一、为何干细胞IND如此之难？ 干细胞治疗产品的研发正步入快车道，但在迈向临床的"关键一跃"——干细胞IND申报环节，许多创新 主体仍面临显著挑战。与传统化学药或生物大分子药物不同，干细胞药物具有活细胞属性、生产工艺链 条长、批次间存在一定异质性等特点，使得监管审评对其安全性和质量可控性提出更高要求。 随着国家药监局连续批准多个干细胞新药进入临床试验阶段，我国干细胞治疗产业正加速迈向"临床验 证"时代。然而，在一片热潮背后，一个现实问题日益凸显：许多技术领先的科研团队，却在干细胞 IND(新药临床试验申请)申报环节陷入停滞——补资料、被质疑、反复修改，甚至错失研发窗口期。 有生物技术企业负责人坦言："我们花了五年时间完成干细胞机制研究和体外验证，但在干细胞IND申 报上卡了近两年，不是技术不行，是不会说监管听得懂的话。"这并非个例。据不完全统计，近三年 内，国内提交的干细胞IND申请中，超过60%经历发补(补充资料)，部分项目因无法有效回应审评意见 而被迫中止。"技术领先 ≠ 临床先行"已成为行业共识。 近年来，国家药品监督管理局药品审评中心(CDE)陆续出台《干细胞相关产品临床研究伦理审查指南》 《人源性干 ...

Domestic News - The Ministry of Commerce and nine other departments announced 20 measures to promote the expansion and upgrade of the "15-minute convenient living circle" by 2030, aiming to establish 100 pilot cities and create 10,000 well-structured living circles with a resident satisfaction rate of over 90% and a chain store rate of over 30% [1] - The Ministry of Ecology and Environment reported that China has built the world's largest carbon emissions trading market, covering over 60% of the country's carbon emissions, and has initiated a voluntary greenhouse gas reduction trading market [1] - The Ministry of Industry and Information Technology, along with other departments, issued a "Light Industry Stabilization Growth Work Plan (2025-2026)" to enhance the role of light industry in economic stability, with a focus on new growth points such as smart home products and sports leisure products [2] - The Ministry of Transport released a plan to build high-quality data sets for the transportation industry by 2030, aiming to improve data supply and support the development of intelligent transportation networks [2] - The Civil Aviation Administration reported that China's civil aviation achieved a total transportation turnover of 151.8 billion ton-kilometers in August, marking a year-on-year increase of 8% [3] Market Updates - The People's Bank of China announced adjustments to the 14-day reverse repurchase operations, which will now be conducted with fixed quantity and interest rate bidding [3] - The National Foreign Exchange Administration reported that in August 2025, banks settled 15,103 billion yuan and sold 14,058 billion yuan, with cumulative settlements from January to August reaching 113,938 billion yuan [3] - The China Automobile Industry Association is conducting an anti-discrimination investigation in response to the U.S. measures against China's integrated circuit sector, focusing on the impact on the automotive industry [4] Housing and Automotive Industry - Shanghai has optimized its housing property tax pilot policies, providing tax exemptions for high-level talents and first-time homebuyers under certain conditions [5] - Xiaomi Auto Technology has initiated a recall of 116,887 electric vehicles produced between February 6, 2024, and August 30, 2025, in compliance with regulations [5]

此外，我国的先进治疗药品在研管线数量达2400个，大幅跃升态势；中国连续三次当选国际人用药品注 册技术协调会（ICH）管委会成员，转化实施71个ICH指导原则。目前，全球同步研发的创新药可在我 国同步申报、同步上市，多个创新药在我国实现全球"首发上市"。据不完全统计，2025年上半年我国创 新药对外授权交易总金额近660亿美元，超过2024年全年的519亿美元。 中国生物医药原始创新实现从"跟跑"到"并跑"的转变，中国研发深度融入国际创新链，中国制造深度融 入国际供应链。 2025年截至目前，我国已有56款创新药获批，其中生物制品达18款，包括首个干细胞治疗产品、首个血 友病基因治疗产品、首个植物源重组表达蛋白等产品相继获批；2024年我国批准了48款创新药上市，其 中生物制品达22款，占比45.8%。 我国加快临床急需和创新产品的上市步伐，创新药临床试验审评平均用时已由2017年的175个工作日缩 短至2024年的50个工作日，创新药上市申请审评用时从2017年的420个工作日缩短至2024年的235个工作 日。 记者今天（19日）从中国生物制品质量控制大会获悉：国家药监局今年已批准56款创新药，其中18款 ...