Key investment points
Event: on January 6,] the State Food and Drug Administration issued the new version of drug production quality management specification – appendix to cell therapy products (Exposure Draft). The draft formulates the specifications of cell therapy products from seven aspects: personnel, plant and facilities, supplier and supplier material management, materials and products, production management, quality management and product traceability system. This exposure draft inherits the provisions of the 2019 version on the management of donors and donor materials, quality assessment and audit of medical institutions by enterprises, product traceability system, etc. at the same time, some contents are revised and public comments are solicited from the society.
Compared with the previous version, the draft for comments is mainly revised in the following aspects:
\u3000\u30001. The draft for comments strengthens the management specification of key materials for cell therapy. For the first time, the draft will include gene modified vectors or other starting biological materials directly used in the production of cell products (including viruses, plasmids, RNA, antigen peptides, antigen proteins, protein RNA complexes, etc.) into the scope of application of GMP regulations. The draft requires enterprises to conduct risk assessment on materials; The determination of the above key materials shall be recorded; Carry out incoming inspection for key materials, and consider specific risks and other measures to reduce risks (such as strengthening quality control); Keep samples of key materials within their validity or shelf life.
\u3000\u30002. This opinion draft further improves and refines the laws and regulations. Compared with the previous version of GMP, the draft for comments has been refined or adjusted in the following three aspects: 1) the qualification standards for the person in charge of production and the person in charge of quality have been appropriately relaxed. The draft for comments has deleted the requirements for their work experience and retained only the requirements for their professional knowledge; 2) Further clarify the concepts related to cell therapy production, such as the division standard of batches; 3) The detailed rules for the implementation of some complex production problems have been improved, such as the workshop division of multiple batches / multiple autologous products / autologous and allogeneic products from one source, the specific conditions and methods for reducing the retention of samples of finished cell products, etc. The above amendments effectively improve the enforceability of laws and regulations and facilitate enterprises to carry out compliant production.
Cell therapy industry chain will benefit widely. Overall, the revised appendix of GMP cell therapy is clearer and more reasonable, which is conducive to promoting the rapid development of the industry. Suggestions: 1) cell therapy equipment providers Truking Technology Limited(300358) , Tofflon Science And Technology Group Co.Ltd(300171) , Zhejiangtailin Bioengineering Co.Ltd(300813) ; 2) Cell therapy cdmo enterprise Yaoming biology, Kingsley biotechnology, boten biology, etc; 3) Cell therapy Enterprises: mingjunuo, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , legendary biology, Keji pharmaceutical, Genxi biology, Yongtai biology, Xinda biology, reindeer medical, boshengji, etc.
Risk tips: the progress of R & D and commercialization of new products does not meet expectations, the market payment ability is weaker than expected, the production quality management risk of cell therapy products, and the risk of deterioration of industry competition pattern.
