Research Report on investment in pharmaceutical and biological industry: favorable policies for cell therapy

[chinapharma.com pharmaceutical stock market] the guiding principle of cell therapy was implemented, and the support of CFDA was strengthened: after the full suspension of cell therapy in May 2016, CFDA issued the technical guidelines for research and evaluation of cell products (Draft for comments) on December 16, 2016, which included cell therapy in the drug management approval, and published the drug registration management measures (Revised Draft) on October 23, 2017, It is clearly pointed out that cell therapy can be declared in accordance with the drug, and then the guideline for acceptance and examination of registration of biological products for treatment (Trial) will be published again on November 30 The announcement of the guiding principles is a further improvement of the cell therapy policy, basically ending the transition period from "the third type of medical technology" to "drug" supervision, paving the way for future development Highlight the particularity of cell therapy as a new drug regulation, and repeatedly mention the quality control of cell samples in various stages: the principle points out that cell therapy products are different from small molecule drugs and large molecule biological drugs in terms of composition and mechanism of action, so corresponding guidance is made in risk control, pharmaceutical research, non clinical research and clinical research In the interpretation, the safety research, tumorigenicity / carcinogenicity research, quality control, production process and other matters are also explained and required, highlighting CFDA's cautious attitude towards the safety of cell therapy The test requirements are similar to those of FDA in the United States, with the characteristics of China at the present stage, which greatly benefits the research projects: 1) the clinical trial design is similar to that of FDA in the United States: Article 14 in the interpretation indicates that the clinical trial design of cell therapy is different from that of traditional clinical trials, which can be divided into early clinical trial stage and confirmatory clinical trial stage, which will greatly reduce the time required for clinical trials; 2) Combined with the actual situation in China: Articles 12 and 13 in the interpretation indicate that non clinical trials can be exempted and non registered clinical trial data can be accepted conditionally, which will greatly accelerate the pace of listing of cell therapy products in China At present, many of the research cell therapy projects in China are unregistered clinical trials that have carried out human body experiments If the clinical data can be adopted conditionally and some of the non clinical trials can be exempted, it will greatly advance the listing schedule of domestic research cell therapy products; 3) the main benefit projects of this policy include stem cell therapy, immune cell therapy and gene editing At present, the number of clinical research of car-t cell therapy in China ranks the second in the world As one of the biotechnology with small gap between China and the world, we expect that car-t project will benefit a lot from this policy Investment strategy and focus on individual stocks: considering the R & D and industrialization capacity of cell therapy, we recommend three listed companies: Anke biology, Fosun medicine and Kingsley biotechnology Original title: Research Report on investment in pharmaceutical and biological industry: guiding principles of cell therapy issued, which greatly benefits the projects under research