创新药械上市加速度

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江苏跑出创新药械上市“加速度”
Xin Hua Ri Bao· 2025-07-15 23:50
Group 1: Industry Achievements - In 2024, Jiangsu approved 352 new drugs, including 13 innovative drugs, accounting for 27.08% of the national total, and 490 Class III medical devices, leading the nation [1] - Jiangsu's innovative drugs and medical devices are rapidly gaining approval, with five innovative drugs approved in May 2025, four of which are related to cancer [1][2] - The first domestically approved BCL-2 inhibitor and a potential best-in-class treatment for erectile dysfunction were launched by Suzhou-based companies [2] Group 2: Regulatory Support and Initiatives - Jiangsu's regulatory agencies are focused on creating a "policy highland" to support the rapid approval of innovative drugs and devices, including a "face-to-face" service initiative that addresses companies' needs directly [4][5] - The province has established a comprehensive service mechanism that includes a dedicated team for each innovative product, ensuring personalized and efficient support throughout the development and approval process [6][5] - Jiangsu is a national leader in implementing pilot programs for drug approval reforms and has established a "white list" system for importing research materials, facilitating faster access for companies [7][9] Group 3: Innovative Products and Market Expansion - Jiangsu's innovative medical devices include a new type of laparoscopic "hand-controlled robotic arm," which enhances surgical efficiency and precision [3] - The province has successfully facilitated the entry of local innovative drugs into international markets, with a Chinese drug approved in the U.S. for a specific type of lung cancer [2] - Jiangsu's first segmented production pilot for ADC drugs has been approved, allowing companies to streamline production processes and reduce costs [8]