How Lecheng, Hainan Navigates the Implementation of State Council Decree No. 818 on Biomedical New Technologies

The “Promotion Provisions” officially came into effect on February 1 this year. Through exploration and pilot initiatives, Boao Lecheng has established a clear pathway for translating policy documents into tangible, implemented projects.

At the conference, Dai Xiaolong noted that as the number of project applications surged from just a few at the beginning of the year to over 200 in April and May, Boao Lecheng promptly adjusted its strategy and established a more refined selection mechanism to better identify high-quality projects. Dai revealed that three selection meetings have been organized to date, focusing on three technical areas: treatment of diabetes and its complications, treatment of neurodegenerative diseases, and management of degenerative joint diseases or injuries. A total of 21 projects were reviewed.

Currently, Boao Lecheng has clarified four access pathways: obtaining clinical trial approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and advancing to Phase II clinical trials or beyond; filing with the Medical Research Registration and Filing System of the National Health Commission and completing investigator-initiated trials (IITs) that demonstrate safety and efficacy; receiving approval from drug regulatory authorities in ICH member countries to enter Phase II registration clinical trials or beyond; and having already been approved for commercial use overseas.

Next, Boao Lecheng will focus its selection on seven key areas of breakthrough biomedical technologies: improving reproductive function, treating liver injury, treating hereditary anemias, preventing tumor recurrence, treating lung injury, treating refractory tissue injuries, and treating tumors.

According to Dai Xiaolong, Lecheng has preliminarily established a baseline approval rate of approximately 30% for each disease area. However, he emphasized that “selection is not a one-off transaction,” and all projects undergo a dynamic adjustment process.

Notably, Lecheng has also established mechanisms for clinical follow-up evaluation and exit.

“We have found that some projects, after approval, cannot be effectively implemented or fail to achieve satisfactory results, becoming ‘zombie projects,’” said Dai Xiaolong. “For such projects, exit procedures will be initiated subsequently.” This dynamic management approach, featuring both entry and exit mechanisms, ensures that limited medical resources are directed toward truly valuable projects.

Addressing the industry’s most pressing concern regarding the relationship between Boao Lecheng policies and national regulations, Dai Xiaolong provided a clear answer: “What Lecheng aims to achieve is a dual-track approach for technologies and pharmaceuticals, allowing them to run in parallel and even switch between each other.”

This differentiated positioning is particularly evident in the application of real-world data. Dai Xiaolong revealed that at a recent conference, Boao Lecheng officially proposed incorporating real-world studies on new biomedical technologies into national pilot programs. “We have currently launched 13 technology projects, with Hainan providing free database establishment for each enterprise and organizing expert guidance on data collection, aiming to generate high-quality real-world evidence.”

By comparing the Regulations, the Lecheng Promotional Provisions, and their respective implementation measures, Dai Xiaolong highlighted several key differences: in terms of regulatory hierarchy, the national Regulations delegate authority to county-level health commissions, whereas in Lecheng, approvals are granted by the Provincial Health Commission and the Drug Administration, with the Lecheng Drug Administration responsible for supervision; regarding institutional access, national requirements mandate that clinical studies be conducted at Grade A tertiary hospitals, while Lecheng requires “capabilities equivalent to those of a Grade A tertiary hospital” rather than strict accreditation; concerning liability subjects, the national framework emphasizes the sponsor’s responsibility, whereas in Lecheng, the medical institution serves as the primary liable party.

Meanwhile, Dai Xiaolong emphasized that there is a time window: “The external environment is still awaiting the implementation of many detailed rules under the national regulations, which will likely only become clear around May next year when they come into effect.”

“This has provided Boao Lecheng with a valuable period for exploration. ‘Regardless of national regulations, Lecheng’s positioning is clear: it serves as the nation’s pilot zone for pioneering initiatives,’ said Dai Xiaolong. ‘During this process, an implicit understanding has emerged: Lecheng leverages these years to conduct exploratory efforts while strictly standardizing regulatory oversight before, during, and after project implementation.’”

Next, Lecheng will focus on three key priorities: accelerating technical review of projects, strengthening disciplinary medical capabilities, and promoting industrial implementation. Regarding the technical review of projects, related work will not stall but will instead be accelerated. Meanwhile, the assessment of project disciplines will be treated as a top-priority issue; a detailed list will be developed in the future to clearly outline various medical institutions and their key disciplines, enabling enterprises to precisely match with the appropriate institutions based on their own technologies. However, for certain high-risk technologies, such as some gene-editing techniques, not all institutions with relevant disciplines will be permitted to conduct them. Initial exploration may be carried out by institutions with public healthcare backgrounds, and once risks are deemed controllable, these technologies will be gradually extended to other institutions.

Dai Xiaolong also announced the mid-term development goals for Lecheng: First, strengthen medical capabilities and attract public Grade A tertiary hospitals to establish a presence in Lecheng. Second, closely monitor developments in national implementation rules and promptly adjust Lecheng’s own regulations accordingly. Third, introduce and support a cohort of large, well-capitalized enterprises making significant investments in Lecheng, facilitating their research and development of new biomedical technologies in the broader health sector. Fourth, enhance communication and collaboration with the National Medical Products Administration (NMPA) to strive for the early inclusion of real-world study data on new biomedical technologies from Lecheng into the pilot program.

Long-term development goals are equally clear: first, to adjust the scope of new biomedical technologies in a timely manner based on actual conditions, while simultaneously advancing real-world studies; second, to establish a comprehensive and standardized regulatory framework for new biomedical technologies, form professional regulatory teams, and position Boao Lecheng as a highland for the cell and gene therapy (CGT) industry; third, within the realm of medical regulation, to develop healthcare institutions that align with Lecheng’s development positioning, meet the requirements of the National Health Commission, and deliver high-quality medical care; and fourth, to seek approval from the State Council to amend relevant regulations, thereby establishing a green channel for Lecheng.