China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) announced the first patient administration of Hexvix (hexyl aminolevulinate hydrochloride) in the Lecheng medical pilot zone in Hainan province. Hexvix is an optical imaging agent used to perform Blue Light Cystoscopy to detect carcinoma of the bladder for diagnosis and post-operative purposes. Yahong is carrying out a real-world data study for the product at the Lecheng site.
Hexvix: Global Approval and Expert Consensus
Hexvix is the world’s only approved agent for assisting in the diagnosis or surgery of bladder cancer and can effectively improve the detection rate of non-muscle invasive bladder cancer (NMIBC) when combined with blue light cystoscopy. The imaging agent is already approved in the US, Europe, and China and has been included in global expert consensus guidelines for the management of NMIBC.
Partnership and Regulatory Milestones
Asieris struck a partnership with Norway-headquartered Photocure ASA (PHO: OSE) in January this year, securing exclusive regulatory filing and commercialization rights to the product in mainland China and Taiwan. Hexvix was approved in March 2022 to be included in the clinical real-world data application pilot in China, following the release of “Real-world Drug Research Implementation Measures” by the bureaus in November this year, designed to encourage clinically urgent imported drugs approved for use in medical institutions in Lecheng to conduct real-world studies.-Fineline Info & Tech
