Core Viewpoint - The article discusses the regulatory challenges and policy support for the biopharmaceutical industry in Shanghai, particularly focusing on the cross-province and cross-border segmented production of biological products, which is essential for integrating into the global supply chain [2][4]. Regulatory Challenges - High regulatory costs and data sharing risks are significant constraints on the segmented production of biological products across provinces and borders [2]. - The State Council issued a directive in January to explore segmented production models and support cross-border segmented production [2]. Policy Support - Shanghai has been actively promoting cross-province and cross-border segmented production since May, including the production of injectable drugs and ADCs [2]. - The Shanghai Municipal Drug Administration has outlined key conditions for contracted production, including a minimum of three years of commercial production experience and adherence to a unified quality management system [2]. Innovation and Approval - In the first half of 2025, 34 domestic innovative medical devices were approved, with Shanghai accounting for 21%, highlighting the city's significant role in the innovation landscape [3]. - The review process for innovative medical devices has been streamlined, reducing technical review timelines from 45 to 40 working days [3]. Support for Overseas Expansion - Policies have been introduced in the Pudong New Area to support biopharmaceutical companies in expanding overseas, including public service policies and talent incentives [4]. - The Pudong Trade Promotion Council has organized over 230 overseas exhibition projects, with more than 30 focused on biotechnology and medical devices, facilitating global market access for Shanghai's biopharmaceutical companies [5].