2025 年 11 月 5 日 行业研究 创新药与 CXO 业绩表现靓丽，医用设备板块有望加速回暖 ——医药生物行业 2025 年三季报总结 要点 创新药与 CXO 业绩表现靓丽，医用设备板块有望持续回暖。25 年前三季度医药 生物板块实现收入 18257.4 亿元（YOY-1.97%），实现归母净利润 1396.6 亿元 （YOY-1.59%）；单三季度实现收入 5985.4 亿元（YOY+0.78%），实现归母净 利润 405.1 亿元（YOY+7.67%）。从毛利表现来看，25 年前三季度医药板块实 现 销 售 毛 利 润 5734.5 亿元（ YOY-6.1%） ， 对 应 整 体 毛 利 率 为 31.4% （YOY-1.4pct）。从各医药申万二级行业表现来看，25Q3 各板块继续分化，医 疗器械和医疗服务板块收入表现靓丽，化学制剂板块净利润继续同比增长，其他 细分子板块表现稍差。 1）化学制剂板块 25Q3 收入同比-0.82%，归母净利润同比+5.05%，我们推测主 要是由于子板块中的创新药公司业绩表现靓丽，头部创新药公司产品销售持续放 量叠加部分公司收到 BD 交易首付款带动业绩增长。我们认 ...

Investment Rating - The report maintains a "Buy" rating for the pharmaceutical and biotechnology sector [4][5]. Core Viewpoints - The proportion of public fund holdings in the pharmaceutical sector has decreased quarter-on-quarter, but the market is expected to experience a rebound [2][23]. - The investment focus should increasingly emphasize the clinical value of pharmaceuticals, driven by domestic and international policy changes [3][34]. - The report highlights the potential for continuous valuation recovery and upward movement in the pharmaceutical sector due to the opening of the US interest rate cut cycle and advancements in domestic innovative drugs [2][35]. Summary by Sections Market Review - Last week, the pharmaceutical and biotechnology index rose by 1.31%, outperforming the CSI 300 index by 1.74 percentage points [1][17]. - The Hong Kong Hang Seng Medical Health Index fell by 0.11%, but still outperformed the Hang Seng Index by 1.97 percentage points [1][17]. Company Updates - Notable clinical application approvals include Shanghai Lai Shi's SR604 injection and YKYY013 injection from Yuekang Pharmaceutical [39]. - Ongoing clinical trials include HRS-8080 from Heng Rui Pharmaceutical and ICP-332 from Nuo Cheng Jian Hua, both in Phase III [39]. Investment Strategy - The report emphasizes a three-stage clinical value investment strategy: "0 to 1" for technological breakthroughs, "1 to 10" for clinical validation, and "10 to 100" for efficiency in the Chinese market [34][35]. - Key recommended companies include Innovent Biologics (H), Eifang Biologics-U, Tian Shi Li, WuXi AppTec (A+H), and Mindray Medical [36]. Fund Holdings - As of Q3 2025, the market value of public funds heavily invested in pharmaceuticals is 11.93%, down by 0.32 percentage points from the previous quarter [2][24]. - The top 20 stocks by market value show significant upward movement for companies like Rongchang Biologics and BeiGene (H) [2][30]. Financial Performance - The pharmaceutical manufacturing industry reported a revenue decline of 2.0% year-on-year for the first nine months of 2025, totaling 182.11 billion yuan [59]. - The report indicates a positive trend in the valuation of the pharmaceutical sector, with a steady recovery in PE ratios since Q1 2025 [34].

2025年10月29日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第10号），有7款产品进入创新通道。 1 . 自膨式颅内药物 洗脱 支架 系统 利兰生物科技（苏州）有限公司总部位于苏州，是一家专注于神经血管介入医疗器械研发、生产和销售的高新技术企业。公司致力于颅内支架、药物洗脱系统等创 新产品的开发，依托先进的生物材料技术和临床合作平台，旨在为脑血管疾病患者提供微创、安全的治疗解决方案，已获得多项国家专利，并与多家三甲医院开展 临床验证，推动神经介入领域的国产化创新。 2 . 植入式无线脑机 接口 系统 申请人 ：上海阶梯医疗科技有限公司 上海阶梯医疗科技有限公司成立于2021年8月，总部位于上海，是一家 专注于植入式脑机接口领域的创新型科技企业 。公司致力于微创植入式脑机接口技术的研发 与应用，产品可应用于运动控制（如瘫痪、精细肢体控制、失语）、神经疾病病灶监测及调控（如帕金森症、抑郁症）、感知觉修复（如失明、失聪）等多个领 域。 公司已成功研制中国首款符合医疗器械标准的高通量植入式脑机接口系统，入选工信部2023年未来产业创新任务"揭榜挂帅"项目，并获得上海市2024年度"科技创新 ...

Core Viewpoint - The recent financial report of Xinmai Medical (688016) shows a mixed performance with a slight increase in total revenue but a significant decline in net profit, indicating potential challenges in cost management and profitability [1] Financial Performance - Total revenue for Q3 2025 reached 1.015 billion yuan, a year-on-year increase of 4.66% compared to 9.74 billion yuan in Q3 2024 [1] - Net profit attributable to shareholders for Q3 2025 was 429 million yuan, down 22.46% from 553 million yuan in Q3 2024 [1] - Gross margin decreased to 70.4%, down 6.75% year-on-year, while net margin fell to 41.69%, a decline of 26.13% [1] - Total expenses (selling, administrative, and financial) amounted to 204 million yuan, representing 20.05% of total revenue, an increase of 54.65% year-on-year [1] - Earnings per share (EPS) for Q3 2025 was 3.54 yuan, down 21.16% from 4.49 yuan in Q3 2024 [1] Accounts Receivable and Cash Flow - Accounts receivable increased significantly by 131.44% to 478 million yuan, raising concerns as it represents 95.24% of profit [2] - Cash flow per share decreased to 2.95 yuan, a decline of 3.26% year-on-year [1] Business Evaluation - The company's return on invested capital (ROIC) was 12.3% last year, indicating strong capital returns, with a historical median ROIC of 20.58% since its listing [3] - The company maintains a healthy cash asset position, suggesting good debt repayment capability [3] Fund Holdings - Several funds have recently increased their holdings in Xinmai Medical, with the largest being Guotai Rong'an Multi-Strategy Flexible Allocation Mixed Fund, holding 101,600 shares [4] Innovation and Product Development - The company has made significant progress in its innovation projects, with multiple new products successfully launched and undergoing clinical applications [5][6] - As of the report date, the company has 31 products on the market and 9 products in the special review process for innovative medical devices [6][7] International Expansion - Overseas sales revenue grew by over 95% year-on-year, now accounting for 17% of total sales, with new product registrations in multiple countries [7]

Core Insights - Shanghai MicroPort EP MedTech Co., Ltd. reported a revenue of 336 million yuan for the first three quarters of 2025, representing a year-on-year growth of 15.65% [1] - The net profit attributable to shareholders was 41.92 million yuan, with a slight year-on-year increase of 0.46%, impacted by the timing of government subsidies related to Innovative Medical Devices [1] - The company achieved a non-GAAP net profit of 24.07 million yuan, marking a turnaround from losses compared to the previous year [1] Financial Performance - In Q3 2025, the company recorded a revenue growth of 21.78% year-on-year [1] - The non-GAAP net profit for Q3 reached 3.26 million yuan, indicating a return to profitability compared to the same quarter last year [1] Market Position and Strategy - MicroPort EP has been focused on the cardiac electrophysiology sector for over a decade, establishing a comprehensive product portfolio with over 30 products based on four major technological pathways [1] - The company has responded actively to national centralized procurement policies, which have laid a solid foundation for increasing market share [1] - The three-dimensional electrophysiology surgeries have been performed in over 1,000 hospitals, with more than 80,000 surgeries completed, ranking first among domestic manufacturers [1] International Expansion - In the first half of 2025, the company successfully expanded its overseas market, covering over 20 countries with a revenue growth rate exceeding 40% [1] - High-end pressure monitoring catheters have shown strong performance, with market penetration in three-dimensional surgeries surpassing that of domestic products [1] Product Innovation - The company has achieved significant breakthroughs in high-end procedures, with the proportion of high-end catheter products gradually increasing [2] - In February 2025, the first batch of Magbot robotic navigation surgeries was successfully completed, filling a technological gap in domestic magnetic-driven catheters and enhancing core performance metrics [2] - As of mid-2025, over 3,000 surgeries using high-end products like pressure ablation catheters have been completed in multiple medical centers, continuously capturing market share [2] Future Outlook - Currently, nine innovative products have entered the special approval process for national innovative medical devices, with five already approved [2] - The company aims to leverage both domestic and international markets to enhance its capabilities, focusing on breakthroughs in high-end atrial fibrillation procedures and aspiring to upgrade from a domestic leader to a global technology player [2]

【导读】三季报密集披露，绩优基金调仓曝光 伴随公募三季报密集披露，绩优基金经理持仓动向备受市场关注。 10月25日，融通产业趋势、平安核心优势、万家趋势领先等基金披露三季报，这些基金大多重仓了人工智能、创新药、有色金属等今年以来热门赛道。在 前十大重仓股中，还涌现出多只"翻倍股"。 在三季报中，基金经理表示，A股市场今年涨幅较大，但从历史规律判断此轮上行趋势大概率没有结束，市场整体估值依然处于合理水平。 李进：此轮上行趋势大概率没有结束 看好人工智能、储能和互联网等 10月25日，融通产业趋势披露2025年三季报。最新持仓显示，前三大重仓股为海博思创、工业富联、中际旭创，持仓市值在2200万元～2500万元区间。值 得注意的是，截至10月24日，海博思创、工业富联、中际旭创年内股价涨幅分别高达313.46%、218.92%、301.99%。 海博思创、工业富联、剑桥科技、中创新航、沪电股份、长飞光纤光缆"新晋"其十大重仓股。 融通基金权益投资部副总经理、融通产业趋势基金经理李进在三季报中表示，A股市场今年涨幅较大，但从历史规律判断，此轮上行趋势大概率没有结 束，这种级别的市场上行大概率都会从悲观到合理估值到疯 ...

Core Points - The article highlights the approval of two innovative medical devices by Pengyue Technology, specifically a cardiac cryoablation device and a disposable sterile cryoablation probe, which are recognized as national-level innovative medical devices [1][2] - The provincial drug regulatory authority has been actively supporting the innovation of medical devices, optimizing the review and approval processes to accelerate the transformation of innovative results [2][3] - The new cardiac cryoablation system is expected to provide a safer, more efficient, and controllable treatment option for patients with persistent atrial fibrillation, with clinical trial results showing an 80% effectiveness rate in preventing recurrence six months post-surgery [2][3] Company Summary - Pengyue Technology has successfully developed a cardiac cryoablation system that addresses the limitations of traditional treatment methods and significantly reduces patient treatment costs [3] - The company formed a collaborative team to apply argon-helium cryogenic technology to surgical treatments, overcoming challenges related to cooling speed and rewarming processes [2] - The new products are set to be applied clinically in December, marking a significant advancement in the medical device industry [3] Industry Summary - The medical device industry in China is experiencing rapid growth, with the market size surpassing one trillion yuan [3] - The provincial drug regulatory authority plans to deepen reforms in drug regulation and support high-quality development in the pharmaceutical industry, aiming to benefit more companies from the regulatory changes [3]

Core Viewpoint - The article highlights the recent approval of four innovative medical devices by the National Medical Products Administration in China, indicating a growing trend in the development and registration of innovative medical technologies in the country [1][8]. Group 1: Approved Products - The approved products include: 1. "Extended Depth of Focus Intraocular Lens" by Aibono Medical Technology Co., Ltd. [1] 2. "Cardiac Cryoablation Device" and "Single-use Sterile Cryoablation Probe" by Shenyang Pengyue Technology Co., Ltd. [1][8] 3. "Cross-linked Polyisobutylene Aspheric Intraocular Lens" by Xi'an Yandale Medical Technology Co., Ltd. [1][8] - As of now, a total of 373 innovative medical devices have been registered in China [1]. Group 2: Company Profiles - Aibono Medical Technology Co., Ltd. is an innovative ophthalmic medical device manufacturer listed on the Sci-Tech Innovation Board, focusing on cataract surgery, myopia control, and vision care solutions. The company reported a total revenue of 787 million yuan (approximately $114 million) with a year-on-year growth of 14.72% and a net profit of 213 million yuan (approximately $31 million) with a growth of 2.53% in the first half of 2025 [6]. - Shenyang Pengyue Technology Co., Ltd., established in 2020, specializes in digital intelligent precision medical fields and has developed a cardiac cryoablation system with independent intellectual property rights [10]. - Xi'an Yandale Medical Technology Co., Ltd. focuses on intraocular lenses for cataract treatment and is led by a team of experts, including members from the American Academy of Engineering [18]. Group 3: Product Details - The "Extended Depth of Focus Intraocular Lens" is designed for vision correction after cataract surgery, featuring a one-piece, foldable design made from a combination of ethyl acrylate and methyl methacrylate [5]. - The "Cardiac Cryoablation Device" is used for treating persistent atrial fibrillation in adult patients, utilizing argon gas for rapid cooling of myocardial cells [9]. - The "Cross-linked Polyisobutylene Aspheric Intraocular Lens" is notable for its high refractive index and is designed for implantation through a small incision, providing an improved visual experience for cataract patients [15].

以下文章来源于Medtec医疗器械设计与制造 ，作者立即预登记 Medtec医疗器械设计与制造 . 2025年国际医疗器械设计与制造技术展览会专注于医疗级别原材料、高精密配件和加工技术与制造设备的展览会。将于2025年9月24-26日在上海世博展 览馆1&2号馆举办。网址：medtecchina.com 行业媒体、自媒体账号， 不限粉丝数量 ，均可使用。 报名方式 扫描下方二维码，填写登记信息（请写明媒体名称，9月23日前报名免费） 大会当天，到 上海世博展览馆 南北大厅观众注册台 4 号媒体通道 ，即可换取专属胸卡，自由进入会场。 展会概况｜ 2 0 2 5 M e d t e c C h i n a 医疗器械产品部件、医械创新材料、电子元件/组件、医疗管件及挤压加工产品、制造设备， 470+ 年度 首发新品 即将亮相在Medtec！ 2023年我国医疗器械工业市场规模达1.18万亿元，流通市场规模1.36万亿元，同比增长6.25%。2024年预计生产企业营收达1.35万亿 元，稳居全球第二大单体国家市场。 2018-2024年累计批准创新医疗器械608项，其中国产占比91.45%（556项），2024年同 ...

中国的创新医疗器械要获得全球市场的认可，挑战仍然很大。 今年中国创新生物药对外授权引发全球关注。相关数据显示，上半年创新药对外授权金额近660亿美 元，让全世界见证了中国生物医药的DeepSeek一刻。 为何创新器械授权难 微光医疗创始人CEO朱锐对第一财经记者表示："中国创新医疗器械目前还没有到爆发点，创新器械爆 发的路径与创新药有较大的差异。创新药把靶点改一下，就成了一个新的专利，但医疗器械的小创新仍 会涉及知识产权问题。" 不过在医疗器械领域，中国创新产品的DeepSeek一刻尚未来临。创新药的出海路径是否能在创新器械 领域重演，是业内热议的话题。 从模仿到创新 9月13日，在中国心血管医生创新俱乐部（CCI）成立十周年大会上，中国心血管创新医疗器械领头 人、中国科学院院士、复旦大学附属中山医院心内科主任葛均波教授表示，中国创新药对外授权如今已 经占据了全球的半壁江山，大量源自于中国的创新药获得了全球的认可，这也为中国创新医疗器械的发 展增添了信心，期待未来有更多的创新医疗器械能走向世界。 回顾过去十年CCI的发展，葛均波称，中国心血管介入医疗器械在很长一段时间内高度依赖进口，价格 高昂，我们最初是希望 ...