Workflow
医疗器械研发
icon
Search documents
正海生物取得一项医疗器械注册证
Zhi Tong Cai Jing· 2026-01-09 08:08
正海生物(300653)(300653.SZ)公告,公司近日取得由国家药品监督管理局下发的《医疗器械注册 证》,产品名称为:钙硅生物陶瓷口腔骨修复材料。 ...
戴维医疗:子公司电子内窥镜图像处理器获得医疗器械注册证
Xin Lang Cai Jing· 2026-01-05 07:53
戴维医疗1月5日公告,公司全资子公司宁波维尔凯迪医疗器械有限公司电子内窥镜图像处理器获得浙江 省药品监督管理局颁发的医疗器械注册证。产品与本公司生产的电子内窥镜配套使用,用于在内窥镜诊 断和/或治疗手术中与电子内窥镜连接,有效地在监视器上显示内窥镜观察人体体腔的视场区域的图 像。以上产品医疗器械注册证的取得,有利于丰富公司产品线,进一步提高公司的核心竞争力,对公司 未来的经营成果将产生积极影响。目前尚无法预测该等产品对公司未来营业收入的影响。 ...
万邦医药(301520.SZ):控制的合伙企业拟认购私募基金份额
Ge Long Hui A P P· 2025-12-22 13:07
格隆汇12月22日丨万邦医药(301520.SZ)公布,为进一步满足安徽万邦医药科技股份有限公司业务布局 及未来发展需要,更好地借助专业机构的专业力量及资源优势,整合各方资源,提高公司的综合竞争 力,由公司控制的合肥群象齐鸣企业管理合伙企业(有限合伙)(简称"合肥群象")于2025年12月22日 与石河子市隆泰股权投资管理企业(有限合伙)等各方签署了《嘉兴隆峰创业投资合伙企业(有限合伙) 合伙协议》及相关文件,合肥群象拟作为有限合伙人以自有资金认缴出资1,000万元,参与认购嘉兴隆 峰创业投资合伙企业(有限合伙)(简称"合伙企业")的基金份额,认缴比例为12.987%。投资方向:新 药研发、医疗器械研发项目等医药相关领域,主要包括优质的新兴医疗企业,包括但不限于新药、创新 药、医疗器械、医疗服务、诊断、生物技术、医药外包研发企业等。 ...
九洲药业(603456.SH)子公司拟参与投资嘉兴隆峰创业投资合伙企业(有限合伙)
智通财经网· 2025-12-22 08:45
智通财经APP讯,九洲药业(603456.SH)发布公告,公司全资子公司宏洲投资拟参与投资嘉兴隆峰创业 投资合伙企业(有限合伙)。合伙企业认缴出资总额为7700万元(包含本次投资),宏洲投资将作为有限合 伙人以自有资金认缴出资额为1000万元,占合伙企业认缴出资总额的12.987%。 合伙企业投资方向:主要投资于新药研发、医疗器械研发项目等医药相关领域,主要包括优质的新兴医 疗企业,包括但不限于新药、创新药、医疗器械、医疗服务、诊断、生物技术、医药外包研发企业等。 ...
九洲药业子公司拟参与投资嘉兴隆峰创业投资合伙企业(有限合伙)
Zhi Tong Cai Jing· 2025-12-22 08:44
九洲药业(603456)(603456.SH)发布公告,公司全资子公司宏洲投资拟参与投资嘉兴隆峰创业投资合 伙企业(有限合伙)。合伙企业认缴出资总额为7700万元(包含本次投资),宏洲投资将作为有限合伙人以 自有资金认缴出资额为1000万元,占合伙企业认缴出资总额的12.987%。 合伙企业投资方向:主要投资于新药研发、医疗器械研发项目等医药相关领域,主要包括优质的新兴医 疗企业,包括但不限于新药、创新药、医疗器械、医疗服务、诊断、生物技术、医药外包研发企业等。 ...
戴维医疗:公司电动手术台获得医疗器械注册证
Xin Lang Cai Jing· 2025-12-10 07:53
戴维医疗12月10日公告,公司电动手术台获得浙江省药品监督管理局颁发的《医疗器械注册证》。本设 备用于常规手术、神经外科、胸腹外科、骨科、泌尿外科肛肠科、整形外科、妇科,肝胆外科及普外科 手术等医疗过程的患者 多体位支撑与操作,使其躺卧成不同的姿势。以上产品医疗器械注册证的取 得,有利于丰富公司产品线,进一步提高公司的核心竞争力,对公司未来的经营成果将产生积极影响。 目前尚无法预测该等产品对公司未来营业收入的影响。 ...
沛嘉医疗-B早盘涨逾6% Taurus NXT系统注册申请获受理
Xin Lang Cai Jing· 2025-12-08 02:24
责任编辑:卢昱君 沛嘉医疗-B(09996)盘中涨超6%,截至发稿,股价上涨5.60%,现报5.85港元,成交额217.68万港元。 12月7日晚,沛嘉医疗发布公告称,于近日,公司收到中华人民共和国国家药品监督管理局的受理通知 书,确认受理TaurusNXT® "非醛交联"干瓣经导管主动脉瓣置换("TAVR")系统的注册申请。 TaurusNXT®为公司内部研发的第三代TAVR系统,采用已获得专利的非醛生物组织交联技术,该技术 旨在提升人工主动脉瓣的耐用性及生物相容性。 此外,沛嘉医疗公布,董事会获悉,执行董事、首席执行官兼公司董事会董事长张一博士透过其所控制 的公司,自2025年12月1日起开始于公开市场上购买公司股份。持股增加合共代价预期不超过1500万港 元。经张博士告知,持股增加反映其对公司内在价值的认可,以及其对公司发展前景及增长潜力的坚定 信心。 此外,沛嘉医疗公布,董事会获悉,执行董事、首席执行官兼公司董事会董事长张一博士透过其所控制 的公司,自2025年12月1日起开始于公开市场上购买公司股份。持股增加合共代价预期不超过1500万港 元。经张博士告知,持股增加反映其对公司内在价值的认可,以及其 ...
新华医疗(600587):收入降幅收窄,产品体系持续丰富:新华医疗(600587):2025年三季报点评
Huachuang Securities· 2025-11-20 13:43
Investment Rating - The report maintains a "Recommendation" rating for the company, with a target price of 20 yuan [2][6]. Core Insights - The company's revenue for the first three quarters of 2025 was 6.978 billion yuan, a decrease of 6.00% year-on-year, while the net profit attributable to the parent company was 434 million yuan, down 29.61% [2][6]. - In Q3 2025, the revenue was 2.188 billion yuan, a decline of 2.20%, and the net profit attributable to the parent company was 49 million yuan, down 63.39% [2][6]. - The company is experiencing a narrowing decline in revenue, with a continuous enrichment of its product system [2][6]. Financial Performance Summary - For 2024A, total revenue is projected at 10.021 billion yuan, with a year-on-year growth rate of 0.1%. For 2025E, it is expected to be 9.660 billion yuan, a decrease of 3.6%, and for 2026E, it is projected to increase by 10.3% to 10.651 billion yuan [2][7]. - The net profit attributable to the parent company is forecasted to be 692 million yuan in 2024A, with a growth rate of 5.8%, and is expected to reach 702 million yuan in 2025E, a growth of 1.5% [2][7]. - The earnings per share (EPS) for 2025E is estimated at 1.16 yuan, with a price-to-earnings (PE) ratio of 13 times [2][7]. Product Development and R&D - The company increased its R&D expenses to 322 million yuan in the first three quarters of 2025, a year-on-year increase of 8.28% [2][6]. - New products approved between July and October 2025 include various medical devices, indicating a further enrichment of the product system [2][6]. Investment Recommendations - Based on the Q3 2025 performance and ongoing profit pressure, the company is expected to achieve net profits of 700 million yuan, 820 million yuan, and 900 million yuan for 2025-2027, representing year-on-year growth rates of 1.5%, 16.3%, and 10.7% respectively [2][6].
敷尔佳(301371)2025年三季报点评:业绩阶段性承压 静待经营企稳
Xin Lang Cai Jing· 2025-11-18 00:39
Core Insights - The company reported a revenue of 1.3 billion yuan for Q1-Q3 2025, a year-on-year decline of 11.5%, and a net profit attributable to shareholders of 330 million yuan, down 36.7% year-on-year [1] - In Q3 alone, the company achieved a revenue of 430 million yuan, a decrease of 17.6% year-on-year, with a net profit of 95.39 million yuan, down 45% year-on-year [2] Financial Performance - The gross profit margin decreased by 1.7 percentage points to 80.4% year-on-year [2] - The sales expense ratio increased by 10 percentage points to 46.3% year-on-year [2] - The management expense ratio rose by 2 percentage points to 5.4% year-on-year [2] - Financial surplus narrowed by 2.4 percentage points due to reduced interest income during the reporting period [2] Product and Channel Strategy - The company focuses on balanced development in medical devices and functional skincare products, launching various new products such as whitening masks and anti-wrinkle masks [2] - The company emphasizes coordinated development of online and offline channels, actively exploring new online platforms and optimizing offline distribution models [2] - Continuous investment in research and development is being made to lay a foundation for long-term growth [2] Investment Outlook - The company is undergoing business adjustments and increasing R&D investments, particularly in Class II and III medical devices [3] - The focus is on expanding the product line and advancing the development of skin improvement and injection filling medical devices [3] - Future revenue and profitability stabilization is anticipated with the formation of core product repurchase and the gradual establishment of e-commerce channel methodologies [3] - Expected EPS for 2025-2027 is projected to be 0.83, 0.89, and 0.94 yuan per share, maintaining a "buy" rating [3]
亚辉龙(688575):国内业务环比改善 海外业绩持续亮眼
Xin Lang Cai Jing· 2025-11-05 00:33
Core Viewpoint - The company reported a decline in overall revenue and net profit for the first three quarters of 2025, but showed signs of recovery in Q3, particularly in domestic operations and overseas growth [1][2]. Group 1: Financial Performance - For the first three quarters of 2025, the company achieved a revenue of 1.287 billion yuan, a year-on-year decrease of 7.69%, and a net profit attributable to shareholders of 60 million yuan, down 72.36% year-on-year [1]. - In Q3 2025, the company recorded a revenue of 478 million yuan, representing a year-on-year increase of 10.25%, while the net profit attributable to shareholders was 34 million yuan, down 25.12% year-on-year [1]. Group 2: Domestic and Overseas Performance - Domestic revenue for the main business was 1.074 billion yuan, a year-on-year decrease of 5.9%, while overseas business saw a significant growth with a revenue of 208 million yuan, up 39% year-on-year [2]. - In Q3 2025, domestic main business revenue reached 403 million yuan, a year-on-year increase of 14.4%, with overseas revenue growing by 68.5% year-on-year [2]. Group 3: Equipment Installation and Market Expansion - The company installed 1,806 new light-emitting devices in the first three quarters of 2025, with a total installation exceeding 12,410 units [3]. - The company’s unique pipeline products have gained recognition, with a specific diagnostic reagent entering the industrialization phase [3]. Group 4: Profit Forecast - The company forecasts total revenues of 1.885 billion yuan, 2.173 billion yuan, and 2.546 billion yuan for 2025-2027, with respective year-on-year growth rates of -6.29%, 15.29%, and 17.17% [4]. - The projected net profit attributable to shareholders for the same period is 119 million yuan, 291 million yuan, and 407 million yuan, with year-on-year growth rates of -60.61%, 144.63%, and 40.19% [4].