To deeply implement the provincial Party committee and provincial government’s strategic decisions on Institute-City integrated development, and fully carry out the key initiatives outlined in the "Henan Provincial Academy of Medical Sciences Development Promotion Regulations," which emphasize supporting the Zhongyuan Medical Science City in pioneering and testing standardized approaches for cutting-edge medical innovations such as cell, immune, and gene therapies, we will accelerate the consolidation of a comprehensive cell and gene industry chain integrating "intelligent manufacturing, resource storage, R&D production, quality inspection services, application translation, and equipment & consumables." This initiative aims to establish the Zhongyuan Medical Science City as a leading hub—both nationally and internationally—focusing on the research, application, and industrialization of cell and gene therapies. These measures are specifically tailored to align with the unique conditions and opportunities of the Aviation Port District.

I. Scope and Methods of Support

(1) Eligible recipients. This measure applies to enterprises, institutions, and other innovative entities with independent legal status that engage in research and development, manufacturing, distribution, and service activities related to cell and gene therapy within the Central Plains Medical Science City—including the International Medical Health Park centered around the South Campus of Zhengzhou University First Affiliated Hospital, as well as the Central Plains International Biotechnology Park. The initiative aims to integrate innovation and industrial resources, supporting the high-level development of specialized parks, cutting-edge platforms, and service hubs dedicated to cell and gene therapy. Key priorities include bolstering the construction of major innovation facilities such as the Central Plains Cell and Immunity Laboratory at the Provincial Academy of Medical Sciences and the Cell Bank at the Provincial Red Cross Blood Center. Additionally, it encourages collaborative efforts among diverse stakeholders to co-create public technology service platforms, positioning these facilities as the province’s central hub for cell and gene therapy storage, preparation, pilot-scale manufacturing, and the commercialization of scientific research outcomes. Ultimately, the goal is to establish a comprehensive, multi-faceted innovation ecosystem and support system spanning the entire value chain—from sample collection and storage to clinical translation and ultimately medical application—thereby driving forward the pilot implementation of medical innovation technologies in the Central Plains Medical Science City.

(II) Redemption Method. The Zhengzhou Airport Economic Comprehensive Experimental Zone Management Committee has established a special fund to support the development of the cell and gene therapy industry in Zhongyuan Medical Science City. The Zhongyuan Medical Science City Management Committee is responsible for drafting implementation details and overseeing their execution.

II. Policy Measures

(1) Support pioneering initiatives to break through barriers in industrial development.

1. Drive breakthroughs in regulatory policies. With the support, guidance, and oversight from relevant departments such as the Provincial Health Commission, the Drug Administration Bureau, and the Medical Insurance Bureau, we will coordinate professional expertise to establish a unified cell standard system covering all stages—from donor screening and sample collection to transportation, storage, cell preparation, quality control, release, clinical trials, and eventual application—ensuring comprehensive, end-to-end traceability throughout the entire lifecycle of biological sample resources. Piloting a "risk-based classification and access management" system for cell and gene therapies at the Central Plains Medical Science City, this initiative will clarify the pathways for translating cell and gene therapy technologies into clinical applications, as well as establish transparent pricing and fee structures. It also aims to encourage real-world studies and foster innovative regulatory models for emerging biomedical technologies. For newly approved cell and gene therapy-related medical service price items, healthcare institutions are encouraged to promptly file and begin implementing these services.

2. Support the development of industry standards. Encourage various innovation entities to lead or participate in drafting international, national, industry, and local standards related to cell and gene therapies, and provide corresponding rewards based on the standard’s level. Specifically: a reward of 2 million yuan will be granted for leading the development and publication of international standards; 1 million yuan for participating in their development and publication. For national standards, the reward is 1 million yuan for leadership and 500,000 yuan for participation. Meanwhile, entities that spearhead the creation and release of industry or local standards will receive rewards of 500,000 yuan and 300,000 yuan, respectively.

(II) Support technology transfer and build a collaborative innovation ecosystem

3. Accelerate the process of innovating, developing, and bringing new products to market. We encourage the development of Class 1 innovative drugs based on cell and gene therapies. For projects that initiate Phase I, Phase II, or Phase III clinical trials in China and commit to achieving commercial production within Zhongyuan Medical Science City, we will provide phased financial support covering 30% of the single-product R&D investment—up to RMB 5 million for Phase I, RMB 10 million for Phase II, and RMB 15 million for Phase III. Additionally, support will be capped at RMB 7.5 million for early-stage clinical trials and RMB 15 million for confirmatory clinical trials. Furthermore, companies that secure "Breakthrough Therapy" or "Orphan Drug" designations from China’s NMPA, the U.S. FDA, or Europe’s EMA will receive a one-time reward of RMB 1 million. Finally, manufacturers receiving a new drug registration certificate and commencing production and settlement within Zhongyuan Medical Science City will be awarded a one-time incentive of RMB 20 million. The total annual support for each entity will not exceed RMB 50 million.

Encourage the development of new medical device and cosmetic ingredients based on synthetic biology and regenerative medicine technologies, intended for applications such as beauty, anti-aging, and tissue repair. A one-time reward of 1 million yuan will be granted for newly approved Class III medical devices, and 500,000 yuan for newly approved Class II medical devices, provided that production and settlement occur at Zhongyuan Medical Science City. A one-time reward of 300,000 yuan will be granted to new cosmetic ingredients that have been registered and filed with the NMPA and successfully included in the *Catalogue of Previously Used Cosmetic Ingredients*. The total annual support for each entity will not exceed 10 million yuan.

For cell and gene therapy drugs newly approved by institutions such as the FDA, EMA, and Japan’s PMDA after development at Zhongyuan Medical Science City—and subsequently granted overseas marketing authorization and successfully launched in relevant international markets—a one-time reward will be provided equivalent to 30% of the product’s actual clinical R&D investment. The maximum annual support amount per entity will not exceed 10 million yuan.

4. Accelerate the clinical translation and application of innovative technologies. Medical institutions within Zhongyuan Medical Science City that are qualified are encouraged to apply for researcher-initiated clinical research projects involving stem cells (somatic cells). Institutions whose projects successfully undergo both national clinical research institution and project registration will receive a one-time reward of 500,000 yuan. Additionally, those completing the clinical studies will be eligible for financial support covering up to 30% of their clinical R&D investment, with a maximum cap of 1 million yuan. Furthermore, institutions whose projects are approved as new medical service price items and subsequently integrated into standard practice will receive a one-time reward of 1 million yuan. Each medical institution can receive cumulative annual support totaling up to 5 million yuan.

5. Promote the local trading and transformation of scientific and technological achievements. For R&D institutions that facilitate technology transfer projects in the fields of cell and gene therapy, as well as synthetic biology—specifically, when a single technology contract involves actual transactions exceeding 1 million yuan between unrelated parties—the institution will receive a reward equal to 5% of the actual transaction value under the technology contract. The maximum annual support amount per institution is capped at 500,000 yuan. Meanwhile, enterprises that adopt and apply these advanced scientific and technological achievements will be rewarded at 10% of the actual transaction value of their respective technology contracts, with a yearly cap of 1 million yuan per enterprise.

(III) Support project clustering and accelerate the development of industrial ecosystems.

6. Accelerate the implementation of major projects. Support breakthroughs in critical areas of the industrial chain—particularly technologies that address "bottlenecks," enable "iterative advancements," or offer "disruptive potential." Encourage the successful localization of independently developed projects that achieve significant milestones and demonstrate strong international competitiveness in fields such as cell and gene therapies, as well as synthetic biology. For projects with actual fixed asset investments (excluding land transfer fees and property purchase costs) reaching or exceeding 20 million yuan, a reward will be provided equivalent to 10% of the actual fixed asset investment. The maximum support per project is capped at 20 million yuan, with support duration not exceeding 3 years. For exceptionally large-scale industry projects—such as those involving Fortune Global 500 companies, top 50 global pharmaceutical firms, or China's Top 100 Pharmaceutical Companies—support criteria may be further enhanced.

7. Support the development of public platforms. We encourage the establishment or expansion of CDMO, GLP, and quality-testing public technical service platforms specifically in the cell and gene therapy sector. These platforms will offer end-to-end, one-stop services covering everything from research and development—including non-registered clinical sample preparation—to safety assessments, integrated IND submissions, clinical trials, GMP-compliant commercial-scale production of clinical samples, quality control, and third-party quality inspection and certification. Additionally, public technical service platforms recognized by the Zhongyuan Medical Science City Management Committee will receive a subsidy equivalent to 30% of their investment in renovation, equipment, and software—capped at RMB 60 million per platform. For cell and gene therapy companies and institutions within Zhongyuan Medical Science City that outsource their R&D and manufacturing activities to approved public technical service platforms (provided these entities are independent of the platforms), a one-time financial incentive will be provided to the commissioning party. This incentive will amount to 10% of the actual contract value (based on bank transfers and invoices)—with a maximum annual reward of RMB 2 million per entity, capped at RMB 10 million cumulatively each year.

(4) Support optimization and strengthening to boost enterprise development momentum.

8. Support the development of breakthrough products. For cell and gene therapy products that achieve annual sales revenues exceeding RMB 100 million, RMB 300 million, RMB 500 million, RMB 1 billion, or RMB 2 billion for the first time, a one-time reward will be provided—calculated as the difference between the current tier and the next higher tier—in the amounts of RMB 300,000, RMB 1 million, RMB 2 million, RMB 4 million, and RMB 6 million, respectively.

9. Encourage the development of science and technology insurance. Commercial insurance companies are encouraged to collaborate with medical institutions and enterprises to create insurance products tailored for the cell and gene therapy sector, including liability insurance for clinical research and trials, product liability coverage, and innovative commercial health insurance options—such as pay-for-performance plans. Eligible companies will receive financial support covering 50% of the actual premium paid per policy, up to a maximum of 500,000 yuan.

III. Supplementary Provisions

1. The Zhengzhou Airport Economic Comprehensive Experimental Zone Management Committee will help enterprises connect with provincial departments such as the Drug Administration, Medical Insurance, and Health Commission. High-quality, innovative products will be eligible for services like an expedited review and approval "green channel." Additionally, if eligible, these companies can also benefit from the Airport Zone's supportive policies on talent, technology, and other areas. Notably, when these measures overlap with existing policies within the zone, support will be provided based on the more favorable terms, ensuring no duplication of benefits.

2. The implementation period for all incentive and subsidy provisions under this measure will commence on January 1, 2025, with payment cycles aligned to the fiscal year. Applicant organizations shall be solely responsible for the authenticity of the submitted materials.

3. This measure is interpreted by the Zhengzhou Airport Economic Comprehensive Experimental Zone Management Committee, with the specific implementation tasks entrusted to the Zhongyuan Medical Science City Management Committee.

4. This measure takes effect from the date of issuance and will remain in force for three years. During this period, should national or Henan Province policies undergo adjustments, this measure will be revised accordingly through the established procedures.