"Several Opinions": Shanghai may set off a "wave" of supporting policies for the development of the biomedical industry

On May 19, Shanghai issued the "Several Opinions on Promoting the High-Quality Development of the City's Biomedical Industry" (hereinafter referred to as the "Several Opinions").

01.

Table 1: Pictures of Shanghai Municipal Biomedical Industry Policy Documents

Source: According to public information

From the perspective of policy support, the "Several Opinions" are at the forefront of the country in terms of improving the ability of innovative sources, strengthening the research and development of innovative products, and accelerating the application of innovative products.

The first is to explicitly include the encouragement of basic research into the industry support policy.

Second, it is the first time to explicitly include support for the development of improved new drugs into the scope of policy support for the biomedical industry.

The third is the first trial of purchasing services for medical artificial intelligence products.

Fourth, it is the first time to focus on optimizing the application process of innovative products in the biomedical industry.

02.

First, from the perspective of drug support policies, in terms of the direction of support, only innovative drugs and improved new drugs are supported, and generic drugs are not involved.

Second, from the perspective of the medical device product support policy, the direction of support is for medical device products that enter the country and the city's special review procedures for innovative medical devices, without distinguishing between the support for the second and third categories of device products; in terms of support strength, Shanghai "for the products that enter the above procedures, obtain the medical device registration certificate for the first time and are produced in this city, and then provide no more than 40% of the R&D investment, up to 5 million yuan in financial support", far exceeds the Suzhou City’s "new medical device registration" The third-class medical device products of the certificate shall be subsidized at 20% of the actual research and development expenses invested in the product, and the maximum support shall not exceed 3 million yuan.

The third is to strongly support the development of overseas markets.

Table 2: Comparison of Shanghai's biomedical industry policies with those of other cities

Source: Firestone Creation is based on publicly available data.

03.

The first is to strengthen the transformation of clinical research.
The "Several Opinions" strengthen support from four aspects: strengthening the incentives for the transformation of clinical research results, establishing a hospital ethical collaborative review work mechanism, improving the clinical research support platform system, and enhancing the innovation ability of industry-medicine integration, specifically including : Take the lead in constructing medical big data open infrastructure in China, establish a production-medicine integration demonstration base and a medical-enterprise demand docking mechanism, improve municipal hospitals' medical-enterprise collaborative research innovation platform and clinical trial digital management platform, and support the establishment of research-oriented institutions with conditions The hospital promotes the "deep integration" of medical enterprises, forms a "tight coupling" in clinical and industrial development, and promotes the transformation of clinical research results.

The second is to strengthen industrialization support, strengthen support for industrialization localization, prevent "overflow of results", and improve the modernization level of the industrial chain, the digitalization, intelligentization, and green transformation of the manufacturing industry, and the promotion of contract R&D and production organization models.
Provide a certain degree of guidance and support, such as "for core technology research in the field of biomedicine, key professional service platform construction, and major product industrialization projects, grant no more than 30% of the approved new investment, up to 15 million yuan in financial support.
Major projects are included The city's special project for the development of strategic emerging industries will provide up to 100 million yuan in financial support".

04.
New methods: strengthen the creation of a better industrial development ecology

From the perspective of the scope of policy support, the "Several Opinions" strengthen research and industrialization links while strengthening clinical research transformation and medical-enterprise collaboration, and strive to build policy support and coverage covering the entire industrial chain of "R&D + clinical + manufacturing + application" Engineering system.

From the perspective of policy support measures, the "Several Opinions" strengthen service innovation and financial innovation, and improve the biomedical industry ecology in terms of improving the industrial innovation service system and innovative industrial financial service models.

From the perspective of improving the industrial service system, the first is to strengthen industry incubation support.
Shanghai "provides discount support for incubator and accelerator construction projects in the biomedical field in accordance with the relevant regulations of Shanghai’s new infrastructure construction"; the second is to strengthen product registration services, Shanghai" Establish product registration guidance service workstations in relevant parks of the biomedical industry, and strengthen early intervention and full guidance in the development process of related products.

From the perspective of innovative industrial financial service models, Shanghai “plays the role of the city’s policy guarantee funds and launches pilot projects for financial products such as “new drug loans”,” and the industry and finance are moving towards deep integration to effectively alleviate corporate financing difficulties.
The "New Drug Loan" financing service is jointly launched by the Shanghai Economic Information Technology Commission and the Shanghai Small and Medium-sized Enterprise Policy Financing Guarantee Fund Management Center.
It is recommended by industry authorities, packaged by guarantee centers for policy guarantees, and cooperative banks provide credit support.
"" model, to provide eligible companies with loan services with a wide range of benefits and fast lending speed.

05、Conclusion

As a "weathervane" for the release of my country's biomedical industry development policy, Shanghai has an industry leading and exemplary role.
In the past, it would trigger other cities to release a more powerful "version 2.
0" on the basis of the "Shanghai Biomedical Industry Policy 1.
0".
The release of a new round of "high starting point" industry support policies for the Shanghai biopharmaceutical industry may set off a new wave of "competition" for the high-quality development support policies of the biopharmaceutical industry.