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生物医药“苏州军团”强势领跑
Su Zhou Ri Bao· 2025-09-11 00:24
信达生物的全球首款双靶点减肥药刚获批上市,亚盛医药的创新药就同时获得美欧监管"绿卡"…… 今年以来,苏州生物医药企业捷报频传,创新成果呈现"井喷"之势。随着8月下旬国务院正式批复同意 在医疗器械领域,苏州三个臭皮匠生物科技有限公司的"硬性接触镜护理消毒仪"获得国家药监局批 准上市。这个看似小巧的产品,来头却不小——它是视光领域截至目前唯一获批进入三类创新医疗器械 绿色通道的产品,解决了硬性接触镜护理的行业痛点。 "苏州把生物医药确定为长期重点打造的主导产业之一,以二十年磨一剑的韧性,持之以恒加大产 业扶持,推动产业发展走在全国前列。"8月25日召开的全市生物医药产业专题工作推进会上,进一步释 放了支持生物医药产业做大做强的鲜明信号。着眼未来,从实验室到生产线,从本土创新到全球合作, 苏州生物医药产业将积极抢抓成果集中爆发的有利契机,加速推动产品上市,不断扩大产业规模和行业 话语权。 稳基固本:外资加码与本土创新双轮驱动 苏州工业园区的生物医药产业园内,一幢幢研发大楼,一座座总部基地,展现出浓厚的国际化创新 氛围。这里汇聚的来自全球各地的顶尖人才和企业,构筑起了苏州生物医药产业的坚实底盘。 数据显示,今年1至7 ...
“粤秀药洲”生物医药与健康产业高质量发展大会举行 国家药监局“春雨行动”在广州越秀落地
第二届"粤秀药洲"生物医药与健康产业高质量发展大会9月9日在广州市越秀区举行。大会以"聚焦创新 转化前沿,加力医药产研融合"为主题,汇聚有关部门、专家学者及行业龙头企业,共同探讨生命健康 产业创新发展的新路径。 大会同期设立两个分会场,分别围绕"院内制剂与医工融合"和"医疗机构自行研制使用体外诊断试剂 (医院LDT)创新发展"主题展开研讨,促进医工结合和检验创新的深入交流。 随后,越秀区市场监管局与广东药科大学合作共建的三大平台正式挂牌,包括生物医药与健康产业临床 转化中心、越秀区食品药品安全科普基地和越秀区创新药械转化服务工作站。多家医疗机构、龙头企 业、产投基金也在现场集中签约,推动产业链上下游深度对接,加快科研成果临床转化和应用推广。 "春雨行动"越秀启动仪式在现场举行。这标志着国家药监局"春雨行动"在越秀区正式落地实施,为区域 产业发展提供更有力的监管和服务支撑。 ...
海南出台药品医疗器械化妆品监管改革实施方案
Hai Nan Ri Bao· 2025-04-30 01:59
Core Viewpoint - The implementation plan for the reform of drug, medical device, and cosmetic regulation in Hainan aims to enhance the competitiveness of the biopharmaceutical industry by introducing 20 reform measures across five key areas [1][2] Group 1: Regulatory Reforms - The plan emphasizes improving the efficiency of review and approval processes, focusing on the actual needs of enterprises during product development and registration [1] - It aims to facilitate the market entry of innovative products, targeting the launch of at least one innovative product annually and the introduction of over 60 licensed medical devices each year [1] Group 2: Innovation in Biopharmaceuticals - The initiative seeks to address bottlenecks in innovation by enhancing clinical research levels and increasing support for traditional Chinese medicine research and development [2] - By the end of 2027, the goal is to promote the registration or filing of over 15 hospital preparations [2] Group 3: International Competitiveness - The plan includes regulatory innovations to enhance product participation in international markets, aiming to create a high ground for real-world research applications [2] - It promotes the "Research and Use + Haikou/Qionghai Production" model to facilitate local production of more innovative drugs and medical devices [2] Group 4: Industry Development - The implementation of the plan is expected to significantly promote structural adjustments, efficiency transformations, and quality improvements in Hainan's biopharmaceutical industry [2] - It aims to create a unique competitive advantage for Hainan's biopharmaceutical sector, contributing to the establishment of a modern industrial system with Hainan characteristics [2]