Original Title: Notice on the Issuance of the "Several Measures for Further Supporting the High-Quality Development of the Biopharmaceutical and Healthcare Industry in the Hengqin Guangdong-Macao Deep Cooperation Zone"

　　(1) Support for R&D of Innovative Biologics and Chemical Drugs

　　1. A subsidy of 40% of the actual R&D expenditure will be provided for innovative biological and chemical drugs. For products that have obtained clinical trial approval or completed Phase I, II, or III clinical trials, the maximum subsidy per product is 10 million yuan, 12 million yuan, 24 million yuan, and 36 million yuan, respectively; for breakthrough therapeutic drugs that have obtained a drug registration certificate, a subsidy of 12 million yuan will be provided.The annual cumulative subsidy for each institution under this provision shall not exceed 120 million yuan.

　　2. For the purchase, transfer, or introduction of clinical trial approvals for mature, in-development innovative biological products and chemical drugs from outside the cooperation zone, provided that Phase II or III clinical trials are initiated within 12 months, a subsidy of 40% of the actual R&D expenses incurred at each stage will be provided, with a maximum subsidy of 20 million yuan and 36 million yuan per product for the aforementioned stages, respectively.Additionally, upon completion of Phase III clinical trials for such a product, the enterprise may apply for a subsidy for the purchase of the clinical trial authorization, calculated as 40% of the portion of the purchase cost allocated to R&D expenses. The maximum subsidy amount for a single product under this provision shall not exceed 82 million yuan, and shall not exceed 80% of the total R&D investment for that drug within the Cooperation Zone.

　　3. The cumulative annual subsidy for each institution under this provision shall not exceed 120 million yuan.

　　(2) For generic drugs approved under the new chemical drug registration classification and drugs that have passed the bioequivalence (BE) evaluation (referring to non-exempt BE products; different dosages are considered a single product), a subsidy of 2 million yuan will be granted for each product upon certification. If a cooperative zone enterprise’s generic drug approved under the new chemical drug registration classification or a drug that has passed the BE evaluation is among the first three of its kind to be approved domestically, an additional subsidy of 1 million yuan will be granted.The annual subsidy for each institution under this provision shall not exceed 15 million yuan in total.

Article 13: Support for Medical Device R&D

　　For Class II and Class III medical devices (excluding Class II diagnostic reagents and equipment components) that obtain a medical device registration certificate for the first time and hold an invention patent, subsidies of up to 3.6 million yuan and 6 million yuan, respectively, will be provided based on 40% of the actual R&D costs. Among these, for products entering the Guangdong Provincial or National Special Review Procedure for Innovative Medical Devices, the maximum subsidy amounts may be increased to 4 million yuan and 7 million yuan, respectively.The cumulative annual subsidy for each institution under this provision shall not exceed 18 million yuan.

Article 14: Support for the R&D of Health and Wellness Products

　　(1) Support for Health Food R&D

　　For entities that have obtained a health food registration certificate and meet the eligibility criteria, a subsidy of 600,000 yuan will be granted for each health food registration certificate obtained. The cumulative annual subsidy for each institution under this provision shall not exceed 6 million yuan.

　　(2) Encouraging the Registration of Foods for Special Medical Purposes

　　For entities that have obtained a registration certificate for foods for special medical purposes and meet the eligibility requirements, a subsidy of 2 million yuan shall be granted for each such certificate obtained. The cumulative annual subsidy for each institution under this provision shall not exceed 10 million yuan.

Article 15: Support for Cosmetics R&D

　　(1) For entities that obtain a Special-Use Cosmetic Registration Certificate issued by the NMPA for the first time and meet the eligibility requirements, a subsidy of 600,000 yuan shall be granted for each certificate obtained. The annual cumulative subsidy for each institution under this provision shall not exceed 6 million yuan.

　　(2) For new cosmetic ingredients that are registered for the first time, applied in cosmetics, and included in China’s List of Cosmetic Ingredients in Use, a one-time subsidy of 1.2 million yuan shall be granted for each such ingredient. The cumulative annual subsidy for each institution under this provision shall not exceed 6 million yuan.

Chapter VI: Optimizing the Industrial Development Ecosystem

Article 16: Supporting High-Quality Development of Industry-Academia-Research Collaboration

　　Support high-quality health and wellness enterprises in conducting industry-academia-research cooperation within the cooperation zone. Encourage such enterprises to collaborate with research institutes and medical institutions (including tertiary hospitals or national regional medical centers) within the zone. A matching subsidy of 1:1 will be provided based on the funds invested by the enterprise in industry-academia-research cooperation projects, with a maximum subsidy of 8 million yuan per project. The cumulative annual subsidy for each entity shall not exceed 24 million yuan.

Article 17: Support for the Construction of Industrial Service Platforms

　　(1) Support the development of Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), and Contract Development and Manufacturing Organizations (CDMOs). Provide support for the construction of specialized technical service platforms for drug screening, drug synthesis, drug toxicology research, efficacy evaluation, laboratory animal services, new drug regulatory submissions, third-party testing (related to drug, medical device, and health product R&D),industrial pilot production and manufacturing, MAH comprehensive services, and big data services for drug R&D. A one-time subsidy of 40% of the total project investment will be provided, with a maximum subsidy of 36 million yuan.

　　(2) A one-time reward of 300,000 yuan shall be granted to laboratories that obtain accreditation from the China National Accreditation Service for Conformity Assessment (CNAS) for the first time.

Article 18: Support for Existing Industrial Service Platforms

　　(1) For established and operational public service and specialized technical platforms in the biomedicine and healthcare sector, a subsidy of 20% of the contract value corresponding to services actually provided and received by institutions within the cooperation zone and Macao partner institutions (with no investment relationship with the platform) in the previous year shall be granted, with an annual cumulative subsidy not exceeding 12 million yuan.

　　(2) Institutions within the Cooperation Zone that utilize the services of the aforementioned platforms shall receive a subsidy equivalent to 20% of the contract value for the services actually purchased. The maximum annual subsidy per institution shall not exceed 1 million yuan.

Article 19: Support for Clinical Medical Institutions

　　Clinical medical institutions that obtain certification under the National Good Clinical Practice (GCP) standards shall be granted a subsidy of up to 6 million yuan, equivalent to 40% of the total project investment; an additional reward of 600,000 yuan shall be granted for each new GCP-certified specialty. The cumulative annual subsidy and reward for each institution shall not exceed 12 million yuan.

Article 20: Support for Biopharmaceutical and Healthcare Industry Activities

　　For industry associations with significant influence established in the Cooperation Zone, starting from the year following their establishment, an annual subsidy of up to 1 million yuan will be provided based on the activities conducted in the previous year, at a rate of 20,000 yuan per event.

Article 21: Support for the Development of Talent Training Bases

　　Support is provided to institutions within the Cooperation Zone for conducting training programs for talent in the biopharmaceutical and healthcare sectors. This includes training in R&D technology and production processes, registration, application, and regulatory policy, biopharmaceutical research methods and practices, quality standards research, as well as specialized training in corporate management, intellectual property protection, and investment and financing. A subsidy of up to 1 million yuan per year will be provided, covering 50% of the actual training costs incurred.

Article 22: Subsidies for Environmental Impact Assessments and Hazardous Waste Disposal of R&D Facilities

　　(1) Support for Environmental Impact Assessments of R&D Facilities

　　For R&D facilities that have passed comprehensive environmental impact assessment (EIA) approval, if an eligible R&D project housed within the facility requires the preparation of an EIA report, the lessee may receive a subsidy of up to 50,000 yuan per project—equivalent to 30% of the EIA service fees—after obtaining the project’s EIA approval and completing acceptance filing. The annual cumulative subsidy for each institution shall not exceed 200,000 yuan.

　　(2) Subsidies for Hazardous Waste Disposal Costs

　　Support is provided to institutions within the cooperation zone that commission qualified professional agencies to handle pharmaceutical waste and wastewater. A subsidy of up to 50% of the actual service fees incurred will be granted, with an annual maximum of 200,000 yuan per institution.

Chapter VII Supplementary Provisions

Article 23 Application Requirements

　　The subsidy amount eligible for an applicant is determined based on the number of on-site R&D personnel and the amount invested in industrialization.

Article 24: Transition from Previous Policies

　　These Measures shall take effect on January 1, 2025, and remain valid until December 31, 2027.

　　For enterprises applying for R&D expense categories under these Measures, if R&D expenses incurred prior to January 1, 2025 are involved, the earliest retroactive date shall be January 1, 2022—the effective date of the previous policy, “Several Measures of the Hengqin Guangdong-Macao Deep Cooperation Zone to Support the High-Quality Development of the Biomedical and Healthcare Industry” (Yue-Ao Shen He Zhi [2022] No. 59)—in accordance with specific provisions.

Article 25: Eligibility Requirements for Applicants

　　The beneficiaries of these measures are independent legal entities that are legally registered and operating in the Cooperation Zone and engaged in business related to the biomedicine and healthcare industry.

Article 26: Registration of Applicant Entities

　　To ensure effective rolling management of policy funds, entities applying for these measures must promptly log in to the Hengqin Guangdong-Macao In-Depth Cooperation Zone Business and Public Service Platform (https://ycfz.hengqin.gov.cn) or other platforms designated by the Cooperation Zone Economic Development Bureau to file their physical office address. These measures apply only to entities that have completed the filing process.

Article 27: Principles of Application

　　While enjoying the incentives and subsidies under these Measures, applicant entities may still apply for other policy support and preferential treatments from the national or Guangdong provincial governments, except where such support is funded or matched by the Cooperation Zone’s finances or where otherwise specified;

　　Where these Measures overlap or intersect with other policies issued by the Cooperation Zone or with similar policies required by higher-level authorities to be funded or co-funded by the Cooperation Zone’s finances, the applicant entity shall choose one policy to apply for and may not submit duplicate applications, unless otherwise specified;

　　The “subsidy” provisions in these Measures apply only to projects funded by the applicant’s own capital or self-raised funds.

　　Article 28: The Economic Development Bureau of the Cooperation Zone shall be responsible for interpreting these Measures, formulating implementation rules, and organizing their implementation.