At the executive meeting of The State Council held recently, Premier Li Qiang presided over and reviewed and approved the high-profile Implementation Plan for the Whole Chain to Support the development of innovative drugs. This initiative has a profound impact on the innovation and development of China's biomedicine field, especially the cell and gene therapy industry, which is expected to usher in new development opportunities.

The review and adoption of the Implementation Plan for the Whole Chain to Support the development of innovative Drugs reflects the country's great importance to the research and development of innovative drugs. The program aims to reduce the cost and risk of new drug creation through comprehensive policy support and optimization process, so as to stimulate the innovation vitality of pharmaceutical enterprises. Among them, for cutting-edge fields such as cell and gene therapy, the implementation of the program will greatly promote its clinical research and product development process.

As a new direction in the field of biomedicine, cell and gene therapy has great therapeutic potential and market prospects. However, due to the characteristics of high technical complexity, large R&D investment and long development cycle, the development of this field is restricted to a certain extent. The review and adoption of the Implementation Plan for the Whole Chain to Support the Development of Innovative Drugs precisely provides more powerful policy guarantees and environmental support for the research and development of such innovative drugs.

The meeting pointed out that the development of innovative drugs is related to the development of the pharmaceutical industry and the health and well-being of the people. It is necessary to strengthen the policy guarantee of the whole chain, coordinate and make good use of policies such as price management, medical insurance payment, commercial insurance, drug equipment and use, investment and financing, optimize the review and approval mechanism and the assessment mechanism of medical institutions, and jointly promote the breakthrough development of innovative drugs. It is necessary to mobilize all aspects of scientific and technological innovation resources, strengthen basic research on new drug creation, and consolidate the foundation of innovative drug development in China.

It is foreseeable that the above measures will work together to boost the development of innovative drugs, especially for high-end technology industries such as cell and gene therapy, which will help it achieve breakthroughs and applications faster. In addition, it will also help the cell and gene therapy industry to achieve more original results in basic scientific research, and enhance China's international competitiveness in this field. At the same time, with the continuous deepening of basic research, more safe and effective cell and gene therapy products will emerge in the future, benefiting patients.

Looking back at the deep medical reform in 2015, since then, the main line of China's biomedical industry has gradually shifted from "regulation + guarantee" to "innovation + efficiency". In the 2024 government work report, innovative drugs were mentioned for the first time, fully demonstrating the country's determination and confidence in innovative drugs. The review and adoption of the Implementation Plan for the Whole Chain to support the development of innovative drugs is undoubtedly a further strengthening and acceleration of this trend.

Impact on the cell and gene therapy industry

1. Strengthen policy guarantees and reduce R&D risks

The "Implementation Plan for the whole Chain to support the development of innovative drugs" proposes to strengthen policy protection for the whole chain, and make good use of policies such as price management, medical insurance payment, commercial insurance, drug equipment and use, and investment and financing. For the cell and gene therapy industry, these policies will greatly reduce research and development costs and market entry barriers, and enhance the innovation enthusiasm of enterprises and market competitiveness.

2. Optimize the review and approval process to accelerate the product to market

The Implementation Plan of the Full Chain to Support the development of innovative Drugs requires the optimization of the review and approval mechanism and the assessment mechanism of medical institutions, which will greatly shorten the time-to-market of cell and gene therapy products. In recent years, the State Food and Drug Administration has carried out a number of reforms in review and approval to encourage the rapid launch of innovative drugs. With the implementation of the Implementation Plan for Supporting Innovative Drug Development across the Chain, it is expected that more cell and gene therapy products will enter clinical trials and market stages.

3. Stimulate source innovation and lay a solid foundation for development

The Implementation Plan for the Whole Chain to Support the development of innovative drugs emphasizes the need to mobilize all aspects of scientific and technological innovation resources and strengthen basic research on new drug creation. For the cell and gene therapy industry, basic research is the source of innovation. By increasing investment and support for basic research, technological breakthroughs and original achievements in the field of cell and gene therapy will be strongly promoted.

Under the continuous promotion of policy dividends, remarkable results have been achieved in the field of cell and gene therapy in China. For example, five CAR T therapies have been approved for market in China, more than 400 cell and gene therapy products have entered the clinical trial stage, and some products are close to market. These achievements not only reflect China's research and development strength in the field of cell and gene therapy, but also provide more treatment options for patients.

Support and supporting policies at the national/local level

Under the strong promotion of policies at the national level, all localities have also introduced supporting policies to support the development of the innovative drug chain. For example, Beijing, Shanghai, Guangzhou and other places have issued a number of policy documents to support the development of biomedical innovation, involving research and development support, clinical trials, medical insurance payments and other aspects. The introduction of these local policies will further promote the rapid development and prosperity of the cell and gene therapy industry.

On March 5, 2024, the government work report named "innovative drugs" for the first time, which greatly enhanced industry confidence and laid the tone for the introduction of subsequent policies. On March 13, a draft for comments on the "Implementation Plan for the Full Chain to Support the Development of Innovative Drugs" was widely circulated in the industry. Although it was not officially confirmed, it had sent a strong policy signal. On April 7, Beijing issued Several Measures to Support the high-quality Development of Innovative Medicine in Beijing (2024), covering clinical development, review and approval, clinical application and payment. Many places, such as Guangzhou and Zhuhai, issued documents almost simultaneously to support the high-quality development of innovative medicine. On June 6, The General Office of the State Council issued the "Key Tasks for Deepening the Reform of the Medical and Health System in 2024", which clearly proposed the development of guidance documents on the whole chain to support the development of innovative drugs and accelerate the review and approval of innovative drugs. On July 2, Shanghai Municipal Government held an executive meeting and agreed in principle to "Several Opinions on Supporting the Innovation and Development of the whole Chain of biomedical Industry" to promote the innovation and development of the whole chain of biomedical industry in Shanghai.On July 5, 2024, the "Implementation Plan for the Whole Chain to Support the Development of Innovative Drugs" was officially reviewed and approved. The whole chain strengthened policy guarantees, coordinated the use of various policy resources, and jointly promoted the breakthrough development of innovative drugs.

Conclusion

The review and approval of the "Implementation Plan for the Full Chain to Support the Development of Innovative Drugs" will have a profound impact on the cell and gene therapy industry. On the one hand, the policy strengthens comprehensive protection for innovative drugs and reduces research and development costs and market access thresholds; on the other hand, optimizing the review and approval process will accelerate the marketing process of cell and gene therapy products and provide patients with more safe and effective treatment.

At the same time, supporting policies at the local level also provide strong support for the development of the cell and gene therapy industry. From financial support to clinical trial awards to medical insurance payment support, a series of measures will form a synergy to promote high-quality development of the cell and gene therapy industry. In accordance with established practice, the "Implementation Plan for the Full Chain to Support the Development of Innovative Drugs" will be published online in the near future.

All in all, the review and approval of the "Implementation Plan for the Full-Chain Support for the Development of Innovative Drugs" will bring unprecedented development opportunities to the cell and gene therapy industry. We look forward to the successful implementation of this implementation plan.