Shanghai launches new measures to promote technological innovation and industrial development in gene therapy
Cell and gene therapy are important new tracks in global technology and industry competition. The Action Plan for Promoting Technological Innovation and Industrial Development of Gene Therapy in Shanghai has been officially issued recently. The Action Plan inherits the Action Plan for Promoting Technological Innovation and Industrial Development of Cell Therapy in Shanghai released in November 2022. It focuses on the innovation chain, industry chain, funding chain, and talent chain of gene therapy in Shanghai, adheres to the principles of adhering to innovative policy sources, strengthening strategic layout, developing the entire chain, strengthening the integration of the four chains, adhering to industry orientation and strengthening policy guarantees, systematically planning the next three years to promote technological innovation and industrial development of gene therapy in our city, condensing key tasks, formulating policy measures, and promoting high-quality development of the gene therapy industry.
As of the end of June this year, 79 gene therapy drugs in China have entered the clinical trial stage, including 19 in Shanghai, ranking among the top in terms of quantity in the country. The first and second CAR-T cell drugs in China are both from Zhangjiang Enterprise in Pudong. This Action Plan points out that it will strengthen the spatial layout of industries such as Pudong Zhangjiang Cell and Gene Industry Park and Minhang Pujiang Gene Future Valley, and promote the construction of public facilities and comprehensive service systems in industrial bases.
Bringing "real gold and silver" to gene therapy product development enterprises
The goals set by the latest released Action Plan include: by 2025, Shanghai's ability to innovate gene therapy technology will be further enhanced, clinical research and transformation application capabilities will be further enhanced, the innovation system will be further improved, and the industrial ecosystem will be further optimized; Construct 5 or more clinical medical research centers and demonstration research wards in gene therapy and related fields; Introduce and cultivate more than 15 leading and backbone enterprises in the gene therapy industry; 1-2 innovative products applied for listing.
The Action Plan includes 4 aspects, 12 major tasks, and 8 safeguard measures, aiming to enhance the innovation sources and clinical research transformation capabilities in the field of gene therapy, enhance the accessibility of gene therapy products, and enhance the level of industrial development.
The innovative breakthroughs in underlying technologies such as gene editing tools and delivery vectors are the core key technologies in the development of gene therapy products. This Action Plan establishes a major project for gene therapy technology innovation in Shanghai, builds a cutting-edge biotechnology research institute in Shanghai, explores new research paradigms such as artificial intelligence empowerment and clinical preparation queues, strengthens basic research, technological breakthroughs, and equipment and material development in the field of gene therapy, and promotes the development of gene therapy products.
As a disruptive technology for directly manipulating genes, gene therapy poses new requirements for clinical research facilities, research capabilities, and ethical review mechanisms.
It is worth noting that the Action Plan will bring real gold and silver to gene therapy product development enterprises. For gene therapy products that have undergone clinical trials in China and have been approved for marketing by registered enterprises in this city and produced in this city, a maximum of 30 million yuan of financial support will be provided, with a cumulative annual support limit of no more than 100 million yuan per unit; For gene therapy companies that have successfully introduced equity financing of over 50 million RMB, a subsidy of no more than 2% of the actual equity financing amount will be provided, with each company not exceeding 10 million RMB per year.
Pudong Zhangjiang is building a genetic industry landmark that rivals international standards
Shanghai has gathered a group of innovative enterprises focusing on the research and development of innovative gene therapy products, raw material research and production, and service outsourcing, covering all aspects of the gene therapy industry chain, and has initially formed the Shanghai gene therapy industry ecosystem.
As a characteristic park that coordinates the development of Zhangjiang Science City's cell and gene industries, Zhangjiang Cell and Gene Industry Park has developed into the most innovative and dynamic cell and gene industry cluster in China, and is also the only cell and gene industry park in China to achieve the integration of the five medical industries. The Zhangjiang Gene Island, with a total construction area of 160000 square meters, will also launch a brand new event, attracting more cell and gene innovation technology enterprises to settle in the park.
According to incomplete statistics, as of January 2023, Zhangjiang accounts for 3/5 of the approved registered clinical trial projects for cell and gene therapies in Shanghai and 1/4 in the country. Meanwhile, in the fields of cell and gene therapy, multiple companies have strengthened their layout and exploration in areas such as solid tumors, rare diseases, and autoimmune diseases.
This Action Plan points out the strengthening of the "1+1" industrial spatial layout. Taking Pudong Zhangjiang Cell and Gene Industry Park as the core, we will build a gene industry landmark that is comparable to international standards, and create a gathering area for gene therapy technology innovation and industrial development; Building a gene therapy industry chain demonstration zone that integrates research and development, testing, and manufacturing, relying on Minhang Pujiang Gene Future Valley and other parks; Based on the needs of the gene therapy industry, we will strengthen the construction of public facilities and comprehensive service systems in the industrial base.
At the same time, we will leverage the role of the Shanghai Pudong Human Genetic Resources Management Service Station, strengthen the promotion of the Implementation Rules of the Regulations on Human Genetic Resources Management, promote the construction of the human genetic resources specialist team in gene therapy related enterprises, and improve service quality.
Text: Yang Zhenying
Official WeChat from Pudong
