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江苏以全链条改革打造全球生物医药研发制造高地减重新药16个月跑出上市加速度
Xin Hua Ri Bao· 2025-10-04 23:18
Core Insights - The article highlights the rapid approval and market entry of the dual-target weight loss drug, Masitide, which is the first of its kind globally, marking a significant milestone in the biopharmaceutical industry [1][4] - The article emphasizes the innovative regulatory reforms in Jiangsu province that facilitate the development and approval of new drugs and medical devices, showcasing a proactive approach to meet industry needs [2][6] Group 1: Masitide and Its Market Impact - Masitide was approved for market entry in just 16 months after the application submission, indicating a significant acceleration in the drug approval process [1] - The drug's unique dual-target design positions it as a disruptive force in the international weight loss medication market, contributing to substantial revenue growth for the company [1][4] Group 2: Regulatory Reforms and Support Mechanisms - Jiangsu province has established a "one enterprise, one policy" support mechanism to address the specific needs of innovative drug and device companies, enhancing the approval process [2][6] - The province's drug regulatory authority has implemented a comprehensive evaluation system for major innovative products, including on-site assessments and personalized solutions to ensure compliance and safety [2][3] Group 3: Broader Industry Innovations - The article mentions the approval of the proton therapy system by Maysun Medical Systems, which represents a significant advancement in cancer treatment technology, offering more precise radiation therapy compared to traditional methods [3] - Jiangsu's "innovative drug and device consulting service interaction platform" has attracted 93 companies, facilitating the registration and inspection processes for over 208 innovative drugs and 250 medical devices [4][5] Group 4: Systematic Reforms and Future Directions - The article outlines a systematic reform approach in Jiangsu aimed at enhancing the entire biopharmaceutical industry chain, from research and development to manufacturing and distribution [6][7] - The province's commitment to optimizing drug regulatory processes and fostering innovation is expected to strengthen its position as a global hub for biopharmaceutical research and manufacturing [6][7]