人民财讯12月29日电，新华医疗（600587）12月29日公告，公司于近日收到山东省药品监督管理局颁发 的《中华人民共和国医疗器械注册证》，产品分别为：白介素6检测试剂盒(量子点荧光免疫层析法)和 降钙素原/白介素6二联检测试剂盒(量子点荧光免疫层析法)。 ...

新华医疗公告称，近日收到山东省药监局颁发的两款《中华人民共和国医疗器械注册证》，分别为白介 素6检测试剂盒和降钙素原/白介素6二联检测试剂盒，批准日期均为2025年12月24日，有效期至2030年 12月23日。截至目前，国内同行业约500家公司已取得同类产品注册证。两款产品丰富了公司体外诊断 产品线，利于提升竞争力，但产品上市后销售情况取决于市场推广，暂无法预测对业绩的具体影响。 ...

中信建投此前指出，公司是国内外周介入和神经介入行业的龙头企业，产品管线丰富，更有多款创新产 品有望陆续获批，在部分产品有望受益集采、进口替代加速的背景下，公司内生业务有望保持快速增 长。2024年公司首次实现扭亏为盈，随着公司销售规模的持续扩大，叠加公司管理经营效率的持续改 善，公司盈利能力有望持续提升。公司在手资金充裕，截至25H1，公司在手现金为25.3 亿元，预计公 司将继续加大产品研发和学术推广力度，并寻求外延并购及对外合作的机会，不断稳固公司行业龙头的 地位。 智通财经APP获悉，归创通桥(02190)盘中涨超5%，截至发稿，涨3.76%，报23.2港元，成交额1539.07万 港元。 消息面上，本月初，归创通桥旗下归创医疗自主研发的ZYLOX KINGKONG 金刚™外周高压球囊扩张 导管经过国家药品监督管理局审查批准，正式获批上市。该产品适用于包括上肢、肾、髂和腹股沟下血 管在内的周围血管的经皮腔内血管成形术，以及治疗自体或人造透析用动静脉痿的狭窄，也适用于外周 血管系统中的支架和覆膜支架的后扩张。 ...

Core Viewpoint - Guichuang Tongqiao (02190) has seen a significant stock price increase following the approval of its ZYLOX KINGKONG peripheral high-pressure balloon dilation catheter by the National Medical Products Administration, indicating strong market potential for the company's innovative products [1] Group 1: Product Approval and Market Impact - The ZYLOX KINGKONG catheter is approved for use in peripheral vascular interventions, including treatment for stenosis in both natural and artificial dialysis arteriovenous fistulas, as well as post-dilation of stents and covered stents in the peripheral vascular system [1] - The approval is expected to enhance the company's product pipeline and market position, contributing to its growth in the peripheral intervention and neuro-intervention sectors [1] Group 2: Financial Performance and Growth Prospects - CITIC Securities has highlighted the company as a leader in the domestic and international peripheral and neuro-intervention markets, with a rich product pipeline and several innovative products expected to gain approval soon [1] - The company is projected to achieve profitability for the first time in 2024, driven by expanding sales scale and improved operational efficiency [1] - As of the first half of 2025, the company reported cash reserves of 2.53 billion yuan, indicating strong financial health and the potential for increased investment in product development and academic promotion [1]

Market Overview - The Shanghai and Shenzhen stock indices opened lower and fluctuated, with the Shenzhen index performing slightly better than the Shanghai index [1] - As of 10:00 AM, the Shanghai Composite Index was at 3293.13 points, down 0.72%, with a trading volume of 75.7 billion yuan; the Shenzhen Component Index was at 13132.78 points, down 0.13%, with a trading volume of 131.1 billion yuan [1] Sector Performance - Out of 33 sectors, 9.07% showed an increase, with the top three being in vitro diagnostics (up 3.46%), healthcare (up 3.31%), and immunotherapy (up 2.88%) [1] - In terms of large single fund flows, 37 sectors experienced net inflows, with the top three being medical devices (1.46 billion yuan), pharmaceutical manufacturing (800.1 million yuan), and virus prevention (723 million yuan) [1] Investor Sentiment - According to Aijian Securities, the approaching National Day holiday has led to a decrease in investor participation [1] - The recent volatility in brokerage stocks, influenced by weekend news, has negatively impacted the market, while the decline of high-priced stocks has suppressed bullish sentiment [1] - Both bullish and bearish parties are adopting a cautious stance, resulting in a weak and fluctuating market consolidation [1] Market Outlook - The current market trend is indicated by the ChiNext Index, which is expected to guide market movements [1] - It is anticipated that the stock indices will continue to fluctuate widely between short- and medium-term moving averages, suggesting a need for investors to manage their positions carefully and select stocks strategically [1]

截至目前，Cardiovalve系统已在欧洲顺利完成确证性临床研究全部150例患者入组，并于今年的伦敦心 脏瓣膜介入治疗会议上正式发布TARGET研究的中期结果，数据表现积极，受到海外研究者专家团队的 认可与好评。此次Cardiovalve系统正式步入CE认证阶段，意味着启明医疗在"四瓣一体"的产品战略布 局上更进一步，在已成熟的主瓣、肺瓣产品线基础上，进一步完善了三尖瓣治疗矩阵。 消息面上，启明医疗近期宣布，Cardiovalve经导管三尖瓣置换系统已正式向欧洲公告机构递交CE认证 的全部申请资料，标志着该产品在欧洲市场的准入进程迈出关键一步。 启明医疗-B(02500)盘中涨超7%，截至发稿，涨4.05%，报2.57港元，成交额489.42万港元。 ...

微创心通-B(02160)盘中涨超9%，截至发稿，涨6.06%，报1.05港元，成交额448.37万港元。 值得注意的是，12月19日，微创医疗宣布心通收购心律的合并落地。此次并购将推动微创医疗旗下结构 性心脏病与心律管理两大核心业务板块的深度整合。随着最新整合方案的公布，意味着微创医疗将加速 构建覆盖心力衰竭全病因、全阶段、全过程的综合器械管理方案。 消息面上，微创心通的VitaFlow Liberty/自由·维心流经导管主动脉瓣及可回收系统，摩洛哥获批上市， 标志着该产品首次进入非洲市场。摩洛哥医疗器械市场对进口产品依赖度高，此次获批为该产品后续拓 展非洲其他国家奠定基础。 ...

Group 1 - The core business of the company is focused on the research, production, and sales of implantable orthopedic medical devices, including joint prostheses and spinal implants [2] - As of September 30, 2025, the company achieved a revenue of 756 million yuan, representing a year-on-year growth of 48.75%, and a net profit attributable to shareholders of 192 million yuan, with a significant increase of 213.21% year-on-year [2] - The company has distributed a total of 359 million yuan in dividends since its A-share listing, with 309 million yuan distributed over the past three years [3] Group 2 - On December 26, the company's stock price fell by 1.82%, with a trading volume of 20.04 million yuan [1] - The financing buy-in amount on December 26 was 2.40 million yuan, while the financing repayment was 2.60 million yuan, resulting in a net financing buy of -0.20 million yuan [1] - The total balance of margin trading for the company as of December 26 was 34.15 million yuan, with the financing balance accounting for 0.50% of the circulating market value, indicating a relatively high level compared to the past year [1]

Group 1 - The core viewpoint of the article highlights the significant stock price increase of MicroPort Cardiac Rhythm Management (02160), which rose over 9% during trading and is currently up 6.06% at HKD 1.05, with a trading volume of HKD 4.48 million [1] - MicroPort's VitaFlow Liberty aortic valve and retrieval system has received approval for sale in Morocco, marking its first entry into the African market, which is heavily reliant on imported medical devices [1] - The acquisition of Cardiac Rhythm by MicroPort Medical has been finalized, which will enhance the integration of its structural heart disease and cardiac rhythm management business segments, accelerating the development of a comprehensive device management solution for heart failure [1]

每日经济新闻 （责任编辑：董萍萍 ） 【免责声明】本文仅代表作者本人观点，与和讯网无关。和讯网站对文中陈述、观点判断保持中立，不对所包含内容 的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。邮箱： news_center@staff.hexun.com 中信建投指出，医疗器械行业长期投资机会来自创新、出海和并购整合，板块的创新性和国际化能 力得到认可，估值正在重估。近期国家药监局发布优先审批高端医疗器械目录，脑机接口、超高场强核 磁、手术机器人等有望受益。短期来看，Q4和26年业绩改善个股存在业绩估值修复机会，部分公司将 于1月份发布年报业绩预告，建议关注前瞻超预期或低预期情况。长期来看，医疗器械行业投资机会来 自创新、出海和并购整合，板块的创新和国际化能力得到认可，估值正在重构。建议持续关注市场空间 大、国产化率低的创新器械赛道，以及并购重组、脑机接口、AI医疗、手术机器人、外骨骼机器人等 主题方向的投资机会。 创业板医药ETF国泰（159377）跟踪的是创医药指数（399275），单日涨跌幅达20%，该指数聚焦 于创新医药领域，从生物制药、化学制药、中药及医疗服务等 ...