中国质量新闻网讯 "检查前收到责任清单，现场有人手把手指导，整改后还来复查巩固，这样的监管让 我们心里有底、经营更稳！"近日，山东省临沂市郯城县某医疗器械经营企业负责人对市场监管部门的 创新举措赞不绝口。2025年以来，郯城县市场监管局创新推行"风险预告—现场补课—回头看"三段式闭 环监管模式，实现监管与服务的同频共振。 一、事前精准预告，让企业"明方向" "进货查验记录填写不完整，按照《医疗器械经营质量管理规范》，应该这样补充……"在郯城县某医疗 器械经营企业内，执法人员一边指出问题，一边现场演示规范填写方法。这是郯城县"百问百答现场 问，药企法规送上门"活动的日常场景，执法人员化身"流动讲师"，结合检查发现的问题开展"一对 一"辅导。针对不同企业痛点，补课内容各有侧重，对新开办企业重点加强法律法规的讲解，对整改企 业手把手指导存在的问题，对偏远企业开展上门服务，确保监管无死角。推行"逢查必考"机制以来，累 计现场考核质量管理人员120余人次，开展靶向辅导20余次，帮助36家企业规范经营条件，6家企业通过 整改提升监管等级。 三、事后回头看，让整改"不打折" "上次指出的问题，现在整改到位了吗？"在助听器经 ...

为保障"零关税"药械政策实施，海口海关积极研究优化通关流程，深入走访调研了解不同类型企业享惠 政策堵点痛点，研提解决措施，让政策红利精准触及享惠主体。 自2024年12月31日首票业务落地以来，海南自贸港药品、医疗器械"零关税"政策已平稳运行一周年，政 策红利持续释放。据海口海关统计，截至2025年12月31日，累计进口"零关税"药械货值约4.6亿元，减 免税款约6200万元。 海南自贸港药品、医疗器械"零关税"政策明确，在博鳌乐城国际医疗旅游先行区内注册登记具有独立法 人资格并经认定的医疗机构、医学教育高等院校、医疗类科研院所，进口政策规定范围内的药品、医疗 器械，可享受免征进口关税、进口环节增值税和消费税，降低医疗机构运营成本，更为患者就医显著减 轻负担。 下一步，海口海关将继续优化监管服务，引导企业用好用足政策，进一步推动"零关税"药械政策红利释 放，助力乐城先行区打造全球优质医疗资源集聚高地。 （文章来源：央视新闻） ...

Investment Rating - The report maintains a "Recommended" rating for several companies in the healthcare sector, including Weili Medical, Zhend Medical, Aohua Endoscopy, and others [33]. Core Insights - The report highlights a shift in the innovative drug sector from quantity to quality, emphasizing the importance of differentiated products and internationalization for future profitability [11]. - The medical device sector is experiencing a recovery in bidding volumes, particularly in imaging equipment, and is expected to benefit from government subsidies for home medical devices [11][19]. - The life sciences service sector is showing signs of recovery, with increasing demand driven by both domestic and international markets [23]. - The pharmacy sector is poised for growth due to the acceleration of prescription outflow and an improving competitive landscape [24]. Summary by Sections Market Review - The report notes a 2.02% decline in the CITIC Medical Index, underperforming the CSI 300 Index by 1.44 percentage points, ranking 27th among 30 sectors [7]. Innovative Drugs - The innovative drug sector is expected to see a significant increase in the number of products launched, with projections of over 30 products by 2027, and a revenue share from innovative products expected to exceed 50% by 2025 [15]. Medical Devices - The report identifies a recovery in bidding for imaging devices and highlights the potential for domestic companies to increase market share through product upgrades and international expansion [19][20]. Life Sciences Services - The life sciences service sector is anticipated to benefit from a recovery in overseas demand and an increase in domestic industrial demand, with a focus on mergers and acquisitions to strengthen market positions [23]. Pharmacies - The pharmacy sector is expected to benefit from the acceleration of prescription outflow and an improved competitive landscape, with recommendations to focus on leading pharmacy chains [24]. Traditional Chinese Medicine - The report emphasizes the importance of basic medicines and state-owned enterprise reforms, suggesting a focus on companies like Kunming Pharmaceutical and Kangyuan Pharmaceutical [27]. Medical Services - The report recommends focusing on companies with national expansion capabilities in the medical services sector, particularly those in traditional Chinese medicine and ophthalmology [26]. Blood Products - The blood products sector is expected to see growth due to relaxed approval processes for plasma stations and an increase in product offerings [12].

近日，三诺生物（300298）发布公告称，公司于近日召开临时股东大会，选举产生了公司第六届董事会 成员。 此外，公司董事会还设立了战略委员会、提名委员会、薪酬与考核委员会和审计委员会等4个专门委员 会，各委员会成员均由董事组成。 在新一届董事会的第一次会议上，公司聘任了新的高级管理人员和证券事务代表，任期同样为三年。总 经理由李心一担任，副总经理包括王世敏、彭旭明、郑霁耘等人，财务总监为何竹子，证券事务代表为 许卉雨。 公告提到，截至本公告日，李少波直接持有公司股份142,685,648股，为公司控股股东、实际控制人，李 少波与公司副董事长、总经理李心一系父女关系，与持有公司5%以上有表决权股份的股东、公司其他 董事、高级管理人员不存在关联关系。 新董事会由7名董事组成，其中包括3名非独立董事：李少波（董事长）、李心一（副董事长）、车宏 菁，3名独立董事：陈纪正、JianyouTan（谭建友）、ZhenqiLiu（刘振启）和1名职工代表董事黄绍波， 任期为三年。 ...

Market Overview - The CITIC Pharmaceutical Index decreased by 2.02%, underperforming the CSI 300 Index by 1.44 percentage points, ranking 27th among 30 primary industries [8] - The top ten stocks with the highest gains this week include Duorui Pharmaceutical, Maillande, and Xiangyu Medical, while the top ten stocks with the largest declines include *ST Changyao and Shuyupingmin [8][37] Overall View and Investment Themes - The domestic innovative drug industry is transitioning from quantity logic to quality logic, emphasizing differentiated and internationalized pipelines, with a focus on products that can generate profits [11] - In the medical device sector, there is a notable recovery in bidding volumes for imaging equipment, and the home medical device market is benefiting from subsidy policies [11] - The CXO and life sciences services sector is expected to see a rebound in overseas investment and a bottoming out of domestic investment, indicating a potential upturn in the innovation chain [11] - The specialty raw materials pharmaceutical industry is anticipated to experience a new growth cycle, with a focus on the impact of patent expirations on new product volumes [11] Specific Industry Insights Innovative Drugs - The company has significantly increased its pipeline, with the number of innovative products rising from 3 to 18 since 2022, and plans to launch an average of 5 innovative products annually over the next three years [15][16] - The revenue share from innovative products is expected to exceed 50% by 2025, driven by a robust pipeline and strategic partnerships [15][16] Medical Devices - The orthopedic market is projected to grow due to aging demographics and increased surgery penetration, with domestic companies benefiting from the acceleration of local replacements [17] - The IVD market, particularly in chemiluminescence, is expected to grow rapidly, with domestic brands increasing their market share through competitive pricing and improved product offerings [18] Life Sciences Services - The life sciences services sector is recovering, with demand expected to rise in both domestic and overseas markets, driven by increased investment in biopharmaceuticals [24] - The industry is characterized by low penetration rates and a trend towards domestic substitution, with significant opportunities for growth through mergers and acquisitions [24] Traditional Chinese Medicine and Medical Services - The traditional Chinese medicine sector is expected to benefit from policy changes and an aging population, with a focus on unique therapeutic areas and high-dividend stocks [26][31] - The medical services sector is anticipated to improve due to anti-corruption measures and the expansion of commercial insurance, enhancing the competitiveness of private healthcare providers [26] Investment Recommendations - The company recommends focusing on the pharmacy sector due to the acceleration of prescription outflow and the optimization of competitive dynamics, suggesting that the pharmacy sector is poised for recovery [25] - In the medical device sector, attention is drawn to companies that are well-positioned to benefit from domestic substitution and technological advancements [19]

海南自贸港药品、医疗器械"零关税"政策明确，在博鳌乐城国际医疗旅游先行区内注册登记具有独立法 人资格并经认定的医疗机构、医学教育高等院校、医疗类科研院所，进口政策规定范围内的药品、医疗 器械，可享受免征进口关税、进口环节增值税和消费税，降低医疗机构运营成本，更为患者就医显著减 轻负担。 央广网海口1月4日消息（记者 蔡文娟）自2024年12月31日首票业务落地以来，海南自贸港药品、医疗 器械"零关税"政策已平稳运行一周年，政策红利持续释放。据海口海关统计，截至2025年12月31日，累 计进口"零关税"药械货值约4.6亿元，减免税款约6200万元。 "这项政策对于我们这些在乐城内注册的医疗机构来说可谓是'锦上添花'，不仅可以减轻患者用药用械 成本，也为我们企业资金周转提供了很大的便利。"海南博鳌超级医院相关负责人冯家龙说。 为保障"零关税"药械政策实施，海口海关积极研究优化通关流程，深入走访调研了解不同类型企业享惠 政策堵点痛点，研提解决措施，让政策红利精准触及享惠主体。 ...

Core Viewpoint - The article emphasizes that cranioplasty is not merely a "patch surgery" but a complex integration of structure and morphology, where the final aesthetic outcome and long-term stability are crucial for patient satisfaction [1][3]. Group 1: Clinical Pain Points - Cranioplasty is often viewed as a "structural repair," but it involves a comprehensive challenge related to geometry, mechanics, and long-term stability [2]. - Irregular defect shapes can lead to "secondary asymmetry" during surgery, as manual adjustments to materials often fail to ensure edge continuity [2]. - Key contour areas are highly sensitive to "millimeter-level errors," which can affect tactile and visual outcomes for patients [2][4]. - Long-term stability is a core indicator of treatment efficacy, with factors like material absorption, thermal expansion, and mechanical stability influencing the durability of the reconstruction [5]. Group 2: Material System - Polyether ether ketone (PEEK) is increasingly chosen for craniomaxillofacial reconstruction due to its long-term clinical validation and alignment with cranioplasty needs [6]. - PEEK's elastic modulus closely matches that of cortical bone, allowing for a more natural edge transition and tactile experience for patients [6]. - The material is non-absorbent and corrosion-resistant, maintaining shape stability over time, which is critical for preventing "secondary changes" in appearance [6]. - PEEK exhibits excellent imaging compatibility, producing minimal artifacts in CT/MRI scans, which is vital for long-term follow-up of patients [7]. - The material possesses sufficient mechanical strength to provide predictable structural support, especially in large defects or load-bearing areas [7]. Group 3: Product Features - The newly approved localized patient-matched PEEK cranioplasty system builds on an established engineering framework, utilizing high-quality materials with over 20 years of clinical experience [9]. - The system allows for anatomical-level restoration of curvature, moving from manual sculpting to digital modeling, which resolves many shape-related issues preoperatively [11]. - The design includes a gradual thinning transition at the defect edges, enhancing tactile and aesthetic outcomes, which is difficult to achieve through manual methods [12]. - Surface roughness is controlled to balance early stability and long-term safety, ensuring a smooth interface with surrounding tissues [14]. - The layout of fixation holes is designed to meet both mechanical requirements and surgical habits, facilitating predictable surgical actions [14]. Group 4: Localization Significance - The localization of the PEEK cranioplasty system enhances accessibility to high-quality reconstruction options, allowing for clearer execution conditions in clinical settings [15]. - A defined delivery schedule supports surgical planning, making personalized implants a routine choice rather than an exception [16]. - Local design teams ensure accurate implementation of design intentions, improving interface stability and reducing risks associated with micro-movements [18]. - The production system is not a simple replication but a transfer of existing international standards, ensuring consistent quality across different regions [21].

对医疗器械公司来说，市场部的核心战场往往在会场上：新品亮相、学术教育、专家共识、渠道触达。 2026年已至，哪些大会必须参加？哪些论坛值得布局？ 思宇MedTech整理了39场医疗器械相关会议，供市场部参考（更多大会信息还在陆续发布中，我们后续会有更完整 的版本） 2026年生物医学工程、智能感知技术与医学应用国际学术会议 会议时间：2026年1月9–11日 会议地点：沈阳 第十届神经学与神经外科国际研讨会 会议时间：2026年1月9–11日 会议地点：三亚 2026年西湖心血管病临床进展研究大会 会议时间：2026年1月16–17日 会议地点：杭州 2026年3月 第三届全球生物医药大会 会议时间：2026年3月19日 会议地点：北京中关村会议中心 会议时间：2026年3月21–23日 会议地点：厦门 2026医学装备展览会 会议时间：2026年3月26–29日 会议地点： 重庆 2026年4月 CMEF 春季（中国国际医疗器械博览会） 会议时间：2026年4月9–12日 会议地点：上海 "第二十六届国际眼科学学术会议"与"第二十六届国际视光学学术会议"（COOC 2026） 会议时间：2026年4月9–1 ...

# 一个规模巨 大 、但变化缓慢的器械赛道 透析是终末期肾病患者不可替代的长期治疗方式，也是医疗器械领域中规模最大的单一治疗场景之一。但 与其市场体量并不匹配的是，该领域在治疗模式和系统效率上的变化相对有限。 在国内，透析治疗仍高度依赖中心化医疗机构，患者需长期、高频往返医院完成治疗。这一模式在保障安 全性的同时，也带来了明显的现实问题：患者时间与体力负担沉重，基层地区可及性不足，医疗机构在医 保控费和耗材集采背景下面临持续运营压力。 在此基础上，透析治疗对患者生存质量的改善空间也相对有限，使得这一领域逐渐呈现出 "刚需、高频、但 系统效率偏低" 的特征。 近日， 上海心光生物医药有限责任公司 （以下简称"心光生物"）宣布完成 数千万元A1轮融资 。本轮融资 由国际知名机构领投，老股东 兴富资本 跟投，凯乘资本担任长期财务顾问。公司表示，募集资金将主要用 于再生型腹膜透析产品的型式检验、临床试验及注册申报等关键节点。 在当前医疗器械投资更加关注 "是否解决真实系统性问题" 的背景下，心光生物所切入的透析赛道，并非高 速变化的热门领域，却长期存在结构性矛盾。本轮融资，更多体现的是资本对透析治疗模式调整可能性的 ...

中化新网讯 天津大学张晓东教授团队开发出一种新型高性能单原子生物催化材料，并将其应用于血管 支架，为心脑血管疾病的长效治疗提供了全新解决方案。相关成果已于2025年12月22日发表于国际期刊 《自然·可持续发展》。 单原子催化剂如同化学反应的"高效管家"，能快速促成关键分子的转化，具有"又快又准"的催化能力， 在能源和医疗等领域拥有广阔的应用前景。然而，如何大规模、精准地制备这类催化剂，是制约其走向 实际应用的关键难题。传统工艺难以精确控制原子分布，高温处理还容易破坏材料结构。而其他能实现 原子级精准调控的高精技术，又往往成本高昂、工艺复杂、产量有限，无法满足大规模生产和实际应用 的需要。 针对这一难题，张晓东团队独辟蹊径，提出了一种通用型单原子催化剂制备策略。他们通过机器学习与 计算机模拟，从近两万种原子结构中筛选出催化活性最高的原子;然后采用离子注入技术，将活性原 子"注入"常用医用镍钛合金的表面，从而实现单原子催化剂的高效、均匀制备。 该方法具有三大优势：规模化制备能力强，仅用数小时即可一次性做出面积达200平方厘米的催化材料; 通用性强，已成功用于制备铂-铜、钴-钒等22种不同的单原子催化剂;条件温和 ...