On June 11, 2018, the new anti-Alzheimer's 2.2 drug Huperzine A Controlled Release Tablets ( FN12), obtained the clinical trial approval issued by the State Drug Administration, and was allowed to enter the clinical trial, the approval number: 2018L02643. At present, there is no Huperzine A controlled-release tablet product for clinical use in China.

As early as 2016, Wanbond Pharmaceutical facilitated the Shanghai Institute of Materia Medica, Chinese Academy of Sciences to sign a technical achievement transfer and industrialization cooperation agreement on the research and development project of a new anti-Alzheimer's drug-Huperzine A controlled-release tablet. The acquisition of the clinical trial approval for the new drug marks a major breakthrough in the research and development of innovative drugs by Wanbangde.

Huperzine A is a highly efficient, highly selective, and reversible acetylcholinesterase inhibitor derived from the traditional Chinese herbal medicine Huperzina serrata. It is clinically used in the treatment of benign memory impairment and Alzheimer's disease in my country. The traditional way of taking huperzine A twice a day leads to poor compliance in patients with Alzheimer's disease (AD), and in view of the wide distribution of the drug target acetylcholinesterase in the central and peripheral regions, it is clinically enhanced by increasing the dose. Efficacy strategies are often accompanied by an increase in peripheral cholinergic side effects, which restricts the increase of the dose of Huperzine A and the exertion of its efficacy.

In order to further improve the efficacy, safety and compliance of the drug in AD patients, under the guidance of Academician Tang Xican, Gan Yong's research team and Zhang Haiyan's research team aimed at the limitations of huperzine A peripheral plasma drug burst release and relatively short half-life. Combined with the two characteristics of the slow elimination pharmacokinetics of Huperzine A and its slow dissociation pharmacodynamics of central acetylcholinesterase, a new type of Huperzine with independent intellectual property rights was designed and developed to meet the needs of fine spatiotemporal regulation. Alkaline A fast/controlled biphasic controlled release tablet. Through preclinical pharmacokinetics, pharmacodynamics, and toxicology studies, it was confirmed that the new preparation significantly reduced the burst release effect of Huperzine A, maintained stable drug release, significantly prolonged drug maintenance time and efficacy maintenance time, and reduced peripheral choline Can side effects. Therefore, Huperzine A controlled-release tablets are expected to achieve multiple goals such as improving compliance, long-acting, and reducing toxicity, and have a good drug prospect.

The research and development process of Huperzine A controlled-release tablets has also received strong support from Li Chuan's research group and Zhong Dafang's research group at the Drug Metabolism Research Center of Shanghai Institute of Materia Medica. The research and development process of this project was also funded by the new drug research and development project of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.