Keshuting® is the commercial brand name of Sugammadex Sodium Injection, a selective relaxant binding agent developed by Hunan Kelun Pharmaceutical. It is a cyclodextrin derivative that specifically encapsulates steroidal neuromuscular blocking agents (rocuronium bromide and vecuronium bromide) to rapidly reverse neuromuscular blockade induced during general anesthesia, restoring spontaneous respiratory and motor muscle function for surgical patients.
Main Indications
Reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adult surgical patients;
Reversal of neuromuscular blockade induced by rocuronium bromide in pediatric and adolescent patients aged 2 years and above.
Clinical Research
Global multicenter phase III pivotal trials confirmed that sugammadex achieves fast, reliable reversal of both moderate and deep neuromuscular blockade, significantly shortening mechanical ventilation duration and reducing postoperative residual neuromuscular blockade risks compared with traditional reversal agent neostigmine;
Registration clinical trials involving Chinese surgical patients verified rapid onset of action, stable reversal efficacy and comparable safety profiles consistent with global multi-center trial results;
Domestic bioequivalence clinical studies for Keshuting® demonstrated consistent pharmacokinetic and pharmacodynamic characteristics with the original imported drug Bridion®, meeting national generic drug consistency evaluation standards for anesthesia adjuvant preparations.
Common Side Effects
Severe adverse reactions: Severe hypersensitivity/anaphylactic reaction (rare but life-threatening), bradycardia, severe hypotension, laryngospasm;
Common mild adverse reactions: Cough, transient hypotension, tachycardia, postoperative incision pain, fever, headache, nausea and vomiting, pharyngeal discomfort after anesthesia recovery.
Approval Status in China
Original imported drug Bridion® (Sugammadex Sodium Injection) was launched in China in 2017;
Keshuting® (Sugammadex Sodium Injection, specification: 2ml:200mg, produced by Hunan Kelun Pharmaceutical) obtained NMPA marketing approval in May 2022 as the second domestic generic version of sugammadex sodium injection in China, a prescription anesthetic reversal drug for hospital intravenous use only.
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