Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to Lecheng Pilot Zone) was approved by the State Council in 2013, focused on the development of related industries of international medical tourism such as licensed medical treatment, prevention and treatment of tumors, health management, rehabilitation care, cosmetic medicine and anti-aging. It aims to make medical technology, devices and drugs keep in pace with international advanced level, build a world-class international medical tourism destination and medical technology innovation platform, and fulfill the three missions of  “letting the Chinese people access the world’s most advanced medical products sooner, promote the development of China’s health industry, boost the reform of medical and health services in China”. Therefore, in November 2020, the Hainan Institute of Real World Data (hereinafter referred to as the Institute) was co-established by the Health Commission of Hainan Province and Lecheng Administration, initiated by Hainan Medical Products Administration. The Institute was approved by the National Medical Products Administration to establish the “NMPA Drug and Medical Device Regulatory Science Research Base”, which is a subordinate body under Lecheng Administration and specialized in real-world studies. As the only “experimental field” of real-world studies of the NMPA, the Institute has brought together the strength of all concerned parties such as regulators, academician teams, clinical institutions, research institutes, medical product enterprises and social groups. Relying on the Lecheng Pilot Zone’s unique policy advantages, valuable practical experience and rich research resources, it is committed to establishing an academic authority in real-world studies of medical products at home and abroad, getting a say in the field of international real-world studies and contributing the “wisdom of Hainan” to the development and innovation of the medical products regulatory science industry in China.

In 2013, the State Council passed nine preferential policies for Lecheng Pilot Zone, which can be summarized as “four licensed issues”. First, licensed medical treatment: licensed market access for medical technology, medical devices and drugs. Second, licensed researches: advanced medical technology research programs such as stem cell. Third, licensed operations: Some medical approval authority is loosened to allow the inflow and operation of foreign capital. Fourth, licensed international exchange: it’s allowed to introduce and establish international organizations and organize international conferences and events. In 2019, four ministries and commissions like the National Development and Reform Commission printed and issued the “Implementation Plan for Supporting the Construction of Boao Lecheng International Medical Tourism Pilot Zone” to provide more preferential policies with a higher value for Lecheng Pilot Zone and national unique policies such as “the qualified clinical application data of some clinically urgently needed imported drugs and medical devices across the pilot zone can be used for the application for registration of medical products”, “real-world data application research will be launched” to promote Lecheng Pilot Zone to achieve breakthroughs in such aspects as construction of an advanced clinical medical center with characteristic technology and a R&D and commercialization base of cutting-edge medical technology. In 2020, the “Overall Plan for the Construction of Hainan Free Trade Port” printed and issued by the CPC Central Committee and the State Council suggested, by 2025, a policy system of the free trade port focused on free trade and investment facilitation. By 2035, it will become a new highland of open economy in China. By the middle of the 21st century, it will be built into a high-level comprehensive free trade port with a strong international influence. As a key park piloting in Hainan Free Trade Port, Lecheng Pilot Zone has taken the initiative to implement policies in such aspects as tax, free trade and investment facilitation of licensed medical products and achieve breakthroughs. With the three preferential policies, Lecheng Pilot Zone has become the only “special medical zone” in China and ushered in new historical development opportunities. Since 2020, it has made “brilliant” achievements in such areas as the application of licensed medical products in sync with the world, 1+X model, system integration and innovation, real-world data trial application, simplification and reform of examination and approval, innovative regulatory mode and global licensed drug insurance, making it an exhibition area of the “early harvests” in the construction of Hainan Free Trade Port and an important window serving the construction of a new development pattern.

Licensed medical products were applied at Lecheng

2. The growing medical institutions

Now there are 17 medical institutions running at Lecheng Pilot Zone, such as Boao Research Based Hospital, Boao Super Hospital, Boao Yiling Life Care Center, Boao International Hospital, and over 20 industrial projects under construction. Among them, the Phase I of Boao Research Based Hospital has 500 beds. The hospital is the first research-based medical institution in China with a mission in clinical studies, integrating medical treatment, scientific research, teaching and prevention, which is built in cooperation with Shanghai Ruijin Hospital and the Medical School of Shanghai Jiaotong University. West China Lecheng Hospital will be completed in September 2022 according to the schedule, with a total floor area of about 65,600 ㎡ and a gross investment of about 700 million yuan. It will introduce 15 top diagnosis and treatment centers from West China Hospital of Sichuan University. Thus far, 52 academician expert teams or first-class clinical specialties have been introduced into the Lecheng Pilot Zone such as academician Li Lanjuan’s clinical center of infectious diseases, academician Zheng Shusen’s clinical center of hepatic-biliary-pancreatic tumors, having signed a contract with 14 academician workstations.

Some medical institutions in the park

3. An expert panel with solid strength

In order to build Lecheng into a new highland of real-world studies, the Institute has invited academician Luo Qingming, president of Hainan University, to serve as honorary president, professor Qu Jia, president of the Eye Hospital of Wenzhou Medical University and professor Chen Pingyan, former director of the department of biostatistics, Southern Medical University as executive presidents, and professor Yao Chen, director of Medical Statistics Office of Peking University First Hospital and professor Sun Xin, director of Chinese Cochrane Center of West China Hospital of Sichuan University as vice president. Through win-win building, the Institute has established a close cooperation relationship with the teams of universities such as the Medical Department of Peking University, the West China Hospital of Sichuan University, Southern Medical University, the Beijing Children’s Hospital Affiliated to Capital Medical University, Hainan University and Wenzhou Medical University to promote the real-world studies together. The Institute has established an academic expert database, gathering dozens of renowned experts and scholars in related fields such as clinic, research methodology, ethics, law, economics and data management. NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan co-established by the Western China Hospital, Sichuan Province Medical Products Administration and Lecheng Administration was approved by the National Medical Products Administration in 2021 and became China’s first key laboratory of real-world studies.

A team of academicians at a medical institution in Lecheng

4. Extensive cooperation with international medical product enterprises

More than 200 innovative medical products have been available in Lecheng Pilot Zone, which have hit domestic market, but have been marketed in developed countries such as Europe, America and Japan. Top 30 pharmaceutical enterprises of the world have launched cooperation with Lecheng, including all of the top ten pharmaceutical enterprises such as Johnson & Johnson, Medtronic, Astellas, MSD, Novartis, Bayer, Roche Group, Merck, Sanofi, Boston Science, Sonova, Cochlea and Menicon. Lecheng has established a deep partnership with these internationally renowned medical product providers. The Ever Lasting International Innovation Medicine Exhibition opened in April 2021 attracted 80 global innovative medical product manufacturers from 16 countries, which exhibited 810 innovative medical products, of which 441 have not hit domestic market, 394 were exhibited in China for the first time, which has basically realized synchrony with the international advanced level in terms of medical technology, devices and drugs.

Some cooperating enterprises with the Ever Lasting International Innovation Medicine Exhibition

Part of the booth map of "Never Ending" International Innovative Pharmaceutical Equipment Exhibition

5. Strong academic exchange atmosphere

By unleashing the platform’s advantages, the Institute has actively launched various academic exchange activities to promote the real-world study capacity and level of China. It has cooperated with regulatory departments, research institutes, academic organizations, medical institutions, societies and associations and industrial and commercial communities to organize various academic activities and events. It has cooperated with medical academic groups and organizations such as the NMPA Centers for Drug and Medical Device Evaluation, Hainan Province Medical Products Administration, the Working Committee on Medicine for Rare Diseases of Chinese Pharmacists Association, Boao Cancer Innovation Institute and Chinese Medical Affairs Conference to organize and host academic forums, experience exchanges, dialogues on practice, training courses, etc. to learn and refer to the practice of the Western countries. Besides, based on the actual conditions of China, they have explored the standards, methods and technical issues in the real-world data application piloting from various dimensions such as theory and practice, system and technology.

Some academic exchanges, training and communication events related with real-world study

6. Fruitful research achievements

On the methodological research of using the real-world data of Lecheng in clinical evaluation, the Institute’s expert team has launched several research programs and made some initial success. It has participated in the drafting of three methodology guiding principles like “Technical Guidance for the Application of Real World Data (RWD) in Clinical Evaluation of Medical Devices (Interim)”, and taken the initiative to finish the “Basic Principles on Supporting the Monitoring and Evaluation of Post-market Drugs with Real World Data” and “Guidance on the Application of Patient-reported Outcomes in Clinical Studies of Drugs” (initial draft). It has published or contributed more than 30 SCI papers and Chinese papers on major journals of the world. In addition, the Institute and Key Laboratory have also undertaken or declared six key majors in the China Medical Products Regulatory Science Action Plan. It’s now organizing the construction of the domestically first regional real-world data platform and preparing for the first Boao International Conference on Real-world Studies of Medical Products.

In the past two years since the piloting program of real-world data application was launched in Lecheng, five medical products have been approved to be marketed by the NMPA through the clinical evaluation assisted with real-world data of Lecheng. They include RET pralsetinib, glaucoma treatment system, CATALYS precision laser system, hot steam treatment device, disposable hot steam prostate treatment apparatus. At present, the fluocinolone acetonide intravitreal implant of EyePoint, the artificial cochlea of Sonova, Trilaciclib for injection also apply for product registration, which are being handled by the NMPA. In addition, six medical devices and five drugs are under pilot study of real-world data application.

7. Quiet and refreshing working environment

The Institute is located at the beautiful Lecheng, next to Wanquan River, blessed with beautiful scenery, a courtyard style working and living environment and complete facilities like kitchen, restaurants, book bar, cafe, gym and basketball courts.

Some working and living environment in the park

8. Majors and training mode

Since 2021, the Institute recruits five doctoral candidates and ten master candidates in three majors, including biomedical engineering, biomedicine and electronic information.

A “dual-tutor system” will be adopted for the graduate education, with tutors from Hainan University and Hainan Institute of Real World Data. The theoretical study will be finished in Hainan University, and the research practice and academic degree paper will be finished at the Institute or renowned universities in China such as Peking University, Sichuan University, Southern Medical University and Wenzhou Medical University where the tutors are working.

Contact number: Zhao Yuanyuan 19927522718