Sugammadex

Residual neuromuscular blockade during the perioperative period is a common complication after surgical anesthesia. In mild cases, it impairs the patient's ventilatory function, and in severe cases, it causes serious adverse events such as respiratory failure and postoperative pulmonary infection. As the world's first approved selective neuromuscular blockade antagonist, sugammadex is a γ-cyclodextrin derivative with a mechanism of action different from that of traditional anticholinesterase drugs. It can specifically bind to the aminosteroid neuromuscular relaxants rocuronium bromide and vecuronium bromide in plasma through molecular inclusion, preventing them from acting on acetylcholine receptors at the neuromuscular junction, and rapidly reversing neuromuscular blockade effects of different degrees. At present, this drug is mainly used to antagonize neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in general anesthesia surgery, and is applicable to adults, children and adolescents aged 2 to 17 years. It can significantly reduce the risks associated with residual neuromuscular blockade and shorten the postoperative anesthesia recovery time.

The global market size of sugammadex had exceeded USD 1.8 billion in 2023, with a compound annual growth rate of more than 12% in the past five years. The growth rate of the domestic market is much higher than the global level. In 2023, its domestic market size was approximately RMB 4.2 billion, with an annual growth rate of more than 35%. In terms of the competitive landscape, the original research product has long occupied nearly 90% of the domestic market share. As generic drugs have been successively approved after the patent expiration, by the end of 2024, 14 domestic enterprises have obtained approval for the marketing of sugammadex sodium injection. After centralized procurement, the price has dropped by more than 90%, which has greatly promoted the accessibility of the drug. The application penetration rate in primary hospitals and day surgery is expected to further expand in the future.

The original research enterprise of sugammadex is Merck Sharp & Dohme, with the trade name Bridion®, and its Chinese compound patent expired in September 2023. The main dosage form approved for the original research product is injection, with specifications including 2ml:200mg and 5ml:500mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the NMPA, and is also a reference preparation published by the FDA. In terms of API registration, as of June 2025, there are 22 registered sugammadex sodium APIs in the "A" status (approved for marketing) published on the CDE platform, among which 19 are domestic registration numbers and 3 are import registration numbers. Multiple domestic enterprises have obtained approval for the marketing of sugammadex sodium preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for sugammadex. The vast majority of products are available from stock. Orders for in-stock products paid before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the R&D needs of API enterprises in various links such as impurity research, quality control, and registration and declaration.