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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· 2025-10-09 01:27
Group 1 - The core point of the article highlights the successful launch of the dual-target weight loss drug, Masitide, which is the first and only approved drug of its kind globally, significantly impacting the international weight loss drug market [1] - The rapid approval and market entry of Masitide are attributed to Jiangsu's robust regulatory framework that facilitates innovation and production efficiency [1] - The biopharmaceutical industry faces challenges in innovation, particularly regarding the gap between traditional drug approval standards and the actual needs of companies [1] Group 2 - Jiangsu Province has implemented a "one enterprise, one policy" support mechanism to address the needs of innovative drug and device companies, facilitating early intervention in the review process [2] - A comprehensive reform initiative covering the entire chain from research and development to manufacturing and distribution is underway in Jiangsu [2] Group 3 - The approval of the proton therapy system by Maysun Medical Systems represents a significant advancement in cancer treatment, offering more precise radiation therapy compared to traditional photon therapy [3] - The complexity of large-scale medical devices requires on-site assembly and testing, leading to challenges in regulatory compliance and quality assurance [3] Group 4 - Jiangsu's "Innovative Drug and Device Consultation Service Interaction Platform" has engaged 93 companies, covering 208 innovative drugs and over 250 medical devices, streamlining the registration and inspection process [4] - The platform supports the transition of innovative drugs and devices from laboratory development to market availability, enhancing the competitiveness of Jiangsu's biopharmaceutical industry [4]
中国首款双靶点玛仕度肽获批,诺和诺德减重新药紧随其后
Ge Long Hui· 2025-07-02 10:52
Core Insights - The global weight loss drug market has entered a "dual-target era" with the approval of the first GCG/GLP-1 dual receptor agonist, Mazdutide, by China's National Medical Products Administration (NMPA) [1][6][15] - Novo Nordisk also presented its new GLP-1/insulin receptor dual agonist, Amycretin, at the 85th American Diabetes Association (ADA) Scientific Sessions [4][11] Group 1: Mazdutide - Mazdutide is the first approved GCG/GLP-1 dual receptor agonist, utilizing a unique mechanism to achieve metabolic regulation through dual pathways [8][10] - In the Phase III GLORY-1 study, the 6mg dose group achieved an average weight loss of 14.8% after 48 weeks, with nearly half of the patients losing over 15% of their body weight [9][10] - The drug also significantly improved metabolic indicators, with an 80.24% average reduction in liver fat content (LFC) in the 6mg group, and 77.3% of patients achieving liver fat resolution [10][14] Group 2: Amycretin - Amycretin, developed by Novo Nordisk, is a long-acting GLP-1 and insulin receptor dual agonist that shows significant weight loss effects in clinical trials [11][13] - In the Phase Ib/IIa study, the high-dose group (60mg) achieved an average weight loss of 24.3% after 36 weeks, significantly outperforming existing GLP-1 drugs [13] - The safety profile of Amycretin is favorable, with most adverse reactions being mild to moderate gastrointestinal symptoms, and a low discontinuation rate of less than 5% [13][14] Group 3: Market Implications - The approval of Mazdutide and Amycretin provides safer and more effective treatment options for the approximately 500 million adults in China who are overweight or obese [14] - Despite the presence of 14 other tri-target weight loss drugs in clinical development, Mazdutide and Amycretin are expected to maintain a leading advantage in the next 3-5 years due to their first-in-class status and validated clinical efficacy [14][15] - The competition between these two drugs reflects the growing demand for healthier living among millions of obese patients, indicating a shift towards comprehensive management of metabolic syndromes beyond just weight loss [15]