China-based Hua Medicine (HKG: 2552) has announced a sales and distribution agreement with online pharma retailer 111 Inc., enabling the latter to sell Hua Medicine’s dorzagliatin on its platform from April 7, 2023, to December 31, 2023. Hua Medicine will charge a fee of not more than RMB 40 million (USD 5.8 million) for this partnership.
Dorzagliatin: A First-in-Class Glucokinase Activator (GKA)
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 the molecule from Roche in December 2011. GK is a blood glucose sensor that plays a crucial role in adjusting endocrine function according to changes in blood glucose concentration.
Commercialization Efforts and Partnerships
In preparation for the commercialization of dorzagliatin, Hua Medicine signed an agreement with Germany-based Bayer in August 2020. Bayer is responsible for marketing, promotion, and medical education activities in China in a deal worth up to RMB 4.5 billion (USD 633.5 million). Hua Medicine retains the Marketing Authorization Holder (MAH) status for the drug. Additionally, Hua Medicine enlisted WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), for commercial-scale manufacturing in February of last year.
Market Approval and Launch of Dorzagliatin
A Category 1 innovative drug, dorzagliatin secured its first market approval in China in October 2022 to improve blood glucose control in adults with type 2 diabetes. It was officially launched in Shanghai in the same month, priced at RMB 420 (USD 61) per box, making it accessible to patients in need.-Fineline Info & Tech
