The number of stem cell clinical research projects in China ranks second in the world. In the China Clinical Trial Registry (ChiCTR), searching with "stem cells" as the keyword, as of September 2024, it can be retrieved that more than 100 medical institutions and 738 stem cell clinical research projects have been successfully registered in ChiCTR, and 38 stem cell clinical research projects have been successfully registered in ChiCTR in 2024.

China's stem cell clinical research has entered a period of vigorous development, including the Beijing-Tianjin-Hebei region represented by Beijing, the Yangtze River Delta region represented by Shanghai, the Pearl River Delta region represented by Shenzhen, the free trade pilot zone represented by Hunan, and the "medical special zone" represented by the Hainan Boao Lecheng International Medical Tourism Pilot Zone, etc.

These regional clusters are making their own efforts to actively seize the commanding heights of the biomedical industry. The Beijing Municipal Government regards stem cells as an important strategic emerging industry during the "14th Five-Year Plan" period. Shanghai has taken diversified measures to steadily promote the development of the stem cell field with policy dividends as the guide. The Shenzhen Municipal Government strongly supports the development of stem cell technology at the policy level...

Among them, Hainan Boao Lecheng International Medical Tourism Pilot Zone is the only national medical special zone in the country, with the policy advantages of "franchised medical treatment, franchised research, franchised operation, and franchised international medical exchange" granted by the state.

In December 2024, Hainan passed the "Promotion of New Biomedical Technologies in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port" (hereinafter referred to as the "Regulations"), which once again strongly supported the transformation and application of new biomedical technologies such as stem cells from the policy and regulatory level. The "Regulations" have a total of 28 articles, covering key links such as clinical trials, transformation applications, and price applications, and will come into effect on February 1, 2025.

Hainan has always been the vanguard in promoting the transformation and implementation of new biotechnologies such as stem cells. As early as 2013, the State Council approved the establishment of the pilot zone and granted it nine policy dividends (also known as the "National Nine Articles"), including the ability to apply for cutting-edge medical technology research projects such as stem cell clinical research; in 2019, the state again issued a document to support the pilot zone to apply for stem cell clinical research and transformation application, also known as the "New National Nine Articles"; in June 2020, Hainan legislated to support medical institutions in the pilot zone to conduct new technology research and transformation application such as stem cells in the region, namely the "Pioneer Zone Regulations".

Industry insiders pointed out that the latest bill is one of the most substantive government regulations in the field of cell therapy in China. It injects strong policy impetus into cutting-edge biomedical technologies such as cell therapy in the form of law, and may even have a far-reaching impact on the development of the entire medical and health industry.

▍The new regulations relax the qualifications of medical institutions and propose government pricing and charging

Stem cell technology is one of the hottest tracks in the current biomedical field. However, there is a "gray area" in the industry. Some practitioners take the opportunity to fish in troubled waters, make false propaganda, exaggerate the efficacy, advocate the dream of longevity, and disrupt the healthy development of the industry.

The Regulations clearly point out that the pilot zone will focus on supporting the clinical research and transformation application of new biomedical technologies such as cell therapy, gene therapy, and tissue engineering.

However, no specific indications are set in the Regulations. As for whether anti-aging research is supported, some clues may be found in the regulations that have been issued.

The Regulations do not explicitly mention the application of stem cells in anti-aging research, and the specific attitude is still unknown. However, according to the previously issued "Regulations on the Pilot Zone" and "Draft Regulations" and other bills, it can be seen that the pilot zone strongly supports the research and application of stem cell technology and does not deny the field of anti-aging research. Therefore, it can be inferred that the pilot zone supports the reasonable and scientific promotion of stem cell anti-aging research and achievement transformation.

Huang Guojun, director of Hainan Qiyan Stem Cell Anti-Aging Hospital, told Health World that just as each drug has corresponding indications, the same is true for stem cell therapy, and different therapies are suitable for different indications. The Regulations support the use of stem cells in a variety of diseases and health fields. Although the indications are not specified in detail, as a local regulation, it is a guiding document, and the relevant indications will be standardized and further clarified in the form of supporting detailed rules. In countries or regions where the dual-track management is being implemented rapidly, the trends of technology research and clinical trials are consistent.

At the same time, Article 16 of the Regulations specifies in detail the situations in which new biomedical technologies cannot be clinically applied, Article 17 points out the need to strengthen the evaluation and supervision of the clinical application of new biomedical technologies, and Article 26 clarifies the handling methods for violations of these regulations. These regulations are conducive to the legal and reasonable clinical research and transformation of new biomedical technologies such as stem cells, and to clear up the chaos in the development of the industry.

The new law also clearly stipulates the qualifications of the initiating medical institutions. The above research in the pilot zone needs to be carried out in medical institutions with Class III Class A capabilities. These institutions need to have diagnosis and treatment subjects and professional departments that are suitable for the application of the transformation and application of new biomedical technologies, so as to standardize and promote stem cell clinical research. Participating companies need to register in the Lecheng Pilot Zone and have independent legal person status.

In this regard, Huang Guojun explained that in fact, the new law adapts to the current trend of hospital transformation. Now many hospitals are turning from large and comprehensive to specialized and refined, and corresponding adjustments have been made to hospital qualifications.

Previously, medical institutions engaged in stem cell clinical research or institutions conducting clinical trials of stem cell drugs were required to conduct them in Class III Grade A hospitals. This time, the Regulations have adopted more flexible support measures for medical institutions. Instead of imposing relevant rigid conditions of Class III Grade A hospitals, they are required to benchmark the standards of Class III Grade A hospitals, improve the level of specialty construction of institutions, and thus improve their comprehensive service capabilities.

It is worth mentioning that the new regulations have clarified the issue of cell therapy costs that people are generally concerned about for the first time. The Regulations clearly point out that the pricing costs are controlled by the government. After the approval of the transformation and application of new biomedical technologies, medical institutions in the pilot zone should apply for price filing with the provincial medical insurance and health and health authorities. After the competent authorities complete the price filing, they should make it public to the society. Medical institutions in the pilot zone charge according to the publicized prices and accept social supervision.

"I think that proposing charges is a relatively big change compared with previous relevant regulations. Previously, some regions have proposed pricing for stem cell therapy, but it was mainly the relevant competent authorities in some regions that gave charging guidance to large hospitals in their jurisdiction for local technologies and certain indications. The new bill turns the exception into a government guidance standard." Huang Guojun said.

Of course, the establishment and implementation of each guiding standard means that the competent department has done a lot of basic work in the early stage, and it also means that the supervision and management means are becoming more and more refined, scientific and intelligent. It can be opened up in accordance with laws and regulations, and it can also be controlled in accordance with laws and regulations. Huang Guojun said that this is an improvement in technology, diagnosis and treatment, information, management and other aspects, and it is also an improvement in the understanding of new things from medical practitioners to the public.

▍Trial first, it is expected to be implemented nationwide in the next 1-2 years
Looking back on the development of my country's stem cell industry, it has gone through different stages from chaos to zero to restart and rapid development:
From 2007 to 2012, China regulated stem cell therapy as a "medical method" rather than a "drug", which caused a chaotic situation;
In January 2012, the former Ministry of Health stopped all stem cell treatment activities in mainland China;
From 2004 to 2012, the 10 stem cell new drug registration applications accepted by the former State Drug Administration were also cleared, and the development of stem cell drugs in mainland China returned to the starting point;
In 2018, the State Drug Administration clarified that cell products can be registered and regulated according to the drug review procedures, and began to accept new INDs for stem cell therapies.

This is an important turning point, indicating that China will restart the clinical application of stem cell therapy and point the way for the development of domestic stem cell new drugs.

At present, stem cell research in mainland China implements a "dual track system". Stem cell products are managed as drugs, and the filing management system for stem cell clinical research continues to be retained, forming a management system of "double supervision" by drug regulatory departments and health management departments.

That is, the health management department supervises stem cell clinical research, and relevant clinical research institutions and clinical research projects must be filed before research can be carried out; the drug regulatory department supervises the registration of clinical trials for new stem cell drugs, obtains clinical trial licenses in accordance with the clinical trial implied licensing system, and completes exploratory and confirmatory trials of new drugs before submitting a listing application.

Huang Guojun pointed out that "it is necessary to clearly distinguish between cell medical technology activities and cell drug research and development. Hainan Province's previous relevant policies and the latest bills issued are all aimed at stem cell clinical research and transformation applications conducted by medical institutions, rather than the declaration of stem cell drugs."

This is also consistent with previous data. According to statistics, since the implementation of the implied clinical trial authorization system (IND) for new stem cell drugs in China in 2021, Shanghai, Beijing, and Guangdong Province have occupied half of the research and development of new stem cell drugs, and there are currently no research and development companies in Hainan Province that have obtained IND stem cell drugs.

Will the new law have an impact on stem cell clinical research and drug development? What specific changes will it bring?

"The law is currently a local behavioral standard. As for the impact on the stem cell clinical research and drug development industry, it depends on the specific implementation in the future." Yu Shukai, Operation Director of Jiuzhitang Meike, pointed out to the health industry that the pilot zone mainly plays a demonstration role of trial and error.

Huang Guojun said that the main role of the new law is to demonstrate and lead, and regulate the development of the industry. For stem cell drug development, although the overall impact is limited, it will still have a certain promoting effect.

"One of the biggest advantages of Lecheng is that it is the location of a cluster of medical institutions. It can cooperate with domestic and international biotechnology companies to complete preclinical and clinical research. The data obtained can support or help biotechnology companies apply for IND. These will help increase the approval of domestic stem cell drugs and promote the rapid listing of drugs." Huang Guojun said.

For example, the new law mentions that real-world data can provide data reference for stem cell drugs to be listed in China. Article 18 stipulates that if a biomedical new technology that is approved for transformation and application applies for drug clinical trials and complies with relevant national regulations, the obtained transformation and application results can be submitted as technical application materials for reference in drug registration applications.

The new law also stipulates the issue of charges, that is, the government clearly proposes pricing and charging information and carries out relevant pilot work. Huang Guojun believes that this has achieved a legal basis, and the research and application of new technologies and new businesses within the legal framework will help standardize and promote the standardization and scientificization of stem cell research, reduce chaos in the stem cell industry, and explore a reasonable industry development model.

In his opinion, as the pilot progresses, if it progresses well, it may be implemented in other regions across the country with corresponding medical levels, medical capabilities, and customer resources in the next 1-2 years.

Yu Shukai also added, "Clearly defining the charges will indeed help standardize the development of the industry and explore the industry's profit model. More importantly, it is a breakthrough, and it is a step forward for the entire industry. After setting this precedent, I believe that other free trade zones will follow up and promote it in the future."

"This is indeed an important change from the policy level to promote cutting-edge medical technologies such as stem cells from the exploratory and experimental stage to the standardized application stage. To a certain extent, it shows the government's determination to further increase its support for the stem cell industry, and it is also a recognition of the maturity and safety of existing technologies. With the advancement of the pilot work, I believe that in the near future, it is likely to show a trend of sparks igniting the prairie fire." A stem cell practitioner told Health World.

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