Remimazolam

The safety and awakening speed of perioperative sedative drugs have always been the core demands in the field of clinical anesthesia. As an innovative short-acting benzodiazepine sedative, remimazolam exerts its sedative effect by acting on γ-aminobutyric acid type A receptors, and has the clinical advantages of rapid onset, fast metabolism, and mild inhibition of respiratory and circulatory functions. At present, it has been approved for indications such as sedation during colonoscopy, induction of general anesthesia, and sedation during intensive care, covering three major scenarios including outpatient endoscopic operations, surgical anesthesia, and ICU care. It is especially suitable for the elderly and vulnerable populations with underlying diseases, which greatly reduces the risk of sedation-related adverse events.

At present, the global remimazolam market is in a stage of rapid expansion. The market size had exceeded 1.8 billion yuan in 2023, with a compound annual growth rate of more than 45% in the past three years. In the domestic market, in addition to the original research product, 3 enterprises have been approved to manufacture generic remimazolam for injection. This variety was included in the 7th batch of national centralized drug procurement in 2022, with the maximum price reduction of the selected products exceeding 80% compared with the original research product, driving the clinical usage to increase by 210% year-on-year, and the accessibility in primary medical institutions has been significantly improved. The competitive landscape presents a differentiated trend where the original research product occupies the high-end surgical market, and generic products seize the market of primary medical institutions and endoscopy centers by virtue of the advantages of centralized procurement. The demand for upstream API supply continues to rise along with the volume expansion of preparations.

The original research enterprise of remimazolam is Paion AG in Germany, with the trade name Byfavo®, and its core compound patent will expire in China in 2028. At present, the main dosage form approved in China is remimazolam for injection, with two specifications of 25mg and 50mg. Both the original research and generic preparations have been included in the *Reference Preparation Catalogue of Chemical Drugs* issued by the NMPA. According to the domestic API registration platform, 7 enterprises have submitted marketing registration applications for remimazolam API so far, among which 3 have passed the A status activation and can be used in association with preparation declarations, and another 12 enterprises' API registration applications are under the review and approval stage. (Data as of October 2025, 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 provide stable and reliable material basis support for the quality research and registration declaration work of API and preparation enterprises.