New Measures to Support the Development of the Modern Life Sciences and Biotechnology Industry in Xiong'an New Area
To fully embrace the guiding principles outlined during the inspection of the Xiong'an New Area and to foster high-standard and high-quality development, new measures have been introduced according to various policy documents. These initiatives are designed to accelerate the advancement of the modern life sciences and biotechnology industry in Xiong'an New Area, positioning it as a hub of innovation and industrial excellence.
Key measures include:
1. Encouraging Open Collaboration in Biopharmaceuticals: Support for designated medical institutions in Xiong'an New Area to legally use drugs and medical devices (excluding vaccines) that are approved abroad but not yet approved in China, to develop high-end medical services. Support for international innovative pharmaceuticals and medical devices to fast-track their registration in China through a special approval channel, leveraging foreign clinical trial data and real-world clinical research.
2. Encouraging R&D Investment: Significant financial incentives for R&D innovation for medical institutions, research institutes, and businesses operating in Xiong'an, with up to 1:1 matching funds for projects aligned with the development direction of Xiong'an New Area, and substantial subsidies for enterprises benefiting from R&D expense tax deductions.
3. Supporting Innovation Platform Construction: Financial support of up to 30 million yuan for national-level innovation entities, with matching funds for newly recognized innovation platforms at both national and provincial levels.
4. Accelerating Industrial Ecosystem Layout: Support for international teams and projects with global patents to establish in Xiong'an New Area, with financial rewards for significant fixed asset investments and for biopharmaceutical companies registering substantial capital in the New Area.
5. Promoting Biopharmaceutical Industrial Park Development: Operational subsidies for newly recognized national, provincial, and district-level biopharmaceutical industrial bases, with additional support for enterprises setting up within these bases.
6. Supporting Digital Medical Development: Initiatives include subsidies for the adoption of digital medical products and services, support for industrial internet innovation projects in key sub-sectors of biopharmaceuticals, and the development of a unified internet medical service and operation platform within the New Area.
7. Support for Market Entry and Industrialization of Drugs and Medical Devices: One-time rewards for preclinical research achievements, clinical trial subsidies, and substantial financial support for the industrialization of innovative drugs and medical devices that obtain registration certificates. This includes up to 20% of the total investment or a maximum of 20 million yuan for projects that industrialize Class III medical devices in Xiong'an New Area, with lesser but still significant support for Class II devices and other projects. Additionally, there is significant funding support for the first set of high-end medical devices and the first batch of new biomedical materials.
8. Support for International Registration and Certification: Enterprises that achieve international market entry for their drugs and medical devices by obtaining approval from recognized bodies such as the FDA (US), EMA (Europe), CE (European Community), PMDA (Japan), WHO, or PIC/S are eligible for financial support. This includes up to 40% of research and clinical trial costs, with a cap of 10 million yuan per enterprise per year. Support is also extended to new drugs entering clinical trials, biological raw materials registering overseas, and auxiliary materials approved by the National Medical Products Administration, with each category receiving tailored financial assistance.
9. Accelerating the Introduction of Public Service Platforms: The New Area is committed to fostering the establishment of contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), contract manufacturing organizations (CMOs), and contract sales organizations (CSOs) by offering up to 20% of total investment in subsidies, capped at 50 million yuan.
10. Encouraging the Development of Special Medical Food Industry: Incentives are provided for enterprises that obtain national registration for health food and special medical purpose formula food, with efforts to solve registration challenges and support for newly approved products, offering a 5% annual revenue reward for the first production settlement in Xiong'an, up to 10 million yuan per enterprise per year for three consecutive years.
11. Promoting Clinical Application and Research of Pharmaceuticals: Support for medical institutions in Xiong'an to participate in drug and device clinical trials without affecting their operational metrics. Innovative drugs completing Phase I-III trials in China and obtaining marketing approval are encouraged for immediate use, with rewards up to 3% of the actual product usage amount, capped at 5 million yuan per institution annually. Additionally, medical institutions qualified for conducting clinical trials according to Good Clinical Practice (GCP) standards are eligible for up to 300,000 yuan in support for conducting a significant number of trial projects.
These comprehensive measures are designed to create a conducive environment for innovation, research, and development in the life sciences and biotechnology sectors, positioning Xiong'an New Area as a leading hub in these fields.
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