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我国新药好药呈现快速增长态势:这些患者迎来临床急需用药新选择
Yang Shi Wang· 2025-07-23 09:14
据了解,我国2018年启动药品审评审批改革,提高审评审批标准,从研发前端到审评末端全流程加快创新药上市,尤其是临床急需新药。 今年上半年我国创新药获批数量同比增长59%,源于改革政策精准发力、效能提升。 央视网消息:国家药监局最新统计显示,我国上半年批准创新药43个,同比增长59%,接近2024年批准创新药48个的全年数量。 国家药监局药品注册管理司司长 杨霆:创新药近年来持续获批上市,数量增长,反映出从2018年以来我国药品审评审批改革取得的成 果,也是我们政策红利的兑现。 我国新药好药呈现快速增长态势 近年来,中国医药创新展现出强劲的上升势头,正从"跟跑"向"并跑"甚至部分领域"领跑"加速迈进。 通过药品审评审批改革,我国新药好药呈现快速增长态势,那么,今年上半年新批准的创新药有哪些突破?哪些患者新增临床急需用药的 选择? 国家药监局药品注册管理司司长 杨霆:在研发管线方面,中国目前创新药的研发管线占到了全球的大约1/4,在临床实验上我们每年有大 概3000个项目正在开展临床实验,这都在世界上居于前列。 杨霆告诉记者,今年上半年获批的新药中,有不少社会高度关注的"明星"产品,包括我国首款干细胞治疗药品、抗 ...
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
2024年11月25日,山东省正式批复,同意在济南市历下区设立省级经济开发区,定名为山东历下经济开 发区,成为济南第14家省级以上开发区。 张晓刚说,自经开区获批以来,区委、区政府高度重视经开区规划建设工作,聚焦土地性质调整、产业 规划编制等关键环节,梳理重点任务,建立工作台账,加大推进力度,加快破题起势。 齐鲁晚报·齐鲁壹点 夏侯凤超 获批复过半年,历下经济开发区(以下简称"历下经开区")再次成为焦点。 7月8日,济南市一场新闻发布会上,历下经开区被视为历下区贯彻落实全市"工业强市"战略的核心抓 手。 半年来,历下经开区交出了怎样的答卷?有哪些新进展,又透露出哪些新信号? 半年成绩单:从"规划蓝图"到"产业实景" "历下经济开发区是历下区贯彻落实全市工业强市战略的核心抓手。"7月8日的新闻发布会上,历下区委 常委、副区长张晓刚说。 推进和破题,首先需要高标准规划引领。 据介绍,历下经开区紧扣全市"13+34"产业链体系,锚定"X+2"主导产业定位,确定现代医药、电子信 息两大主导产业,聚焦细胞与基因治疗、高端软件两大特色方向,前瞻布局脑机接口、智能机器人、生 成式人工智能等未来产业,着力打造现代化科创高地。 ...
14个医药健康重大项目签约落地昌平
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]
渤因生物完成数千万元天使+轮融资,加速非病毒载体基因治疗产品开发
IPO早知道· 2025-05-26 01:58
产品管线包括老年肌少症、膀胱癌、血友病A等。 本文为IPO早知道原创 作者|C叔 微信公众号|ipozaozhidao 据 IPO早知道消息, 近日,上海渤因生物科技有限公司 ( 下称 "渤因生物" ) 完成数千万元的天 使 +轮融资。本轮投资由张江生命健康产业孵化天使基金( 下称 "张科禾苗基金")领投,老股东峰 瑞资本和创始人个人持续加码,凯乘资本担任本轮独家财务顾问。 所募资金将主要用于公司产品管 线推进和首个产品的早期临床验证,并支持公司技术平台迭代。 渤因生物 由 耶鲁大学博士联合国内基因治疗转化研究资深科学家共同创立。公司主要从事非病毒载 体基因疗法开发,专注于解决领域内载体容量限制、不可重复给药和高生产成本三大痛点,投身全球 基因治疗 2.0革命。 渤因生物 拥有 无末端 DNA制备、LNP体内细胞类型靶向递送和体内电/力转染递送三大技术平台, 并已进行了国内外全方位的 知识产权 保护。 公司重点布局肝脏、眼睛、肌肉、膀胱和血液细胞递 送领域 , 旨为遗传病和重大慢性疾病患者提供突破性疗法,产品管线包括老年肌少症、膀胱癌、血 友病A等。公司 前期还 入选默克中国加速器 第四期。 渤因生物 CEO ...
红杉医疗被投企业多款医疗大模型顺利落地|Healthcare View
红杉汇· 2025-03-27 15:53
Group 1 - Shenzhen People's Hospital, Shukun Technology, and Huawei have formed a deep collaboration to deploy the DeepSeek-R1 model and the "Shukun Kun" multi-modal healthcare model, enhancing the hospital's medical and research capabilities [3] - The platform equipped with DeepSeek and "Shukun Kun" medical models will provide comprehensive research support, enabling rapid construction of multi-modal databases and offering data analysis tools for researchers [5] - The global first peritoneal dialysis model was launched by Shenzhou Medical and Sun Yat-sen University First Affiliated Hospital, utilizing advanced DHC+DeepSeek dual-engine architecture for precise understanding and processing of complex information in the field [7] Group 2 - Yingxi Intelligent has deployed its first bipedal humanoid robot named "Supervisor" in its AI-driven fully automated drug discovery laboratory, aimed at enhancing laboratory operations [10] - The innovative implantable neurostimulation system by Boruikang has passed the review by the National Medical Products Administration, marking a significant advancement in medical technology [12] - The commercial production base for small nucleic acid drugs by Zhaowei Technology has officially commenced operations, featuring advanced equipment and a total designed capacity of 48 production lines [20] Group 3 - Zhengxu Bio's self-developed base editing drug CS-101 has successfully treated a Malaysian patient with beta-thalassemia, marking another significant achievement in gene editing therapy [23] - The OCT intravascular imaging catheter developed by Weiguang Medical has received registration approval for dual indications, enhancing diagnostic efficiency in coronary and carotid artery diseases [26] - The first platelet-related cell new drug XJ-MK-002 has been granted orphan drug designation by the FDA for treating congenital thrombocytopenia, showcasing innovation in rare disease treatment [28] Group 4 - The new generation PI3Kα inhibitor JYP0035 capsule has received approval for clinical trials, aimed at treating PIK3CA mutated, HR-positive, HER2-negative breast cancer, indicating strong R&D capabilities [30] - The first domestically developed antibacterial fishbone suture line has been approved by the NMPA, representing a breakthrough in surgical materials [43] - The flexible ultrasound probe project led by Suzhou Nolaisheng Technology has been approved as a national key research and development project, highlighting advancements in ultrasound technology [39]