去年上海9个国产1类创新药获批 数量创历年新高 多款为全球或全国首创

Group 1 - In 2025, Shanghai approved 9 domestic innovative Class 1 drugs and 7 imported innovative drugs, marking a record high. Additionally, 13 innovative medical devices were approved for market entry. Among the 9 domestic drugs, several are global or national firsts [1] - The first domestically developed human-derived long-acting GLP-1 receptor agonist, Eysuparaglutide α injection (brand name: Yinuo Qing), has a half-life of 204 hours, allowing for weekly administration without dose titration [1] - The first recombinant adeno-associated virus (rAAV) vector gene therapy drug, Bopadacogen injection (brand name: Xinjiu Ning), enables long-term self-expression of coagulation factor IX through a single intravenous injection [1] Group 2 - During the "14th Five-Year Plan" period, Shanghai approved a total of 32 domestic Class 1 innovative drugs, including multiple first-in-class products such as Duoglie Aitin tablets and the world's first EGFR-targeted ADC [1] - In the field of innovative medical devices, Shanghai approved 47 Class III products during the "14th Five-Year Plan" period, including the first domestic proton therapy system and the first laparoscopic surgical robot [2] - The Shanghai Municipal Drug Administration plans to shorten the review and approval timelines for eligible innovative drug clinical trials and reduce the review cycle for Class II medical devices, aiming to compress the entire registration cycle to 6 months [2]