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近期流感用药需求激增;国家药监局原副局长陈时飞被提起公诉
(原标题:近期流感用药需求激增;国家药监局原副局长陈时飞被提起公诉) 这里是《21健讯Daily》,欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件! 政策动向 上海:聚焦细胞与基因治疗、罕见病、高质量首仿药、人工智能医疗器械等重点领域和产品 建立在研重点品种服务清单 11月24日,上海市人民政府办公厅今日印发《上海市全面深化药品医疗器械监管改革促进医药产业高质量发展的若干措施》的通知,其中提到, 聚焦细胞与基因治疗、罕见病、儿童用药、高质量首仿药、人工智能医疗器械、医用机器人、脑机接口、粒子治疗设备、创新中医诊疗设备等重 点领域和产品,建立在研重点品种服务清单,在临床试验、注册上市、检查检验、生产许可等环节跨前指导。夯实国家、市、区三级联动服务机 制,支持国家药监局药品审评检查长三角分中心、医疗器械技术审评检查长三角分中心能力提升,加快区生物医药产品注册指导服务工作站扩能 升级,开展在研创新产品信息收集、重点项目跨前指导和跟踪服务。 药械审批 一品红获得重酒石酸利斯的明口服溶液注册证书 11月24日,济川药业(600566.SH)公告称,公司计划使用自有资金以集中竞价交易方式回购部分公司股份,资 ...
上海:聚焦药品医疗器械重点领域和产品,建立在研重点品种服务清单
Xin Lang Cai Jing· 2025-11-24 09:55
Core Viewpoint - The Shanghai Municipal Government has issued measures to deepen the reform of drug and medical device regulation, aiming to promote high-quality development in the pharmaceutical industry, focusing on key areas such as cell and gene therapy, rare diseases, and pediatric medications [1] Group 1: Key Areas of Focus - The measures emphasize the importance of specific fields and products, including cell and gene therapy, rare diseases, pediatric medications, high-quality first generic drugs, artificial intelligence medical devices, medical robots, brain-machine interfaces, particle therapy equipment, and innovative traditional Chinese medicine diagnostic and treatment devices [1] Group 2: Regulatory Support - A service list for key varieties under research will be established, providing proactive guidance in clinical trials, registration and listing, inspections, and production licensing [1]
昌平生命谷(国际)生物工程创新中心启动
Xin Jing Bao· 2025-11-23 09:05
在随后召开的2025北京."生命谷"医药数智化赋能生命健康之路研讨会上,与会专家聚焦"数智化赋能生 命健康"这一前沿议题,围绕人工智能助力公立医院高质量发展、AI重塑医药研发、计算医学驱动虚拟 临床试验等主题进行分享。高校、科研院所、行业协会、金融机构及企业代表参加活动。 新京报讯11月22日,以"智绘生命创领未来"为主题的生命谷(国际)生物工程创新中心启动大会暨2025北 京."生命谷"医药数智化赋能生命健康之路研讨会举行。中国卫生经济学会会长、国家卫生健康委财务 司原司长何锦国,昌平实验室党委副书记朱建红,区委书记、未来科学城党工委书记甘靖中,区委副书 记、区长,未来科学城党工委副书记、管委会主任刘晓东,北京农学院党委常委、副院长张劲柏出席。 据悉,生命谷(国际)生物工程创新中心是中国生命科学与未来产业前沿技术成果转化的战略首站,将聚 焦细胞与基因治疗、AI医疗等前沿赛道,锚定人工智能、电子信息、半导体等,形成"研发-中试-产业 化"全生命周期的生态闭环。这里汇聚全球顶尖科研资源与产业链上下游企业,依托国家级平台和临床 资源,将成为生物工程领域创新突破与成果转化的首选高地,为北京国际科技创新中心建设贡献" ...
国家生物医药产业园区竞争力排行榜出炉 江宁高新区,排名进四位
Nan Jing Ri Bao· 2025-11-10 23:55
Core Insights - Jiangning High-tech Zone has significantly improved its competitiveness ranking, moving up 4 places to 13th in the 2024 National Biopharmaceutical Industry Park Competitiveness Ranking released at the 2025 China Biotechnology Innovation Conference [3][4] - The ranking is based on a comprehensive evaluation of various dimensions including environment, industry, technology, talent, and cooperation, aimed at promoting the development and transformation of China's biopharmaceutical industry clusters [3] Group 1: Industry Overview - Jiangning High-tech Zone is recognized as a key cluster for the biopharmaceutical industry in the Yangtze River Delta, positioning biopharmaceuticals as its primary industry for regional transformation [3] - The park has attracted nearly 400 pharmaceutical companies, covering six major sectors including new drug development, cell and gene therapy, and high-end medical devices [3] Group 2: Performance Metrics - In 2024, the park successfully listed two Class 1 innovative drugs, with the pharmaceutical industry's revenue growth exceeding 30%, leading the city [3] - By the beginning of 2025, Jiangsu Province's first Class 1 innovative drug was developed in this zone, with a nearly 40% revenue growth for the first three quarters of the year, showcasing the industry's explosive growth potential [3][4] Group 3: Strategic Focus Areas - Jiangning High-tech Zone is strategically focusing on four emerging sectors: cell and gene therapy, nuclear medicine, beauty and health, and brain-computer interfaces, employing a model of "leading enterprises + chain extension + ecosystem construction" to build a competitive industrial cluster [4] - In the cell and gene therapy sector, the zone has established a complete industrial chain from gene synthesis to commercial production, leveraging leading companies such as Genscript and Ruigen Biotech [4] - The nuclear medicine sector aims to create a comprehensive ecosystem in collaboration with GE Healthcare and Dongcheng Andico, focusing on the entire production chain from target discovery to clinical transformation [4]
“敢”的底气——探寻中关村生命科学园打造生命科学新高地的时代脉动
Zheng Quan Ri Bao· 2025-11-10 16:26
Core Insights - The Beijing Zhongguancun Life Science Park has transformed into a vital axis for Beijing's international technology innovation center, becoming a key base for life sciences, biotechnology, and new pharmaceutical industries in China [1][3] - The park has developed a vibrant industrial ecosystem with hundreds of pharmaceutical companies, supported by favorable policies and capital, creating a "biopharmaceutical rainforest" [1][3] Innovation Chain - The park features a comprehensive innovation chain that includes basic research, technology development, clinical validation, and production sales, exemplified by institutions like the National Protein Science Center [2][3] - Key research institutions and hospitals within the park facilitate the transition from scientific discovery to practical applications in medicine [2] Industry Ecosystem - Over 600 innovative pharmaceutical companies, including BeiGene and Innovent Biologics, are located in the park, focusing on transforming research findings into potential new drug candidates [3][4] - The park has evolved from being policy-driven to a self-driven industry ecosystem, showcasing a mature life sciences innovation environment [3] Achievements and Recognition - The park has produced significant innovations, including China's first billion-dollar drug, Zebutine, and has been recognized as the top life sciences park in China according to a report by the China Biotechnology Development Center [4][8] - The park's unique advantages include a strong industrial foundation, natural clustering effects, and a complete industrial chain, supported by top research institutions and talent reserves in Beijing [4] Entrepreneurial Environment - The park is described as an "ideal paradise" for scientists, with many researchers becoming entrepreneurs, leading to the establishment of 112 companies founded by scientists [5][6] - The support for early-stage scientific entrepreneurship is a key attraction of the Zhongguancun Life Science Park, providing essential resources and funding [6][7] Funding and Investment - The Beijing government has established a 20 billion yuan pharmaceutical health industry investment fund to support the development of the industry [8] - The park's operational platform has partnered with over 50 market-oriented investment funds, investing in 468 pharmaceutical health projects to empower original innovations [8] Future Development - The 2024 Beijing Action Plan emphasizes the importance of building research hospitals and accelerating the construction of the Zhongguancun Life Science Park's third phase to enhance its global competitiveness [9][10] - The park aims to maintain its leading position in emerging fields such as cell and gene therapy, with a focus on platform construction to support industry development [10][12]
符合条件企业拟给予市级算力券补贴
Bei Jing Qing Nian Bao· 2025-11-05 18:56
Core Viewpoint - The document outlines a series of measures aimed at promoting the high-quality development of the pharmaceutical and health industry in Changping District, Beijing, through 17 specific initiatives focused on innovation, industry support, and creating a premier industrial cluster [1] Group 1: Enhancing Innovation Capability - The measures prioritize enhancing innovation capability by supporting original innovation, clinical transformation, and AI empowerment in the pharmaceutical sector [2] - Initiatives include establishing a joint natural science fund, supporting key scientific research, and upgrading the Beijing Synthetic Biology Manufacturing Technology Innovation Center to a national-level platform [2] - The establishment of a national technology transfer center and support for AI applications in healthcare, including funding of up to 50 million yuan for exemplary AI+medical projects, are also highlighted [2] Group 2: Improving Industry Service Platforms - The measures propose various initiatives to address the full lifecycle needs of enterprises from R&D to market launch, including streamlined communication with regulatory bodies to expedite the approval process for innovative drugs and devices [3] - Financial support mechanisms are introduced, such as collaboration between health insurance companies and innovative pharmaceutical firms to develop specific disease insurance products [3] - A "stock-loan-debt guarantee" system is proposed to enhance financial support for technology-driven enterprises, with funding of up to 500,000 yuan for qualifying investment institutions [3] Group 3: Accelerating Industrial Clustering - The measures focus on developing key areas such as the Life Science Park and International Medical Device City to promote industrial clustering and specialization [4] - Specific initiatives include the establishment of a brain-machine interface incubation fund and the creation of a high-end medical equipment innovation center [4] - Financial incentives are provided for projects that enhance park capacity and attract global leading management organizations, with funding support of up to 50% of project costs, capped at 5 million yuan [4] Group 4: International Development and Talent Support - Additional measures are proposed to enhance international development and talent support, aiming to unlock the regional development potential and elevate the pharmaceutical and health industry in northern Beijing [5]
眼科CGT加速迈向临床转化阶段 资本赋能进一步给行业“加油”
Zheng Quan Ri Bao Wang· 2025-11-04 11:40
Core Insights - Cell and gene therapy (CGT) is recognized as a transformative biomedical technology aimed at treating diseases at their source, particularly in the ophthalmology sector, which is moving towards clinical application [1][2] - The industry is witnessing a strategic shift from focusing on rare genetic diseases to addressing common complex eye diseases, such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) [2][3] - The integration of capital into the CGT ecosystem is crucial for bridging the gap between laboratory breakthroughs and commercial implementation, with significant interest from investors [3][4] Industry Development - Advances in gene editing precision, standardization of stem cell therapies, and innovative delivery systems are propelling ophthalmic CGT from basic research to clinical application [2] - The market for ophthalmic CGT is expected to experience explosive growth due to increasing prevalence of eye diseases driven by aging populations and changing visual habits [2] Capital Empowerment - Capital is playing a pivotal role in connecting the innovation chain, industry chain, and funding chain, thereby accelerating the establishment of a comprehensive industrial ecosystem for ophthalmic CGT [3] - Over 40 CGT companies are reportedly queued for listing on the Hong Kong Stock Exchange in 2024, reflecting a 30% increase in valuation compared to the previous funding round, indicating strong market confidence in the sector [3] Company Strategies - He Eye Hospital Group is leveraging its comprehensive eye health ecosystem to focus on CGT, stem cell regenerative medicine, and smart ophthalmic equipment, aiming to integrate cutting-edge technology with healthcare data [4] - The company emphasizes an open ecosystem for CGT, fostering collaboration with other enterprises in technology and capital [4]
2025年国际基因组学大会眼科大会在沈阳举办
Zheng Quan Ri Bao· 2025-10-31 13:12
Core Insights - The "2025 International Genomics Conference on Ophthalmology (ICGEYE) and CGT Innovation and Industrial Transformation Summit" was successfully held in Shenyang, co-hosted by several organizations including Liaoning He Eye Hospital Group [2] - The conference focused on the theme "Genes, Cells, AI: Co-creating a New Landscape for Precision Treatment in Ophthalmology," gathering nearly a hundred top scientists and representatives from various sectors to discuss the integration of cell and gene therapy (CGT) with artificial intelligence in ophthalmology [2][3] - The event aims to promote the transformation of significant technological achievements and inject new momentum into the high-quality development of the ophthalmology industry [2] Industry Developments - The chairman of He Eye Hospital, Professor He Wei, highlighted that cell and gene therapy is a key development area in international medicine, with continuous technological breakthroughs and innovations emerging in recent years [3] - The conference has been held for eight consecutive years in Shenyang, facilitating cross-disciplinary integration among genomics, ophthalmology, stem cell therapy, biomedical fields, big data, and artificial intelligence [3] - The event featured four major thematic forums focusing on CGT applications and breakthroughs in ophthalmology, clinical translation advancements, anti-aging mechanisms, and capital empowerment for the ophthalmic CGT industry [3] Networking and Knowledge Sharing - The conference included deep dialogue sessions among scientists, entrepreneurs, and investors, emphasizing the connection between innovation, industry, and funding chains to explore new opportunities in the ophthalmic CGT sector [3] - Additional activities such as industry roadshows, visual health awareness events, and product exhibitions were organized to facilitate practical collaboration and public education on eye health, enhancing both academic and social value [3]
逆市爆发!高弹性港股通创新药ETF(520880)放量暴拉5%!三生制药、映恩生物-B飙涨12%
Xin Lang Ji Jin· 2025-10-31 03:10
Group 1 - The core viewpoint of the news highlights the strong performance of the Hong Kong Stock Connect Innovative Drug ETF (520880), which has seen significant capital inflow and a notable increase in trading volume, indicating investor confidence in the innovative drug sector [1][3]. - The innovative drug sector is benefiting from favorable policy developments, including the introduction of a dual-track adjustment model for basic medical insurance and commercial insurance, which is expected to alleviate payment pressures for high-value innovative drugs [3]. - The "14th Five-Year Plan" emphasizes support for the development of innovative drugs and medical devices, focusing on major diseases and new technology platforms, suggesting a long-term growth potential for companies in these areas [3]. Group 2 - The Hong Kong Stock Connect Innovative Drug ETF (520880) passively tracks the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, which exclusively invests in innovative drug R&D companies, with over 70% of its holdings in large-cap innovative drug leaders [4][5]. - As of the end of September, the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index has shown a year-to-date increase of 108.14%, outperforming other innovative drug indices [5][6]. - The ETF has a total fund size of 1.806 billion and has maintained the highest liquidity among similar indices, with an average daily trading volume of 493 million since its inception [6].
“十四五”以来北京中关村平均每年新设科技型企业约4万家
Zhong Guo Xin Wen Wang· 2025-10-30 12:08
Core Insights - Zhongguancun is actively building a corporate matrix characterized by strong large enterprises, numerous unicorns, and vibrant small and medium-sized enterprises, with 31 innovation consortia and technology innovation centers established to support leading tech firms and hard-tech unicorns [1][2] - In 2024, Zhongguancun is projected to have 20,800 national high-tech enterprises, 532 listed companies, and 93 unicorns, with an average of 40,000 new tech companies established annually since the 14th Five-Year Plan, representing a 40% increase compared to the previous five-year period [1] Financial Performance - The total revenue of Zhongguancun enterprises is expected to approach 10 trillion yuan in 2024, which is 1.4 times that of 2020, accounting for one-sixth of the national high-tech zones and approximately one-third of Beijing's GDP [1] Innovation and Technology - Zhongguancun has made significant breakthroughs in its role as a "testbed" for technology system reforms, implementing 24 new reform measures and over 50 supporting policies, with pilot measures being deployed nationwide [2] - The region is leading in artificial intelligence, with a comprehensive strength ranking among the top globally, having established the world's first AI district and registering 136 large models, which constitutes 25.2% of the national total [2] Ecosystem and Collaboration - Zhongguancun has established over 10,000 branch offices in the Beijing-Tianjin-Hebei region, enhancing its open innovation ecosystem and leading the entrepreneurial incubation into its 4.0 phase with 25 benchmark incubators [3] - The area hosts 116 regional headquarters of multinational companies and 230 foreign R&D centers, solidifying its position as a global innovation network hub [3]