In order to deeply implement the spirit of Jiangsu Province's "Several Policies and Measures on Promoting the High-Quality Development of the Province's Biomedical Industry" and Nanjing Municipality's "Several Policies and Measures on Promoting the High-Quality Development of the City's Biomedical Industry" and other documents, to promote the high-quality development of the biomedical industry in the Jiangbei New Area, and to build a globally influential biomedical industry cluster, the following measures are formulated:

Article 1 Support the construction of major innovation platforms and the settlement of innovation projects. Encourage the construction of technological innovation centers in the field of biomedicine, clinical medical research centers and other major platforms, the newly approved provincial and above technological innovation centers, clinical medical research centers, according to the amount of national or provincial allocations to the account, to give 1:1 supporting support (the total amount of support from the state, province, city, and the new area does not exceed the total amount of the project). Well-known clinical experts, scientists, professors or those who have had a successful entrepreneurial experience founded on the development of biomedical industry in the new area has led the support role of science and technology-based innovative enterprises settled, assessed by the maximum of 10 million yuan of project funding can be given.

Second, support for innovative drug research and development. To carry out clinical trials in the country and in the new area for translation, manufacturing and sales of innovative drugs, according to its research and development progress will be rewarded in phases: Class 1 biologics, chemical drugs, traditional Chinese medicines and natural medicines to obtain clinical approvals, according to the actual investment in research and development costs (audited by qualified third-party institutions) 30% will be rewarded up to a maximum of 5 million yuan; the completion of phase I, II, III clinical trials, according to the actual clinical research in each phase, the actual clinical research will be rewarded up to 5 million yuan. The completion of phase I, II and III clinical trials will be rewarded at 20% of the actual clinical research expenses of each phase, up to 10 million yuan, 20 million yuan and 30 million yuan respectively, with the maximum annual reward for a single enterprise not exceeding 100 million yuan.

Article III Support for high-end medical device research and development and industrialization. For independent research and development of Class III medical device products newly obtained medical device registration certificate and in the new area for transformation, manufacturing and sales, according to the input of the product actual research and development costs (audited by a qualified third-party institution) 20% to be rewarded, a single enterprise each year, up to a maximum reward of 5 million yuan; independent research and development of Class II and Class III medical device products into the innovative medical device special review procedures and complete the clinical trial submitted for product registration, respectively Clinical trials submitted to the product registration, respectively, to give 1 million yuan, 2 million yuan reward, a single enterprise annual incentive up to 10 million yuan.

Article IV supports the commissioned production of biomedical products. Innovative biotechnology companies will research and development of pharmaceutical or medical device products in accordance with relevant state policies entrusted to the production of other biomedical enterprises in the new area of non-affiliated, each year, in accordance with the recognized amount of commissioned production services actually occurred in the previous year (audited by qualified third-party institutions) 5% of the proportion of the commissioning party to be rewarded, the maximum amount of incentives for a single enterprise each year does not exceed 2 million yuan, the cumulative total of not more than 10 million yuan.

Article V supports medical institutions to strengthen the supply of clinical resources. Encourage medical institutions in the new area layout of provincial clinical medical research centers, cultivate national clinical medical research centers, research hospital construction. Encourage the new area has obtained clinical trial qualification of medical institutions, increase the number of beds for clinical research, increase the proportion of the total number of hospital beds. Medical institutions within the new area to declare the qualification of clinical trials, every new drug clinical trial quality management standard (GCP) professional discipline, will be rewarded 500,000 yuan. For medical institutions to undertake clinical trials of new drugs within the new area of the enterprise or by the investigator initiated clinical research projects, complete the project filing and effectively carry out the project team to undertake the project up to 500,000 yuan of incentives.

Article VI supports the construction of industrialization projects in the field of biomedicine. For industrial projects with a total investment of not less than 2 billion yuan, after identification, according to the total project investment (audited by a qualified third-party institution) of 10% to 30% to be supported, the maximum amount of support does not exceed 500 million yuan. For new drug industrialization projects with total investment in actual fixed assets (excluding land, plant, etc., including equipment, GMP standard plant renovation, etc.) amounting to more than 60 million yuan and medical device industrialization projects with more than 30 million yuan, the projects will be supported according to 10% of the total investment in actual fixed assets, with the maximum amount of support for a single project not exceeding 20 million yuan.

Article VII support for biomedical investment funds and management companies gathered. The establishment of a total size of not less than 2 billion yuan of biomedical science and technology innovation angel fund, recognized investment institutions invested in the new area of biomedical projects, according to the type of project to follow the investment, a single project to follow the investment amount of not more than 20 million yuan. For all kinds of market-oriented private equity and venture capital funds set up by law to drive the headquarters of biomedical innovation projects (R&D, industrialization, financing and future listing of the main body) to settle in the new area, the fund management company will be rewarded in accordance with the 2% of the total amount of the project's incoming investment (including the investment already made, excluding the agreed return investment), with a maximum of 5 million yuan per year, upon recognition.

Article VIII supports the financing and listing of biomedical enterprises. Resident in the new area within five years and the first three rounds of financing in a single market-oriented operation of professional investment institutions to obtain equity investment capital increase of 20 million yuan and above biomedical enterprises, in accordance with the actual amount of investment 1% to give the enterprise incentives, a single enterprise cumulative incentives of a maximum of not more than 5 million yuan. Support for the implementation of the listing program and shareholding reform of enterprises, the founding shareholders due to equity transfer or shareholding reform of the economic contribution of up to 10 million yuan, according to the economic contribution to the new area to give the enterprise up to 80% of the maximum reward. After the listing of enterprises, in addition to the rewards in accordance with the relevant provincial and municipal policies, the founding shareholders in the stock transfer within three years after the expiration of the stock release period to generate economic contribution of 10 million yuan, according to the economic contribution of the new district to give enterprises a maximum of no more than 60% incentive.

Article IX support the declaration of national medical insurance and the first (set) application demonstration. Support for innovative products in the new area to declare access to the national health insurance catalog, and promote innovative products through the Jiangsu Province drugs (medical supplies) sunshine procurement and comprehensive supervision platform to declare the grid, into the provincial and municipal procurement catalog. For medical institutions to purchase the first time to enter the health insurance catalog of innovative products, according to the actual amount of the first procurement of 3% to give funding; the first procurement of high-end medical equipment for medical institutions first (sets) equipment (by the Jiangsu provincial level and above), according to the current year, the product of a single (sets) 5% of the transaction amount of funding. The above individual medical institutions will be funded up to a maximum of 5 million yuan per year.

Article X supports the gathering of high-level talents. Qualified high-end new drug research and development and innovative medical device research and development enterprises to introduce new annual salary income of more than 500,000 yuan of high-level talent, according to their personal contribution to the economy of the new area in the previous year to give the employer ninety percent of the subsidies, each person up to 500,000 yuan per year, the subsidy funds are mainly used for the performance of talent incentives.

Article XI supports the open sharing of scientific and technological service resources. Encourage biomedical enterprises to use the new area open sharing of instrumentation services and experimental animal services, qualified biomedical enterprises to issue science and technology innovation vouchers, a single enterprise up to 500,000 yuan per year.

Article XII supports the organization of professional conferences and activities. For international, national and specialized biomedical industry exhibitions, summits, forums, academic exchanges and other activities settled in the new area, after approval and consent, the activities will be subsidized at a rate not exceeding 20% of the total expenses (audited by qualified third-party institutions), and the maximum subsidy for a single activity will not be more than RMB 500,000 yuan.

This document applies to the Nanjing Jiangbei New Area Directly Administered Zone, effective from March 6, 2023 and valid until March 6, 2026. If this policy measures and other similar policies and opinions are duplicated, in accordance with the principle of "high not repeated" to be supported. This policy is interpreted by the Administrative Committee of Jiangbei New Area.