On June 25, the NMPA official website showed that Tonghua Jinma’s Category 1 new drug “Octahydroaminoacridine Succinate” has been approved for marketing in China for the treatment of mild-to-moderate Alzheimer’s disease (AD).
Octahydroaminoacridine Succinate (formerly known as Octahydroaminoacridine Succinate) is a Category 1 chemical new drug developed by Tonghua Jinma Pharmaceutical Group. It is a new chemical entity with original, fully independent intellectual property rights from China and is a key project of the National 13th Five-Year Plan for Major New Drug Development. This drug belongs to the class of acetylcholinesterase inhibitors and possesses dual cholinesterase inhibitory activity, capable of simultaneously inhibiting both acetylcholinesterase and butyrylcholinesterase. In vitro experiments have shown that the inhibitory potency of Octahydroaminoacridine Succinate against both cholinesterases is several times that of conventional first-line drugs, suggesting better clinical therapeutic efficacy.
Alzheimer’s disease is a common neurodegenerative disorder and the leading cause of dementia in the elderly. Currently, the global number of AD patients has exceeded 50 million, imposing a heavy disease burden on patients and their families. Due to the complex pathological mechanisms of AD and the difficulty of drug development, very few drugs for AD have been approved globally in recent years. According to Insight Database statistics, over the past five years (from 2021 to the present), only 3 new AD drugs and 6 modified new drugs have been approved worldwide. The former refers to biologics led by Aβ monoclonal antibodies (lecanemab, donanemab, aducanumab), which are currently only used in early-stage, mild patients, while the latter includes various modified new drugs such as prodrugs, oral dissolving films, and patches. In terms of mechanisms, a total of 11 cholinesterase inhibitors for Alzheimer’s disease have been approved globally, including 3 new drugs and 8 modified new drugs. Among these, the 3 new drugs were approved between 1996 and 2000. The successful approval of Octahydroaminoacridine Succinate marks the first innovative drug targeting cholinesterase inhibitors in China in 20 years.
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