutation [4][6]. - Huadong Medicine is focused on developing a diverse pipeline of innovative drugs, particularly in oncology, with over 80 projects currently in development [5][6][8].

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 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 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]