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In the fierce competition of global pharmaceutical research and development, the development of orphan drugs has always faced enormous challenges due to their targeting of rare diseases and relatively small patient populations. However, the existence of the orphan drug qualification recognition mechanism has brought a glimmer of hope for these drugs that are committed to overcoming the challenges of rare diseases. The orphan drug recognition mechanism established by the US Food and Drug Administration (FDA) provides a series of policy support, such as accelerated approval and tax reductions, to encourage pharmaceutical companies to invest in the research and development of orphan drugs. Since the beginning of this year, multiple domestically produced innovative drugs have stood out and successfully obtained FDA orphan drug qualification certification, shining brightly on the international pharmaceutical stage.