​Normative Document No. 2[2024] of the Office of the Administrative Committee of Nansha Economic and Technological Development Zone of Guangzhou Municipality

Normative Document No. 2[2024] of the Office of the Administrative Committee of Nansha Economic and Technological Development Zone of Guangzhou Municipality

Notice by the Office of the Administrative Committee of Nansha Economic and Technological Development Zone of Guangzhou Municipality and the Office of Nansha District People's Government of Guangzhou Municipality on Issuing the Measures for Supporting the High-Quality Development of the Biomedical Industry in Nansha, Guangzhou

All towns (street communities), departments of and agencies directly under Nansha Economic and Technological Development Zone (Nansha District):

The Measures for Supporting the High-Quality Development of the Biomedical Industry in Nansha, Guangzhou has been approved by the Administrative Committee of Nansha Economic and Technological Development Zone of Guangzhou Municipality and Nansha District People's Government and is hereby issued to you for your compliance and implementation. Problems encountered in the implementation shall be directly reported to the Bureau of Investment Promotion.

Office of the Administrative Committee of Nansha Economic and Technological Development Zone of Guangzhou Municipality 

Office of Nansha District People's Government of Guangzhou Municipality 

April 30, 2024

Measures for Supporting the High-Quality Development of the Biomedical Industry in Nansha, Guangzhou

In line with the directives outlined in the Notice of the State Council on Issuing the Overall Plan for Promoting Comprehensive Cooperation among Guangdong, Hong Kong and Macao by Further Deepening Opening-up in Nansha District of Guangzhou (Normative Document No.13 [2022] of the State Council), the Opinions of the National Development and Reform Commission, Ministry of Commerce, and State Administration for Market Regulation on Supporting Nansha, Guangzhou in Liberalizing Market Access and Strengthening Regulatory System Reform (Normative Document No. 1786 [2023] of NDRC), the Notice of the General Office of the State Council on Issuing the Action Plan for Robustly Promoting High-Level Opening-Up to Attract and Utilize Foreign Investment (Normative Document No. 9 [2024] of the General Office of State Council), and the Notice of the Office of the Guangzhou Municipal Government on Issuing Several Policy Measures for Promoting the High-Quality Development of the Biomedical Industry in Guangzhou (Office of Guangzhou Government Notice No. 1 [2024]), these measures are hereby formulated to promote the high-quality development of Nansha’s biomedical industry, establish a world-class hub for medical innovation, forge a "Greater Bay Area Medical Port", and elevate Nansha's status as an internationally renowned destination for medical services.

For the purposes of these measures, the term "biomedical enterprises" refers to enterprises primarily engaged in the R&D and production of pharmaceuticals and medical devices, as well as the provision of medical services.

Article 1: Incentives for Cell and Gene Technology Applications. Support will be provided to cell and gene therapy enterprises that, upon registration with health authorities, collaborate with medical institutions to conduct clinical applications of restricted cell transplantation technologies. Qualified enterprises from the Hong Kong SAR and Macao SAR are encouraged to leverage the human genetic resources within the mainland to conduct medical research, excluding research on human stem cells, gene diagnosis, and gene treatment. Qualified foreign-invested enterprises that engage in the expansion of pilot projects in the development and application of gene diagnosis and treatment technologies shall be eligible for an incentive equivalent to 2 percent of their actual annual foreign investment amount. The maximum annual incentive for an individual enterprise shall not exceed 100 million yuan.

Article 2: Incentives for Leading Enterprises. Internationally or domestically renowned biomedical enterprises (listed on the Forbes Global 2000, selected as one of the top 50 global pharmaceutical companies by PharmExec magazine, or ranked among the top 100 Chinese pharmaceutical enterprises by the China National Pharmaceutical Industry Information Center from January 1, 2023, to the last day of the validity period of these measures) that establish wholly-owned or majority-owned subsidiaries (including their subsidiaries) in Nansha, acquire land to invest in the new production and research & development facilities, and successfully complete the construction and put the facilities into operation, with a cumulative fixed asset investment (excluding land acquisition costs) exceeding 200 million yuan for an individual project, shall be eligible for an incentive equivalent to 10% of their cumulative fixed asset investment (excluding land acquisition costs). The maximum total incentive for an individual enterprise shall not exceed 100 million yuan, which shall be disbursed over three years in proportions of 30 percent, 30 percent, and 40 percent in the first, second, and third years, respectively. Enterprises that complete construction and commence operations of such facilities within three years after the expiration of these measures shall also be eligible for this incentive.

Article 3: Incentives for Building Clean Production Factory. Biomedical enterprises that acquire real estate to invest in new clean production facilities with an area exceeding 1,000 square meters and subsequently bring them into operation, with a cumulative fixed asset investment exceeding 5 million yuan for an individual project, shall be eligible for an incentive equivalent to 25 percent of their cumulative fixed asset investment. The maximum total incentive for an individual enterprise shall not exceed 5 million yuan. Enterprises that complete construction and commence operations of such facilities within one year after the expiration of these measures shall also be eligible for this incentive.

Biomedical enterprises that rent premises to construct new clean production facilities with an area exceeding 1,000 square meters and subsequently bring them into operation, with a cumulative fixed asset investment exceeding 5 million yuan for an individual project, shall be eligible for an incentive equivalent to 15 percent of their cumulative fixed asset investment. The maximum total incentive for an individual enterprise shall not exceed 3 million yuan. Enterprises that complete construction and commence operations of such facilities within one year after the expiration of these measures shall also be eligible for this incentive.

Article 4: Incentives for Clinical Trials. Enterprises that commit to independently undertaking industrialization (or outsourced production) of Class 1 biological products, Class 1 chemical drugs, and Class 1 traditional Chinese medicines and natural medicines in Nansha and have obtained clinical trial permits, shall be eligible for an incentive of 2 million yuan. Upon completion of Phase III clinical trials, a further incentive of 15 million yuan shall be awarded. The total annual incentive for an individual enterprise in respect of Class 1 biological products, Class 1 chemical drugs, and Class 1 traditional Chinese medicines and natural medicines shall not exceed 30 million yuan. Products conditionally approved for market by the National Medical Products Administration based on Phase II clinical trial data shall be eligible for the incentive designated for enterprises completing Phase III clinical trials.

Enterprises that commit to independently undertaking industrialization (or outsourced production) of Class 2 biological products (excluding Class 2 in vitro diagnostic reagents), Class 2 chemical drugs, and Class 2 traditional Chinese medicines and natural medicines in Nansha, and have obtained clinical trial permits, shall be eligible for an incentive of 1 million yuan. Upon completion of Phase III clinical trials, a further incentive of 8 million yuan shall be awarded. The total annual incentive for an individual enterprise in respect of Class 2 biological products (excluding Class 2 in vitro diagnostic reagents), Class 2 chemical drugs, and Class 2 traditional Chinese medicines and natural medicines shall not exceed 16 million yuan. Products conditionally approved for market by the National Medical Products Administration based on Phase II clinical trial data shall be eligible for the incentive designated for enterprises completing Phase III clinical trials.

Article 5: Incentives for Registration Certificates. Enterprises that obtain a medical device registration certificate (including those transferred in) and commit to independently undertaking industrialization (or outsourced production) of Class II innovative medical devices, Class III medical devices, and Class III innovative medical devices in Nansha shall be eligible for incentives of 1 million yuan, 3 million yuan (500,000 yuan for Class III in vitro diagnostic reagents), and 5 million yuan, respectively. The total annual incentive for an individual enterprise shall not exceed 10 million yuan (with incentives awarded for a maximum of 3 Class III in vitro diagnostic reagents per year).

Enterprises that obtain a new veterinary drug registration certificate (including those transferred in) and commit to independently undertaking industrialization (or outsourced production) of Class I and Class II products (excluding veterinary diagnostic products) in Nansha shall be eligible for incentives of 1 million yuan and 600,000 yuan, respectively. The total annual incentive for an individual enterprise shall not exceed 2 million yuan.

Article 6: Rental Subsidies for R&D and Production premises. Biomedical enterprises in Nansha that reported R&D investment or business revenue exceeding 10 million yuan in the previous fiscal year shall be eligible for a subsidy equivalent to 50 percent of the rental cost for self-used R&D and production facilities located in Nansha. This subsidy will be provided for three consecutive calendar years. The subsidized rental rate shall not exceed 25 yuan per square meter per month, and the maximum annual rental subsidy for an individual enterprise shall be capped at 2 million yuan, without exceeding the actual rental expenditure.

Article 7: Incentives for Output Value Growth. Biomedical enterprises that achieve an increase in annual industrial output value compared to the previous fiscal year shall be awarded an incentive of 100,000 yuan for every increment of 20 million yuan.

Article 8: Incentives for CRO/CMO/CDMO Enterprises. Wholly-owned or majority-owned subsidiaries of Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), or Contract Development and Manufacturing Organizations (CDMOs) established in Nansha that generate annual revenues exceeding 20 million yuan and provide services to unaffiliated enterprises, shall be eligible for an incentive equivalent to 5 percent of their service contract settlement amounts. The maximum annual incentive for an individual enterprise shall not exceed 10 million yuan.

Article 9: Application Scenario Incentives. The enterprises, medical institutions, universities, and research institutes located in Nansha (hereinafter referred to as "partners") that collaborate with local biomedical enterprises on projects with individual contract settlement amounts exceeding 20 million yuan can be awarded an incentive equivalent to 1 percent of the respective contract settlement amount. The maximum annual incentive for an individual partner shall not exceed 5 million yuan.

Clinical trial institutions located in Nansha that comply with the National Good Clinical Practice (GCP) guidelines and provide new drug clinical trial services to local biomedical enterprises in Nansha shall be eligible for an incentive equivalent to 5 percent of their annual total revenue derived from such new drug clinical trial services offered to the biomedical enterprises in Nansha. The maximum annual incentive for an individual clinical trial institution shall not exceed 3 million yuan.

Supplementary Provisions

(i) The incentives specified in Articles 4, 5, 8, and 9 of these measures may be claimed in conjunction with those stipulated in the Notice of the Office of the Guangzhou Municipal Government on Issuing Several Policy Measures for Promoting the High-Quality Development of the Biomedical Industry in Guangzhou (Office of Guangzhou Government Notice [2024] No. 1). However, for any given project, the incentives specified in Articles 2 and 3 of these measures shall not be claimed concurrently.

(ii) For matters or projects that qualify for funding support under these measures as well as other support provisions available in Nansha District, the highest funding shall prevail and shall be granted only once, unless otherwise specified. Enterprises may concurrently benefit from the same type of policy support at the municipal and district levels. However, the district’s cost-sharing portion required by municipal policies shall be deducted when the enterprise applies for district support. Enterprises that have already received preferential support under the district's "Tailored Enterprise Support" initiative shall not be eligible for similar support measures under these guidelines.

(iii) Beneficiaries of the support stipulated in these measures must sign relevant commitment letters. If beneficiaries violate their commitments, they are obligated to return the received support funds and pay interest at the prevailing Loan Prime Rate (LPR) for the corresponding period. Additionally, such beneficiaries shall be barred from applying for any support funds for a period of three years. Enterprises found to have maliciously obtained government policy funds will be brought to judicial authorities for legal proceedings.

(iv) All monetary units referenced in these measures are denominated in Renminbi (RMB). The amounts involving "no more than", "above", "maximum", "exceeding", and "higher than" are inclusive of the base number.

(v) These Measures shall enter into force from the date of issuance and shall remain valid until April 30, 2027. Where there is any adjustment or change to relevant laws, regulations, or policies within the validity term of the Measures, such adjustment or change shall prevail.

Form of Disclosure: Active Disclosure

Issued by the Office of the Administrative Committee of Nansha Economic and Technological Development Zone of Guangzhou Municipality on April 30, 2024