1、研究背景：

我国生物医用材料市场巨大，但民族产业发展整体上仍处于“中不敌洋”的被动局面，技术含量高的产品市场长期由进口产品主导。受制于整体产业的高风险、高投入，社会资本往往徘徊不前。目前，国内的科研力量和成果不断向世界一流靠拢或达到国际领先，为我国在较高的起点上实现产业跨越式发展提供了机遇，急需建立以临床及市场需求为导向的科研开发与转化平台、整合产学研医专业人

员进行技术攻关、吸引与引导社会资金投入，打造全创新链一体化产业发展新途径。

2、研究目标：

充分利用广东省及大珠三角区在生物材料产业发展方面的优势，围绕生物材料科学基础、材料与植入器械的后续工程化和技术集成等领域开展前瞻性基础研究和技术创新及产业化，建成专业人才汇聚、机制创新、多学科交叉的国内一流科研与应用开发推广平台。以我国学者提出的生物适配创新理论及技术为驱动核心，针对临床上的典型疑难问题研发多种新型组织修复材料，推动创新产品基础研究、工程化、性能和质量评价、临床试验等一体化发展。设立“生物医用材料与植入器械产业投资基金”，由国家和地方政府资金引，募集社会资金，实现创新企业孵化与产业集群汇聚。

3、研究内容：

（1）生物适配型组织修复材料创新技术平台建设

（2）生物适配型组织修复材料工程化技术平台建设

（3）新型生物医用材料检测评价平台建设

（4）新型生物医用材料与器械临床转化及推广平台建设

4、拟解决的重大科学问题或关键技术问题：

针对传统的材料生物相容性理念和临床疗效之间的不适配共性问题，阐明新型组织修复材料在典型病理环境下的生物适配机制，发展以生物适配创新理论为核心的生物医用材料功能化设计与制造创新技术体系，建立适合新型生物材料和产品特性的安全、有效性评价技术和标准规范，确立针对临床疑难病症的动物模型及临床实验规范。

5、研究思路和方案：

与广东省共建，由国家级研发平台等牵头建设创新科技和工程化平台，形成创新驱动源头，由国家级生物材料检测中心和医疗机构联合高校和科研院所搭建创新检测评价平台和CFDA认可的临床试验中心，通过资深投资基金平台及其优秀的专业投融资管理团队与各方合作设立产业投资基金，引导技术转化，在与地方政府共建的协同创新研究院实现企业孵化，达到产融结合及全创新链一体化发展，形成具有示范效应和产业集聚作用的创新基地。

6、研究基础和团队：

申报单位华南理工大学拥有国家人体组织功能重建工程技术研究中心、省部级重点实验室；建有“新型生物医用材料及其组织修复”学科创新引智基地，形成面向海内外开放的创新研究平台。与东莞市人民政府共建华南协同创新研究院，为企业孵化提供了政策和场地的充分保障；中国科学院深圳先进技术研究院建有中组部“千人计划基地”及科技部创新人才培养示范基地,是国内海归密度最高、国际化学术交流氛围最好的研究机构之一,并涵盖了中科院上海硅酸盐研究所和中科院金属研究所的相关成果转化。中国食品药品检定研究院是我国“四品一械”检定、标准研究和制定权威机构，在医疗器械综合性能评价及风险研究方面处于国内领先地位。参与单位还拥有广东省医学生物力学重点实验室（南方医科大学）和广东省骨科学重点实验室（中山大学）。前海和骏投资基金管理有限责任公司及其关联公司和团队在包括大健康等领域已累计经手股权投资案例数百宗，涉及资金超百亿元。华南理工大学作为首席科学家单位完成的国家“973”项目在国际上首次提出了生物适配的理念，已开发一批新型生物医用材料，为本项目顺利执行奠定了坚实的基础。

7、预期成果和效益：

本项目将建成国际领先生物材料科技创新平台，生物材料检验评价中心及临床试验中心，并吸引海外联合研发团队；研发10-20项新一代生物材料和植入器械及其工程化技术；孵化15家以上新型生物材料企业；培养一批创新人才，构建产、学、研、医、金（融）相结合的创新模式，引领产业集聚，发挥示范作用。

1. Research background:

my country's biomedical materials market is huge, but the overall development of national industries is still in a passive situation of "China lost to foreign countries", and the market for products with high technology content has long been dominated by imported products. Subject to the high risk and high investment of the overall industry, social capital often lingers. At present, the domestic scientific research strength and achievements are constantly moving closer to the world-class or reaching the international leading position, which provides an opportunity for my country to realize the leap-forward development of the industry from a relatively high starting point. It is urgent to establish a clinical and market demand-oriented scientific research development and transformation platform. 、Integrate industry-university-research medical professionals

Staff to carry out technical research, attract and guide social capital investment, and create a new way for the development of the whole innovation chain integrated industry.

2. Research objectives:

Make full use of the advantages of Guangdong Province and the Greater Pearl River Delta Region in the development of the biomaterials industry, and carry out forward-looking basic research and technological innovation and industrialization in the fields of biomaterials scientific basis, subsequent engineering and technology integration of materials and implanted devices, etc. Build a domestic first-class scientific research and application development and promotion platform with professional talents gathering, mechanism innovation, and multi-disciplinary crossover. Driven by the innovative theory and technology of biological adaptation proposed by Chinese scholars, develop a variety of new tissue repair materials for typical clinical problems, and promote the integration of basic research, engineering, performance and quality evaluation, and clinical trials of innovative products. developing. The "Biomedical Materials and Implantable Device Industry Investment Fund" will be established, which will be led by national and local government funds to raise social funds to realize the incubation of innovative enterprises and the convergence of industrial clusters.

3. Research content:

(1) Construction of innovative technology platform for biocompatible tissue repair materials

(2) Construction of engineering technology platform for biocompatible tissue repair materials

(3) Construction of new biomedical material testing and evaluation platform

(4) Construction of a platform for clinical transformation and promotion of new biomedical materials and devices

4. Major scientific problems or key technical problems to be solved:

Aiming at the common problem of incompatibility between traditional material biocompatibility concepts and clinical efficacy, clarify the biological adaptation mechanism of new tissue repair materials in typical pathological environments, and develop biomedical materials centered on the innovative theory of biological adaptation Functional design and manufacturing innovation technology system, establish safety and effectiveness evaluation technology and standard specifications suitable for new biological materials and product characteristics, and establish animal models and clinical experiment specifications for clinically difficult diseases.

5. Research ideas and plans:

Co-constructed with Guangdong Province, the national R&D platform will lead the construction of innovative technology and engineering platforms to form the source of innovation, and the national biological material testing center and medical institutions will join universities and scientific research institutes to build innovative testing and evaluation platforms and CFDA accreditation The clinical trial center, through the senior investment fund platform and its excellent professional investment and financing management team, cooperates with all parties to set up industrial investment funds, guide technology transformation, realize business incubation in the collaborative innovation research institute jointly built with local governments, and achieve industry-finance Combined with the integrated development of the whole innovation chain, an innovation base with demonstration effect and industrial agglomeration effect will be formed.

6. Research foundation and team:

The applicant South China University of Technology has the National Human Tissue Function Reconstruction Engineering Technology Research Center and the provincial and ministerial key laboratories; it has established an innovation and intelligence base for the discipline of "new biomedical materials and tissue repair", forming an innovative research platform open to domestic and overseas. . The South China Collaborative Innovation Research Institute is jointly established with the Dongguan Municipal People's Government, which provides full guarantee of policies and venues for business incubation; the Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences has established the "Thousand Talents Program Base" of the Organization Department of the Central Committee and the training demonstration of innovative talents of the Ministry of Science and Technology. The base is one of the research institutions with the highest density of returnees and the best atmosphere for international academic exchanges in China, and covers the transformation of relevant achievements of the Shanghai Institute of Ceramics, Chinese Academy of Sciences and the Institute of Metal Research, Chinese Academy of Sciences. The China National Institute for Food and Drug Control is an authoritative organization for the verification, standard research and formulation of "four products and one device" in my country, and is in a leading position in China in the comprehensive performance evaluation and risk research of medical devices. The participating units also own the Guangdong Provincial Key Laboratory of Medical Biomechanics (Southern Medical University) and the Guangdong Provincial Key Laboratory of Orthopaedic Science (Sun Yat-Sen University). Qianhai Hejun Investment Fund Management Co., Ltd. and its affiliated companies and teams have accumulated hundreds of equity investment cases in fields including big health, involving funds exceeding 10 billion yuan. The national "973" project completed by South China University of Technology as the chief scientist unit put forward the concept of biological adaptation for the first time in the world, and has developed a batch of new biomedical materials, which has laid a solid foundation for the smooth implementation of this project.

7. Expected results and benefits:

This project will build an international leading biomaterial technology innovation platform, a biomaterial inspection and evaluation center and a clinical trial center, and attract overseas joint R&D teams; develop 10-20 new-generation biomaterials and implantable devices and their engineering technologies; incubate 15 It is a new type of biomaterials enterprise with more than 10,000 people; it cultivates a group of innovative talents, builds an innovative model combining production, learning, research, medicine, and finance (finance), leads industrial agglomeration, and plays an exemplary role.