中欧专家在沪聚焦心胸疾病前沿进展 专家：中国创新药发展药政改革功不可没 上海市胸科医院胸外科主任李志刚表示，中国和欧洲国家在肺癌早筛领域差别明显。在欧洲国家，很多 肺癌患者在发现时已进展为中晚期，而中国在早诊早筛理念的倡导下，很多肺部小结节患者被发现。在 对进展期肺癌的管理中，欧洲国家全链条管理模式和中国外科技术的精细化、微创化值得双方借鉴。 在ESMO2025上，陆舜教授发布了晚期鳞状非小细胞肺癌患者免疫联合抗血管协同抗肿瘤疗法研究成 果。陆舜教授介绍，ESMO2025主席论坛上的演讲者中有不少来自中国，许多中国在研药物的研究数据 作为最新突破性摘要(LBA)发布；数月前举行的2025年美国临床肿瘤学会(ASCO)年会上，中国专家的发 言数量亦创下新高。近年来，中国创新药企与外企的国际授权合作(BD)数量不断增加。高质量数据的 披露是BD的关键基石，ESMO2025上中国创新药企集体亮相吸引了更多潜在的国际合作伙伴关注，为 未来"出海"奠定了坚实基础。 "2025年中欧心胸疾病学术论坛"(简称：论坛)24日起举行，汇聚国内外众多权威专家，聚焦心胸疾病领 域的前沿进展与跨文化协作。本届主论坛围绕"中国之声—— ...

Core Insights - The National Medical Products Administration (NMPA) has approved 210 innovative drugs and 269 innovative medical devices during the 14th Five-Year Plan period, indicating a sustained acceleration in growth [1][2][4] - China's biopharmaceutical market has become the second largest globally, with approximately 30% of the world's innovative drugs under development, reflecting increasing global recognition of Chinese innovative drugs [1][2][5] - The industry is witnessing a significant improvement in supply-demand dynamics, driven by innovation as a core growth engine, presenting potential investment opportunities [1][2][7] Regulatory and Approval Processes - The NMPA has established priority review and approval channels for key products, enhancing support for innovative drug and device development [2][4] - The approval time for supplementary applications has been reduced from 200 working days to 60 days, and for innovative drug clinical trial reviews from 60 days to 30 days [4][10] - A total of 394 pediatric drugs and 147 rare disease drugs have been approved since the beginning of the 14th Five-Year Plan, addressing critical medication needs [3] Company Performance and R&D Investment - Heng Rui Medicine reported a revenue of 15.76 billion yuan in the first half of 2025, a year-on-year increase of 15.88%, with innovative drug sales contributing 60.66% of total revenue [5] - Fosun Pharma achieved a revenue of 19.51 billion yuan, with innovative drug revenue exceeding 4.3 billion yuan, reflecting a 14.26% year-on-year growth [6] - United Imaging Healthcare reported a revenue of 6.02 billion yuan, a 12.79% increase, with R&D investment reaching 1.14 billion yuan [7] Internationalization and Market Expansion - Chinese innovative drugs are increasingly entering international markets, with companies like Fosun Pharma engaging in licensing agreements to expand their global footprint [8][9] - The demand for breakthrough therapies in Western markets is driving the internationalization of Chinese pharmaceutical companies, enhancing their competitiveness [9] - The NMPA is committed to promoting the internationalization of drug regulation and facilitating the export of Chinese pharmaceuticals [9][10] Technological Advancements - The industry is experiencing a wave of disruptive technologies, including CRISPR gene editing and mRNA therapies, which are enhancing China's role in global biopharmaceutical innovation [7][9] - The NMPA is focusing on high-end medical devices and innovative technologies, such as brain-computer interfaces and new radiation therapy equipment, to support the development of the medical device sector [10]

Core Viewpoint - The National Medical Products Administration emphasizes the importance of formulating the "14th Five-Year" drug planning to enhance drug regulation capabilities and promote high-quality development of the pharmaceutical industry, aiming to transition China from a major pharmaceutical country to a strong pharmaceutical nation [1] Group 1: Drug Regulation Development - The meeting highlighted the need to develop an overall strategy for drug regulation during the "14th Five-Year" period [1] - It aims to address deep-seated contradictions and issues in drug regulation, enhancing governance capabilities [1] - The focus is on creating a comprehensive drug safety responsibility system and a full-chain regulatory mechanism [1] Group 2: Reform and Innovation - There is a call for comprehensive deepening of drug review and approval system reforms [1] - The meeting encourages the innovation and development of traditional Chinese medicine and high-end medical devices [1] - It also emphasizes the need to reform the review and approval mechanisms for cosmetics to promote high-quality development [1] Group 3: Regulatory Capacity Building - The meeting stresses the importance of improving the regulatory standards and legal framework [1] - It highlights the need for strengthening technical support capabilities and leading with information technology [1] - The goal is to build a high-quality team of drug regulatory professionals to enhance overall regulatory capabilities [1]

Core Viewpoint - The document emphasizes the exploration of feasible pathways to utilize international new drug clinical real-world data for the registration and licensing of imported pharmaceuticals in China [1] Group 1: Regulatory Reforms - The document outlines the need to deepen the reform of the drug and medical device review and approval system [1] - It highlights the enhancement of drug supervision and inspection capabilities at ports [1] - The document mentions the improvement of management systems for urgently needed imported drugs and medical devices [1] Group 2: Digital Governance - The document calls for the advancement of digital government reforms to elevate the level of intelligent and specialized social governance [1]