坚定出海方向，把握结构性机遇 - 医药行业 2026 年策略 20260108 摘要 2025 年创新药企凭借对外授权交易（BD）取得突破，全球前十大创新 交易中八项来自中国企业，提升市场信心，但 BD 首付款仅为部分价值 兑现，临床数据验证仍是关键。 中国创新药发展加速，从 me-too/fast follow 向 best-in-class/first- in-class 升级，出海成关键驱动力。ADC、双抗等技术积累领域已突破， 小核酸、基因治疗等新兴领域展现潜力。 医疗器械领域各细分市场表现分化：低值耗材（如丁腈手套）已具产业 话语权；IVD 疫情期间出口良好；高端医疗设备和高值耗材出海初期， 高值耗材被认为更具突破性。 医疗器械出海成绩显著，心血管支架、人工关节、心脏起搏器等增速可 观，本土企业在关节和内镜检查耗材方面实现出口突破，进入发达国家 市场，定价和利润回报可期。 高值耗材与药品差异在于其独立知识产权和创新性，可进行 license out。通过合作或自建渠道建立发达国家销售网络，有望抵消国内集采 影响，推动医疗器械板块增速回升。 Q&A 2025 年医药行业的整体表现如何？创新药在其中扮演 ...

据悉，美敦力北京数字化医疗创新基地是全球首个聚焦医疗科普与患者服务的主题创新空间，自2025年10月正式 启用以来，打造了集科技展示、科普教育、患者互动、远程服务于一体的多功能平台。基地内特设美敦力博物 馆，不仅收藏着全球第一台电池驱动的体外心脏起搏器等珍贵展品，还系统呈现医疗技术迭代历程和智能化未来 愿景；还规划了数字疗法患者体验区、互动空间等专属区域，既为患者提供近距离接触前沿医疗科技的窗口，也 为医患沟通、患者互助搭建了实体桥梁。 出席此次活动的所有患者都是美敦力心律失常患者数字化全周期服务平台——"美敦力心律管家"的用户，该平台 以患者需求为核心，整合了远程随访、健康知识科普、术后康复指导、线上社群交流等多重功能，通过"线上+线 下"联动模式，为患者提供从术后随访到长期健康管理的一站式支持。目前该平台的注册者已经超过15万人。 本次活动中，心律失常患者代表参观了创新基地内的美敦力博物馆。从全球第一台电池驱动的体外心脏起搏器原 型，到如今胶囊大小的无导线心脏起搏器，一件件跨越数十年的医疗设备，清晰呈现了心律失常治疗技术的迭代 轨迹。"没想到起搏器能从那么大一台，变成现在几乎不影响生活的样子。"一位植入起 ...

Core Viewpoint - The article discusses the implications of Hainan's recent closure and its potential as a free trade zone, highlighting both opportunities and risks associated with this transition [4][5][7]. Group 1: Economic Opportunities - Hainan's closure represents a significant leap towards a higher level of openness, offering a unique environment characterized by "zero tariffs, low tax rates, and simplified tax systems" [5][7]. - The potential for Hainan to become a new Singapore and the heart of the RCEP (Regional Comprehensive Economic Partnership) is emphasized, contingent on overcoming development bottlenecks [8]. - The introduction of the policy allowing "30% value-added processing to be exempt from tariffs" is seen as a key to reshaping the real economy in Hainan [17]. Group 2: Industrial Challenges - Hainan's economic structure is described as "dumbbell-shaped," with a weak industrial base, relying heavily on agriculture and low-end tourism [9][10]. - The risk of falling into "industrial hollowing" is highlighted, where the economy could become overly reliant on service sectors without a solid manufacturing foundation [11][14]. - Historical examples suggest that economies lacking a robust industrial backbone ultimately face challenges in employment and income stability [14][15]. Group 3: Strategic Development Areas - Three key sectors for development are identified: luxury goods assembly, biomedicine, and future technologies like aerospace and deep-sea industries [19][22][25]. - The luxury goods sector can benefit from a model where high-value assembly occurs in Hainan, leveraging its tariff exemptions [20][21]. - The biomedicine sector can utilize special policies in Boao Lecheng to import and assemble advanced medical devices, enhancing local capabilities [22][24]. Group 4: Logistics and Connectivity - Hainan's geographical isolation poses challenges for becoming a global shipping hub, as it is not located on major shipping routes [28][30]. - The article suggests that Hainan should focus on creating a "functional platform" rather than merely competing on logistics speed [34]. - Strategies include leveraging "seventh freedom rights" for air travel and establishing a competitive fuel pricing model to attract international shipping [35][41]. Group 5: Unique Selling Propositions - Hainan's potential lies in offering unique privileges that cannot be found elsewhere in China, particularly in healthcare, education, data access, airspace, and culture [52][53]. - The establishment of international medical facilities and educational institutions can attract both domestic and international students, capturing significant educational spending [57][59]. - The development of a "digital nomad zone" with unrestricted internet access aims to attract global talent, enhancing Hainan's appeal as a destination for professionals [61]. Group 6: Future Challenges - The article outlines a "triangle dilemma" that Hainan must navigate: overcoming geographical disadvantages, avoiding industrial homogenization, and preventing economic hollowing [64]. - The success of Hainan will depend on integrating high-level open policies with unique local resources to create a vibrant economic ecosystem [65].

Core Insights - The official launch of Hainan's zero-tariff and low-tax policy marks a significant step towards higher levels of openness, but it poses both opportunities and risks for policymakers, entrepreneurs, and residents [3][5] - The success of Hainan's free trade zone will depend on its ability to transition from a policy-driven economy to one that fosters industrial growth and innovation [5][9] Industry Challenges - Hainan's economic structure is characterized by a weak industrial base, primarily reliant on agriculture and low-end tourism, lacking a robust manufacturing sector [7][9] - The risk of "deindustrialization" looms if Hainan attempts to bypass traditional manufacturing in favor of high-end services without a solid industrial foundation [7][9] Economic Opportunities - The introduction of a 30% value-added tax exemption for processing and manufacturing presents a unique opportunity to revitalize Hainan's economy by attracting high-value industries [9][11] - Potential growth sectors include luxury goods assembly, biomedicine, and advanced technology, leveraging Hainan's unique geographical and regulatory advantages [11][15][17] Strategic Positioning - Hainan must transform from a geographical outlier to a functional hub by creating a platform for international trade and logistics, similar to Dubai's model [19][22] - The implementation of the "seventh freedom" in aviation could enhance Hainan's connectivity and attractiveness for international logistics [22][25] Consumption and Market Differentiation - Hainan's tourism strategy must evolve beyond low-cost offerings to focus on unique privileges and high-value experiences that cannot be found elsewhere in China [35][37] - Key areas for differentiation include healthcare, education, data access, airspace management, and cultural experiences, which can attract both domestic and international consumers [37][38][40][42][45] Future Outlook - Hainan faces a complex challenge of overcoming its geographical disadvantages, avoiding homogeneous competition, and preventing industrial hollowing [47] - The future success of Hainan will hinge on integrating high-level open policies with its unique resources, aiming for a transformation from a policy landscape to a thriving industrial ecosystem [47]

微创心律管理（CRM）是全球少数拥有完整心律管理产品线的企业之一，其产品覆盖心脏起搏器、植 入式心脏复律除颤器（ICD）、心脏再同步治疗除颤器（CRT-D）、导线、心律管理患者监护仪及心律 不齐诊断器械等。这些产品是心律市场和部分心衰患者所依赖的关键治疗手段。该公司的海外渠道体系 完善，在欧洲、中东、非洲等地已形成稳定市场基础，贡献大部分营收，并在全球多个国家建立了渠道 网络。 合并后的微创心通，凭借其在结构性心脏病、心律管理及心衰领域的产品布局，将构建覆盖心力衰竭全 病因、全阶段、全过程的综合管理方案，为不同致病因素、各疾病分期及"监测—诊断—治疗—管理"全 过程提供完整的心衰管理服务。目前，该公司已规划覆盖心衰全周期管理的丰富在研管线，其中合并后 的首款心衰产品IABP（主动脉内球囊反搏）产品预计将于2026年在国内获批。 微创医疗表示，依托此次合并，微创心通将整合形成"结构性心脏病+心律管理+心衰管理"三位一体的 综合平台。后续通过渠道协同、运营提效以及持续的研发投入与全球化拓展，新平台的盈利能力有望实 现稳步、持续提升。 转自：中国证券报·中证网 中证报中证网讯（记者 齐金钊）日前，微创医疗科学有限公 ...

Core Insights - The A-share medical commercial sector continues to show strong upward momentum, becoming a core highlight in the health industry, characterized by a "high standard leading the rise, with the entire chain following suit" [1] - The implementation of medical insurance data sharing is accelerating the development of commercial health insurance, enhancing the insurance experience for patients with pre-existing conditions and the elderly, while expanding the coverage of special drug insurance [1] - The commercial health insurance market in China is projected to exceed 551.2 billion yuan by 2025, with a growth rate of 20%, indicating a significant expansion in demand driven by consumer upgrades [2] Group 1: Market Performance - The medical commercial sector is experiencing a robust rally, with companies like Huaren Health leading the charge with a 20% limit-up performance, attracting significant capital focus [1] - Other companies such as Luyuan Pharmaceutical and Zhongyao Holdings also reached their daily limit, indicating a broad-based rally within the sector [1] Group 2: Insurance Market Developments - The sharing of medical insurance data is now in the implementation phase, which is expected to enhance the market demand for commercial health insurance significantly [1] - By 2030, the compensation scale for commercial health insurance is anticipated to reach 471.57 billion yuan, providing a continuous influx of capital into the medical commercial sector [1] Group 3: Industry Growth Projections - The commercial health insurance market is expected to account for nearly 50% of the health insurance sector by 2025, marking the beginning of a "new development era" for the industry [2] - The current personal medical out-of-pocket ratio in China stands at 43%, significantly higher than the World Health Organization's recommended range, indicating substantial growth potential for commercial health insurance [2] Group 4: Opportunities in Specific Sectors - The DTP pharmacy sector is positioned to benefit directly from the expansion of commercial health insurance payments, serving as a key payment pathway for pharmaceutical companies [3] - The TPA (Third Party Administrator) sector is also set to experience growth due to the diversification of medical services driven by the development of commercial health insurance [3] - Innovative medical devices that are not fully covered by insurance are expected to achieve payment breakthroughs through commercial insurance, benefiting companies involved in high-value, high-tech medical equipment [3]

（文章来源：证券日报） 合并后的微创心通，凭借其在结构性心脏病、心律管理及心衰领域的产品布局，将构建覆盖心力衰竭全 病因、全阶段、全过程的综合管理方案，为不同致病因素、各疾病分期及"监测—诊断—治疗—管理"全 过程提供完整的心衰管理服务。 目前，该公司已规划覆盖心衰全周期管理的丰富在研管线，其中合并后的首款心衰产品IABP（主动脉 内球囊反搏）产品预计将于2026年在国内获批，意味着微创心通将加速推进心衰商业化。 依托此次合并，微创心通将整合形成"结构性心脏病+心律管理+心衰管理"三位一体的综合平台。后续 通过渠道协同、运营提效以及持续的研发投入与全球化拓展，新平台的盈利能力有望实现稳步、持续提 升。 业内人士分析，并购完成后，双方渠道、注册、物流体系将进一步整合，微创心通的结构性心脏病产品 有望依托微创心律管理平台更快进入新市场，微创心律管理在国内也可借助微创心通的结构性产品形成 组合式销售以及渠道复用，提升营销效率。 本报讯 （记者矫月）12月15日，微创医疗科学有限公司（以下简称"微创医疗"）宣布，其旗下微创心 通医疗科技有限公司（以下简称"微创心通"）与微创心律管理的战略合并议案已获微创心通股东大会审 ...

新华财经上海12月16日电（记者潘清、杜康）在我国人口老龄化加速的背景下，心血管疾病高发对相关 诊疗行业发展提出更高要求。上海创新型高端医疗器械企业微创医疗16日宣布，通过推进业务整合，加 快构建全球化心衰专业器械平台。 微创心律管理是全球少数拥有完整心律管理产品线的企业之一，产品覆盖心脏起搏器、植入式心脏复律 除颤器（ICD）、心脏再同步治疗除颤器（CRT-D）、导线、心律管理患者监护仪及心律不齐诊断器械 等。 依托此次合并，微创心通将整合形成"结构性心脏病+心律管理+心衰管理"三位一体的综合平台。后续 通过渠道协同、运营提效以及持续的研发投入与全球化拓展，新平台的盈利能力有望实现稳步持续提 升。 微创医疗在港交所发布的自愿公告显示，12月15日微创心通召开股东大会，审议通过并购微创心律管理 有限公司的重大资产重组议案。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，面向心衰全病因、覆盖病程全阶段的复杂诊疗需求，加速构建贯穿"监测—诊断—治疗 —管理"全过程的全球化心衰专业器械平台。 值得注意的是，微创心通收购微创心律管理采取"零现金"换股方式，避免大额现金支出对微创心通运营 ...

作为全球少数拥有完整心律管理产品线的企业之一，微创心律管理（CRM）产品覆盖心脏起搏器、植 入式心脏复律除颤器（ICD）、心脏再同步治疗除颤器（CRT-D）、导线、心律管理患者监护仪及心律 不齐诊断器械等，属于心律市场和部分心衰患者所依赖的关键治疗手段。目前，CRM的海外渠道体系 完善，在欧洲、中东、非洲等地已形成稳定市场基础，贡献大部分营收，并在全球多个国家建立渠道网 络。 在收购微创心律管理后，微创心通将凭借自身在结构性心脏病、心律管理及心衰领域的产品布局，将构 建覆盖心力衰竭全病因、全阶段、全过程的综合管理方案，为不同致病因素、各疾病分期及"监测-诊 断-治疗-管理"全过程提供完整的心衰管理服务。 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，面向心衰全病 因、覆盖病程全阶段的复杂诊疗需求，加速构建贯穿"监测—诊断—治疗—管理"全过程的全球化心衰专 业器械平台。 公开材料显示，我国心血管疾病现有患者人数达3.3亿，且死亡率居首位，高于肿瘤及其他疾病，且心 血管问题年轻化日趋明显。然而，与其庞大患者基数和复杂的病因结构相比，心衰器械治疗的渗透率仍 处于较低水平，现有器械应用主 ...

Core Insights - The Zhangjiang Pharma Valley is positioning itself as a global hub for innovative pharmaceuticals and medical devices, aiming to become the first choice for scientists and a pioneer in institutional reforms by 2025 [1][2][10] Industry Overview - The biopharmaceutical industry is one of Shanghai's three leading industries and a focal point of the new technological revolution and competition [2] - Pudong is tasked with building a world-class biopharmaceutical industry cluster, enhancing its innovation capabilities [2][10] Current Developments - Pudong hosts over 4,000 biopharmaceutical companies, including 9 of the top 10 global pharmaceutical firms and 10 of the top 20 medical device companies [3] - There are nearly 2,000 research pipelines in development, with Pudong accounting for 14% of the national new drug approvals and business development transaction amounts [3][11] - Zhangjiang Pharma Valley has approved 29 first-class domestic new drugs, with several innovative drugs set to launch in 2025 [3][4] Innovation Achievements - In the field of innovative medical devices, 38 products have been approved, with significant advancements in cardiac electrophysiology [3][4] - The establishment of a comprehensive service center aims to provide full-chain services from consultation to industry exchange, enhancing the platform's capabilities [4] Policy Initiatives - The "Implementation Plan for Promoting the High-Quality Development of the High-end Medical Device Industry" aims for an industrial output value of 30 billion yuan within three years [5] - Pudong has a solid foundation in high-end medical devices, with 468 research and production enterprises and a significant share of the city's industrial output [5][6] Strategic Focus Areas - Pudong is focusing on integrating artificial intelligence, medical engineering, and cross-industry collaborations to enhance the development of medical devices [7][8] - The region is also exploring international market expansion, with over 60 companies successfully exporting products [6] Future Aspirations - The establishment of a global "0 to 1" innovation R&D center in Pudong reflects the area's attractiveness for innovative drug development [9][10] - Pudong aims to leverage its unique advantages in integrated circuits, biopharmaceuticals, and artificial intelligence to create a new paradigm of deep integration between technological and industrial innovation [10]