日前，我省成功获批全国第11家、第二批试点唯一一家、东北三省一区首家优化药品补充申请审评 审批程序改革试点，为我省医药产业发展注入强劲动力。8月7日，省政府新闻办召开新闻发布会，省药 监局相关负责同志介绍我省获批试点有关情况，并回答记者提问。 国家药监局于2024年启动优化药品补充申请审评审批程序改革试点，以化学药品为重点，在有能 力、有条件的省级药品监管部门开展试点工作，为辖区内药品上市后变更提供前置指导、核查、检验和 立卷服务。首批批准了10家试点单位，主要集中在长三角、珠三角等医药产业发达地区。 我省是第二批改革试点唯一一家获批单位。此项工作的获批，将大幅缩短药品补充申请技术审评时 间，由200个工作日压缩至60个工作日，降低企业研发申报成本，不仅惠及省内企业，更将为东北区域 医药产业协同发展提供支撑。 为了将这一利好政策尽快落地，我省药监部门将向全省药品上市许可持有人宣传解读试点政策，推 动药品补充申请申报进入快车道。同时，强化业务培训，规范申请程序，高标准启动试点工作，力争实 现"开门红"。目前，已有两家企业的药品品种向省药监局提交了申请，审评正在加快进行中，尽快将政 策转化为实际生产力。 药品补充 ...

Core Viewpoint - The National Medical Products Administration (NMPA) reported a significant increase in the approval of innovative drugs in China, with 43 new drugs approved in the first half of the year, representing a 59% year-on-year growth, nearing the total of 48 approved in the entire previous year [1][3][7]. Group 1: Drug Approval Statistics - In the first half of this year, 43 innovative drugs were approved, which is close to the total of 48 approved in the entire previous year [1][7]. - The approval of innovative drugs has increased by 59% compared to the same period last year, reflecting the effectiveness of the drug review and approval reform initiated in 2018 [3][5]. Group 2: Types of Approved Drugs - The newly approved drugs include significant treatments for major diseases such as cancer, metabolic disorders, and immune diseases, including China's first gene therapy product for hemophilia B [7][9]. - Notable products include a stem cell therapy drug, an anti-influenza drug, and treatments for rare diseases, providing new options for patients in urgent need [9][11]. Group 3: Policy and Reform Impact - The drug review and approval reform has accelerated the process from the research phase to market entry, particularly for urgently needed new drugs [3][5]. - The NMPA has prioritized the development and approval of drugs for rare diseases and pediatric medications through specific initiatives, aiming to approve 70 pediatric drugs and 21 rare disease drugs by 2025 [9][11]. Group 4: China's Position in Global Drug Development - China's pharmaceutical innovation is showing strong growth, transitioning from a "follower" to a "runner" and even "leader" in certain areas [11]. - Currently, China's innovative drug development pipeline accounts for approximately 25% of the global total, with around 3,000 clinical trials conducted annually, placing China among the top in the world [11].

Core Insights - The approval of innovative drugs in China has significantly increased, with 43 new drugs approved in the first half of 2025, marking a 59% year-on-year growth, nearing the total of 48 approved in 2024 [1][9] - The growth reflects the success of the drug review and approval reforms initiated in 2018, which have enhanced the efficiency and effectiveness of the approval process [2][13] Regulatory Reforms - The drug review and approval reform has accelerated the entire process from research to market, particularly for urgently needed new drugs [2][4] - The National Medical Products Administration (NMPA) has implemented various channels such as breakthrough therapy designation and priority review to encourage innovation [2][16] - The average review time for drug applications has been reduced from 200 working days to 60 working days, facilitating faster market entry for new products [4][16] Innovative Drug Approvals - Among the newly approved drugs, notable breakthroughs include the first gene therapy product for hemophilia B and a drug for rare metabolic diseases [9][12] - In 2025, 70 pediatric drugs and 21 rare disease drugs were approved, highlighting a focus on addressing critical health needs [11][12] Industry Competitiveness - China's innovative drug development pipeline accounts for approximately 25% of the global total, with around 3,000 clinical trials conducted annually, positioning the country among the leaders in the field [15][17] - The NMPA plans to enhance policy support to guide companies in developing clinically valuable drugs, particularly those targeting major diseases [16][17] Future Initiatives - The NMPA aims to revise approval procedures and strengthen intellectual property protections to foster innovation [17] - Efforts will be made to enhance international collaboration and regulatory alignment to support Chinese innovative drugs entering global markets [17]

Group 1 - Beijing has approved 17 innovative drugs and 54 Class III innovative medical devices in the past five years, ranking among the top in the country [1] - A comprehensive implementation plan for the biopharmaceutical industry chain was developed, proposing 50 specific measures across five areas: market access, supply chain, clinical application, international cooperation, and key element assurance [1] - Beijing established a provincial-level innovation service station for drugs and medical devices, and introduced a "white list" system for importing research and development materials [1] Group 2 - In 2024, a green channel for the import approval of urgently needed clinical drugs and devices will be established, focusing on rare disease medications [2] - A total of 23 clinical urgently needed drug imports have been approved in the past year, benefiting over 2,000 patients [2] - Drug review and approval reforms have reduced the approval time for innovative drug clinical trials from 60 days to 30 days, with some projects approved in as little as 18 working days [2] Group 3 - Beijing has created an integrated sampling inspection model for imported drugs, achieving customs clearance and sampling within 24 hours [3] - Over the past five years, the Tianzhu port has completed 15,000 customs clearances and over 5,100 sampling batches, with annual increases in clearance numbers [3] - From January to May, 613 batches of imported drug inspections were accepted, with a year-on-year value increase of 58% [3]