Several Measures to Further Support the High-Quality Development of the Biopharmaceutical and Healthcare Industry in the Hengqin Guangdong-Macao Deep Cooperation Zone
2025-08-12 00:00
Original Title: Notice on Issuing the “Several Measures for Further Supporting the High-Quality Development of the Biopharmaceutical and Healthcare Industry in the Hengqin Guangdong-Macao Deep Cooperation Zone”

To implement the “Overall Plan for the Construction of the Hengqin Guangdong-Macao In-depth Cooperation Zone,” vigorously support the development of Macao-branded traditional Chinese medicine (TCM) industries, accelerate the development of the health industry with a focus on TCM research, development, and manufacturing, strive to build a world-class, distinctive hub for the biomedicine and health industry, and promote the moderate diversification of Macao’s economy, these measures are hereby formulated in light of the actual conditions of the Hengqin Guangdong-Macao In-depth Cooperation Zone (hereinafter referred to as the “Cooperation Zone”).

Chapter I: Support for the Development of Benchmark Projects

Article 1: Support for the Establishment of Benchmark Projects

  Vigorously attract globally competitive industrial projects with strong R&D capabilities and promising growth potential. For projects conducting R&D in the Cooperation Zone’s key support sectors with cumulative new paid-in capital contributions of no less than 10 million yuan, a reward of up to 20 million yuan, equivalent to 10% of the new paid-in capital, shall be granted, disbursed in two installments at a 4:6 ratio.

  Support will be provided for the establishment of high-quality Australian-funded projects in the Cooperation Zone. For Australian-funded projects meeting the requirements of this Article, a reward of up to 20 million yuan, equivalent to 12% of their new paid-in capital, shall be granted, disbursed in two installments at a ratio of 4:6.

Article 2: Support for Increased Investment in Benchmark Projects

  For flagship projects meeting the requirements of Article 1 that construct biopharmaceutical and healthcare laboratories or GMP workshops, a one-time subsidy of up to 5 million yuan will be provided at a rate of 2,000 yuan per square meter.

Chapter II: Enhancing the “Macao-Registered + Hengqin-Produced” Brand

Article 3: Support for “Macao Supervised Manufacturing,” “Macao Supervised Production,” or “Macao Design”

  For biopharmaceutical and healthcare products approved and registered in Macao, manufactured in the Cooperation Zone, and authorized to bear the “Macao Supervised Manufacturing,” “Macao Supervised Production,” or ““Macao-designed” marks shall be granted a subsidy of 20% of the actual production costs (excluding raw material costs; the same applies hereinafter) to the marketing authorization holder’s (or registrant’s, filer’s; the same applies hereinafter) affiliated company in the Cooperation Zone. The subsidy shall not exceed 20 million yuan per product, and the cumulative annual subsidy for each entity shall not exceed 40 million yuan.

Article 4: Support for Enterprises Producing in Hengqin

  For biomedical and healthcare products that meet the requirements of Articles 9, 10, 12, 13, 14, and 15, have obtained approval and registration from the National Medical Products Administration (hereinafter referred to as NMPA), the State Administration for Market Regulation, or the Guangdong Provincial Medical Products Administration, and are manufactured within the Cooperation Zone, a subsidy of 20% of the actual production costs shall be granted to the marketing authorization holder. The maximum subsidy per product is 18 million yuan, and the cumulative annual subsidy for each entity shall not exceed 36 million yuan.

Article 5: Support for Enterprises Obtaining Production Licenses for Biomedical and Health Products

  (1) A reward of 1 million yuan shall be granted to enterprises that obtain a drug manufacturing license (Classes A, B, C, or D) for the first time, or that purchase, transfer, or introduce such a license from outside the Cooperation Zone. If the enterprise meets the following criteria, additional rewards may be stacked:

  1. For enterprises that have obtained the aforementioned drug production licenses, if production commences within 24 months, a reward equal to 40% of the costs incurred for acquiring the license and included under R&D expenses will be granted in the year following the commencement of production. This reward shall not exceed 2% of the enterprise’s annual sales revenue. The annual reward amount shall be disbursed equally over three years: 30% in the first year, 30% in the second year, and 40% in the third year.

  2. The cumulative reward for a single product shall not exceed 20 million yuan, and the annual cumulative reward for each institution shall not exceed 50 million yuan.

  (2) A reward of 500,000 yuan shall be granted for the first issuance of a medical device manufacturing license (Classes II and III);

  (3) A reward of 300,000 yuan shall be granted for the first issuance of a food production license;

  (4) A reward of 200,000 yuan shall be granted for the first issuance of a Special-Use Cosmetics Production License;

Chapter III: Supporting the International Development of Enterprises in Macau and Hainan

Article 6: Supporting the Global Expansion of Biomedical and Health Products

  (1) Encouraging Pharmaceutical Enterprises to Pursue International Registration

  For pharmaceutical enterprises whose products obtain international registration approvals, a one-time subsidy of 50% of the registration fees incurred for each product’s international registration approval will be provided, with a maximum subsidy of 500,000 yuan. If the product results in actual exports, an additional one-time reward of 300,000 yuan will be granted.

  (2) Encouraging Drug License-Out

  For overseas licensing transactions with an upfront payment of 100 million yuan or more (where the parties have no investment or other affiliations), the licensing company shall be granted a subsidy in accordance with regulations. The subsidy amount shall not exceed 50% of the costs incurred for third-party professional services, with an annual maximum subsidy of 6 million yuan.

Article 7: Encouraging the Introduction of New Imported Drugs

  For new drug varieties with exclusive import rights that demonstrate significant clinical advantages and promising market prospects, the marketing authorization holder shall receive a subsidy of up to 30% of the actual expenses incurred per variety, not exceeding 36 million yuan, upon obtaining the NMPA Drug Registration Certificate.

Article 8: Strengthening Quality Standardization Management

  For institutions established in the Cooperation Zone that have passed the China Good Manufacturing Practice (hereinafter referred to as GMP) audit or an international GMP audit (including those from the United States, Japan, Australia, the European Union, the World Health Organization, the Pharmaceutical Inspection Co-operation Scheme (PIC/S), countries along the Belt and Road, ASEAN, and Portuguese-speaking countries), a subsidy of up to 50% of the actual expenses incurred in the Cooperation Zone shall be provided, with a maximum subsidy of 1.2 million yuan.

  Chapter IV: Key Support for the Development of the Traditional Chinese Medicine Industry

Article 9: Support for Traditional Chinese Medicine R&D

  The Cooperation Zone supports the research and development of innovative TCM drugs, improved new TCM drugs, compound preparations based on ancient classic TCM formulas, drugs with identical names and formulas, and TCM preparations:

  (1) Support for the R&D of Innovative TCM Drugs

  1. Independent R&D of innovative TCM drugs is encouraged. A subsidy of 50% of the actual R&D costs will be provided for innovative TCM drugs. For each product that obtains a clinical trial approval and completes Phase I, II, or III clinical trials, a maximum subsidy of 11 million yuan, 14 million yuan, 26 million yuan, and 40 million yuan, respectively, will be granted for each stage. A one-time reward of 15 million yuan will be granted for breakthrough therapeutic drugs that obtain a drug registration certificate.

  2. Encourage the introduction of mature innovative TCM drugs. For the purchase, transfer, or introduction of clinical trial approvals for mature innovative TCM drugs currently in development from outside the cooperation zone, provided that Phase II and III clinical trials are initiated within 12 months, a subsidy of 50% of the actual R&D costs incurred at each stage will be provided, with a maximum subsidy of 26 million yuan and 40 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, equivalent to 40% of the portion of the purchase cost allocated to R&D expenses. The maximum total subsidy for a single product under this provision shall not exceed 91 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 150 million yuan.

  (2) Support for the R&D of improved new TCM drugs. A subsidy of 40% of the actual R&D expenditure will be provided for improved new TCM drugs. For products that obtain a clinical trial authorization and complete Phase I, II, or III clinical trials, the maximum subsidies per product are 3 million yuan, 4 million yuan, 14 million yuan, and 20 million yuan, respectively. The cumulative annual subsidy for each institution under this provision shall not exceed 40 million yuan.

  (3) Support for the R&D of TCM compound preparations based on ancient classic formulas. A subsidy of 40% of the actual R&D costs will be provided for TCM compound preparations based on ancient classic formulas, with a maximum subsidy of 6 million yuan per product. The annual cumulative subsidy for each institution under this provision shall not exceed 12 million yuan.

  (4) Support for the R&D of drugs with identical names and formulas. A subsidy of 40% of the actual R&D costs will be provided for drugs with identical names and formulas, with a maximum subsidy of 500,000 yuan per product. The cumulative annual subsidy for each institution under this provision shall not exceed 2.5 million yuan.

  (5) Support for the R&D of TCM formulations. For TCM formulations developed by medical institutions that have obtained a registration approval number from the Guangdong Provincial Drug Administration or a filing number for traditional TCM formulations, a subsidy of 50% of the actual R&D costs will be provided, with a maximum subsidy of 300,000 yuan per variety. The annual cumulative subsidy for each institution (or contracted R&D institution) under this provision shall not exceed 3 million yuan.

Article 10: Support for the Development of TCM Standards

  (1) The Cooperation Zone supports the research and formulation of new standards for Chinese medicinal materials, Chinese herbal slices, and processing specifications. For standards recognized and included by the Guangdong Provincial Drug Administration, a research institution shall receive a reward of 120,000 yuan per variety; for standards newly included in national standards, a research institution shall receive a reward of 1.2 million yuan per variety.

  (2) Support is provided for the research and formulation of new standards for Chinese medicinal materials, Chinese herbal slices, and processing specifications based on biosynthetic technology or artificial cultivation. For standards recognized and included by the Guangdong Provincial Drug Administration or incorporated into national standards, a reward of 1.2 million yuan will be granted to the research institution for each variety.

  (3) The cumulative annual award for each institution under this provision shall not exceed 5 million yuan.

Article 11: Encouraging the Registration of Traditional Chinese Medicine Products Developed in Hengqin in Macao

  (1) For innovative TCM drugs, improved new drugs, classic formula TCM compound preparations, and drugs with the same name and formula developed in the Cooperation Zone and for which a Macao company affiliated with a Cooperation Zone enterprise has obtained a clinical trial pre-approval or registration certificate issued by the Macao Special Administrative Region Government’s Drug Administration, subsidies or rewards shall be provided at 120% of the standards set forth in Articles 9 and 10, based on the progress of R&D and actual R&D expenditures.

  (2) For independently developed drug varieties that are simultaneously filed in Macao and the Mainland through a Macao company affiliated with an enterprise in the Cooperation Zone, and which have obtained approval from the National Medical Products Administration (NMPA) or the Guangdong Provincial Drug Administration in the Mainland, as well as a pre-clinical trial authorization or registration certificate from the Macao SAR Government’s Drug Administration, the difference between the subsidy standards for Mainland registration and those for Macao registration shall be supplemented. Applicants for this subsidy must have their Mainland registration approvals filed through a company in the Cooperation Zone.

Chapter V: Strengthening R&D Support

Article 12: Support for the R&D of Biologics and Chemical Drugs

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

  1. A subsidy of 40% of the actual R&D expenditure shall be provided for innovative biological and chemical drugs. For products that have obtained a clinical trial authorization or completed Phase I, II, or III clinical trials, the maximum subsidy per product shall be 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 shall 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.

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