Workflow
医疗器械国产替代
icon
Search documents
苏州市助力医疗器械产业创新活力持续迸发 累计65款产品进入审批快车道
Su Zhou Ri Bao· 2025-07-04 00:35
据了解,普能医疗申报的软件,可用于设计近距离放射治疗计划,能动态引导设备进行近距离放 疗,提升治疗效果。赛纳思医疗申报的消融系统,有望攻克肥厚型梗阻性心肌病治疗难题,其技术已获 美国食品药品监督管理局(FDA)突破性器械认证。 省药监局苏州检查分局、省药监局审评核查苏州分中心相关负责人介绍,创新医疗器械特别审查程 序,是我国高端医疗器械加速打破进口垄断、实现国产替代的特别通道。国家药监局将对获批创新医疗 器械的产品优先安排审查、加快审评审批效率,大幅度缩短产品上市时间,保证创新产品尽快应用于临 床。 近年来,苏州检查分局、审评核查苏州分中心坚持政策引导、科学监督、优化服务"三位一体"服 务,助力苏州医疗器械产业创新活力持续迸发,结出丰硕成果。截至昨天(7月3日),苏州进入国家创 新医疗器械特别审批通道的产品累计65款,占全国10%、江苏60%;成功上市的国家三类创新产品34 款,占全国9%、江苏69%;进入国家优先审批通道的产品12款,占全国11%,江苏100%。 近日,苏州又有两款医疗器械通过审查,进入国家创新医疗器械特别审批通道,可优先审查,更快 用于临床诊疗。目前,苏州共有65款创新医疗器械进入这一审批 ...
我国医疗器械市场迈入万亿元规模 上市公司竞相加码布局
Zheng Quan Ri Bao· 2025-07-01 09:46
近日,中国物流与采购联合会发布《中国医疗器械供应链发展报告(2025)》。报告显示,2024年我国 医疗器械工业市场规模达到1.2万亿元,物流仓储总面积达2358.08万平方米,医疗器械物流运输自有车 辆超过4万台。截至2025年5月,全国累计批准创新医疗器械353个,较2024年增加37个。 政策提速落地推动产业发展 今年6月,迪安诊断股份有限公司相关负责人在投资者交流会上表示,公司将以"AI+数据"为引擎,引 领产业生态智能化未来。公司自主研发的病理AI大模型"灵眸"已获得国家二类医疗器械注册证,其高精 准度已达到临床级应用标准,可辅助诊断57种以上的肿瘤与癌症。公司还通过在越南设立海外子公司拓 展国际IVD市场,增强全球化供给能力。 2025年4月21日,康基医疗控股有限公司旗下杭州康基唯精医疗机器人有限公司自主研发的四臂多孔腹 腔镜手术机器人SR01-200正式获批上市。该产品被业内视为国产替代的重要突破,在满足临床需求的 同时,也有望改善高端设备对进口的依赖。公司还计划在全国三甲医院建设培训中心,年内预计落地约 10家,进一步推动产品普及和术式推广。 在医疗器械流通环节,英特集团股份有限公司则持续加 ...
蓝帆医疗: 蓝帆医疗股份有限公司公开发行可转换公司债券2025年跟踪评级报告
Zheng Quan Zhi Xing· 2025-06-27 16:15
蓝帆医疗股份有限公司 公开发行可转换公司债券 三、本报告引用的资料主要由该公司或第三方相关主体提供,联合资信 履行了必要的尽职调查义务,但对引用资料的真实性、准确性和完整性不作 任何保证。联合资信合理采信其他专业机构出具的专业意见,但联合资信不 对专业机构出具的专业意见承担任何责任。 www.lhratings.com 联合〔2025〕5291 号 联合资信评估股份有限公司通过对蓝帆医疗股份有限公司主体 及其相关债券的信用状况进行跟踪分析和评估,确定下调蓝帆医疗 股份有限公司主体长期信用等级为 AA-,下调"蓝帆转债"信用等级 为 AA-,评级展望为稳定。 特此公告 联合资信评估股份有限公司 评级总监: 二〇二五年六月二十七日 跟踪评级报告 | 声 明 一、本报告是联合资信基于评级方法和评级程序得出的截至发表之日的 独立意见陈述,未受任何机构或个人影响。评级结论及相关分析为联合资信 基于相关信息和资料对评级对象所发表的前瞻性观点,而非对评级对象的事 实陈述或鉴证意见。联合资信有充分理由保证所出具的评级报告遵循了真 实、客观、公正的原则。鉴于信用评级工作特性及受客观条件影响,本报告 在资料信息获取、评级方法与模 ...
华创医药周观点:骨科耗材行业近况更新2025/06/22
Market Review - The overall market performance for the week saw the CITIC Pharmaceutical Index decline by 4.16%, underperforming the CSI 300 Index by 3.71 percentage points, ranking last among 30 CITIC first-level industries [5] - The top ten stocks by increase included Angli Kang, Yuekang Pharmaceutical, and Innovation Medical, with gains of 21.21%, 19.34%, and 18.96% respectively [4][5] - The bottom ten stocks included Aoyang Health and Kanghui Pharmaceutical, with declines of 1% and 2% respectively [5] Overall Viewpoint and Investment Themes - The pharmaceutical sector is currently undervalued, with public funds (excluding pharmaceutical funds) having low allocations to this sector. The company remains optimistic about the growth of the pharmaceutical industry by 2025, driven by macroeconomic factors and the performance of major products [9] - In the innovative drug sector, there is a shift from quantity to quality, emphasizing differentiated products and international pipelines. Companies that can deliver profitable products are recommended for attention [9] - In the medical device sector, there is a notable recovery in bidding volumes for imaging equipment, and the home medical device market is supported by subsidy policies. The company suggests focusing on key players in this area [9] - The innovation chain (CXO + life sciences services) is expected to see a rebound in overseas investment and a bottoming out in domestic investment, indicating a potential for high growth in 2025 [9] - The pharmaceutical industry is anticipated to enter a new growth cycle, with a focus on specialty raw materials and the expiration of patents leading to new opportunities [10] Orthopedic Consumables Industry Update - The orthopedic consumables market is categorized into joint, spine, trauma, and sports medicine segments, with joint and spine categories holding approximately 90% market share in 2022 [16] - The market size for joint products is projected to grow from 187 billion yuan in 2024 to 408 billion yuan by 2029, with a CAGR of approximately 16.9% [24] - The spine products market is expected to grow from 171 billion yuan in 2024 to 335 billion yuan by 2029, with a CAGR of about 14.4% [24] - The trauma products market is forecasted to increase from 170 billion yuan in 2024 to 315 billion yuan by 2029, with a CAGR of around 13.2% [24] - The sports medicine market is anticipated to grow from 41 billion yuan in 2022 to 145 billion yuan by 2027, with a CAGR of 28.7% [24] Procurement Progress - The national procurement for orthopedic consumables has led to significant price reductions, with average price drops of 82% for joint products and 84% for spine products [30][31] - The procurement process has seen a high participation rate, with 171 companies bidding for spine products and a 98% success rate in the latest sports medicine procurement [35] - The domestic market is experiencing a rapid increase in the localization rate of orthopedic products, with joint product localization rising from 47% in 2020 to 79% in 2024 [25] International Expansion - The global orthopedic consumables market is projected to reach 48.6 billion USD (approximately 348.9 billion yuan) in 2024, with China's market share expected to be 17% [37] - Domestic companies are increasingly focusing on international markets, with significant growth in overseas revenue share for companies like Spring Medical and Dabo Medical [38]
鼎智科技(873593):专注精密运动控制解决方案,受益于人形机器人产业加速落地预期
Hua Yuan Zheng Quan· 2025-05-21 06:32
证券研究报告 机械设备 | 自动化设备 北交所|首次覆盖报告 hyzqdatemark 2025 年 05 月 21 日 证券分析师 赵昊 SAC:S1350524110004 zhaohao@huayuanstock.com 万枭 SAC:S1350524100001 wanxiao@huayuanstock.com 市场表现: | 基本数据 | | | | 年 | 05 | | 日 | 20 | | | 月 | 2025 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 收盘价(元) | | | | | | | 51.00 | | | | | | | 一 年 最 低 | 最 | 高 | / | | | | | | 内 | | | | | (元) | | | | | | 72.37/13.50 | | | | | | | | 总市值(百万元) | | | | | | | | | | 6,857.55 | | | | 流通市值(百万元) | | | | | | | | | | 5,887.23 ...
新股前瞻|医疗器械国产替代加速,大医集团能否撑起50亿估值?
智通财经网· 2025-05-08 02:12
港交所于近日又迎来一家高端医疗器械企业。公告显示,西安大医集团股份有限公司 (简称:大医集团) 已向港交所主板递交上市申请,中信建投国际、浦银国际、民银资本为其联席保荐人。 招股书显示,自成立以来,大医集团历经七轮股权融资,投资方包括方略、长安汇通、高瓴、璟沃投 资、深圳角度、聚贤德医、Honesta等。在2022年12月29日至2024年2月5日期间的最后一轮融资中,投 资者按每股33.53元的价格认购共计2251.69万股股份,以此计算,大医集团的最新投后估值为51.35亿 元。 2020年,大医集团曾申请科创板上市,后因文件超过有效期被上交所中止审核,2021年公司撤回了上市 申请。如今转道港股上市,大医集团是否能够向资本市场讲出新故事? 应收账款增长较快拖累业绩 公开资料显示,大医集团成立于2011年,是创新放射外科解决方案的全球领先企业和引领者,致力构建 新一代智能放射外科生态系统。公司的核心产品CybeRay是全球首个实时影像引导伽玛放射外科系统, 分别于2021年3月及2022年7月获得FDA及中国国家药监局批准,目前正处于适应症扩展的研发阶段;另 一款旗舰产品TaiChiRT Pro则是全球首 ...
迈瑞医疗:24年砥砺前行,25年趋势向上-20250430
HTSC· 2025-04-30 02:00
Investment Rating - The investment rating for the company is maintained at "Buy" with a target price of RMB 328.30 [7][8]. Core Views - The company reported a revenue of RMB 367.26 billion and a net profit attributable to the parent company of RMB 116.68 billion for 2024, reflecting a year-on-year growth of 5.1% and 0.7% respectively. The profit was below market expectations due to delays in domestic equipment upgrade policies [1]. - The company is expected to achieve steady growth in 2025, driven by the acceleration of domestic equipment upgrade policies and ongoing efforts in product promotion both domestically and internationally [1]. - The company’s three core business segments are projected to perform well in 2025: 1. IVD segment revenue reached RMB 137.65 billion in 2024, with a year-on-year increase of 10.8% and strong overseas growth [2]. 2. Medical imaging segment revenue was RMB 74.98 billion, up 6.6% year-on-year, supported by the launch of high-end products [2]. 3. Life information and support segment revenue was RMB 135.57 billion, down 11.1% year-on-year, but expected to rebound in 2025 due to improving domestic policies [2]. Summary by Sections Financial Performance - The company’s revenue for 1Q25 was RMB 82.37 billion, with a net profit of RMB 26.29 billion, showing a year-on-year decline of 12.1% and 16.8% respectively, but a quarter-on-quarter increase of 13.8% and 154.9% [1]. - The company’s revenue forecast for 2025 is RMB 40.545 billion, with a projected net profit of RMB 12.84 billion, reflecting a growth of 10.04% [6]. Market Expansion - The company’s overseas revenue reached RMB 164.34 billion in 2024, growing by 21.3%, with significant contributions from the Asia-Pacific and European regions [3]. - Domestic revenue was RMB 202.92 billion, down 5.1% year-on-year, but expected to improve in 2025 due to the release of medical infrastructure orders and enhanced competitiveness [3]. Profitability and Valuation - The EPS forecast for 2025 is adjusted to RMB 10.59, with a PE ratio of 31x for 2025, leading to a target price of RMB 328.30 [4]. - The company is recognized as a leading domestic medical device manufacturer with strong brand influence and a continuously improving global sales network [4].
华创医药周观点:华海药业创新研发进入收获期2025/04/26
证券研究报告 | 医药生物 | 2025年4月26日 www.hczq.com 华创医药投资观点&研究专题周周谈·第123期 华海药业创新研发进入收获期 本周周专题联系人:王宏雨 | 华创医药团队: | | | --- | --- | | 首席分析师 郑辰 | 执业编号: S0360520110002 邮箱: zhengchen@hcyjs.com | | 联席首席分析师 刘浩 | 执业编号: S0360520120002 邮箱: liuhao@hcyjs.com | | 医疗器械组组长 李婵娟 | 执业编号: S0360520110004 邮箱: lichanjuan@hcyjs.com | | 中药和流通组组长 高初蕾 | 执业编号:S0360524070002 邮箱:gaochulei@hcyjs.com | | 分析师 王宏雨 | 执业编号: S0360523080006 邮箱: wanghongyu@hcyjs.com | | 分析师 朱珂琛 | 执业编号: S0360524070007 邮箱: zhukechen@hcyjs.com | 本报告由华创证券有限责任公司编制 报告仅供华创证券有限责任公 ...
【光大研究每日速递】20250421
光大证券研究· 2025-04-20 13:17
点击注册小程序 查看完整报告 特别申明: 本订阅号中所涉及的证券研究信息由光大证券研究所编写,仅面向光大证券专业投资者客户,用作新媒体形势下研究 信息和研究观点的沟通交流。非光大证券专业投资者客户,请勿订阅、接收或使用本订阅号中的任何信息。本订阅号 难以设置访问权限,若给您造成不便,敬请谅解。光大证券研究所不会因关注、收到或阅读本订阅号推送内容而视相 关人员为光大证券的客户。 今 日 聚 焦 【石油化工】石化24年报总结:不确定环境下的确定性,"三桶油"及油服再创佳绩—— 石油化工行业周 报第 399 期( 20250414 — 20250420 ) 根据 S&P Global 统计, 2024 年全球海上勘探开发投资同比增长 8.6% ,陆上勘探开发投资同比下降 7.9% ,预计 25 年全球上游资本开支恢复增长,有望达到 5824 亿美元以上,同比增长 5% ,上游资本开支的持 续扩增为油服景气奠定基础 。国内"三桶油"坚持增储上产,资本开支和产量持续增长,旗下油服企业有望 持续受益,我们持续看好油服企业工作量的增长和盈利能力的改善。 (赵乃迪/蔡嘉豪/王礼沫) 2025-04-20 您可点击今日推送内容 ...
【医药生物】我国对美加征关税全面执行,建议关注医疗器械国产替代机会——医药行业跨市场周报(20250420)(王明瑞/黎一江)
光大证券研究· 2025-04-20 13:17
报告摘要 点击注册小程序 查看完整报告 特别申明: 本订阅号中所涉及的证券研究信息由光大证券研究所编写,仅面向光大证券专业投资者客户,用作新媒体形势下研究 信息和研究观点的沟通交流。非光大证券专业投资者客户,请勿订阅、接收或使用本订阅号中的任何信息。本订阅号 难以设置访问权限,若给您造成不便,敬请谅解。光大证券研究所不会因关注、收到或阅读本订阅号推送内容而视相 关人员为光大证券的客户。 风险分析: 控费政策超预期、研发失败风险、政策支持不及预期、板块估值下挫风险。 行情回顾: 发布日期: 2025-04-20 上周,A股医药生物指数下跌0.36%,跑输沪深300指数0.94pp,跑赢创业板综指0.17pp,在31个子行业中排名 第24,表现较差。港股恒生医疗健康指数上周收涨0.57%,跑输恒生国企指数0.66pp。 上市公司研发进度跟踪: 上周,百济神州的BGB-C354、恒瑞医药的SHR-4506注射液的临床申请新进承办;百济神州的BGB-21447片、 海思科的HSK45030分散片的IND申请新进承办。上周,石药集团的IBI3002、正大天晴的HRS-5817正在进行三 期临床;海思科的TQB3473正 ...