创新药本地化生产

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新政策打消投资顾虑,跨国药企重金扩大上海创新药产能
Di Yi Cai Jing· 2025-07-30 10:27
Core Insights - The introduction of innovative drugs into the Chinese market is driving multinational pharmaceutical companies to explore local manufacturing, enhancing supply chain advantages and competitiveness in meeting local market demands [1][6]. Group 1: Investment and Expansion - Roche Pharmaceuticals announced an investment of 2.04 billion yuan to establish a new biopharmaceutical production base in Shanghai, aimed at strengthening its supply chain and local production capabilities [2]. - The new facility will focus on the localized production of the ophthalmic drug, Faricimab, which is the world's first approved bispecific antibody for ophthalmology, and is included in the national medical insurance [2]. - Daiichi Sankyo plans to invest approximately 1.1 billion yuan in Shanghai for a new ADC production facility to meet the growing demand for oncology products [2][3]. Group 2: Policy and Regulatory Environment - The National Medical Products Administration (NMPA) has initiated a pilot program for segmented production of biological products, allowing different stages of production to occur in various locations, enhancing flexibility for multinational companies [6][7]. - The pilot program aims to improve production efficiency and optimize industrial division of labor, facilitating international cooperation in the biopharmaceutical sector [6][7]. - Shanghai is actively implementing the segmented production pilot, with local authorities developing quality supervision measures for segmented production of biological products [9][10]. Group 3: Market Growth and Trends - The Chinese pharmaceutical market has experienced rapid expansion, with the core hospital market projected to reach 882.2 billion yuan by 2024, reflecting a compound annual growth rate of 3.3% [4]. - The share of innovative drugs in the core hospital market has increased from 21% in 2015 to 29% in 2024, with newly approved innovative drugs accounting for 10% of the overall pharmaceutical market by 2024 [4][10]. - The ongoing reforms in China's pharmaceutical regulatory environment are creating a conducive atmosphere for multinational companies to introduce innovative products and enhance local production capabilities [11].
罗氏20亿加码投资上海,布局更多创新药本地化生产
Di Yi Cai Jing Zi Xun· 2025-05-08 09:24
Group 1 - Roche Pharmaceuticals China announced an investment of 2.04 billion RMB to establish a new biopharmaceutical production base in Shanghai, enhancing its supply chain and local production capabilities [1][3] - The new facility will be located in the Zhangjiang Hi-Tech Park, covering approximately 53 acres with a building area of about 25,000 square meters, dedicated to the localized production of the bispecific antibody drug, Rozlytrek® [1][3] - The project is expected to be completed by 2029 and commence production in 2031, marking a significant milestone in Roche's localization efforts in China [1][3] Group 2 - Roche's commitment to the Chinese market remains strong, with the new production base representing a major breakthrough in localizing innovative drug production [3] - The new facility will be Roche's second innovative drug production base in China, working in synergy with the existing base located nearby [3] - Roche aims to further explore localized production of innovative drugs and contribute to the sustainable development of China's biopharmaceutical industry, aligning with the "Healthy China 2030" initiative [3] Group 3 - The Pudong New Area government plans to strengthen the entire chain layout in the biopharmaceutical sector, focusing on both research and manufacturing [4] - The initiative aims to create a world-class biopharmaceutical industry cluster, facilitating the launch of new products and ensuring that innovative drugs benefit the Chinese population [4]