China-based Hua Medicine (HKG: 2552) has announced the achievement of a significant development milestone for its diabetes treatment, HuaTangNing (dorzagliatin tablets, HMS5552). According to the terms of the 2020 collaboration agreement with Bayer AG (ETR: BAYN) focused on dorzagliatin, Hua is now eligible to receive a new milestone payment of RMB 800 million (USD 110 million) from Bayer.
Bayer-Hua Collaboration and Financial Terms
The collaboration between Bayer and Hua Medicine, which began in August 2020 with a deal valued at RMB 4.5 billion (USD 663.8 million), assigns Hua as the Marketing Authorization Holder (MAH) responsible for clinical studies, regulatory filings, supply, and distribution. Bayer, in turn, is in charge of marketing, promotion, and medical education activities for the drug. HuaTangNing received its first market approval in October 2022 for the treatment of metformin-intolerant type 2 diabetes, either as a monotherapy or in combination with metformin. The market launch followed in November, with the drug priced at RMB 420 (USD 62) per box. As of February 2023, Hua had received a combined RMB 400 million (USD 59 million) in milestone payments.
Dorzagliatin’s Mechanism of Action and Global Rights
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 the development of HMS5552 (dorzagliatin) in February 2012. At the same time, eight other GKA drug candidates entered Phase II trials globally, all of which ended in failure. GKAs are blood glucose sensors that adjust endocrine function according to blood glucose concentration changes. The unique mechanism of action of dorzagliatin, which distinguishes it from other failed GKAs, focuses on the two-way regulation function rather than solely on the hypoglycemic effect.-Fineline Info & Tech
