Shanghai issues new Opinions to bolster genetic diagnostic development

Biomedicine is one of the three leading industries that Shanghai is prioritizing for development, as it represents a critical area for fostering new, high-quality productivity. 

In recent years, the city has made concerted efforts to establish itself as a global leader in biomedical innovation, launching a series of policy initiatives that have yielded significant results. 

On 30 July, Information Office of Shanghai Municipality held a press briefing, introducing the details of the “Several Opinions on Supporting the Innovation and Development of the Entire Biomedicine Industry Chain.”

In 2021, Shanghai issued several opinions on promoting the biomedicine industry, leading to notable achievements.

Since then, 19 Class 1 innovative drugs and 25 Class 3 innovative medical devices have been approved, highlighting Shanghai’s leadership in the field. Breakthroughs in oncology, metabolism, immunology, and neurology have led to the development of globally first-in-class drugs, national first-in-class cell therapies, and world-class medical devices, accelerating the industry’s growth.

From 2021 to 2023, the biopharmaceutical industry’s scale grew from 761.7 billion yuan to 933.7 billion yuan, with the manufacturing output rising from 171.2 billion yuan to 186 billion yuan. In the first half of this year, the manufacturing output reached 93.5 billion yuan, a 3.7 billion yuan increase from the same period last year.

Emerging fields like cell and gene therapy, synthetic biology, medical robots, and high-end medical imaging are driving new momentum.

The business environment has improved with a comprehensive acceleration system covering R&D, clinical trials, manufacturing, and application. Technological, talent, financial, and data support capabilities have been strengthened. Over 3,000 demonstration research beds have been built, and 27 municipal clinical medical research centers have been established. Additionally, 72 innovative and quality drugs and medical devices have been integrated into hospitals, and the Huhuibao customized commercial medical insurance has been launched, fostering a diverse payment mechanism for innovative drugs and devices.

Shanghai’s biomedicine industry is currently transitioning to higher quality and efficiency. To address the industry’s pain points and meet the urgent needs of enterprises, the city has issued the “Several Opinions on Supporting the Innovation and Development of the Entire Biomedicine Industry Chain.” These opinions focus on key areas such as R&D, clinical trials, review and approval, application promotion, industrialization, investment and financing, data resources, and internationalization. The opinions emphasize full-chain innovation, reform, and empowerment, introducing 37 policy measures across eight areas.

The following six aspects are primarily supported:

1.    Further encourage original innovation. 

Enhance support for the R&D of innovative drugs and devices, encourage original innovations, and focus on developing blockbuster products. Invest in cutting-edge fields like gene and cell therapy, mRNA, synthetic biology, and regenerative medicine. Support AI technology to advance drug research and offer more intelligent application scenarios.

2.    Further expand clinical resource advantages. 

Increase the number of research beds and develop well-equipped, intensive and shared research wards. Improve transformation mechanisms for valuing clinical results in lieu of shares and refine result evaluation and team incentives. Guide insurance institutions to bolster risk compensation for clinical trials and innovations and enhance risk-sharing mechanisms.

3.    Further shorten product development and launch cycles.

Implement innovative measures like establishing trial-ready cohorts to reduce clinical start-up time to within 25 weeks. Introduce mechanisms such as “one set of materials, one submission” for ethical reviews, cutting the overall process to 3 weeks. Support the national registration reform initiative to reduce drug supplementary application reviews to 60 working days and clinical trial approvals to 30 working days. Accelerate Class 2 medical device reviews, shortening the average review time to 40 working days.

4.    Further accelerate innovative product application and promotion. 

Facilitate the inclusion of more “new and quality drugs and devices” in hospitals and medical insurance, ensuring Shanghai’s medical institutions are well-equipped. Increase medical insurance payments for innovative products, with separate budgeting for diagnosis and treatment projects, and payments in DRG/DIP (Diagnosis Related Groups/Disease-Intervention Packet) formats. Support the international expansion of Shanghai’s innovative drugs and devices.

5.    Further enhance the full-factor support system. 

Boost investment and financing by leveraging biopharmaceutical industry parent funds, equity investment funds, and innovation transformation funds, while strengthening strategic relief investments. Encourage corporate venture capital, establish industrial merger and acquisition funds, and support mergers and restructuring to strengthen companies. Maximize the value of data elements, promote the open sharing of cohort research data, and develop high-quality corpora and industry datasets, ensuring legal and compliant data transactions and safe cross-border data flow. Launch 5 million square meters of standardized factory space to expedite major industrial projects.

6.    Further unleash vitality of reform and innovation. 

Enhance institutional opening-up and support qualified foreign-invested enterprises in the China (Shanghai) Pilot Free Trade Zone (including Lingang New Area) to develop and apply genetic diagnosis and treatment technologies. Optimize policies for importing R&D items and facilitate the entry and exit of cell therapy products and related special items. Utilize city-district joint task forces and the “four 100” list system to improve enterprise services and continue creating a top-tier business environment. 

In the next phase, Shanghai will accelerate policy implementation to benefit enterprises more efficiently. With the collaborative efforts of all stakeholders, Shanghai’s biopharmaceutical industry is poised for higher-level, higher-quality development.