China-based Hua Medicine (HKG: 2552) has announced that its Category 1 drug dorzagliatin has been approved by the National Medical Products Administration (NMPA) for improving blood glucose control in adults with type 2 diabetes. The first-in-class oral hypoglycemic drug represents an innovative treatment option for patients in China.
Approval Based on Successful Clinical Trials
The approval is based on the positive results from the SEED and DAWN studies, both Phase III regulatory clinical trials. These studies demonstrated that dorzagliatin, either alone or in combination with metformin, effectively reduced blood glucose levels while reducing the risk of hypoglycemia. Additionally, dorzagliatin significantly improved β-cell function and reduced insulin resistance, with a favorable safety and tolerability profile.
Innovative Mechanism of Dorzagliatin
Dorzagliatin is a first-in-class glucokinase activator (GKA) designed to restore 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 had entered Phase II trials globally but ultimately failed. Unlike previous GKAs, dorzagliatin focuses on restoring the dual regulatory function of glucokinase (GK), addressing both hyperglycemia and hypoglycemia risks.
Partnership with Bayer for Commercialization
In August 2020, Hua Medicine struck a deal worth RMB 4.5 billion (USD 632.3 million) with Germany-based Bayer AG for the commercialization of dorzagliatin. Under the agreement, Hua Medicine, as the Marketing Authorization Holder (MAH), is responsible for clinical studies, regulatory filings, supply, and distribution. Bayer will handle marketing, promotion, and medical education activities. The market filing for dorzagliatin was accepted for review by the NMPA in April 2021, and Hua Medicine partnered with WuXi STA, a subsidiary of WuXi AppTec (603259.SS), for the commercial supply of the drug in February 2024.-Fineline Info & Tech
