Easton Bio (688513.SH) Receives NMPA Approval for Remimazolam Besylate for Injection

CHENGDU, China — July 16

Chengdu Easton Bio Pharmaceuticals Co., Ltd (688513.SH) said on Wednesday that it has received a drug registration certificate from China's National Medical Products Administration for its Remimazolam Besylate for Injection, a sedative classified as a Category II psychotropic substance under Chinese law.

The approval marks a key milestone for the Shanghai STAR Market-listed pharmaceutical company, adding a general anesthetic agent to its portfolio of branded generic drugs.

The active pharmaceutical ingredient is remimazolam besylate, an ultra-short-acting benzodiazepine sedative designed for rapid onset and quick recovery. The drug is approved for two clinical indications: sedation and anesthesia during non-tracheal intubation surgical procedures, as well as induction and maintenance of general anesthesia.

Remimazolam besylate has drawn growing attention in China's anesthesiology market as hospitals seek shorter-acting sedatives that reduce recovery times and improve patient throughput in outpatient surgical settings.

The drug is subject to regulation under China's Regulations on the Administration of Narcotic Drugs and Psychotropic Substances, which imposes strict controls on the production, distribution, and prescribing of Category II psychotropic medications.

Easton Bio, founded in Chengdu in the southwestern province of Sichuan, focuses on the research, development, manufacturing, and commercialization of pharmaceutical products spanning anesthesiology, cardiovascular diseases, and other therapeutic areas. The company has been steadily expanding its pipeline of specialty generics following its listing on the STAR Market of the Shanghai Stock Exchange.

The company disclosed the regulatory approval through an announcement published by Gelonghui, a financial news platform covering Chinese capital markets.