China-based Hua Medicine has announced the commercial launch of its Category 1 drug, dorzagliatin, with the first prescription issued in Shanghai. Priced at RMB 420 (USD 59.00) per box, the drug is now available in pharmacies across multiple locations in China. This marks a significant milestone for the company and the treatment of type 2 diabetes mellitus.
Dorzagliatin: A First-in-Class Glucokinase Activator
Dorzagliatin is a first-in-class glucokinase activator (GKA) designed to control the progressive degenerative characteristics of diabetes by restoring glucose homeostasis in patients with type 2 diabetes mellitus. Hua Medicine obtained global development and marketing rights to Roche’s lead GKA compound RO5552 in December 2011 and initiated the development of HMS5552 (dorzagliatin) in February 2012. At that time, about eight GKA drug candidates globally entered Phase II trials but ultimately failed. Unlike previous GKAs, dorzagliatin focuses on restoring the core function of glucokinase (GK) as a blood glucose sensor, which adjusts endocrine function according to changes in blood glucose concentration. Many failed GKAs were initially designed with a focus on the hypoglycemic effect, ignoring the two-way regulation function, leading to efficacy issues and hypoglycemia risks.
Commercialization and Partnerships
Hua Medicine has been well-prepared for the commercialization of dorzagliatin. In August 2020, the company struck a RMB 4.5 billion (USD 632.3 million) deal with Germany-based Bayer. Under the agreement, Hua Medicine, as the Marketing Authorization Holder (MAH), is responsible for clinical studies, regulatory filings, supply, and distribution, while Bayer will handle marketing, promotion, and medical education activities. The market filing for dorzagliatin was accepted for review in China in April 2021. In February of this year, Hua Medicine turned to WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), for the commercial supply of the drug.-Fineline Info & Tech
