Core Viewpoint - The approval process for the first domestically developed Alzheimer's drug, "Jiuyiqi" (Glycyrrhizin Sodium Capsules), has encountered significant setbacks, indicating challenges in the drug's re-registration and the broader difficulties in Alzheimer's drug development in China [1][7]. Approval Challenges - "Jiuyiqi" was conditionally approved in November 2019 for treating mild to moderate Alzheimer's disease, but its re-registration application has not been approved, as indicated by the absence of an approval number in the recent notification from the National Medical Products Administration (NMPA) [1][3]. - The NMPA requires companies to submit a new application for re-registration, and "Jiuyiqi" has faced scrutiny regarding its clinical trial data and the adequacy of its ongoing studies [2][3]. Industry Context - The drug's approval difficulties reflect a global challenge in Alzheimer's drug development, primarily due to the unclear pathogenic mechanisms of the disease and the complexities involved in clinical trials [7][8]. - The pricing of "Jiuyiqi" has made it a more accessible option for patients compared to imported alternatives, which can cost significantly more [7]. Controversies and Legal Issues - "Jiuyiqi" has been surrounded by controversy regarding its efficacy and the reliability of its clinical trials, leading to public debates and legal disputes among key figures in the scientific community [4][5]. - Despite the controversies, the drug was included in the national medical insurance directory, highlighting its perceived value in the market [6]. Future Prospects - The future of "Jiuyiqi" and its potential re-registration remains uncertain, as the company must provide additional data to support its application [7][8]. - The case of "Jiuyiqi" serves as a significant example in the history of original drug development in China, illustrating the complexities and challenges faced by pharmaceutical companies in the Alzheimer's treatment landscape [7][8].