FirstinClass ",as its name implies, is the first new drug model. According to the definition of FDA, granting a class of drugs refers to drugs that use a brand-new and unique mechanism of action to treat a certain disease. This is a completely innovative method and the first drug that can treat this disease. In the declaration of NMPA, it should also belong to 1. 1 class. Along with "FirstinClass", "orphan medicine" is often mentioned. But in fact they belong to different classification methods. "FirstinClass" is classified according to the global drug research and development progress, and "orphan drugs" are classified according to the indications of drugs. Orphandrug refers to a drug specially used to treat rare diseases. 1983, the United States promulgated the orphan drug act, and in 20 17, the FDA of the United States continued to launch the modernization plan of orphan drugs. The Orphan Drug Development Office (OOPD) of FDA recognizes orphan drugs, gives them special preferential policies and extends patent protection. It can be said that most orphan drugs may be "Class I" drugs, but "Class I" drugs not only overlap with orphan drugs.