Boao Lecheng's 'Product + Evidence' Synergy: Launching 100 Cutting-Edge Innovations with Real-World Research Accelerating Clinical Evaluation of Novel Therapeutics and Devices

In Boao in November, the sound of the tide resonates with applause.

On November 21, the inaugural Hainan Boao Lecheng Global Innovative Drugs and Medical Devices Expo (hereinafter referred to as the “Expo”) opened in the Lecheng International Medical Tourism Pilot Zone. The Expo featured numerous highlights, with the centralized launch of 100 internationally innovative drugs, medical devices, foods for special medical purposes, and new biomedical technologies. These included many “first-of-their-kind” achievements, such as innovative drugs for small cell lung cancer and the world’s first intelligent cochlear implant system, covering multiple frontier fields including oncology treatment, AI-assisted diagnosis and treatment, and cell therapy.

Real-World Studies (RWS) are increasingly applied in the regulation of pharmaceuticals and medical devices, serving as a vital bridge between clinical needs and industrial innovation. On the second day of the expo, November 22, the 4th Boao International Conference on Real-World Studies for Pharmaceuticals and Medical Devices (hereinafter referred to as the “RWS Conference”) was held under the theme “Real-World Studies Facilitating Clinical Evaluation of Innovative Pharmaceuticals and Medical Devices.” The event brought together more than 700 industry leaders from international organizations, domestic and foreign regulatory agencies, renowned medical institutions, top-tier academic institutions, and multinational pharmaceutical and medical device companies. Participants discussed new concepts in regulatory science, shared cutting-edge scientific achievements, and contributed to the advancement of global health.

The Boao Lecheng International Medical Tourism Pilot Zone has taken shape and gained momentum, emerging as a premier hub for the aggregation, demonstration, and innovation of cutting-edge international medical technologies and innovative pharmaceuticals and medical devices. It serves not only as a “window” for the high-level opening-up of the Hainan Free Trade Port but also as the preferred destination for domestic patients seeking access to advanced international treatments.

The consecutive holding of two major conferences has created a profound “product + evidence” resonance in Boao Lecheng. The former demonstrated Lecheng’s capacity to attract and cluster global innovative drugs and medical devices, while the latter highlighted its ability to export standards as a source hub for real-world studies.

As many attendees noted, under the historic opportunity presented by the Hainan Free Trade Port’s island-wide customs closure operations, Boao Lecheng has become not only China’s “Medical Special Zone” but also a key node in the global pharmaceutical innovation network. The two conferences have concluded, but the story of Lecheng continues.

At the opening ceremony of the expo, two ceremonies were held first.

Preparatory Launch Ceremony Held for the Expert Committee on the Introduction of Innovative Pharmaceutical and Medical Device TechnologiesThe committee will establish 12 specialized subcommittees covering oncology, rare diseases, neurology, hepatobiliary and pancreatic surgery, cardiology, rheumatology and immunology, ophthalmology, otolaryngology, respiratory medicine, dermatology and medical aesthetics, reproductive health, and special foods. The initiative aims to bring together authoritative academicians and experts from various fields to fully leverage their advisory and technical support roles. This will facilitate more scientific decision-making in the introduction of innovative pharmaceuticals and medical devices, ensure more precise alignment with clinical needs, and thereby enhance the overall efficiency and sustainability of these efforts.

In Boao Lecheng, the introduction and application of innovative drugs and medical devices are no longer subject to prolonged waits. Instead, efficient approval processes and scientific decision-making mechanisms have enabled a rapid transition from “availability overseas” to “clinical use domestically.” The launch of preparatory work for the Expert Committee on the Introduction of Innovative Drugs and Medical Devices marks a more scientific and precise step forward by Lecheng in promoting the adoption of such innovations. Comprising 12 specialized subcommittees, the committee brings together authoritative experts from various fields, providing robust intellectual support and technical assurance for the introduction of innovative drugs and medical devices.

At the conference, the White Paper on the Introduction and Use of Internationally Innovative Drugs and Medical Devices in the Hainan Boao Lecheng International Medical Tourism Pilot Zone was released for the first time. This white paper covers aspects ranging from international approval of drugs and medical devices, special licensed introduction, and application of real-world data, to localized production and future introduction plans, thereby helping to achieve “zero time lag” in global medical innovation.

The “Light of Innovation” Awards Ceremony for Pharmaceuticals and Medical Devices was held concurrently, featuring multiple awards including the “Pioneering Trial” Breakthrough Innovation Award, the “Light of Life” Clinical Value Award, the “First Use in China” Market Pioneer Award, the “Boao Lecheng Partner” Best Collaboration Award, and the “Boao Lecheng Partner” Contribution Award for Agency Introduction, to honor entities that have achieved outstanding results in the field of medical innovation.

Furthermore, in alignment with the specialized strengths of various medical institutions, the conference established 14 parallel sessions across facilities in the Boao Lecheng International Medical Tourism Pilot Zone. These sessions focused on precise exchanges in key areas such as oncology, rare diseases, hepatobiliary and pancreatic surgery, and neurological disorders. Additionally, two satellite meetings—the “China Innovative Drugs and Medical Devices Global Expansion Matchmaking Session” and the “2025 Global Launch and Investment Promotion Conference for Innovative Drugs and Medical Devices”—were held. Leveraging the advantages of the Hainan Free Trade Port’s international trade and investment platform, these events created a targeted platform for industrial resource matchmaking and academic exchange, further reinforcing Lecheng’s role as a bridge connecting China with global markets.

The two-day expo, themed “Converging Global Innovative Technologies to Build a Healthy Future for Humanity,” brought together government representatives, medical institutions, research institutes, university experts, and corporate delegates from both China and abroad. Academicians Wei Yuquan of the Chinese Academy of Sciences and Wu Yuzhang of the Chinese Academy of Engineering attended the opening ceremony.

Among the medical experts in attendance were over a hundred authoritative figures from China and abroad, including Dr. Tan Huay Cheh, Fellow of the American College of Cardiology and Chairman of the National Heart Foundation Singapore; Professor Zhang Shu from Fuwai Hospital, Chinese Academy of Medical Sciences; Professor Qu Jia, Director of the National Clinical Research Center for Ophthalmology and Otolaryngology, as well as Chairman and Dean of the Hainan Lecheng Real-World Data Research Institute; Professor Yang Shiming, President-Elect of the Otolaryngology Branch of the Chinese Medical Association; Professor Zhang Xuejun, Director of the Institute of Dermatology at Huashan Hospital, Fudan University; Professor Sun Haixiang, Director of the Center for Reproductive Medicine at Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School; Professor Yang Xiaoguang, Vice Chairman of the Chinese Nutrition Society; Dr. Wang Enmin, Dean of Pengbo (Hainan) Boron Neutron Capture Therapy Hospital; and Professor Chen Shengdi, Lifetime Professor at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.

As China’s sole “medical special zone,” Boao Lecheng’s ultimate goal is to accelerate the introduction and standardized application of innovative global pharmaceuticals and medical devices in China, thereby better meeting the diverse health needs of the public.

This expo is not merely a showcase for products, but also an invitation from Boao Lecheng to the world: it is not only a “showcase window” for medical innovation, but also a “gravitational field” for industrial cooperation.

If the “Boao Lecheng Speed” serves as an accelerator for innovative drugs and medical devices, then real-world research constitutes the “fertile data soil” in which they take root and flourish on this land.

On November 22, the Real-World Research Conference continued its proceedings, shifting the focus from “product introduction” to “evidence generation.”

Centered on the theme “Real-World Research Facilitating Clinical Evaluation of Innovative Drugs and Medical Devices,” the Real-World Research Conference attracted extensive participation from regulatory authorities, renowned medical institutions, and pharmaceutical and medical device companies both in China and abroad. At the conference, real-world data were no longer viewed as cold numbers, but rather served as critical evidence supporting the review and approval of drugs and medical devices, as well as post-marketing surveillance and evaluation.

High-quality data form the foundation of real-world studies. Research in China on using real-world evidence (RWE) from pharmaceuticals and medical devices to support regulatory decision-making originated in Hainan.

Lei Ping, a member of the Party Leadership Group and Deputy Director of the National Medical Products Administration (NMPA), systematically summarized four major achievements from the six-year pilot program on real-world research (RWR) in China. First, product market approval has been accelerated: the Hainan RWR data pilot has facilitated the market launch of a total of 21 products, including 6 pharmaceuticals and 15 medical devices. Second, an evidence rule system has been established, with the NMPA issuing 12 guidelines related to real-world evidence. Third, regulatory science research has been deepened through more than 20 RWR projects, yielding a range of new regulatory tools, standards, and methods. Fourth, a cooperation and exchange platform has been built, notably through the continuous hosting of the Boao Real-World Research Conference and engagement with global regulatory agencies. He pointed out that future efforts will focus on advancing RWR in greater depth, including building a high-quality data foundation, establishing a high-value rule system, expanding multi-dimensional application scenarios, and deepening multi-faceted communication and collaboration.

Ning Guang, an academician of the Chinese Academy of Engineering and president of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, pointed out from a clinical perspective that real-world studies serve as “an important bridge connecting clinical needs with industrial innovation.”

The practice at Ruijin Hainan Hospital is encouraging. On April 1, 2025, isatuximab injection, a hematologic oncology therapeutic agent for the treatment of multiple myeloma (MM), completed its supply rollout in China. It became the first drug in China to be approved by the National Medical Products Administration (NMPA) with key evidence derived from real-world study data collected in the Boao Lecheng International Medical Tourism Pilot Zone.

Ning Guang specifically noted that isatuximab injection, an innovative drug for hematologic malignancies, completed patient enrollment in just 238 days, fully demonstrating the “Boao Lecheng Speed” enabled by its clinical and research model.

The inaugural ceremony for the international journal *Real-World Data and Regulatory Science* was held concurrently with the Real-World Research Conference, marking a critical step in strengthening China’s academic voice in the field of real-world research. This journal will focus on cutting-edge international technologies and case studies where real-world research data supports regulatory decision-making, providing new tools, standards, and methodologies for global regulatory science.

In addition, the conference features 10 sub-forums covering core areas of real-world research (RWR), including pharmaceuticals and medical devices, traditional Chinese medicine (TCM), and new biomedical technologies. It also includes three workshops, specialized training sessions, and a Young Scholars Forum to delve into the methodologies, techniques, and practical applications of RWR. Specifically, the content spans from clinical evaluation of drugs and medical devices to characteristic pathways for RWR in TCM; from AI-enabled data governance to evidentiary challenges posed by emerging biomedical technologies.

A new landscape, driven by real-world evidence studies and accelerating the global openness of innovative drugs and medical devices, is rapidly taking shape on the shores of the South China Sea.