Tandospirone

As a common mental disorder, anxiety disorder has long been limited by the disadvantages of excessive sedation and high addiction risk in traditional clinical medication. The advent of tandospirone provides a safer option for the treatment of such diseases. As a new generation of azaspirodecanedione anti-anxiety drug, it can selectively agonize 5-hydroxytryptamine 1A receptors and regulate the excessively high 5-hydroxytryptamine activity to exert anti-anxiety effects. Meanwhile, it has minimal impact on neurotransmitters such as dopamine and norepinephrine, and causes no obvious addiction or withdrawal reactions. Clinically, it is mainly used for anxiety states caused by various neuroses, as well as anxiety states associated with somatic diseases such as essential hypertension and peptic ulcer. It is especially suitable for people with chronic anxiety who require long-term medication, and can also be used as an adjuvant therapeutic drug for depression.

The global market size of anti-anxiety drugs maintains steady and continuous growth. Among them, tandospirone, with its advantage of lower adverse reactions, has achieved a market growth rate higher than the overall average level of anti-anxiety drugs in recent years. In terms of the domestic market, the hospital sales of tandospirone exceeded 1.2 billion yuan in 2023, with a compound annual growth rate of 17.2% in the past three years. At present, the domestic preparation market is shared by the original research product and 3 domestic generic drug enterprises. After the implementation of volume-based procurement, the price of preparations has dropped significantly, which further drives the rapid rise in demand for upstream API. A number of domestic pharmaceutical enterprises have laid out the R&D and registration of APIs for this variety.

The original research enterprise of tandospirone is Sumitomo Pharma of Japan, with the trade name "Sediel". Its core compound patent in Japan expired in 2011, and the original compound patent in China also expired in 2011. The main dosage forms approved by the original research are tablets, with specifications of 5mg and 10mg. This product has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also listed in the FDA Reference Preparations Catalogue. Up to now, nearly 10 domestic enterprises have obtained CDE registration numbers for tandospirone APIs, among which 6 are in A status. Tandospirone tablets from the original research enterprise and a number of generic drug enterprises have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of tandospirone impurity reference standards, covering the needs of the whole research chain including synthesis process impurities, degradation impurities, enantiomers, etc. Most of the products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of different scenarios such as API R&D, quality research, and registration declaration.