The Shanghai municipal government has issued a comprehensive set of measures aimed at bolstering the region’s biopharmaceutical industry. The finalized policies, following a public consultation period in June 2021, are set to take effect from August 1, 2024, through July 31, 2029. The measures cover a wide range of areas, including support for companies, enhancement of clinical resources and hospitals, streamlining of regulatory reviews, financial incentives, empowerment of data resources, and promotion of international market expansion for Chinese firms.
Key measures include:
- Focusing on cutting-edge fields such as cell and gene therapy, mRNA, synthetic biology, and regenerative medicine, with significant investments in R&D of high-end medical equipment and modern traditional Chinese medicine.
- Utilizing advanced technologies like generative AI and deep learning for intelligent applications.
- Supporting top global research scientists with core intellectual properties to conduct disruptive research in Shanghai.
- Offering annual subsidies of up to RMB 10 million for CROs providing preclinical research services.
- Providing financial support of up to 40% of R&D investment for Category 1 drugs, with a cap of RMB 10 million for Phase I, RMB 20 million for Phase II, and RMB 30 million for Phase III trials.
- Enhancing clinical resource advantages by promoting research-oriented hospitals and establishing high-quality biological sample libraries.
- Improving the efficiency of ethical review meetings and promoting the mutual recognition of medical ethical review results.
- Supporting CROs to enhance clinical trial services and providing insurance coverage for clinical trials and product liability.
- Reducing review times for drug applications and implementing dedicated coaching mechanisms for key products.
- Bolstering the clinical application of innovative products by updating the “New and Excellent Drug and Device” catalog and recommending inclusion in the National Reimbursement Drug List.
- Strengthening support for entrepreneurial and industrialization activities, including guidance for innovative products and support for the construction of technical service platforms.
- Enhancing investment and financing support through the use of various funds and policies to encourage early investment in small enterprises and hard technologies.
- Unleashing the value of data resources by promoting data sharing and utilization, creating high-quality AI corpora, and establishing a biopharmaceutical special zone on the Shanghai Data Exchange.
- Promoting the internationalization of industries by supporting foreign-funded enterprises to establish regional headquarters and R&D centers in Shanghai and facilitating the import and export of cell therapy products.- Flcube.com