On October 16, 2021, the “Academic Annual Conference of NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan and Regulatory Science Summit on Clinical Research, Evaluation and Commercialization” was kicked off in Hainan.

The opening ceremony of the event was attended by heads and experts of related organizations and departments including Li Lanjuan, Zheng Shusen and Liu Liang, academicians with the Chinese Academy of Engineering, Mao Zhenbin, former first-class inspector with the Technology and International Cooperation Department of National Medical Products Administration, Qu Jia, president of Eye Hospital of Wenzhou Medical University, Wang Kunjie, vice president of West China Hospital of Sichuan University, Gu Gang, Party committee secretary and director of Lecheng Pilot Zone, Jia Ning, Party group secretary and director of Hainan Healthcare Security Bureau, Li Wenxiu, a Party group member and deputy director of Hainan Health Commission, Zhu Ning, Party group secretary and director of Hainan Medical Products Administration, Liu Zhefeng and Lv Xiaolei, both a Party committee member and deputy director of Lecheng Pilot Zone Administration, and Song Haibo, deputy director of the Important Monitoring and Evaluation Department of Center for Drug Evaluation, NMPA. The event was also attended by another 400 experts and scholars from every field, who discussed and explored the great blueprint for the development of real-world studies.

In January 2021, the NMPA released a “Notification on the Accreditation of the Second Batch of Key Laboratories”, formally approving the establishment of the nation’s only “NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan” (the Key Laboratory), which signified that real-world study and its application have received more and more attention from the national competent departments and industries.
Based on West China Hospital of Sichuan University, the Key Laboratory is built, managed and shared by West China Hospital, Boao Super Hospital and the Adverse Drug Reaction Monitoring Center of Lecheng Pilot Zone, which aims to “keep the foothold in Hainan and cover the whole nation”, take Boao Lecheng as the test field, and innovate the real-world study practice, so as to make a series of research achievements unique to Hainan Free Trade Port and provide a strong technical support for China to “take the lead in the world” in real-world data applications.

At the site, academician Li Lanjuan, academician Zheng Shusen, academician Liu Liang, Mao Zhenbin, Qu Jia, Wang Kunjie, Gu Gang, Jia Ning, Liu Wenxiu, Zhu Ning, Lv Xiaolei and Sun Xin went onto the platform to announce the formal establishment of the Key Laboratory.

Academician Li Lanjuan was appointed as director of the Academic Committee of the Key Laboratory and Professor Sun Xin was appointed as director of the Key Laboratory.

After the completion ceremony, Li Lanjuan delivered a speech on behalf of the Academic Committee. She said, with the favorable special policies, Lecheng Pilot Zone had introduced over 170 new drugs and medical devices from abroad and generated a lot of real-world data. The NMPA attached a lot of importance to it, and these real-world data will be taken as the valid data for the approval of new drugs and medical devices, and real and reliable standards are required. The Key Laboratory has very excellent statistical analysis talents that can better develop standards and boost the development of real-world studies in China. “I’m convinced that in the future Lecheng will become a hot region in China and even the world. It will develop rapidly and make bigger achievements, I hope.”

Academician Zheng Shusen introduced, Real-world Study Consortium for Hepatobiliary & Pancreatic Diseases will take Boao Lecheng as a practice base for studies, launch real-world studies for new drugs and medical devices and absorb international cutting-edge technologies and advanced diagnosis and treatment strategies. Based on the real-world study practice of each member organization and Chinese big data platform for hepatobiliary and pancreatic diseases, it will develop a supporting system for clinical decision-making and keep improving China’s capacity in clinical studies, diagnosis and treatment of aforesaid diseases to satisfy the clinical needs of patients and enable them to use international innovative drugs sooner.

Academician Liu Liang delivered a keynote speech with the title of “R&D and Post-marketing Re-evaluation of Zheng Qing Feng Tong Ning, a New TCM Drug for Treatment of Rheumatoid Arthritis”. He believed that some requirements must be met for Chinese medicines to go global. First, treat the intractable diseases. Second, curative effects must be confirmed and recognized internationally. Third, production quality and safety must be good. Fourth, chemical structure is unique and the mechanism of actions is clear. Fifth, scholars of the world pay wide attention to and participate in clinical researches, and obtain real-world data on clinical efficacy as per international standards. “We have worked hard in this direction all the time. I believe that in the future, real-world studies on Chinese medicines can also be carried out in Lecheng to accelerate their marketing progress and boost the development of TCM industry.”

Gu Gang, Party committee secretary and director of Lecheng Pilot Zone Administration, delivered a speech and said, Lecheng had become a symbol of Hainan Free Trade Port in the field of international medicines and taken the lead in the studies and uses of innovative medical products. The precondition is that the NMPA has spared no effort to support the real-world studies at Lecheng. “I am convinced that with the support and participation of everyone, the Key Laboratory will become an important basis of real-world studies in Lecheng. It signifies that Lecheng not only can provide medicines and medical advice and hopes to the patients, but also can make achievements and breakthroughs in scientific research. Every step signifies that Lecheng has become closer to the goal of becoming an international first-class medical tourism destination.”

Zhu Ning, Party group secretary and director of Hainan Medical Products Administration (HMPA), pointed out, since the establishment of the Key Laboratory, under the guidance of the National Medical Products Administration (NMPA), the HMPA and Lecheng Pilot Zone Administration had gone all out to support related work to go on smoothly around the national development goal of regulatory science for medical products. A series of achievements have been made to provide a strong technical guidance for scientific regulation. It’s believed that with the concerted efforts of all parties such as regulators, industrial and academic communities and medical institutions, real-world studies will become a new engine for the development of medical industry and allow more patients to share the services in the construction of Hainan Free Trade Zone.

Professor Wang Kunjie, vice president of West China Hospital of Sichuan University, delivered an opening address on behalf of the member organizations of the Key Laboratory and the hosting units of the event. He said, as a supporting institution for the Key Laboratory, West China Hospital of Sichuan University will continue to firmly stand behind the Key Laboratory and promote the innovation of regulatory system and mechanism closely around the major strategic demands of the state and based on the national development strategy of Hainan Free Trade Port. Based on the policy advantages of the National Pilot Base for Medical Products Regulatory Innovation Base and technologies in data, technology, talent, team and platform, it will launch integrated scientific studies in an effort to contribute more wisdom and schemes to the high-quality development of real-world data study, application and commercialization in China.

Later, Sun Xin, director of the Key Laboratory, delivered a report with the title of “Promoting the Construction of the Key Laboratory”, briefly introducing for the leaders and experts the functional positioning, running mechanism, management system of the Key Laboratory, the composition of its academic committee and leadership, the development of its core technical team and core expert database and the achievements made in the current stage, and the construction and development goals of the Key Laboratory in the future.

After the completion ceremony, the real-world study consortia for infectious diseases, hepatobiliary & pancreatic diseases, medical examination, eye diseases, respiratory system diseases and tumors were established, which were respectively initiated by academicians of Chinese Academy of Engineering Li Lanjuan, Zheng Shusen and Shang Hong, president Qu Jia of Eye Hospital of Wenzhou Medical University, president Li Weimin of West China Hospital of Sichuan University, vice president Cai Jianqiang of Tumor Hospital of Chinese Academy of Medical Sciences.

The initiator of each consortium made a brief speech to introduce the participating organizations of the consortium, development direction and construction goals, and the expectation to cooperate sincerely with the participating organizations, experts and scholars to promote the establishment of an ecosystem for scientific and real-world studies in related disciplines and fields, and ultimately fully promote the generation and commercialization of high-quality real-world data in various fields.

The signing ceremony of the strategic agreement
At the site of the event, the “strategic agreement between the NMPA Key Laboratory for Research and Evaluation of Eye Disease Medical Products and the NMPA Key Laboratory for Real-world Research and Evaluation in Hainan” was signed formally. The supporting institutions agreed to co-build a nationally leading professional and research-based key laboratory, with an aim to provide science and technology support for the visual health of the people in the region and nationwide.

Finally, the four-party strategic agreement of Lecheng Pilot Zone Administration, Eye Hospital of Wenzhou Medical University, and Key Laboratory for Real-world Research and Evaluation in Hainan & real-world study launch event for OcuMension low concentration atropine were held successfully. Under the tenet of resource sharing and collaborative development, each signing party will promote Lecheng to a top base for medical R&D and commercialization and join hands to promote the scientific implementation of real-world study for the low-concentration atropine eye drop OT-101 independently developed by OcuMension, and boost the research and production of drugs for delaying the short-sight development of children in China.
Other members that attended the opening ceremony included Li Qiu, president of Children’s Hospital Affiliated to Chongqing Medical University, Li Li, president of the First People’s Hospital of Kunming, Qin Lunxiu, vice president of Fudan University Huashan Hospital, Shang Hongcai, executive vice president of Dongzhimen Hospital of Beijing University of Chinese Medicine, Yang Yang, vice president of Third Hospital Affiliated to Sun Yat-Sen University, Xie Wei, vice president of Zhongnan Hospital of Wuhan Univeristy, Wang Li, director of National Drugs Pre-clinical Safety Evaluation Center, and Han Xiaoxu, deputy director of National Medical Examination and Clinical Research Center.
The event was guided and supported by National Medical Products Administration, Hainan Medical Products Administration, Lecheng Pilot Zone Administration and West China Hospital of Sichuan University, hosted by NMPA Key Laboratory for Real-world Research and Evaluation in Hainan, Chinese Cochrane Center of West China Hospital of Sichuan University, Sichuan Center of Technology Innovation for Real World Data and West China Branch of ISPOR, and co-organized by Chengdu Big Data Association, Boao Lecheng Real-world Study Innovation Center and Boao Lecheng Pilot Zone Institute of Development.