China-based Hua Medicine has announced receiving a RMB 400 million (USD 59 million) milestone payment under the terms of a cooperation deal with Bayer (ETR: BAYN). The payment is related to Hua’s first-in-class glucokinase activator (GKA) dorzagliatin, which was approved in China in October 2022 for the treatment of metformin-tolerant type 2 diabetes, either as a monotherapy or combined with metformin.
Cooperation Deal with Bayer
In August 2020, Bayer struck a RMB 4.5 billion (USD 663.8 million) deal with Hua Medicine. Under the agreement, Hua, as the Marketing Authorization Holder (MAH), is responsible for clinical study, regulatory filing, supply, and distribution. Bayer takes charge of marketing, promotion, and medical education activities. The October 2022 approval was followed by a market launch in November, with a price tag of RMB 420 (USD 62).
Commercialization Efforts
To prepare for the commercialization of dorzagliatin, Hua signed agreements with Sinopharm Group and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (603259.SS), to support the supply chain and post-marketing commercial supply, respectively.
Dorzagliatin: Mechanism and Development
Dorzagliatin is designed to control the progressive degenerative characteristics of diabetes by restoring glucose homeostasis in patients with type 2 diabetes mellitus. Hua obtained global development and marketing rights to the compound, then named RO5552, from Roche in a December 2011 deal and initiated development of HMS5552 (dorzagliatin) in February 2012. At the time, eight other GKA drug candidates entered Phase II trials globally but ended in failure. Dorzagliatin’s mechanism of action stands out due to its focus on restoring glucose homeostasis rather than solely on the hypoglycemic effect, which was a common oversight in the failed GKAs.-Fineline Info & Tech
