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]

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]

金十数据6月9日讯，常山药业6月9日公告，股票连续两个交易日收盘价格涨幅偏离值累计超过30%，根 据深圳证券交易所的相关规定，属于股票交易异常波动的情况。自2025年5月6日至6月9日期间，公司股 价累计涨幅达147.69%，已经严重偏离同行业和创业板综合指数增长幅度。公司艾本那肽注射液用于治 疗2型糖尿病的上市许可申请已经获得国家药监局受理，目前处于专业审评阶段，艾本那肽注射液上市 审评后续环节仍然较多，艾本那肽最终能否获批上市及获批时间仍存在不确定性。公司艾本那肽注射液 拟用于减重适应症的临床试验申请已经获得国家药监局受理，目前处于审评阶段，能否获得临床试验批 准通知书存在不确定性。 常山药业：艾本那肽注射液处于审评阶段，能否获批存在不确定性 ...