Tiropramide

For the clinical treatment of anxiety disorders, highly selective GABA_A receptor modulators have always been the core direction for optimizing medication safety. Remimazolam is a third-generation non-benzodiazepine anxiolytic, which exerts anxiolytic effects by selectively acting on the α2/α3 subunits of the GABA_A receptor. It not only retains definite anxiolytic efficacy, but also avoids the common adverse reactions of traditional benzodiazepines such as sedation, muscle relaxation, addiction and cognitive impairment. It is mainly used for the long-term treatment of generalized anxiety disorder in adults, and can also assist in improving the acute symptoms of patients with social anxiety disorder, especially suitable for the patient population who need long-term medication and have high requirements for maintaining work status.

At present, the global market size of anxiolytic drugs has exceeded 60 billion US dollars, among which the annual compound growth rate of highly selective non-benzodiazepine drugs remains at 8.2%, which is significantly higher than the average growth rate of the category. As a new generation of representative variety in this细分领域, remimazolam is still in the early stage of commercialization worldwide, and its core patents are still under the protection period. Only the original research enterprise has achieved large-scale production, and domestic pharmaceutical enterprises are intensively promoting the R&D and clinical declaration of generic drugs. In the future, with the expiration of patents and the expansion of indications, the market penetration space is expected to reach more than 3 billion yuan.

The original research enterprise of remimazolam is Boehringer Ingelheim, Germany, and the original research trade name is Remimazolam (the general dosage form is remimazolam for injection). The expiration time of its core compound patent in Europe and the United States is 2032, and the expiration time of the compound patent in China is 2033. At present, the main approved dosage form is injection, with specifications of 5mg and 20mg. The original research preparation has been included in the FDA Orange Book Reference Preparation Catalog, and has not been included in the *Catalog of Reference Preparations for Chemical Drugs* in China for the time being. There is no approved remimazolam preparation on the market in China, and the API registration platform has not yet publicly announced a valid API registration number in A status. (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 remimazolam, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the reference standard needs of the whole process of drug R&D, quality research and declaration.