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培育本土MNC、50亿级大单品,上海浦东发力全球创新药械首发地
第一财经· 2025-07-26 05:56
Core Viewpoint - The article emphasizes the ambition of Pudong New Area to become a global hub for innovative biopharmaceuticals, focusing on the development of "First-in-class," "First-in-China," and "First-in-Human" products, alongside significant growth in large-scale innovative drug companies and international market penetration [1][2]. Group 1: Industry Growth and Achievements - The biopharmaceutical industry in Pudong has seen rapid growth, with the industry scale increasing from 240.8 billion yuan in 2020 to 410 billion yuan in 2024, representing a compound annual growth rate of 14% [2]. - Pudong accounts for approximately 20% of the national innovative drug pipeline and 6% of the global pipeline, with 24 new drug approvals since 2020 [2]. - The region has achieved significant milestones in innovative products, including First-in-class and First-in-China drugs, with examples like the new target drug from Hualing Pharmaceutical and several stem cell and gene therapy products [2][3]. Group 2: Policy and Institutional Innovations - Pudong has implemented various policy measures to streamline clinical trials and product approvals, including a unified ethical review process for clinical studies [5][6]. - The area has introduced a recommendation catalog for innovative drugs and devices, with 75 products included, leading to a 63% year-on-year increase in usage of these products in local medical institutions [6]. - Ongoing reforms aim to enhance the efficiency of drug approvals and market access, including pilot programs for segmented production of biopharmaceuticals [6][7]. Group 3: Entrepreneurial Ecosystem for Scientists - Pudong aims to establish itself as a preferred location for scientific entrepreneurship by creating low-cost innovation incubation zones and fostering collaboration with universities and research institutions [9][10]. - The region's lower R&D costs and higher clinical trial efficiency compared to developed countries have attracted international recognition, with over 30 overseas authorizations in 2024 [9][10]. - The "nuclear explosion" zone in Pudong is designed to concentrate high-energy innovation entities, including incubators and research centers, to stimulate the growth of biopharmaceutical startups [10][11].
培育本土MNC、50亿级大单品,上海浦东发力全球创新药械首发地
Di Yi Cai Jing Zi Xun· 2025-07-26 01:58
Core Viewpoint - The Pudong New Area aims to become a global hub for innovative biopharmaceuticals, targeting significant growth in the industry by 2027, with specific goals for new drug approvals and market expansion [1][2]. Group 1: Industry Growth and Innovation - The biopharmaceutical industry in China is rapidly developing, with Pudong's innovative drug pipeline ranking second globally, surpassing Europe and Japan combined [2]. - Pudong's biopharmaceutical industry scale is projected to grow from 240.8 billion yuan in 2020 to 410 billion yuan by 2024, with an annual compound growth rate of 14% [2]. - The area has received approvals for 24 new drugs and 29 innovative medical devices since 2020, with a notable increase in the number of "First-in-class" and "First-in-China" products [2][3]. Group 2: Regulatory and Institutional Innovations - Pudong is implementing reforms to reduce institutional transaction costs and expedite the approval process for clinical trials and product launches [5]. - The area has established a unified ethical review process for clinical trials, enhancing efficiency in medical ethics reviews [5]. - In 2023, Pudong has introduced 75 innovative products into its medical institutions, with a 63% year-on-year increase in the usage of innovative medical products [5]. Group 3: Entrepreneurial Ecosystem - Pudong is positioning itself as a preferred location for scientists and entrepreneurs by creating low-cost innovation incubation zones and fostering collaboration with universities and research institutions [7]. - The area has seen a significant increase in overseas transactions, with 30% of national trade volume in biopharmaceuticals occurring in Pudong [7]. - The establishment of high-quality incubators and innovation centers in the Zhangjiang area has led to the creation of over 100 new biopharmaceutical startups annually [8][10]. Group 4: Future Development Plans - The Pudong New Area plans to develop a "1+1+X" model for biopharmaceutical functions, focusing on innovation hubs and industry clusters [7][10]. - The area aims to support the growth of large enterprises and significant products through tailored policies and service packages [10].