Source: Official website of Guangzhou Municipal People's Government, Guangzhou Daily

The National Development and Reform Commission, the Ministry of Commerce and the General Administration of Market Regulation issued the Opinions on Supporting Guangzhou Nansha to relax Market Access and Strengthen the Reform of the regulatory System. The relaxation of market access includes several aspects, including cell therapy: To support the improvement of management standards for the research and development and application of new technologies for various new drugs and medical devices, to allow cell and gene therapy enterprises to rely on medical institutions to carry out clinical application of restricted cell transplantation therapy technologies after filing with health departments, and to allow qualified Hong Kong and Macao enterprises to use human genetic resources in China to conduct medical research other than human stem cells, gene diagnosis and therapy.

Recently, the official website of the Guangzhou Municipal Government issued an interpretation of the relevant program to clarify the "restricted cell transplantation treatment technology" in the "Nansha Opinion", pointing to cord blood stem cell transplantation treatment technology and allogeneic hematopoietic stem cell transplantation technology.

Related stem cell content is captured as follows:

The New Deal opens a "golden opportunity" for Nansha to "allow cell and gene therapy enterprises to rely on medical institutions to carry out clinical application of restricted cell transplantation therapy technology after being filed by the health department." On January 9 this year, the 45 words in the "Nansha Opinion" aroused the strong attention of stem cell practitioners, rare disease patients and even the capital market, and the industry lamented that "the spring of Nansha health has arrived!"

The "restricted cell transplantation treatment technology" in the "Nansha Opinion" refers to cord blood stem cell transplantation treatment technology and allogeneic hematopoietic stem cell transplantation technology. As an important branch of cell and gene therapy, regenerative medicine with stem cells as the core is called by the scientific community as the third medical technology revolution after drug therapy and surgical treatment. Stem cell technology opens a new way for the treatment of major refractory diseases, and is a new technological peak and a new industrial "track" that countries around the world are competing for.　

Before the introduction of the Nansha Opinion, throughout the country, there is no clear policy to "permit" cell and gene therapy companies to carry out clinical application of restricted cell transplantation therapy technology, and more is a local "encourage" policy. Some patients with rare diseases want to get stem cell treatment, but there is no policy available. "It must be seen that the restrictions are reasonable and necessary to ensure that biomedical and medical devices can be used more safely in humans." Xie Jiasheng, executive president of Guangdong Medical Valley, said that from another point of view, the global stem cell industrialization has entered a period of rapid development, which may be faster than the update of laws and regulations, and this contradiction has limited the rapid transformation of cutting-edge technologies into products and the benefit of the people to a certain extent. Therefore, the opinions and arrangements of the three ministries to support Guangzhou Nansha to relax market access in this field are very timely.　　　

"Nansha has advantages in terms of policy, innovation resources, geographical location and concentration of medical institutions." Xie Jiasheng believes that in the Nansha pilot, the future risk is controllable. He revealed that Guangdong Medical Valley, as a national science and technology business incubator located in Nansha, received information from excellent cell therapy companies across the country as soon as the policy was introduced, many of which are ready to bring cutting-edge scientific research results to Nansha transformation, hoping to make products as soon as possible.

"Many patients who have been reaching out to us because of the lack of treatment options for their diseases are finally seeing the hope of new therapies that are effective, safe and regulated by the government." Jiashan Group chairman Dr. Zhang Wei told reporters. The group, located in Nansha, is a precision medical platform service provider for China's new generation of clinical genomic diseases.

"Many hospital leaders and clinical specialists have also contacted to ask if this policy can be used to provide their patients with a new generation of better therapies and improved quality of life." In addition, the most contacted is the medical industry investment institutions, hoping to accelerate the promotion of industrial landing." Taking this opportunity, Jiashan Group has also accelerated the three business closed loops from the initial focus on clinical genetic screening, to providing clinical genomic disease diagnosis products, and now improving the genomic disease treatment plate.

Zhang Wei lamented that in the past, clinical genomic diseases could only be diagnosed or screened at an early stage. "After finding a child with a problem, what we do our best to ensure is the health of the second child in the family. However, there is a lack of effective treatment for children who have been diagnosed, and they are lifelong patients with the disease, which brings great pressure and burden to families and medical care. This new policy opens a window for effective, supervised treatment for these patients. I believe that domestic biomedical companies will take advantage of the policy to improve the quality of life for patients, promote the development of innovative medical drugs, and win a position in the global industry competition."