Tonghua Jinma (000766.SZ): The raw materials and formulations of succinyl octahydroaminoacridine tablets have been accepted for marketing by the State Drug Administration

Zhitong Finance App News, Tonghua Jinma (000766.SZ) issued a voluntary disclosure notice on the patent protection status of the national Class 1 chemical drug amber octahydroaminoacridine tablets. Amber octahydroaminoacridine tablets are a novel, potent, cholinesterase inhibitor with a clear mechanism of action. It is a new chemical class 1 drug with completely independent intellectual property rights and a new chemical molecular structure for the treatment of mild and moderate Alzheimer's disease.

The crystal form is an important physico-chemical property of the compound. Amber octahydroaminoacridine is the raw material for amber octahydroaminoacridine tablets. The main crystal forms of amber octahydroaminoacridine were granted in China in October 2020 (“New Crystals, Preparation Methods and Applications of Acridine Derivatives”) and “Cholinesterase Inhibitor Polymorphism and Their Applications” in April 2023.

At the same time, the main crystal forms of successively aminoacridine have been protected by international PCT (Patent Cooperation Treaty) patents, of which a Japanese patent was granted in September 2022. Authorized by Europe in May 2023. The specific countries are the following 15 countries: the United Kingdom, Germany, Switzerland, Sweden, the Netherlands, Denmark, Finland, Belgium, France, Austria, Spain, Norway, Ireland, Greece, and Italy. A US patent was granted in September 2024.

The main crystal protection period of octahydroaminoacridine above is 20 years (calculated from the date of application).

The raw materials and formulations of amber octahydroaminoacridine tablets developed by the company have been accepted for marketing by the State Drug Administration and have entered the review and approval process of the Drug Evaluation Center of the China Drug Administration. There are many uncertainties about the drug review and approval time, approval results, and future product market competition situation.