细胞与基因治疗产品
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利好来了!刚刚,上海重磅发布!
券商中国· 2025-11-24 12:54
上海重磅发布 日前,上海市人民政府办公厅印发《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》。 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。 完善医疗卫生机构伦理协作审查机制,简化统一受理资料和流程、增加会议频次、缩短审查时间,推进长三角 区域多中心临床试验伦理协作审查。加强临床医疗数据标准化,强化数据在研发创新中的运用。建立以临床价 值为导向的创新医疗器械筛选评估机制,加速转化上市。 支持中药研发创新。建立医疗机构规范收集整理人用经验数据机制,探索人用经验数据作为真实世界证据用于 药品注册申报。制订医疗机构应用传统工艺配制中药制剂备案管理规定。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。鼓励医疗机构、研发单位和药品企业共同打造中药创新与产 业转化平台,支持中药创新药临床研究和古代经典名方中药复方制剂研究,鼓励中药大品种培育和经典品种二 次开发。外省市按照国家药品 ...
上海生物医药产业规模将破万亿元
Zhong Guo Xin Wen Wang· 2025-10-25 05:59
中国经济第一城已悄然培育出又一个增长极。 近日,上海市科委向外界透露,上海生物医药产业规模持续增长,从2021年7617.14亿元增长至2024年 9847.02亿元,年均复合增长率8.94%;2025年上半年达5005.66亿元,预计今年将突破1万亿元。 这意味着,继电子信息、汽车、高端装备、软件和信息服务四大万亿级产业集群之后,上海正式迎来第 五个万亿级产业板块。 更值得关注的是,随着生物医药迈入万亿阵营,上海重点布局的人工智能、集成电路、生物医药三大先 导产业,正集体崛起为新的经济支柱。 数字背后,是一场产业生态的聚变。 如,上海生物医药产业不仅总体规模逼近万亿元,制造业环节同样表现惊艳。从2021年到2024年,制造 业产值从1712亿元增长至2011.67亿元,年均复合增长6.9%。 作为国内最早布局生物医药产业的城市之一,上海生物医药实力雄厚。根据《上海市生物医药产业发 展"十四五"规划》提出的目标,到2025年,上海将初步建成世界级生物医药产业集群核心承载地,包括 6个百亿元级产业园区,产业规模超1万亿元。 此外,创新药械的突破,最能体现一个地区的研发实力。 2021年至2025年8月,上海获批 ...
历下经开区获批复过半年,新进展透露哪些新信号
Qi Lu Wan Bao Wang· 2025-07-09 02:15
Core Insights - The Lixia Economic Development Zone has been identified as a key driver for the "Industrial Strong City" strategy in Jinan, with significant progress made since its approval six months ago [1][2] - The zone focuses on modern medicine and electronic information as its main industries, with a forward-looking approach to future industries such as brain-computer interfaces and artificial intelligence [2][3] Development Progress - The Lixia Economic Development Zone was officially approved as a provincial-level economic development zone on November 25, 2024, becoming the 14th such zone in Jinan [1] - Key breakthroughs include spatial layout optimization and the establishment of dual industrial chains centered around electronic information and modern medicine [2] Industry Focus - The zone aims to create a high-quality industrial park that integrates production and urban development, emphasizing green and low-carbon initiatives [2] - The development strategy includes building a modern medical industry demonstration park and a software industry cluster, leveraging partnerships with leading companies like Huawei and ZTE [3][4] Investment Strategy - A targeted investment strategy has been implemented, with a focus on attracting leading enterprises and high-value projects in key industries [4] - The zone has identified 21 chain-leading enterprises and 33 target enterprises for supply chain enhancement, aiming for concentrated industrial development [4] Future Outlook - The Lixia Economic Development Zone is positioned as a central hub for industrialization in the Lixia District, with ongoing projects aimed at enhancing industrial capacity and resource aggregation [5] - Plans include the establishment of a software industry cluster and collaboration with national think tanks for comprehensive research and development [5]
14个医药健康重大项目签约落地昌平
Bei Jing Ri Bao Ke Hu Duan· 2025-07-06 21:43
Group 1 - The 42nd National Pharmaceutical Industry Information Annual Conference and the 2025 Beijing-Changping Life Science Forum opened, focusing on the layout of pharmaceutical research and the transformation of original achievements, with 14 major pharmaceutical health industry projects signed in Changping District [1] - Major projects include investments from companies such as Mindray Medical, Diyi Group, Yourui Bio, and others, as well as innovative collaborations with institutions like Shantou University and the National Research Institute of High-Performance Medical Devices [1][2] - The Beijing Future Pharmaceutical Industry Chain Research Institute was unveiled, aiming to support key technology collaboration and promote international development of the pharmaceutical industry [1] Group 2 - A joint initiative was launched among Tsinghua University, Peking University, China Agricultural University, and Beijing University of Chemical Technology to drive breakthroughs in biomedicine and synthetic biology, enhancing China's position in the global pharmaceutical value chain [2] - The "Support Measures for the Development of the Pharmaceutical Health Industry in the Changping Group of the China (Beijing) Free Trade Pilot Zone" were announced, focusing on cross-border R&D cooperation and aligning with international standards [2] - Changping District has established a complete industrial chain from basic research to terminal medical services, with an average annual growth rate of 9.3% in pharmaceutical health industry revenue over the past three years, projected to reach 104 billion yuan in 2024, a year-on-year increase of 14.3% [2][3] Group 3 - The district has seen continuous innovation, with four key technologies selected as major scientific achievements for the 2025 Zhongguancun Forum, and 27 cell and gene therapy pipelines entering clinical stages, accounting for 5% of the national total [3] - The Zhongguancun synthetic biology manufacturing industry cluster has attracted 121 innovative enterprises, and the "Future City" health industry has formed a 10 billion yuan cluster [3] - Changping District aims to enhance the ecosystem of industrial elements and improve service quality, striving to make the Life Science Park a globally competitive hub for the pharmaceutical health industry [3]