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生产环节“分段”,新药上市提速
Xin Hua Ri Bao· 2025-07-09 21:58
Core Viewpoint - The article discusses the innovative approach of segmented production in the biopharmaceutical industry in Suzhou, which aims to optimize resource allocation, shorten drug development cycles, and integrate China's biopharmaceutical industry into the global supply chain [1][2]. Group 1: Segmented Production Model - The segmented production model allows for the separation of raw material production and formulation production, enabling different companies to handle specific production tasks, thus maximizing the utilization of production facilities and reducing costs [1][2]. - Antibody-drug conjugates (ADCs) are highlighted as a key area benefiting from this model, as their complex structure requires expertise in both biopharmaceutical and chemical synthesis [1][2]. Group 2: Regulatory and Implementation Challenges - The implementation of segmented production faces challenges such as ensuring equipment compatibility, logistics management, and regulatory compliance across different manufacturers [2]. - The Suzhou Industrial Park has initiated research and practical investigations to explore the feasibility of segmented production and has proposed supportive policies to address common demands from enterprises [2][3]. Group 3: Policy Support and Pilot Programs - The Ministry of Commerce issued a high-level policy to support the Suzhou Industrial Park, allowing the selection of 1-2 enterprises to conduct pilot programs for segmented production [3]. - Suzhou Shengdiya Biopharmaceutical Co., Ltd. has become the first pilot enterprise, successfully obtaining approval for its segmented production of a specific ADC product [4][5]. Group 4: Future Prospects and Innovations - The article emphasizes the ongoing exploration of segmented production, with various companies planning to implement external segmentation and cross-border collaborations, indicating a higher marketization level and potential challenges [7]. - The Suzhou Industrial Park is actively working on institutional reforms to enhance the regulatory framework and improve the efficiency of resource allocation in the biopharmaceutical sector [8][9].