Idebenone

In the clinical treatment of central nervous system degenerative diseases, mitochondrial function damage has been confirmed as one of the core pathological features of diseases such as Alzheimer's disease and cognitive impairment associated with cerebrovascular diseases. Idebenone, as a mitochondrial metabolism activator, is an important option for the treatment of these diseases. It can activate the respiratory activity of brain mitochondria, improve energy metabolism in the brain, inhibit lipid peroxidation, and reduce oxidative damage to nerve cells. Clinically, it is mainly used for brain function damage caused by chronic cerebrovascular diseases and brain trauma, etc. It can improve mental and behavioral disorders such as subjective symptoms, language, anxiety, depression, memory loss and intelligence decline. It has also demonstrated definite efficacy in the treatment of rare diseases such as hereditary optic neuropathy, covering patient groups including elderly patients with cognitive impairment, patients in the recovery period of brain injury and patients with rare diseases.

At present, the global idebenone market size has exceeded 1.2 billion US dollars, with a compound annual growth rate of 8.2% in the past five years. The growth rate of the Chinese market is significantly higher than the global average, with a compound annual growth rate of 14.7%. The growth momentum mainly comes from the increase in the consultation rate of cognitive impairment diseases and the clinical promotion of rare disease indications. In terms of the competitive landscape, the original research product has long occupied more than 60% of the global market share, and domestic generic drug companies have entered the market one after another. As provincial-level centralized procurement gradually covers this variety, the market share of generic drugs shows a continuous upward trend. At present, Chinese and Japanese enterprises are the main capacity providers of API supply.

The original research enterprise of idebenone is Takeda Pharmaceutical Company Limited of Japan, with the original brand name Avan. Its core compound patent expired in Japan and major European and American markets in 2008, and the compound patent in China expired in 2009. The approved dosage form of the original research product is mainly tablet, with a specification of 30mg. It has been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and is also listed in the FDA Reference Preparation Catalogue. In terms of domestic API registration, more than 10 enterprises have obtained CDE registration numbers for idebenone APIs, among which 7 varieties are registered in Status A. The domestically approved idebenone preparations on the market cover multiple dosage forms such as tablets and ointments. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for idebenone API. Most products support spot supply. Spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in the whole process of R&D, quality control and declaration.