National health commission: attach great importance to cell therapy and actively promote related work

The first session of the 13th National People's Congress
Reply to recommendation no. 6238

On behalf of:
Your suggestion on the rapid advancement of cellular immunotherapy in clinical translational application is received. Doing business with State Food and Drug Administration, the reply is as follows:

Cell therapy is one of the important development directions in the future medical field. We attach great importance to it and actively promote related work together with the national drug administration.

1. further improve the immune cell therapy management system

In order to further standardize and promote the development of somatic cell therapy, the commission is working with the state food and drug administration to develop the management measures for clinical research and transformation application of somatic cell therapy, and plans to solicit opinions from the society in the near future. In the process of formulation, the management of somatic cell therapy developed by the medical institution and carried out in the medical institution was conducted by drawing on the experience of record management of stem cell clinical research. At the same time, we will fully absorb the opinions of relevant experts and apply for the clinical trial and marketing license for somatic preparations manufactured according to the guidelines for research and evaluation of cell products (trial) issued by the original state food and drug regulatory bureau in 2017.

2. Strengthen the research and development support of cell therapy and straighten out the way out of products

Our committee has supported a number of pharmaceutical enterprises and research institutes in the major scientific and technological projects of "major new drug creation" and "prevention and treatment of AIDS, viral hepatitis and other major infectious diseases", and carried out research on several car-t technologies, including lung cancer, liver cancer and multiple myeloma. A total of 41.4 million yuan was allocated from the central government budget to support the cultivation and development of relevant innovation teams. A number of car-t research projects have been included in the 2018 project plan of the new drug special project in an open and merit-based way. At present, several domestic enterprises with relatively strong r&d progress will be funded. Outlet for open cell therapy related research and products, at the end of 2017 by commission jointly with the state food and drug supervision bureau issued by the cell products research and evaluation of technical guidelines (trial) ", restart the cellular therapy product research and the application for registration, and the transition to be as a drug, industrialization production conditions required of cell therapy products to make detailed regulations, comply with the relevant provisions of the product listed. Recently, more than 10 cell therapy products will be approved for clinical trials.

3. Improving the technical evaluation ability of innovative biological drugs such as immune cell therapy

By commission in the "major drug discovery" national science and technology major projects of the subject project plan in 2018, China's food and drug verification research institute entrusted to undertake directional topic "innovation biotechnology drug evaluation and standardized key technology research", to establish relevant innovation biotechnology medicine scientific evaluation system, thus crack evaluation technology bottleneck, support for cell and gene therapy drug innovation biotechnology such as standardization of drug evaluation and research, for in accordance with the drug for the treatment of immune cells such as pave the way for the preparation of medicines for management.

Your suggestion is of great significance to promote the development of cell therapy in China. We will carefully study and absorb it and actively promote the above work.

Thank you for your care and support for health care.

National health council