创新医疗器械
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江苏省医疗器械检验所联合省药监局审评中心走进园区开展“面对面”服务
Yang Zi Wan Bao Wang· 2025-11-21 03:57
在座谈会上省医疗器械检验所介绍检验周期压减、技术服务、专人首问负责等一系列优质服务举措,随 后针对企业代表提出的医疗器械注册申报、送检样品准备等诉求,与审评中心人员一道现场答疑,并结 合最新法规标准与工作实践逐一回复。下一步,双方将紧紧围绕企业急难愁盼,着力发挥党建引领作 用,为推动创新医疗器械成果转化落地、助力医疗器械产业高质量发展贡献力量。 近日,江苏省医疗器械检验所有院室党支部与省药监局审评中心医疗器械审评科党支部联合走进江北新 区医药谷开展企业"面对面"服务。到南京生物医药谷10余家企业,对接服务需求、共解发展难题,以实 际行动促进党建与业务工作深度融合、同频共振。在参观全国高校生物医药区域技术转移转化中心过程 中,双方详细了解近年来各大高校、企业团队的创新产品转化情况和当地扶持政策,共同表示将依托省 医疗器械检验所南京江北新区服务站深化开展创新医疗(002173)器械产品转化各项服务工作。 ...
瑞银展望2026:医药行业投资展望
瑞银· 2025-11-18 01:15
瑞银展望 2026:医药行业投资展望 20251117 摘要 中国医药市场预计以 7%的年化增长率增长,至 2.1 万亿美元,主要驱 动力为人口老龄化,预计 2040 年 65 岁及以上人口将占 27%,导致医 疗保健支出增加,尤其是在 75 岁以上人群中。 中国医药市场资金主要来源于医保和自费,商业保险作为新兴市场预计 未来 5 年复合增长率为 15%,国家医保未来 5 年内预计以 7.2%的年化 增速扩张,医保结余相对健康。 创新药、创新医疗器械、医疗服务和中药在中国医药市场中具有较高增 长潜力,创新药未来 5 年复合增长率预计达到 20%,到 2030 年预计接 近 60%。 生物科技企业将在 2025 年至 2026 年迎来盈亏平衡,对外授权活动显 著增加,中国创新药已占全球管线储备的 1/3,新产品和新适应症获批 方面涵盖多种分子形式。 看好海外收入占比较高的 CDMO 企业,中国国内投融资环境有所恢复, 研发活动有所增加,但价格竞争压力依然存在,中国投融资数据同比增 长超过 100%,较 2019 年水平提升 33%。 Q&A 中国医药市场在未来 5 至 10 年的发展趋势如何? 根据瑞银证券的研 ...
恩威医药最新公告:拟出资2000万元与专业投资机构共同设立基金
Sou Hu Cai Jing· 2025-11-14 10:45
以上内容为证券之星据公开信息整理,由AI算法生成(网信算备310104345710301240019号),不构成 投资建议。 恩威医药(301331.SZ)公告称,公司作为有限合伙人以自有资金认缴出资2000万元,参与设立嘉兴磐霖 嘉颐创业投资合伙企业(有限合伙)。该基金规模为20100万元,投资方向包括医疗(创新药、创新医 疗器械)及科技(企业级服务、硬科技)等。合伙企业尚需完成中国证券投资基金业协会备案和工商变 更登记手续,实施过程存在不确定性。公司本次投资可能面临较长的投资回报期,以及投资项目不能实 现预期收益或投资失败的风险。 ...
“十五五”规划分析及产业投资机遇展望
Ping An Securities· 2025-11-12 10:27
Group 1: Economic Strategy - The "15th Five-Year Plan" emphasizes economic construction as the core focus, aiming to build a modern industrial system centered on advanced manufacturing[9] - Key industrial development lines include "hard technology," advanced manufacturing, domestic circulation, and energy resource security[3] - The plan aims to create a market space of 10 trillion yuan by optimizing traditional industries and fostering emerging sectors over the next five years[8] Group 2: Hard Technology and Advanced Manufacturing - The plan highlights the importance of original innovation and key core technology breakthroughs, particularly in AI and digital technologies[12] - The automotive industry is expected to see accelerated commercialization of L3/L4 autonomous driving technologies during the "15th Five-Year Plan" period[34] - The focus on advanced manufacturing aims to enhance the global competitiveness of traditional industries like chemicals and machinery, with a push towards smart and green manufacturing[8] Group 3: Domestic Circulation and Consumption - The plan stresses the need to boost consumption and expand effective investment, particularly in the real estate sector, to support high-quality development[3] - The "anti-involution" policy is expected to improve the operational environment for construction materials and consumer goods, benefiting companies in these sectors[3] Group 4: Resource Security - The plan calls for strengthening the exploration and development of strategic mineral resources, particularly rare earths, to enhance their strategic importance[3] - It emphasizes the need for a new energy system, focusing on clean and efficient utilization of fossil energy while promoting renewable energy sources[3] Group 5: Market Outlook and Risks - The equity market is expected to maintain high volatility, with a focus on sectors benefiting from industrial recovery and performance superiority[3] - Key risks include macroeconomic fluctuations, lower-than-expected corporate profit growth, and geopolitical uncertainties[3]
第11批药品集采结果公布,医药板块持续活跃
Mei Ri Jing Ji Xin Wen· 2025-11-12 05:59
消息面,第11批国家组织药品集中带量采购(简称"集采")结果正式公布,将于2026年2月实施。 国家药监局数据显示,"十四五"期间,我国共批准创新药210个、创新医疗器械269个,且均保持加速增 长态势。目前,我国生物医药市场规模跃居全球第二,在研创新药约占全球的30%。2025年上半年,创 新药对外授权总金额接近660亿美元,全球市场对中国创新药的认可度正在不断提升。 截至2025年11月12日 13点44分 ,A股三大指数集体调整,上证指数跌0.14%,深证成指跌0.62%,创业 板指跌0.81%。科创医药ETF基金(588130)上涨1.22%,最新报价1.164元,换手率7.36%。成分股方面 涨跌互现,热景生物领涨8.23%,三生国健上涨6.13%,亚辉龙上涨6.12%,百济神州-U上涨5.02%,泽 璟制药-U上涨4.40%;赛分科技领跌1.80%,博瑞医药下跌1.61%,联影医疗下跌1.49%,神州细胞下跌 1.28%,康希诺下跌1.17%。 (文章来源:每日经济新闻) 据了解,此次集采共纳入55种药品,覆盖抗感染、抗过敏、抗肿瘤、降血糖、降血压、降血脂、消炎镇 痛等领域常用药品,全部采购成功。 ...
中金基金丁天宇:2026年创新医疗器械和创新药等投资机会值得关注
Zhong Zheng Wang· 2025-11-11 12:40
Core Viewpoint - The investment opportunities in the pharmaceutical industry for 2026 are highlighted, particularly in innovative medical devices, innovative drugs, and high-growth CXO and upstream life sciences companies [1] Group 1: Investment Opportunities - Innovative medical devices are identified as a focus area, contingent on performance alignment [1] - After a correction in innovative drugs, certain high-quality targets are recommended for attention [1] - High-growth CXO and upstream life sciences companies are also considered worthy of attention if they can maintain robust business growth [1] Group 2: Market Conditions - The pharmaceutical sector has been at a low point since peaking in 2021, presenting current investment opportunities [1] - Institutional investors may reallocate resources when the fundamentals of pharmaceutical companies improve and performance aligns [1] Group 3: Stock Selection Strategy - The company aims to identify and predict significant turning points in the lifecycle of industries and companies [1] - The strategy involves early market positioning to capture excess returns as industry and company values become recognized, leading to simultaneous performance and valuation increases [1] - A preference for innovative drug industry chains (CXO, upstream life sciences) as a high-probability offensive base, while positioning medical devices as a defensive allocation [1]
海南自贸港加快构建现代化产业体系
Hai Nan Ri Bao· 2025-11-11 01:56
Core Viewpoint - Hainan is accelerating the construction of a modern industrial system with unique characteristics and advantages, focusing on high-quality development and the integration of technology and industry [4][8][24]. Group 1: Modern Industrial System Development - Hainan is leveraging its unique advantages to build a modern industrial system, emphasizing the optimization and upgrading of leading industries [4][10]. - The "4532" strategy is being implemented to enhance the modern industrial system, with the semiconductor industry beginning to take root in Hainan [9]. - The agricultural sector, particularly the South Seed Industry, has over 2,800 related enterprises with an annual output value exceeding 18 billion yuan [10]. Group 2: Key Industries and Economic Growth - The four leading industries in Hainan—tourism, modern services, high-tech industries, and tropical agriculture—accounted for 67% of the province's GDP in 2024, with a notable increase from 2020 [14]. - The marine economy has shown an average nominal growth rate of 13.9% over four years, contributing to 34.1% of the GDP in 2024 [11]. - The clean energy sector has achieved over 70% in power generation and 86% in installed capacity [12]. Group 3: Innovation and Technology Integration - Hainan is focusing on the deep integration of technological innovation and industrial innovation to drive significant breakthroughs and enhance productivity [17][21]. - The province has seen a rapid increase in R&D investment, reaching 10.961 billion yuan in 2024, a 22.1% increase from the previous year [21]. - Companies like Keda Xunfei are leveraging AI to enhance industrial capabilities, with over 800,000 developers engaged in the region [15]. Group 4: Strategic Initiatives and Future Prospects - Hainan is actively promoting the development of key parks such as Sanya Yazhou Bay Science and Technology City and Boao Lecheng International Medical Tourism Pilot Zone, which are crucial for industrial clustering [12][24]. - The province is exploring new economic models in deep-sea technology and low-altitude industries, aiming to establish a comprehensive low-altitude economy [23]. - The focus on biomedicine is evident with advancements in cell and gene therapy, supported by favorable policies in the Boao Lecheng area [24].
虹桥论坛发出中国高水平对外开放最强音—— 中国特色开放路径展现强大生命力
Zheng Quan Shi Bao· 2025-11-05 18:37
Group 1: Global Open Index Trends - The global openness is showing a complex pattern of "overall tightening, increasing differentiation, and energy conversion" with a slight decline in the global openness index by 0.05% year-on-year for 2024, down 0.34% from 2019, and down 5.39% from 2008 [1][2] - Economic openness index decreased by 0.22% and cultural openness index decreased by 0.58% year-on-year for 2024, both below the levels of 2019 and 2008 [2] Group 2: China's Role in Global Openness - China has emerged as a significant force in maintaining global openness, with its openness index rising from 0.5891 in 1990 to 0.7634 in 2024, marking an increase of nearly 30% over 35 years [1][4] - In the context of overall global tightening, China's openness index has increased by 12.44% since 2008 and by 1.44% since 2019, ranking first among major economies for 2024 with a year-on-year increase of 0.5% [4] Group 3: Foreign Investment in China - As of July 2025, foreign investment in China has led to the establishment of over 1.27 million enterprises with a total investment exceeding $3 trillion, with a direct investment return rate of approximately 9% over the past five years, ranking among the highest globally [5] Group 4: Multinational Companies' Perspectives - Multinational companies like GE Healthcare and Boston Scientific are optimistic about the opportunities in China's market, focusing on local innovation and adapting global technologies to meet local clinical needs [6][7] - The ongoing China International Import Expo is seen as a testament to China's strong market appeal and the stability of its open policies, enhancing Shanghai's role as a hub for global enterprises [6]
擘画“十五五”:深化医改、赋能创新,锚定医药发展新航向
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-29 11:44
Core Insights - The article discusses the strategic opportunities in China's pharmaceutical sector as it transitions from the "14th Five-Year Plan" to the "15th Five-Year Plan," emphasizing the integration of health initiatives and global biopharmaceutical competition [1][2] Industry Development - The "15th Five-Year Plan" outlines a health-first development strategy, focusing on enhancing public health capabilities, promoting hierarchical diagnosis and treatment, and supporting the development of innovative drugs and medical devices [2][3] - The plan aims to bind pharmaceutical industry upgrades with national economic structure optimization, driving high-quality industry development [2][3] Innovation in Pharmaceuticals - During the "14th Five-Year Plan," China approved 210 innovative drugs and 269 innovative medical devices, with the biopharmaceutical market becoming the second largest globally, accounting for approximately 30% of global innovative drugs in development [1][2] - The approval of innovative drugs has accelerated, with 43 drugs approved in the first half of 2024, marking a 59% year-on-year increase [5][6] Medical Device Sector - From 2014 to 2024, 315 innovative medical devices were approved, with 65 approved in 2024 alone, indicating a sustained high level of approvals [6][7] - The government has introduced measures to support the development of high-end medical devices, including optimizing approval processes and enhancing regulatory frameworks [6][7] Public Health and Disease Control - The article highlights the importance of strengthening public health capabilities and disease control systems, particularly in managing major infectious and chronic diseases [9][10] - The "15th Five-Year Plan" emphasizes the need for a comprehensive approach to disease prevention and control, integrating various health services [9][10] Challenges and Recommendations - Experts suggest increasing funding for innovative drug research and improving the investment environment for pharmaceutical companies [7][8] - The need for enhanced collaboration between healthcare, insurance, and pharmaceutical sectors is emphasized to create a more efficient healthcare delivery system [3][4]
聚焦器械创新 赋能产业发展——创新医疗器械申报专题培训在苏州成功举办
Yang Zi Wan Bao Wang· 2025-10-29 08:29
Group 1 - The training session aimed to enhance the quality and efficiency of innovative medical device application submissions, aligning with the State Council's directive for high-quality development in the pharmaceutical industry [1][3] - Over 10,000 participants from regulatory bodies, production companies, research institutions, and medical organizations attended the training, indicating strong interest and engagement in the topic [1][3] - Experts from the National Medical Products Administration provided insights on key aspects of the innovative medical device review process, addressing common issues and emphasizing the importance of clinical evaluation [3] Group 2 - The training focused on practical guidance for applicants, helping them navigate the innovative review application process and improve their understanding of clinical trial design and objectives [3] - The event fostered a collaborative environment where participants discussed common challenges and solutions, reinforcing a shared vision for the development of innovative medical devices [3] - This initiative serves as a significant step towards implementing national reforms in pharmaceutical regulation and enhancing the research and compliance capabilities of the medical device industry [3]