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A large number of investigational new drug (IND) applications of cellular products have been submitted in recent years. Up to October 2022, two cellular products have been approved to be marketed in China, which provide effective therapeutic approach to treat serious diseases. Genetic manipulation systems are used to modify or edit genes in various types of cellular products, including lentivirus, γ-retrovirus, adenovirus, sendaivirus or other viral vectors, as well as DNA, RNA, protein, protein-RNA complex or other non-viral vector systems. A guidance on CMC study and evaluation of ex vivo genetic manipulation systems was issued by CDE, NMPA on May 2022, in order to illustrate criterions on CMC research and evaluation of such systems. This paper provides a detailed interpretation of the guidance, combined with the guidance drafting logic, to help readers better understand the content of the guidance.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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