Hyphens Pharma International Limited announced that its subsidiary, Hyphens Pharma Pte. Ltd., has signed an exclusive sub-license and supply agreement with Hana Pharm Co., Ltd. to develop and commercialise Byfavo® 20mg(remimazolam besylate 20mg) in Singapore. Byfavo® is an ultra-short-acting intravenous benzodiazepine anaesthetic drug that is used to induce and maintain sedation in adults undergoing short medical procedures such as colonoscopy.

Clinical data has demonstrated that remimazolam has a rapid onset and offset of action combined with a favourable cardio-respiratory safety profile. In the U.S., a comprehensive Phase III clinical programme for procedural sedation was conducted, where the safety and efficacy of Byfavo® was evaluated in three pivotal studies involving patients either undergoing colonoscopy (two studies) or bronchoscopy (one study). Byfavo® 20mg was approved in South Korea for procedural sedation in adults in 2021 and has been approved by other key agencies including U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2020 and 2021 respectively.

It has also been commercialised in these three markets.