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经皮肾小球滤过率测量设备
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营收净利双升!华东医药三季报出炉,创新药迎里程碑式进展,核心管线成果密集兑现
Quan Jing Wang· 2025-10-27 11:44
Core Insights - The company reported steady revenue and profit growth for the first three quarters of 2025, with total revenue reaching 32.664 billion yuan, a year-on-year increase of 3.77%, and net profit attributable to shareholders of 2.748 billion yuan, up 7.24% [1] - Significant investment in R&D was noted, with expenditures rising to 2.186 billion yuan, a 35.99% increase, indicating a strong commitment to innovation [1] - The company’s innovative products are increasingly contributing to revenue, with sales from innovative products reaching 1.675 billion yuan, a substantial growth of 62% year-on-year [2] Financial Performance - For the first nine months of 2025, the pharmaceutical industrial segment achieved revenue of 11.045 billion yuan, a growth of 11.10%, and net profit of 2.475 billion yuan, up 15.62% [2] - In Q3 2025, the segment reported revenue of 3.728 billion yuan, a 14.95% increase, and net profit of 894 million yuan, an 18.43% rise [2] - The company maintained a resilient operational performance despite increased R&D investments, with quarterly revenue and profit showing a consistent upward trend [1] Product Development and Innovation - The company has made significant advancements in its core therapeutic areas, including endocrine, oncology, and autoimmune diseases, with over 90 innovative drug pipeline projects underway [4] - The ADC drug pipeline has shown promising progress, with several candidates receiving IND approvals in both China and the U.S. [5] - The company is preparing for negotiations regarding national medical insurance and commercial insurance for three innovative products, aiming to enhance drug accessibility and drive sales growth [3] Market Position and Strategy - The company has established a strong market presence with its CAR-T product, achieving significant order volumes that exceed previous year's totals [2] - The company’s innovative drug candidates are positioned to address various conditions, including diabetes and cancer, with several products nearing market entry [6][7] - The industrial microbiology segment has also shown robust growth, with a 28.48% increase in revenue, indicating a diversified growth strategy [9] Future Outlook - The company aims to continue its focus on research-driven, patient-centered approaches to foster sustainable high-quality growth [11] - The medical aesthetics business is expected to enhance its brand effect and core competitiveness through a global product matrix [10] - The ongoing development of innovative products and the expansion of market access are anticipated to provide solid momentum for future performance [11]
华东医药:全资子公司收到瑞玛比嗪注射液药品注册证书
Xin Lang Cai Jing· 2025-10-17 10:27
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]
华东医药:公司正积极与合作方沟通
Zheng Quan Ri Bao Wang· 2025-09-15 13:41
Core Viewpoint - Huadong Medicine (000963) is actively communicating with its partner regarding the supply timeline for the product "Yanduo" [1] Group 1: Product Details - MediBeacon TGFR consists of a transcutaneous glomerular filtration rate measurement device and Lumitrace (Remabizine) injection, managed as a medical device and a drug in China respectively [1] - The transcutaneous glomerular filtration rate measurement device was approved in February 2025, and the company has completed inventory preparations with its partner in advance [1] - The drug portion will be produced independently by the company, ensuring a stable supply with sufficient buffer periods and multiple safeguard mechanisms [1]
获批创新器械!肾功能评估新突破
思宇MedTech· 2025-02-24 04:28
合作伙伴征集:2025全球手术机器人大会 报名:首届全球眼科大会 | 展位有限 报名:首届全球心血管大会 | 奖项评选 报名:首届全球骨科大会 | 奖项评选 2025年2月18日,NMPA官网显示,国家药品监督管理局批准了 美德康公司 MediBeacon Inc. 的" 经皮肾小球滤过率测量设备"(国械注进 20253070094) 创新产品注册申请。 慢性肾脏病(CKD)是全球主要的死亡原因之一,患者数量已超过8亿,且在过去二十年间,与此相关的死亡人数持续攀升。 该系统的经皮肾小球滤过率 (tGFR)测量方法经过精心设计,能够有效适用于成年人群,无需考虑年龄、体重、性别、种族或民族等因素。 值得注意的是,2025年1月17日,该产品获得美国FDA批准。 # 产品介绍 该产品由主机、传感器和固定贴组成,与该公司生产的 瑞玛比嗪注射液 配合使用,主要用于评估患者肾小球滤过率。 测量原理 该产品采用 漫反射校正 和 背景分离校正 的 荧光示踪剂无创测量方法 , 通过放置在皮肤上的传感器,记录 瑞玛比嗪注射液 荧光强度随时间的变化。 TGFR传感 器 每秒记录2.5次荧光读数 , 获取具有时变光学性质的荧光信号衰 ...
最新!2款创新器械获批上市
思宇MedTech· 2025-02-19 03:46
截至目前,我国上市的创新医疗器械累计 326项 。 # 一次性使用球囊型冷冻消融导管 报名:首届全球眼科大会 | 展位有限 报名:首届全球心血管大会 | 奖项评选 报名:首届全球骨科大会 | 奖项评选 2025年2月18日,NMPA官网显示,国家药品监督管理局批准了 心诺普医疗技术(北京)有限公司 (简称" 心诺普医疗 ")的" 一次性使用球囊型冷冻消融导 管 "(国械注准20253010391)和 美德康公司 MediBeacon Inc. 的" 经皮肾小球滤过率测量设备" (国械注进20253070094)两个创新产品注册申请。 合作伙伴征集:2025全球手术机器人大会 产品介绍 该产品由 球囊型冷冻消融导管 和 手动回缩器套包 组成,与心诺普医疗生产的 冷冻消融仪 配合使用,主要用于治疗成人患者 药物难治性、复发性、症状性 的阵发性房颤。 其技术特点如下: 心诺普医疗 特殊流体喷射装置: 可保证球囊前半球表面温度的均匀分布,从而实现有效消融。 球囊内压力监测技术: 能够保证球囊稳定贴靠,并实现球囊内部压力的稳定。 降低风险: 通过上述技术,可有效降低消融过程中球囊因压力波动而产生的弹跳移位风险。 心诺普 ...