Hua Medicine (2552) has announced that the Hong Kong Department of Health has approved its global first-in-class glucokinase activator, dorzagliatin (MYHOMSIS®, 華領片®), for marketing, addressing the treatment needs of adult Type 2 diabetes patients. This approval follows the acceptance of dorzagliatin’s New Drug Application in September 2025 under Hong Kong’s “1+” pharmaceutical regulatory innovation mechanism.

Dorzagliatin is the first innovative primary care drug approved under the “1+” mechanism, representing a significant milestone in expanding the reach of China-developed innovative treatments. The announcement notes that this approval serves as a key step in Hua Medicine’s strategic goal to extend from the Chinese market to Southeast Asia and globally, centering Hong Kong as a hub for building its marketing network and R&D collaboration activities.

According to the announcement, Hua Medicine is partnering with local research institutions, including the team led by Professor Juliana Chan at the Chinese University of Hong Kong, to further explore dorzagliatin’s impact on β-cell glucose sensitivity. Published results from the SENSITIZE 1/2 studies indicate improvements in insulin secretion and glucose sensitivity in both monogenic and Type 2 diabetes populations. The company is also seeking marketing approval in Macao, aiming for a broader rollout within the Guangdong-Hong Kong-Macao Greater Bay Area, and intends to advance registration efforts in the Southeast Asian market to serve a wider patient base.