中药新药
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促转化、破壁垒 创新药研发的“北京方案”
Bei Jing Shang Bao· 2026-01-26 16:37
作为全国首个医药健康产业规模破万亿的城市,北京近年来在医药健康领域取得一系列瞩目成就,在创 新药、创新医疗器械领域频频突破。不过,在创新成果的"高光"之下,一些长期存在的挑战依然待解。 新药研发"双十定律"(十年时间、十亿美元)所伴随的漫长周期与高昂成本风险、科技成果从实验室到 病床的转化难题等,仍是产业升级面临的主要瓶颈。 在政协北京市第十四届委员会第四次会议期间,北京商报记者邀请到三位政协委员,共同探讨北京将如 何利用其独特优势,破解新药研发周期长、转化难的瓶颈,为万亿级医药健康产业下一步高质量发展探 寻"北京路径"。 市政协委员郭田德: AI技术为制药按下加速键 近年来,从早期研究与发现(靶点识别与验证、化合物筛选与优化、临床前研究)到临床试验的模拟验 证,AI技术正深度渗透新药研发全链条。来自科学技术界的市政协委员,中国科学院大学讲席教授、 前沿交叉科学学院院长郭田德在接受北京商报记者采访时表示,AI技术的融入正为制药这一高投入、 长周期的过程按下加速键。 传统新药研发周期漫长,通常需要十年以上才能将新药成功推向市场。在郭田德看来,近年来,人工智 能的发展为创新药研发带来了重要机遇。通过AI技术,可以 ...
促转化、破壁垒,创新药研发的“北京方案”
Bei Jing Shang Bao· 2026-01-26 14:07
在政协北京市第十四届委员会第四次会议期间,北京商报记者邀请到三位政协委员,共同探讨北京将如何利用其独特优势,破解新药研发周期长、转化难的 瓶颈,为万亿级医药健康产业下一步高质量发展探寻"北京路径"。 近年来,从早期研究与发现(靶点识别与验证、化合物筛选与优化、临床前研究)到临床试验的模拟验证,AI技术正深度渗透新药研发全链条。来自科学技术 界的市政协委员、中国科学院大学讲席教授、前沿交叉科学学院院长郭田德在接受北京商报记者采访时表示,AI技术的融入正为制药这一高投入、长周期 的过程按下加速键。 传统新药研发周期漫长,通常需要10年以上才能将新药成功推向市场。在郭田德看来,近年来,人工智能的发展为创新药研发带来了重要机遇。通过AI技 术,可以显著缩短药物研发周期。 北京作为全国首个医药健康产业破万亿的城市,在发展创新药尤其是AI制药方面具有独特优势。郭田德表示,首先,在人才方面,无论是制药领域还是AI 技术领域,北京都聚集了全国顶尖的专业人才;其次,北京拥有先进的研发设备与良好的创新环境,特别适合聚焦于药物早期研发环节,发挥其在科研与创 新方面的引领作用。 作为全国首个医药健康产业规模破万亿的城市,北京近年来在 ...
山东将全面深化药械监管改革,以全链条改革激发产业创新活力
Qi Lu Wan Bao· 2026-01-19 10:07
Core Viewpoint - The Shandong Provincial Government has introduced a series of reform measures aimed at enhancing the regulatory framework for pharmaceuticals and medical devices, promoting high-quality development in the pharmaceutical industry [3][4]. Group 1: Reform Measures - The implementation opinions focus on addressing the challenges in the pharmaceutical industry by introducing breakthrough reform measures that stimulate innovation throughout the entire industry chain [4]. - A "one-stop" innovation service network will be established, covering provincial, municipal, and county levels, to accelerate the review and approval process for innovative drugs and medical devices [4]. - The regulatory mechanism will be optimized by integrating registration checks, production licensing, and quality management inspections to minimize disruptions to normal production [4]. Group 2: Industry Growth - The initiative emphasizes fostering new growth drivers in the industry by focusing on cutting-edge innovations such as gene and cell therapy, AI in pharmaceuticals, and high-end medical devices [4]. - Support will be provided for the development of traditional Chinese medicine (TCM) aimed at treating major diseases, including the establishment of a platform for the transformation of TCM into new drugs [4]. - The "Medical Device Spring Rain Action" will be launched to support the transformation of medical device innovations, particularly in areas like surgical robots and biomaterials [4]. Group 3: Clinical Transformation - The reform will enhance collaboration among various departments, creating a seamless connection between clinical trials, clinical use, and insurance coverage [5]. - Clinical trial processes will be optimized, encouraging qualified medical institutions to undertake trial projects and establishing incentive mechanisms [5]. - A green channel mechanism will be implemented for innovative drugs and medical devices, ensuring timely access for healthcare institutions to new products [5]. Group 4: Safety and Regulation - The initiative emphasizes strict regulatory measures to ensure safety in drug development and usage, adhering to the "four strictest" requirements [6]. - A smart regulatory platform utilizing big data and AI will be developed to ensure traceability throughout the supply chain [6]. - There will be a focus on enhancing risk monitoring and emergency response capabilities, alongside strict enforcement against illegal activities [6].
山东省卫生健康委:以组合拳护航医药产业创新升级
Qi Lu Wan Bao· 2026-01-16 15:34
Core Viewpoint - The Shandong Provincial Government is implementing a comprehensive reform plan to enhance the regulation of pharmaceuticals and medical devices, aiming to promote high-quality development in the pharmaceutical industry, which is crucial for national economy and security [1][2]. Group 1: Policy Initiatives - The Shandong Provincial Health Commission will utilize a combination of policy guidance, service optimization, and regulatory assurance to inject new momentum into the high-quality development of the pharmaceutical industry [1]. - A dynamic linkage mechanism will be established between hospital drug supply and the medical insurance drug catalog, facilitating the clinical application of innovative drugs [1]. Group 2: Clinical Evaluation and Support - A comprehensive clinical evaluation system will be developed to assess the safety, efficacy, economic viability, innovation, suitability, and accessibility of drugs, particularly focusing on conditionally approved innovative drugs [2]. - Clinical trial support capabilities will be enhanced by incorporating clinical research into the evaluation of public hospitals' quality, allowing for dedicated beds for innovative drug trials not to count towards total bed numbers [2]. Group 3: Traditional Medicine and Collaboration - The "Qilu Traditional Chinese Medicine Brand Project" will be implemented to promote the quality and added value of traditional Chinese medicine, including the establishment of ecological planting bases for medicinal materials [2]. - A regular consultation mechanism will be established among the Health Commission, Medical Insurance Bureau, and Drug Administration to facilitate data sharing and address cross-sector issues related to innovative drug evaluation and clinical application [3].
《郑州市中医药发展促进条例》3月1日起施行
Zheng Zhou Ri Bao· 2026-01-16 00:47
Core Viewpoint - The implementation of the "Zhengzhou Traditional Chinese Medicine Development Promotion Regulations" marks a significant step towards the legalization and standardization of traditional Chinese medicine (TCM) in Zhengzhou, effective from March 1, 2026, addressing public health needs and development challenges in the TCM sector [1][2]. Group 1: Legislative Framework - The new regulations aim to transform policy deployment into legal frameworks, providing legal guarantees for the establishment of a national TCM innovation development pilot zone and enhancing the Zhengzhou Qihuang cultural brand [2][3]. - The regulations address core issues such as service systems, industry development, and talent cultivation, establishing specific chapters for regulation [3]. Group 2: Industry Development - The regulations support the establishment of TCM research platforms and the transformation of TCM achievements into industrial applications, including the construction of regional TCM preparation centers and standardized preparation rooms in medical institutions [3][4]. - The integration of TCM with other industries such as food, culture, tourism, and health is encouraged to create a new ecological model for TCM industry in Zhengzhou [3]. Group 3: Talent and Technology Empowerment - A multi-level talent system is being developed, focusing on high-end, mid-level, and grassroots talent cultivation, with the introduction of high-end talent teams [5]. - The integration of artificial intelligence with TCM services, research, and regulation is highlighted as a new focus area, aiming to create a smart TCM ecosystem [5][6]. Group 4: Quality and Safety Measures - The regulations mandate the establishment of a quality traceability system for TCM materials, ensuring safety and quality throughout the supply chain [4][8]. - Measures to combat counterfeit products and promote international TCM cultural exchange are included to enhance Zhengzhou's global influence in TCM [4]. Group 5: Infrastructure and Investment - The government plans to clarify departmental responsibilities and promote collaboration among various departments to strengthen the grassroots TCM service foundation [8]. - Investment in infrastructure, talent, and research is prioritized, along with the optimization of medical insurance payment policies to reflect the value of TCM [8].
西安:支持企业培育一批过亿元中药大品种 持续在生产领域扩大产能
Mei Ri Jing Ji Xin Wen· 2025-12-17 07:03
Core Viewpoint - The Xi'an Municipal Government has issued the "Implementation Plan for Promoting the Capacity Enhancement of the Biopharmaceutical Industry (2025-2027)", focusing on developing a comprehensive traditional Chinese medicine (TCM) industry chain [1] Group 1: Industry Development - The plan aims to build a TCM industry chain that includes "herb cultivation - traditional Chinese medicine production - brand development" [1] - Encouragement is given to areas like Zhouzhi County to establish TCM production bases and restore the functionality of the Wanshou Road National TCM Professional Market [1] - Support will be provided for the construction of an online trading platform to ensure sustainable development and continuous supply of TCM herbs, addressing the upstream cultivation shortfall [1] Group 2: Production and R&D - The initiative includes fostering enterprises to cultivate a number of TCM products with annual revenues exceeding 100 million [1] - There will be an increased focus on the research and development of classic prescriptions, proven formulas, and new TCM drugs, as well as support for the secondary development of major TCM products and the transformation of hospital preparations [1] - The goal is to strengthen the "Qin Medicine" brand and expand production capacity in the sector [1] Group 3: Economic Goals - By 2027, the target is to achieve an industry scale of 9 billion in the TCM chain group within the city [1]
非药行业2026年度投资策略:复苏中前行,聚焦出海、创新
Changjiang Securities· 2025-12-15 14:59
Investment Rating - The report maintains a "Positive" investment rating for the healthcare sector [14] Core Insights - The non-pharmaceutical sector is facing performance pressure in 2025 due to price reductions from centralized procurement, medical insurance cost control, and the closure of retail pharmacies. However, companies are leveraging overseas expansion and innovation to achieve growth [4][9] - For 2026, the domestic fundamentals are expected to improve, with companies seeking new growth points primarily through overseas expansion and innovation, particularly in insulin and medical devices [9] - The report highlights that the insulin market is stabilizing post-centralized procurement, with significant overseas opportunities for leading companies like Mindray Medical and Ganli Pharmaceutical [10][24] - The focus on innovation in traditional Chinese medicine and medical devices is expected to create alpha opportunities for individual stocks [9][11] Summary by Sections Non-Pharmaceutical Sector - The non-pharmaceutical sector is under pressure but has opportunities through overseas expansion and innovation. Insulin and medical devices are key areas for long-term growth [4][9] - Companies like Mindray Medical and Ganli Pharmaceutical are beginning to realize overseas revenue, indicating a significant long-term market potential [9] Biopharmaceuticals - The report prioritizes insulin, with ongoing attention to blood products and vaccines. The insulin market is stabilizing, and companies are focusing on innovation and business development [10][24] - The report notes that the insulin market in developed countries is valued at $13.2 billion, with significant growth potential in emerging markets [24] Traditional Chinese Medicine - The focus is on innovation and the basic drug catalog, which is crucial for accelerating drug sales and enhancing market presence [11][12] - The report anticipates a recovery in performance due to early flu outbreaks and emphasizes the importance of retail pharmacy sales [11] Medical Devices - The report indicates that the medical device sector is at a turning point, with overseas revenue for leading companies expected to exceed 50% in 2025 [12] - The report suggests focusing on low-value consumables and in vitro diagnostics as key growth areas [12] Vaccines - The vaccine sector is currently facing challenges, with price reductions and low demand impacting sales. However, there are ongoing developments in innovative vaccines that warrant attention [39][40] - The report highlights the importance of tracking clinical progress and market performance of major vaccine candidates [40]
琛蓝健康荣膺2025年度青岛市民营领军标杆企业
Sou Hu Cai Jing· 2025-12-09 08:11
Core Insights - Qingdao's private economy development bureau announced the list of leading benchmark enterprises for 2025, with Chenlan Health Industry Group recognized for its innovative achievements in health product research and comprehensive industry layout [1][5] - This award follows previous recognitions for Chenlan Health, including "Qingdao Marine High-Growth Enterprise," "Shandong Province Gazelle Enterprise," and "Innovative Enterprise of Science and Technology in China" [1] Company Overview - Established 20 years ago, Chenlan Health adheres to the mission of "based on biotechnology, benefiting human health," focusing on the "ocean + traditional Chinese medicine" industry development direction [2] - The company has built three major research bases and four industrial bases, creating a comprehensive health industry chain covering brand raw materials, dietary supplements, ecological safe ingredients, e-commerce, new traditional Chinese medicine, and medical devices [2] Strategic Development - Chenlan Health operates multiple brands, including Xinkangrui, Kang'er Biology, Shenzhou Youpin, Yishengkang, and Silver Century, integrating research, production, warehousing, logistics, and sales into a high-tech enterprise [3] - The company actively promotes public health initiatives and has undertaken various social responsibility projects, such as the "National Silver Age Health Project" and donations to build schools and support COVID-19 relief efforts [3] Future Outlook - The recognition as a "2025 Leading Benchmark Enterprise" is seen as validation of Chenlan Health's commitment to technological innovation and high-quality development [5] - Looking ahead, the company aims to continue its mission of providing scientific, professional, and compassionate health care, contributing to the "Healthy China" initiative [5]
将农历三月三所在周设为岐黄文化宣传周
Zheng Zhou Ri Bao· 2025-12-05 00:48
Core Viewpoint - The newly approved "Zhengzhou Traditional Chinese Medicine Development Promotion Regulations" aims to enhance the development of traditional Chinese medicine (TCM) in Zhengzhou, focusing on service, industry growth, talent cultivation, and cultural inheritance, with implementation starting on March 1, 2026 [1][2]. Group 1: Service and Management - The regulations integrate TCM development into national economic and social planning, establishing a service and management system that aligns with TCM development principles [2]. - A cultural promotion week for TCM will be established annually, fostering a societal atmosphere that values and utilizes TCM [2]. - Support for the construction of national TCM medical centers and the establishment of TCM clinics in community health service centers and township hospitals is emphasized [2][3]. Group 2: Industry Support - A collaborative mechanism for TCM industry development will be established, covering the entire industry chain from cultivation to production [4]. - The regulations encourage the development of new TCM drugs and the use of modern technology in traditional medicine production, aiming to enhance quality and efficacy [4]. - The establishment of smart shared TCM pharmacies utilizing modern information technology is promoted to improve service delivery [4]. Group 3: Talent Development - A talent strategy for TCM will be implemented, focusing on the cultivation and incentive mechanisms tailored to TCM characteristics [5][6]. - The regulations support the introduction of high-level TCM talents, including academicians and renowned practitioners, to enhance the expertise within the field [6]. - Emphasis is placed on the development of intelligent devices for TCM practices, alongside the establishment of academic inheritance systems to promote traditional knowledge and skills [6].
上海:支持疗效确切、特色优势明显的医疗机构中药制剂及名老中医方开发转化为中药新药
Zheng Quan Shi Bao Wang· 2025-11-24 09:15
Core Viewpoint - The Shanghai Municipal Government has issued measures to enhance the regulation of pharmaceuticals and medical devices, aiming to promote high-quality development in the pharmaceutical industry, with a particular focus on supporting traditional Chinese medicine (TCM) innovation [1] Group 1: Support for Traditional Chinese Medicine - The measures include establishing a mechanism for medical institutions to systematically collect and organize human experience data, exploring its use as real-world evidence for drug registration applications [1] - Regulations will be formulated for the filing management of TCM preparations made using traditional processes in medical institutions [1] - The government will support the development and transformation of effective TCM preparations and classic formulas from renowned TCM practitioners into new TCM drugs [1] Group 2: Collaboration and Innovation Platforms - Medical institutions, research units, and pharmaceutical companies are encouraged to collaboratively create platforms for TCM innovation and industrial transformation [1] - Support will be provided for clinical research on innovative TCM drugs and the study of classic TCM compound preparations [1] - The cultivation of major TCM varieties and the secondary development of classic varieties will be promoted [1] Group 3: Regulatory Flexibility - TCM formula granules produced in other provinces according to national drug standards will be exempt from filing requirements when sold in Shanghai [1]